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Urinary incontinence – An individual and societal ill
Urinary incontinence is a major health care concern, both in terms of the numbers of women who are suffering and with respect to societal costs and the impact on health care spending. Approximately 15 years ago, an international group reported in the Journal of the American Medical Association that 200 million people worldwide – 75%-80% of them women – were suffering from urinary incontinence (JAMA 1998;280:951-3).
Since then, a high prevalence of urinary incontinence has been documented in various studies and reports. Experts have estimated, for instance, that between 13 million and 25 million adult Americans experience transient or chronic symptoms, and that approximately half of these patients suffer from severe or bothersome symptoms. Again, the majority of these individuals are women.
Consumer-based research suggests that 25% of women over the age of 18 years experience episodes of urinary incontinence, according to prevalence data collected by the National Association for Continence. In 2001, 10% of women under the age of 65 years and 35% of women over 65 had symptoms of involuntary leakage, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Despite this, nearly two-thirds of patients never discussed bladder health with their health care provider and on average, women wait over 6 years from symptom onset before a diagnosis is established. Moreover, the costs are significant; in 2001, the cost for urinary incontinence in the United States was $16.3 billion (Obstet. Gynecol. 2001;98:398-406).
There are four types of urinary incontinence – urge, stress, mixed, and overflow. Urge incontinence typically is accompanied by urgency. Stress incontinence occurs with the increased abdominal pressure that accompanies effort, exertion, laughing, coughing, and sneezing. Overflow incontinence generally involves continuous urinary loss and incomplete bladder emptying.
Over the next four installments of Master Class in Gynecologic Surgery, I have chosen to feature the workup and treatment of urinary incontinence. For our first installment, I have asked my former resident Dr. Sandra Culbertson, who is now a professor in the department of obstetrics and gynecology at the University of Chicago, to share her knowledge of the optimal approach for evaluating urinary incontinence in the office. As she explains, it is critical to discern the uncomplicated cases of stress urinary incontinence from possibly complicated cases that require more assessment.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller had no relevant financial disclosures.
Urinary incontinence is a major health care concern, both in terms of the numbers of women who are suffering and with respect to societal costs and the impact on health care spending. Approximately 15 years ago, an international group reported in the Journal of the American Medical Association that 200 million people worldwide – 75%-80% of them women – were suffering from urinary incontinence (JAMA 1998;280:951-3).
Since then, a high prevalence of urinary incontinence has been documented in various studies and reports. Experts have estimated, for instance, that between 13 million and 25 million adult Americans experience transient or chronic symptoms, and that approximately half of these patients suffer from severe or bothersome symptoms. Again, the majority of these individuals are women.
Consumer-based research suggests that 25% of women over the age of 18 years experience episodes of urinary incontinence, according to prevalence data collected by the National Association for Continence. In 2001, 10% of women under the age of 65 years and 35% of women over 65 had symptoms of involuntary leakage, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Despite this, nearly two-thirds of patients never discussed bladder health with their health care provider and on average, women wait over 6 years from symptom onset before a diagnosis is established. Moreover, the costs are significant; in 2001, the cost for urinary incontinence in the United States was $16.3 billion (Obstet. Gynecol. 2001;98:398-406).
There are four types of urinary incontinence – urge, stress, mixed, and overflow. Urge incontinence typically is accompanied by urgency. Stress incontinence occurs with the increased abdominal pressure that accompanies effort, exertion, laughing, coughing, and sneezing. Overflow incontinence generally involves continuous urinary loss and incomplete bladder emptying.
Over the next four installments of Master Class in Gynecologic Surgery, I have chosen to feature the workup and treatment of urinary incontinence. For our first installment, I have asked my former resident Dr. Sandra Culbertson, who is now a professor in the department of obstetrics and gynecology at the University of Chicago, to share her knowledge of the optimal approach for evaluating urinary incontinence in the office. As she explains, it is critical to discern the uncomplicated cases of stress urinary incontinence from possibly complicated cases that require more assessment.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller had no relevant financial disclosures.
Urinary incontinence is a major health care concern, both in terms of the numbers of women who are suffering and with respect to societal costs and the impact on health care spending. Approximately 15 years ago, an international group reported in the Journal of the American Medical Association that 200 million people worldwide – 75%-80% of them women – were suffering from urinary incontinence (JAMA 1998;280:951-3).
Since then, a high prevalence of urinary incontinence has been documented in various studies and reports. Experts have estimated, for instance, that between 13 million and 25 million adult Americans experience transient or chronic symptoms, and that approximately half of these patients suffer from severe or bothersome symptoms. Again, the majority of these individuals are women.
Consumer-based research suggests that 25% of women over the age of 18 years experience episodes of urinary incontinence, according to prevalence data collected by the National Association for Continence. In 2001, 10% of women under the age of 65 years and 35% of women over 65 had symptoms of involuntary leakage, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Despite this, nearly two-thirds of patients never discussed bladder health with their health care provider and on average, women wait over 6 years from symptom onset before a diagnosis is established. Moreover, the costs are significant; in 2001, the cost for urinary incontinence in the United States was $16.3 billion (Obstet. Gynecol. 2001;98:398-406).
There are four types of urinary incontinence – urge, stress, mixed, and overflow. Urge incontinence typically is accompanied by urgency. Stress incontinence occurs with the increased abdominal pressure that accompanies effort, exertion, laughing, coughing, and sneezing. Overflow incontinence generally involves continuous urinary loss and incomplete bladder emptying.
Over the next four installments of Master Class in Gynecologic Surgery, I have chosen to feature the workup and treatment of urinary incontinence. For our first installment, I have asked my former resident Dr. Sandra Culbertson, who is now a professor in the department of obstetrics and gynecology at the University of Chicago, to share her knowledge of the optimal approach for evaluating urinary incontinence in the office. As she explains, it is critical to discern the uncomplicated cases of stress urinary incontinence from possibly complicated cases that require more assessment.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago, immediate past president of the International Society for Gynecologic Endoscopy (ISGE), and a past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville, Ill., and Schaumburg, Ill.; the director of minimally invasive gynecologic surgery and the director of the AAGL/SRS fellowship in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column, Master Class. Dr. Miller had no relevant financial disclosures.
The Hoopla Over Mesh: What It Means for Practice
The Food and Drug Administration's warning last summer of the risks associated with transvaginal placement of mesh for repair of pelvic organ prolapse and stress urinary incontinence – and its overall, ongoing review of how mesh products are cleared for use–have changed the climate for ob.gyns. and patients. It has upped the ante for comprehensive patient counseling and brought to the fore the fact that pelvic floor repair is a combination of art, science, judgment, skill, training, and experience.
In July 2011, the FDA issued a “safety communication” to physicians and patients, which was based on an analysis of adverse event reports and a systematic literature review, warning that the transvaginal placement of mesh to treat pelvic organ prolapse (POP) appears to be riskier than traditional repairs without any evidence of greater effectiveness. While an earlier FDA notice issued in 2008 had said in essence that there may be a problem with transvaginal mesh, the most recent warning said there is a problem – that serious complications associated with surgical mesh used for transvaginal repair of POP are not rare.
The agency made a distinction between apical and posterior repair, and anterior repair, concluding that there is no evidence that either apical or posterior repair done with mesh provides any added benefit compared with traditional surgery without mesh.
With regard to anterior repair, the FDA concluded that mesh augmentation may provide an anatomic benefit compared with traditional nonmesh repair, although this anatomic benefit may not necessarily lead to better symptomatic results.
The FDA also reviewed all types of midurethral sling (MUS) devices used to treat stress urinary incontinence (SUI), grouping retropubic and transobturator slings as first-generation and mini-slings as second-generation devices.
Whereas these devices were deemed to be as effective as or better than traditional repairs, the FDA stated its concerns about the potential for long-term problems including mesh erosion and pelvic pain. Moreover, the agency stated the need for more data to better evaluate mini-slings for comparative efficacy and complications.
More broadly, the FDA is reevaluating how transvaginal mesh products should be regulated and brought to market. Unlike other devices that are widely used by ob.gyns., not one of the pelvic floor mesh kits for POP or midurethral slings for SUI has been evaluated by way of an independent, FDA-mandated randomized clinical trial. This is because transvaginal meshes are currently classified as class II devices and, as such, have been cleared for market by the less rigorous 510(k) notification process rather than a more rigorous premarket approval (PMA) process.
While the FDA considers the 510(k) pathway still suitable for MUS devices used to treat SUI, the agency is taking a harder look at transvaginal mesh used to repair POP and has recommended reclassification of these devices into class III. This switch would require the more onerous PMA process and allow the FDA to require clinical trials comparing procedures that involve mesh with those in which mesh is not used.
How the FDA Regulates Devices
That transvaginal mesh devices are embroiled in a broader and ongoing controversy over how best to regulate or approve medical devices is important to understand. Innovation and potential market share continue to drive a steady stream of new medical devices for gynecologic surgery.
Until 36 years ago there was no federal regulation of medical devices. The Medical Device Amendments of 1976 established three device classes, based on risk levels and the ability of postmarketing controls to manage those risks. The law then identified pathways, based largely on this classification system, for bringing devices to the market.
Class I devices are generally those for which general postmarketing controls such as good manufacturing processes and record keeping are deemed sufficient to provide reasonable assurance of safety and effectiveness. Devices in class II, which are “moderate risk,” need special controls such as performance standards and postmarketing surveillance to provide reasonable assurance of safety and effectiveness. In class III are life-sustaining or life-supporting “high-risk” devices that cannot be placed in class I or II because there is insufficient information to establish requisite assurance with postmarketing controls.
While FDA-approved randomized and controlled clinical trials are required for class III devices as part of the standard PMA process, class II devices are cleared for the market based on the substantially less rigorous 510(k) Premarket Notification Program process, which requires manufacturers to demonstrate safety and effectiveness by proving “substantial equivalence” to another device that is already cleared by the FDA based on intended use and product design.
Whereas clinical data are not required, this review of substantial equivalence requires labeling and performance data, including material safety, mechanical performance, and animal testing. Approval of the first surgical mesh for repair of POP was judged to be substantially equivalent to surgical mesh used for hernia repair.
In recent years there has been growing concern about this process of clearing medical devices based simply on substantial equivalence with a predicate. New products should not necessarily be assumed to have equal or improved safety and efficacy. The Institute of Medicine weighed in this past summer with a report on the 510(k) clearance process, calling it flawed in its ability to provide determinations about each device's safety and effectiveness.
The future of transvaginal mesh products is now entangled in these concerns. Unlike devices for endometrial ablation and transcervical hysteroscopic sterilization, which are justifiably classified as class III devices, all transvaginal mesh devices to date have been cleared as class II devices.
Since 2001, the FDA has cleared via the 510(k) approval process more than 100 synthetic mesh devices or kits indicated for POP repair, and more than 75 mesh devices to treat SUI (including 7 second-generation mini-slings), using the 510(k) notification process. None of the clearances were based on clinical data.
While there have indeed been some randomized clinical trials (in its recent review, FDA officials reported having looked at 22 randomized controlled trials and 38 observational studies on the use of mesh to treat POP), many of these trials have been designed and conducted with industry sponsorship.
The FDA typically calls upon its advisory panels to provide independent expert advice when specific issues or problems arise and when regulatory decisions need to be made both before and after approval of medical devices.
After issuing its “safety communication” last July, the FDA convened the Obstetrics and Gynecology Devices Advisory Panel in September to make recommendations regarding the safety and effectiveness of surgical mesh for repair of POP and SUI. Ironically, transvaginal mesh devices had previously been regulated by the FDA's Plastic Surgery Devices Panel.
The 2-day public hearing included presentations regarding adverse events and effectiveness of transvaginal mesh for POP and then SUI by FDA staff reviewers, key medical organizations, related industry as a consortium, and public advocacy groups as well as personal testimony by patients having undergone these procedures.
After hearing the testimony and an exhaustive discussion, the majority of panel members supported reclassifying mesh devices for POP from class II to class III. On the other hand, while the majority did not recommend the reclassification of devices for SUI, the panel concurred that more clinical data was warranted to establish the safety and efficacy of second-generation mini-slings.
The FDA's final regulatory decisions will slowly evolve as the issues of safety and effectiveness are balanced with reducing the burden for industry and continuing to foster a hospitable climate for medical innovation.
Adverse Event Reports
The FDA's safety communication released in July, which updated the 2008 FDA Public Health Notification, was generated by continuing concerns raised by rising reports of adverse events as well as concern voiced by the American Urogynecologic Society.
The adverse event reports have been compiled via the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which collects both mandated reporting by manufacturers and voluntary reports by physicians, patients, and any interested party. It is presumed that complications are generally underreported.
From 2008 to 2010, the FDA received 2,874 adverse event reports associated with urogynecologic mesh – about three times the number of reports filed from 2005 to 2007. Of these, 1,503 were associated with products for POP, and 1,371 were associated with products for SUI.
It is unclear, of course, how much of this increase reflects an increase in actual adverse events and how much stems from the increased use of mesh, an increased awareness of adverse events, possible duplication of reporting, and other factors that are inherent limitations of the reporting process. Moreover, the complication rate is not known because the total number of adverse events and the total number of implanted delivery systems are not known.
Erosion, exposure, and extrusion continue to be the most frequent and concerning adverse events associated with mesh used for POP and SUI. With its more recent review, the FDA has new concerns about the delayed appearances of erosion and mesh exposure. While there are few treatment cohorts to evaluate after 36 months, there have been a number of reports of long-term adverse outcomes – some at time points up to 60 months post procedure.
Moreover, the FDA is concerned about the risk for later development of dyspareunia and new pelvic pain from mesh contraction, retraction, vaginal shrinkage, and subsequent reoperation – problems not identified or flagged when the agency completed its last comprehensive review before issuing the 2008 notification.
Current State of Transvaginal Mesh
In the most recent safety communication, the FDA instructs patients to be aware of the risks associated with surgical mesh for transvaginal repair of POP and SUI. It warns patients that having transvaginal mesh surgery may increase their risk of needing additional surgery due to mesh-related complications, and it advises patients to ask their surgeons about all POP treatment options.
The alert also tells patients to notify their physicians regarding vaginal or pain symptoms after surgery with transvaginal mesh, and to let their health care providers know they have implanted mesh – advice that, in and of itself, can create fear. Any patient doing diligent research will see the statement and related discussion.
In issuing the communication, the FDA has set the bar at a higher level of expectation for patient counseling and informed consent.
While the FDA does not regulate the practice of medicine by regulating how or which physicians can use devices, the agency indirectly is regulating the use of transvaginal mesh devices through its alerts.
And without question, the probability for medical-legal conflict has been substantially heightened. Propelled by the FDA warnings, a cursory Internet search for “pelvic mesh lawyers” or “vaginal mesh lawsuit attorneys” yields a list of firms encouraging free case reviews.
Patients should be counseled that transvaginal mesh procedures are considered innovative techniques for pelvic floor repair that demonstrate high rates of anatomic cure in shorter-term series.
Preoperative counseling should cover the following principles and guidelines:
▸ There are potential adverse sequelae of transvaginal mesh repairs.
▸ There are limited data comparing transvaginal mesh systems with traditional vaginal prolapse repairs or with traditional use of graft material in the form of augmented colporrhaphy and sacrocolpopexy.
▸ The placement of surgical mesh for POP by sacrocolpopexy for apical prolapse is a well established clinical practice and may result in lower rates of mesh complications.
▸ Transvaginal apical or posterior repair with mesh does not appear to provide any added benefit compared with traditional surgery without mesh.
The main role for mesh with POP repair is in the anterior compartment, where a higher risk of recurrence with traditional repairs has been documented.
Overall, transvaginal mesh repair of POP is best suited to women who are high risk due to medical conditions and in those with recurrent prolapse, particularly of the anterior compartment.
▸ The effectiveness of retropubic and transobturator suburethral slings for SUI has been demonstrated, while the safety and effectiveness of single-incision mini-slings is less well established.
Rather than the fault of the device or method, the failure or success of transvaginal mesh repairs may rely far more on the skill and judgment of the surgeon.
All surgery incorporates an intricate blend of art and science. We must be realistic in evaluating our skills, experience, and expertise in performing transvaginal mesh procedures.
Even in the best of circumstances, factors such as obesity, hypoestrogenism, advanced age, poor nutrition, extreme life activity, multiparity, Northern European descent, smoking, prior reparative surgery, and diabetes may reduce the success of transvaginal mesh procedures and increase complications.
While patient concerns will be heightened, the decision to perform a particular type of restorative or reparative surgery for POP, with or without mesh, should always favor reduced risk along with optimal and durable outcome that is both anatomic and functional in nature. And clinical decision making, as always, must be guided by our Hippocratic vow “primum non nocere”!
Vitals
Source Elsevier Global Medical News
Source Elsevier Global Medical News
To Mesh or Not to Mesh?
On July 13, 2011, the Food and Drug Administration issued a safety communication, “Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,” intended for health care providers and patients. Previously, on Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information statement on serious complications associated with surgical mesh placed transvaginally to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
In the July 2011 bulletin, the FDA stated that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare. … Furthermore, it is not clear that transvaginal pelvic organ prolapse repair with mesh is more effective than traditional nonmesh repair in all patients with pelvic organ prolapse and it may expose patients to greater risk.”
In its bulletin, the FDA noted a marked increase in reported adverse events related to surgical mesh devices used to repair POP and SUI in reporting years 2005-2007 vs. 2008-2010. The most frequent complications reported to the FDA regarding transvaginal mesh placement for POP were mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Also noted were recurrent prolapse, neuromuscular problems, vaginal scarring/shrinkage, and emotional problems. Moreover, men may experience irritation and pain to the penis during intercourse secondary to exposed mesh.
The FDA also reported on its systematic review of literature from the period of 1996-2011 to evaluate transvaginal mesh safety and effectiveness. In particular, the FDA noted the following:
▸ Potential for additional risk when mesh is utilized in POP surgery.
▸ Greater rate of complications in POP surgery when mesh placed transvaginally, rather than transabdominally.
▸ No advantage of mesh for either apical or posterior repair, compared with traditional surgery without mesh.
▸ Although mesh may be beneficial anatomically for anterior repair, symptoms may not improve over conventional anterior repair.
The FDA then went on to make recommendations to both health care workers and patients.
Health care workers are advised to obtain specialized training for each mesh placement technique. Mesh should be considered only after weighing the risks and benefits, as well as considering other nonsurgical and surgical options including nonmesh and transabdominal mesh techniques.
Patients must be made aware that surgical mesh is a permanent implant, which may make future surgical repair more challenging.
Moreover, mesh may place the patient at greater risk for requiring additional surgery for the development of additional complications. Removal of mesh when complications arise may involve multiple surgeries and may negatively impact the patient's quality of life. Complete removal of the mesh may not be possible, and even if it is removed, symptoms may continue. Patients also must realize the lack of long-term data.
To understand how this latest FDA bulletin will impact the surgical treatment of POP and SUI, I have called upon Dr. Andrew I. Brill, director of minimally invasive surgery and reparative pelvic surgery at California Pacific Medical Center, San Francisco. He also is a voting member of the FDA Obstetrics and Gynecology Device Panel. Prior to moving to the Bay Area in 2006, Dr. Brill was professor of obstetrics and gynecology at the University of Illinois at Chicago, where he directed one of the first accredited fellowships in minimally invasive gynecology. Dr. Brill is a past president of both the AAGL and the board of directors of the AAGL/Society of Reproductive Surgeons Fellowship in Minimally Invasive Gynecology. Widely recognized in the United States and abroad as a leading educator in the field of minimally invasive gynecology, Dr. Brill is a frequent lecturer and telesurgeon, and he continues to be a regular contributor to peer literature and textbooks, having coauthored a leading textbook and more than 50 articles and book chapters.
The Food and Drug Administration's warning last summer of the risks associated with transvaginal placement of mesh for repair of pelvic organ prolapse and stress urinary incontinence – and its overall, ongoing review of how mesh products are cleared for use–have changed the climate for ob.gyns. and patients. It has upped the ante for comprehensive patient counseling and brought to the fore the fact that pelvic floor repair is a combination of art, science, judgment, skill, training, and experience.
In July 2011, the FDA issued a “safety communication” to physicians and patients, which was based on an analysis of adverse event reports and a systematic literature review, warning that the transvaginal placement of mesh to treat pelvic organ prolapse (POP) appears to be riskier than traditional repairs without any evidence of greater effectiveness. While an earlier FDA notice issued in 2008 had said in essence that there may be a problem with transvaginal mesh, the most recent warning said there is a problem – that serious complications associated with surgical mesh used for transvaginal repair of POP are not rare.
The agency made a distinction between apical and posterior repair, and anterior repair, concluding that there is no evidence that either apical or posterior repair done with mesh provides any added benefit compared with traditional surgery without mesh.
With regard to anterior repair, the FDA concluded that mesh augmentation may provide an anatomic benefit compared with traditional nonmesh repair, although this anatomic benefit may not necessarily lead to better symptomatic results.
The FDA also reviewed all types of midurethral sling (MUS) devices used to treat stress urinary incontinence (SUI), grouping retropubic and transobturator slings as first-generation and mini-slings as second-generation devices.
Whereas these devices were deemed to be as effective as or better than traditional repairs, the FDA stated its concerns about the potential for long-term problems including mesh erosion and pelvic pain. Moreover, the agency stated the need for more data to better evaluate mini-slings for comparative efficacy and complications.
More broadly, the FDA is reevaluating how transvaginal mesh products should be regulated and brought to market. Unlike other devices that are widely used by ob.gyns., not one of the pelvic floor mesh kits for POP or midurethral slings for SUI has been evaluated by way of an independent, FDA-mandated randomized clinical trial. This is because transvaginal meshes are currently classified as class II devices and, as such, have been cleared for market by the less rigorous 510(k) notification process rather than a more rigorous premarket approval (PMA) process.
While the FDA considers the 510(k) pathway still suitable for MUS devices used to treat SUI, the agency is taking a harder look at transvaginal mesh used to repair POP and has recommended reclassification of these devices into class III. This switch would require the more onerous PMA process and allow the FDA to require clinical trials comparing procedures that involve mesh with those in which mesh is not used.
How the FDA Regulates Devices
That transvaginal mesh devices are embroiled in a broader and ongoing controversy over how best to regulate or approve medical devices is important to understand. Innovation and potential market share continue to drive a steady stream of new medical devices for gynecologic surgery.
Until 36 years ago there was no federal regulation of medical devices. The Medical Device Amendments of 1976 established three device classes, based on risk levels and the ability of postmarketing controls to manage those risks. The law then identified pathways, based largely on this classification system, for bringing devices to the market.
Class I devices are generally those for which general postmarketing controls such as good manufacturing processes and record keeping are deemed sufficient to provide reasonable assurance of safety and effectiveness. Devices in class II, which are “moderate risk,” need special controls such as performance standards and postmarketing surveillance to provide reasonable assurance of safety and effectiveness. In class III are life-sustaining or life-supporting “high-risk” devices that cannot be placed in class I or II because there is insufficient information to establish requisite assurance with postmarketing controls.
While FDA-approved randomized and controlled clinical trials are required for class III devices as part of the standard PMA process, class II devices are cleared for the market based on the substantially less rigorous 510(k) Premarket Notification Program process, which requires manufacturers to demonstrate safety and effectiveness by proving “substantial equivalence” to another device that is already cleared by the FDA based on intended use and product design.
Whereas clinical data are not required, this review of substantial equivalence requires labeling and performance data, including material safety, mechanical performance, and animal testing. Approval of the first surgical mesh for repair of POP was judged to be substantially equivalent to surgical mesh used for hernia repair.
In recent years there has been growing concern about this process of clearing medical devices based simply on substantial equivalence with a predicate. New products should not necessarily be assumed to have equal or improved safety and efficacy. The Institute of Medicine weighed in this past summer with a report on the 510(k) clearance process, calling it flawed in its ability to provide determinations about each device's safety and effectiveness.
The future of transvaginal mesh products is now entangled in these concerns. Unlike devices for endometrial ablation and transcervical hysteroscopic sterilization, which are justifiably classified as class III devices, all transvaginal mesh devices to date have been cleared as class II devices.
Since 2001, the FDA has cleared via the 510(k) approval process more than 100 synthetic mesh devices or kits indicated for POP repair, and more than 75 mesh devices to treat SUI (including 7 second-generation mini-slings), using the 510(k) notification process. None of the clearances were based on clinical data.
While there have indeed been some randomized clinical trials (in its recent review, FDA officials reported having looked at 22 randomized controlled trials and 38 observational studies on the use of mesh to treat POP), many of these trials have been designed and conducted with industry sponsorship.
The FDA typically calls upon its advisory panels to provide independent expert advice when specific issues or problems arise and when regulatory decisions need to be made both before and after approval of medical devices.
After issuing its “safety communication” last July, the FDA convened the Obstetrics and Gynecology Devices Advisory Panel in September to make recommendations regarding the safety and effectiveness of surgical mesh for repair of POP and SUI. Ironically, transvaginal mesh devices had previously been regulated by the FDA's Plastic Surgery Devices Panel.
The 2-day public hearing included presentations regarding adverse events and effectiveness of transvaginal mesh for POP and then SUI by FDA staff reviewers, key medical organizations, related industry as a consortium, and public advocacy groups as well as personal testimony by patients having undergone these procedures.
After hearing the testimony and an exhaustive discussion, the majority of panel members supported reclassifying mesh devices for POP from class II to class III. On the other hand, while the majority did not recommend the reclassification of devices for SUI, the panel concurred that more clinical data was warranted to establish the safety and efficacy of second-generation mini-slings.
The FDA's final regulatory decisions will slowly evolve as the issues of safety and effectiveness are balanced with reducing the burden for industry and continuing to foster a hospitable climate for medical innovation.
Adverse Event Reports
The FDA's safety communication released in July, which updated the 2008 FDA Public Health Notification, was generated by continuing concerns raised by rising reports of adverse events as well as concern voiced by the American Urogynecologic Society.
The adverse event reports have been compiled via the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which collects both mandated reporting by manufacturers and voluntary reports by physicians, patients, and any interested party. It is presumed that complications are generally underreported.
From 2008 to 2010, the FDA received 2,874 adverse event reports associated with urogynecologic mesh – about three times the number of reports filed from 2005 to 2007. Of these, 1,503 were associated with products for POP, and 1,371 were associated with products for SUI.
It is unclear, of course, how much of this increase reflects an increase in actual adverse events and how much stems from the increased use of mesh, an increased awareness of adverse events, possible duplication of reporting, and other factors that are inherent limitations of the reporting process. Moreover, the complication rate is not known because the total number of adverse events and the total number of implanted delivery systems are not known.
Erosion, exposure, and extrusion continue to be the most frequent and concerning adverse events associated with mesh used for POP and SUI. With its more recent review, the FDA has new concerns about the delayed appearances of erosion and mesh exposure. While there are few treatment cohorts to evaluate after 36 months, there have been a number of reports of long-term adverse outcomes – some at time points up to 60 months post procedure.
Moreover, the FDA is concerned about the risk for later development of dyspareunia and new pelvic pain from mesh contraction, retraction, vaginal shrinkage, and subsequent reoperation – problems not identified or flagged when the agency completed its last comprehensive review before issuing the 2008 notification.
Current State of Transvaginal Mesh
In the most recent safety communication, the FDA instructs patients to be aware of the risks associated with surgical mesh for transvaginal repair of POP and SUI. It warns patients that having transvaginal mesh surgery may increase their risk of needing additional surgery due to mesh-related complications, and it advises patients to ask their surgeons about all POP treatment options.
The alert also tells patients to notify their physicians regarding vaginal or pain symptoms after surgery with transvaginal mesh, and to let their health care providers know they have implanted mesh – advice that, in and of itself, can create fear. Any patient doing diligent research will see the statement and related discussion.
In issuing the communication, the FDA has set the bar at a higher level of expectation for patient counseling and informed consent.
While the FDA does not regulate the practice of medicine by regulating how or which physicians can use devices, the agency indirectly is regulating the use of transvaginal mesh devices through its alerts.
And without question, the probability for medical-legal conflict has been substantially heightened. Propelled by the FDA warnings, a cursory Internet search for “pelvic mesh lawyers” or “vaginal mesh lawsuit attorneys” yields a list of firms encouraging free case reviews.
Patients should be counseled that transvaginal mesh procedures are considered innovative techniques for pelvic floor repair that demonstrate high rates of anatomic cure in shorter-term series.
Preoperative counseling should cover the following principles and guidelines:
▸ There are potential adverse sequelae of transvaginal mesh repairs.
▸ There are limited data comparing transvaginal mesh systems with traditional vaginal prolapse repairs or with traditional use of graft material in the form of augmented colporrhaphy and sacrocolpopexy.
▸ The placement of surgical mesh for POP by sacrocolpopexy for apical prolapse is a well established clinical practice and may result in lower rates of mesh complications.
▸ Transvaginal apical or posterior repair with mesh does not appear to provide any added benefit compared with traditional surgery without mesh.
The main role for mesh with POP repair is in the anterior compartment, where a higher risk of recurrence with traditional repairs has been documented.
Overall, transvaginal mesh repair of POP is best suited to women who are high risk due to medical conditions and in those with recurrent prolapse, particularly of the anterior compartment.
▸ The effectiveness of retropubic and transobturator suburethral slings for SUI has been demonstrated, while the safety and effectiveness of single-incision mini-slings is less well established.
Rather than the fault of the device or method, the failure or success of transvaginal mesh repairs may rely far more on the skill and judgment of the surgeon.
All surgery incorporates an intricate blend of art and science. We must be realistic in evaluating our skills, experience, and expertise in performing transvaginal mesh procedures.
Even in the best of circumstances, factors such as obesity, hypoestrogenism, advanced age, poor nutrition, extreme life activity, multiparity, Northern European descent, smoking, prior reparative surgery, and diabetes may reduce the success of transvaginal mesh procedures and increase complications.
While patient concerns will be heightened, the decision to perform a particular type of restorative or reparative surgery for POP, with or without mesh, should always favor reduced risk along with optimal and durable outcome that is both anatomic and functional in nature. And clinical decision making, as always, must be guided by our Hippocratic vow “primum non nocere”!
Vitals
Source Elsevier Global Medical News
Source Elsevier Global Medical News
To Mesh or Not to Mesh?
On July 13, 2011, the Food and Drug Administration issued a safety communication, “Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,” intended for health care providers and patients. Previously, on Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information statement on serious complications associated with surgical mesh placed transvaginally to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
In the July 2011 bulletin, the FDA stated that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare. … Furthermore, it is not clear that transvaginal pelvic organ prolapse repair with mesh is more effective than traditional nonmesh repair in all patients with pelvic organ prolapse and it may expose patients to greater risk.”
In its bulletin, the FDA noted a marked increase in reported adverse events related to surgical mesh devices used to repair POP and SUI in reporting years 2005-2007 vs. 2008-2010. The most frequent complications reported to the FDA regarding transvaginal mesh placement for POP were mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Also noted were recurrent prolapse, neuromuscular problems, vaginal scarring/shrinkage, and emotional problems. Moreover, men may experience irritation and pain to the penis during intercourse secondary to exposed mesh.
The FDA also reported on its systematic review of literature from the period of 1996-2011 to evaluate transvaginal mesh safety and effectiveness. In particular, the FDA noted the following:
▸ Potential for additional risk when mesh is utilized in POP surgery.
▸ Greater rate of complications in POP surgery when mesh placed transvaginally, rather than transabdominally.
▸ No advantage of mesh for either apical or posterior repair, compared with traditional surgery without mesh.
▸ Although mesh may be beneficial anatomically for anterior repair, symptoms may not improve over conventional anterior repair.
The FDA then went on to make recommendations to both health care workers and patients.
Health care workers are advised to obtain specialized training for each mesh placement technique. Mesh should be considered only after weighing the risks and benefits, as well as considering other nonsurgical and surgical options including nonmesh and transabdominal mesh techniques.
Patients must be made aware that surgical mesh is a permanent implant, which may make future surgical repair more challenging.
Moreover, mesh may place the patient at greater risk for requiring additional surgery for the development of additional complications. Removal of mesh when complications arise may involve multiple surgeries and may negatively impact the patient's quality of life. Complete removal of the mesh may not be possible, and even if it is removed, symptoms may continue. Patients also must realize the lack of long-term data.
To understand how this latest FDA bulletin will impact the surgical treatment of POP and SUI, I have called upon Dr. Andrew I. Brill, director of minimally invasive surgery and reparative pelvic surgery at California Pacific Medical Center, San Francisco. He also is a voting member of the FDA Obstetrics and Gynecology Device Panel. Prior to moving to the Bay Area in 2006, Dr. Brill was professor of obstetrics and gynecology at the University of Illinois at Chicago, where he directed one of the first accredited fellowships in minimally invasive gynecology. Dr. Brill is a past president of both the AAGL and the board of directors of the AAGL/Society of Reproductive Surgeons Fellowship in Minimally Invasive Gynecology. Widely recognized in the United States and abroad as a leading educator in the field of minimally invasive gynecology, Dr. Brill is a frequent lecturer and telesurgeon, and he continues to be a regular contributor to peer literature and textbooks, having coauthored a leading textbook and more than 50 articles and book chapters.
The Food and Drug Administration's warning last summer of the risks associated with transvaginal placement of mesh for repair of pelvic organ prolapse and stress urinary incontinence – and its overall, ongoing review of how mesh products are cleared for use–have changed the climate for ob.gyns. and patients. It has upped the ante for comprehensive patient counseling and brought to the fore the fact that pelvic floor repair is a combination of art, science, judgment, skill, training, and experience.
In July 2011, the FDA issued a “safety communication” to physicians and patients, which was based on an analysis of adverse event reports and a systematic literature review, warning that the transvaginal placement of mesh to treat pelvic organ prolapse (POP) appears to be riskier than traditional repairs without any evidence of greater effectiveness. While an earlier FDA notice issued in 2008 had said in essence that there may be a problem with transvaginal mesh, the most recent warning said there is a problem – that serious complications associated with surgical mesh used for transvaginal repair of POP are not rare.
The agency made a distinction between apical and posterior repair, and anterior repair, concluding that there is no evidence that either apical or posterior repair done with mesh provides any added benefit compared with traditional surgery without mesh.
With regard to anterior repair, the FDA concluded that mesh augmentation may provide an anatomic benefit compared with traditional nonmesh repair, although this anatomic benefit may not necessarily lead to better symptomatic results.
The FDA also reviewed all types of midurethral sling (MUS) devices used to treat stress urinary incontinence (SUI), grouping retropubic and transobturator slings as first-generation and mini-slings as second-generation devices.
Whereas these devices were deemed to be as effective as or better than traditional repairs, the FDA stated its concerns about the potential for long-term problems including mesh erosion and pelvic pain. Moreover, the agency stated the need for more data to better evaluate mini-slings for comparative efficacy and complications.
More broadly, the FDA is reevaluating how transvaginal mesh products should be regulated and brought to market. Unlike other devices that are widely used by ob.gyns., not one of the pelvic floor mesh kits for POP or midurethral slings for SUI has been evaluated by way of an independent, FDA-mandated randomized clinical trial. This is because transvaginal meshes are currently classified as class II devices and, as such, have been cleared for market by the less rigorous 510(k) notification process rather than a more rigorous premarket approval (PMA) process.
While the FDA considers the 510(k) pathway still suitable for MUS devices used to treat SUI, the agency is taking a harder look at transvaginal mesh used to repair POP and has recommended reclassification of these devices into class III. This switch would require the more onerous PMA process and allow the FDA to require clinical trials comparing procedures that involve mesh with those in which mesh is not used.
How the FDA Regulates Devices
That transvaginal mesh devices are embroiled in a broader and ongoing controversy over how best to regulate or approve medical devices is important to understand. Innovation and potential market share continue to drive a steady stream of new medical devices for gynecologic surgery.
Until 36 years ago there was no federal regulation of medical devices. The Medical Device Amendments of 1976 established three device classes, based on risk levels and the ability of postmarketing controls to manage those risks. The law then identified pathways, based largely on this classification system, for bringing devices to the market.
Class I devices are generally those for which general postmarketing controls such as good manufacturing processes and record keeping are deemed sufficient to provide reasonable assurance of safety and effectiveness. Devices in class II, which are “moderate risk,” need special controls such as performance standards and postmarketing surveillance to provide reasonable assurance of safety and effectiveness. In class III are life-sustaining or life-supporting “high-risk” devices that cannot be placed in class I or II because there is insufficient information to establish requisite assurance with postmarketing controls.
While FDA-approved randomized and controlled clinical trials are required for class III devices as part of the standard PMA process, class II devices are cleared for the market based on the substantially less rigorous 510(k) Premarket Notification Program process, which requires manufacturers to demonstrate safety and effectiveness by proving “substantial equivalence” to another device that is already cleared by the FDA based on intended use and product design.
Whereas clinical data are not required, this review of substantial equivalence requires labeling and performance data, including material safety, mechanical performance, and animal testing. Approval of the first surgical mesh for repair of POP was judged to be substantially equivalent to surgical mesh used for hernia repair.
In recent years there has been growing concern about this process of clearing medical devices based simply on substantial equivalence with a predicate. New products should not necessarily be assumed to have equal or improved safety and efficacy. The Institute of Medicine weighed in this past summer with a report on the 510(k) clearance process, calling it flawed in its ability to provide determinations about each device's safety and effectiveness.
The future of transvaginal mesh products is now entangled in these concerns. Unlike devices for endometrial ablation and transcervical hysteroscopic sterilization, which are justifiably classified as class III devices, all transvaginal mesh devices to date have been cleared as class II devices.
Since 2001, the FDA has cleared via the 510(k) approval process more than 100 synthetic mesh devices or kits indicated for POP repair, and more than 75 mesh devices to treat SUI (including 7 second-generation mini-slings), using the 510(k) notification process. None of the clearances were based on clinical data.
While there have indeed been some randomized clinical trials (in its recent review, FDA officials reported having looked at 22 randomized controlled trials and 38 observational studies on the use of mesh to treat POP), many of these trials have been designed and conducted with industry sponsorship.
The FDA typically calls upon its advisory panels to provide independent expert advice when specific issues or problems arise and when regulatory decisions need to be made both before and after approval of medical devices.
After issuing its “safety communication” last July, the FDA convened the Obstetrics and Gynecology Devices Advisory Panel in September to make recommendations regarding the safety and effectiveness of surgical mesh for repair of POP and SUI. Ironically, transvaginal mesh devices had previously been regulated by the FDA's Plastic Surgery Devices Panel.
The 2-day public hearing included presentations regarding adverse events and effectiveness of transvaginal mesh for POP and then SUI by FDA staff reviewers, key medical organizations, related industry as a consortium, and public advocacy groups as well as personal testimony by patients having undergone these procedures.
After hearing the testimony and an exhaustive discussion, the majority of panel members supported reclassifying mesh devices for POP from class II to class III. On the other hand, while the majority did not recommend the reclassification of devices for SUI, the panel concurred that more clinical data was warranted to establish the safety and efficacy of second-generation mini-slings.
The FDA's final regulatory decisions will slowly evolve as the issues of safety and effectiveness are balanced with reducing the burden for industry and continuing to foster a hospitable climate for medical innovation.
Adverse Event Reports
The FDA's safety communication released in July, which updated the 2008 FDA Public Health Notification, was generated by continuing concerns raised by rising reports of adverse events as well as concern voiced by the American Urogynecologic Society.
The adverse event reports have been compiled via the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which collects both mandated reporting by manufacturers and voluntary reports by physicians, patients, and any interested party. It is presumed that complications are generally underreported.
From 2008 to 2010, the FDA received 2,874 adverse event reports associated with urogynecologic mesh – about three times the number of reports filed from 2005 to 2007. Of these, 1,503 were associated with products for POP, and 1,371 were associated with products for SUI.
It is unclear, of course, how much of this increase reflects an increase in actual adverse events and how much stems from the increased use of mesh, an increased awareness of adverse events, possible duplication of reporting, and other factors that are inherent limitations of the reporting process. Moreover, the complication rate is not known because the total number of adverse events and the total number of implanted delivery systems are not known.
Erosion, exposure, and extrusion continue to be the most frequent and concerning adverse events associated with mesh used for POP and SUI. With its more recent review, the FDA has new concerns about the delayed appearances of erosion and mesh exposure. While there are few treatment cohorts to evaluate after 36 months, there have been a number of reports of long-term adverse outcomes – some at time points up to 60 months post procedure.
Moreover, the FDA is concerned about the risk for later development of dyspareunia and new pelvic pain from mesh contraction, retraction, vaginal shrinkage, and subsequent reoperation – problems not identified or flagged when the agency completed its last comprehensive review before issuing the 2008 notification.
Current State of Transvaginal Mesh
In the most recent safety communication, the FDA instructs patients to be aware of the risks associated with surgical mesh for transvaginal repair of POP and SUI. It warns patients that having transvaginal mesh surgery may increase their risk of needing additional surgery due to mesh-related complications, and it advises patients to ask their surgeons about all POP treatment options.
The alert also tells patients to notify their physicians regarding vaginal or pain symptoms after surgery with transvaginal mesh, and to let their health care providers know they have implanted mesh – advice that, in and of itself, can create fear. Any patient doing diligent research will see the statement and related discussion.
In issuing the communication, the FDA has set the bar at a higher level of expectation for patient counseling and informed consent.
While the FDA does not regulate the practice of medicine by regulating how or which physicians can use devices, the agency indirectly is regulating the use of transvaginal mesh devices through its alerts.
And without question, the probability for medical-legal conflict has been substantially heightened. Propelled by the FDA warnings, a cursory Internet search for “pelvic mesh lawyers” or “vaginal mesh lawsuit attorneys” yields a list of firms encouraging free case reviews.
Patients should be counseled that transvaginal mesh procedures are considered innovative techniques for pelvic floor repair that demonstrate high rates of anatomic cure in shorter-term series.
Preoperative counseling should cover the following principles and guidelines:
▸ There are potential adverse sequelae of transvaginal mesh repairs.
▸ There are limited data comparing transvaginal mesh systems with traditional vaginal prolapse repairs or with traditional use of graft material in the form of augmented colporrhaphy and sacrocolpopexy.
▸ The placement of surgical mesh for POP by sacrocolpopexy for apical prolapse is a well established clinical practice and may result in lower rates of mesh complications.
▸ Transvaginal apical or posterior repair with mesh does not appear to provide any added benefit compared with traditional surgery without mesh.
The main role for mesh with POP repair is in the anterior compartment, where a higher risk of recurrence with traditional repairs has been documented.
Overall, transvaginal mesh repair of POP is best suited to women who are high risk due to medical conditions and in those with recurrent prolapse, particularly of the anterior compartment.
▸ The effectiveness of retropubic and transobturator suburethral slings for SUI has been demonstrated, while the safety and effectiveness of single-incision mini-slings is less well established.
Rather than the fault of the device or method, the failure or success of transvaginal mesh repairs may rely far more on the skill and judgment of the surgeon.
All surgery incorporates an intricate blend of art and science. We must be realistic in evaluating our skills, experience, and expertise in performing transvaginal mesh procedures.
Even in the best of circumstances, factors such as obesity, hypoestrogenism, advanced age, poor nutrition, extreme life activity, multiparity, Northern European descent, smoking, prior reparative surgery, and diabetes may reduce the success of transvaginal mesh procedures and increase complications.
While patient concerns will be heightened, the decision to perform a particular type of restorative or reparative surgery for POP, with or without mesh, should always favor reduced risk along with optimal and durable outcome that is both anatomic and functional in nature. And clinical decision making, as always, must be guided by our Hippocratic vow “primum non nocere”!
Vitals
Source Elsevier Global Medical News
Source Elsevier Global Medical News
To Mesh or Not to Mesh?
On July 13, 2011, the Food and Drug Administration issued a safety communication, “Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,” intended for health care providers and patients. Previously, on Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information statement on serious complications associated with surgical mesh placed transvaginally to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
In the July 2011 bulletin, the FDA stated that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare. … Furthermore, it is not clear that transvaginal pelvic organ prolapse repair with mesh is more effective than traditional nonmesh repair in all patients with pelvic organ prolapse and it may expose patients to greater risk.”
In its bulletin, the FDA noted a marked increase in reported adverse events related to surgical mesh devices used to repair POP and SUI in reporting years 2005-2007 vs. 2008-2010. The most frequent complications reported to the FDA regarding transvaginal mesh placement for POP were mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Also noted were recurrent prolapse, neuromuscular problems, vaginal scarring/shrinkage, and emotional problems. Moreover, men may experience irritation and pain to the penis during intercourse secondary to exposed mesh.
The FDA also reported on its systematic review of literature from the period of 1996-2011 to evaluate transvaginal mesh safety and effectiveness. In particular, the FDA noted the following:
▸ Potential for additional risk when mesh is utilized in POP surgery.
▸ Greater rate of complications in POP surgery when mesh placed transvaginally, rather than transabdominally.
▸ No advantage of mesh for either apical or posterior repair, compared with traditional surgery without mesh.
▸ Although mesh may be beneficial anatomically for anterior repair, symptoms may not improve over conventional anterior repair.
The FDA then went on to make recommendations to both health care workers and patients.
Health care workers are advised to obtain specialized training for each mesh placement technique. Mesh should be considered only after weighing the risks and benefits, as well as considering other nonsurgical and surgical options including nonmesh and transabdominal mesh techniques.
Patients must be made aware that surgical mesh is a permanent implant, which may make future surgical repair more challenging.
Moreover, mesh may place the patient at greater risk for requiring additional surgery for the development of additional complications. Removal of mesh when complications arise may involve multiple surgeries and may negatively impact the patient's quality of life. Complete removal of the mesh may not be possible, and even if it is removed, symptoms may continue. Patients also must realize the lack of long-term data.
To understand how this latest FDA bulletin will impact the surgical treatment of POP and SUI, I have called upon Dr. Andrew I. Brill, director of minimally invasive surgery and reparative pelvic surgery at California Pacific Medical Center, San Francisco. He also is a voting member of the FDA Obstetrics and Gynecology Device Panel. Prior to moving to the Bay Area in 2006, Dr. Brill was professor of obstetrics and gynecology at the University of Illinois at Chicago, where he directed one of the first accredited fellowships in minimally invasive gynecology. Dr. Brill is a past president of both the AAGL and the board of directors of the AAGL/Society of Reproductive Surgeons Fellowship in Minimally Invasive Gynecology. Widely recognized in the United States and abroad as a leading educator in the field of minimally invasive gynecology, Dr. Brill is a frequent lecturer and telesurgeon, and he continues to be a regular contributor to peer literature and textbooks, having coauthored a leading textbook and more than 50 articles and book chapters.
The Where and Why of Postsurgical Adhesions
The prevention of postsurgical adhesions is one of the greatest unmet needs in medicine today. Surgical series have shown that adhesions are present after 80%-90% of abdominal and pelvic surgeries, and that these abnormal fibrous connections have a tremendous propensity to reform after adhesiolysis. (We will define adhesions here as “attachments between surfaces at nonanatomical locations.”)
In gynecologic surgery, postoperative adhesions are a frequent cause of infertility, pain, bowel obstruction, and difficulty in later procedures. Adhesions can occur after minimally invasive procedures, which have the potential for trocar injury to structures adherent to the anterior abdominal wall. Other intraoperative injuries can occur due to obscured normal anatomy or restricted access. A significant number of patients also undergo second surgeries to treat sequelae that are directly related to adhesions.
The literature is replete with studies of adhesion development and reports of its incidence and its consequences. Still, the problem of postoperative adhesion development often goes underestimated or unrecognized. This is because we don't routinely perform early second-look operations to assess adhesion development, and because there are no serum markers or sensitive imaging techniques to allow their identification. In addition, we do not follow our patients who seek care from other providers as insurance coverage changes or as other health problems arise, such as bowel obstruction being treated by a general surgeon.
As gynecologic surgeons, we must appreciate that while infections, endometriosis, and other peritoneal insults may contribute to adhesion development, surgery is the most common cause. We also must appreciate how tissue injury leads to the development of adhesions, and why adhesion reformation so commonly occurs.
This understanding is critical to our consideration and use of the “barrier” products currently available for reducing postsurgical adhesions — and critical to our efforts to employ the tenets of gynecologic microsurgery and to achieve as optimal a surgical outcome as possible. At this point in time, use of approved surgical adjuvants in combination with good surgical technique offers the best chance at adhesion reduction and prevention.
Incidence of Adhesions
A series of reports published in the early to mid-1980s documented how commonly adhesions develop after various types of reproductive pelvic surgery. Through early second-look laparoscopy, postoperative adhesions were found to occur, in these studies, in 55%–100% of patients after their primary gynecologic surgery.
In a multicenter study published in 1987, my colleagues and I also showed that gynecologic surgeries performed at the time of laparotomy are frequently complicated by both adhesion reformation and de novo adhesion formation. More than half of the 161 women (51%) who had a second-look laparoscopy 1–12 weeks after reproductive pelvic surgery were found to have de novo adhesion formation (adhesions in at least one new location). Adhesion reformation was also widespread: At the initial laparotomy, 121 of the patients (all of whom were treated for infertility) were noted to have some form of adhesion, and adhesion reformation subsequently occurred at the site of adhesiolysis in 85% of these women, with no differences with respect to adhesion type (Fertil. Steril. 1987;47;864–6).
It was hoped, and largely expected, that the growth of laparoscopy and minimally invasive surgery approaches in more recent years would reduce postoperative adhesion development — that minimally invasive techniques would prove to be less adhesiogenic than laparotomy. Questions remain, but thus far, such hopes have diminished and our expectations for significant improvement have gone unsubstantiated.
One multicenter study on adhesion development after initial laparoscopic procedures found that the incidence of adhesions at an early second-look procedure was 97% — no lower than in prior reports of second-look laparoscopy after laparotomy.
In this study, 68 women underwent operative laparoscopic procedures, including adhesiolysis, and had second-look procedures within 90 days. The good news was that de novo adhesion formation between the two laparoscopic procedures occurred in only 8 of the women (12%) and at 11 of 47 possible sites — much less frequently than after laparotomy. Adhesion scores also decreased at the second look compared with the status of the pelvis at the initial procedure. Still, with the high rate of adhesion reformation, almost all of the women developed postoperative adhesions.
Thus, even when the initial procedure was performed laparoscopically, adhesion development was an all-too-common occurrence, and appeared to be independent of the character of the initial adhesion (Fertil. Steril. 1991;55:700–4).
More recently, data from randomized studies of various adhesion barriers and potential anti-adhesion adjuvants have further dashed hopes that laparoscopy per se can reduce adhesion development.
For instance, in a recent small pilot study of a fibrin-based product called Adhexil, “control” ovaries that were not treated had a 27% increase in the mean adhesion score between an initial laparoscopic procedure and second-look laparoscopy. The women in the study had undergone bilateral ovarian surgery, with ovaries randomized for application of the product or no treatment (Fertil. Steril. 2011;95:1086–90). Clearly, a laparoscopic approach to their procedures did not prevent the development of adhesions.
Many of the initial studies on adhesion development were comprised of patients with infertility, but more recent observations have been extended to women without infertility and to men. Studies have covered patients undergoing colectomies, for instance, as well as neonates undergoing cardiothoracic procedures.
In a recent review article on adhesion prevention and reduction, members of an interdisciplinary consensus conference stated that adhesions develop after “nearly all” abdominal and pelvic procedures performed through either standard laparotomy or laparoscopic approaches. With respect to gynecologic surgery, they point out, research has shown that the most common site for postsurgical adhesion development is the ovary (Surg. Innov. 2010;17:183–8).
Consequences
Pelvic adhesions are a well-recognized cause of infertility, contributing to up to an estimated 40% of the cases of infertility in women. Adhesions are also a leading cause of bowel obstruction and a significant cause of chronic or recurrent pelvic pain.
The contribution of pelvic adhesions to chronic pelvic pain is not completely understood. Adhesions may be the cause of pain in some women, and in other women, an incidental finding that is not contributing to pain. In patients who have endometriosis as well, the question remains as to the contribution of endometriosis per se, or adhesions, to the pain. Endometriosis can cause adhesions and chronic pelvic pain, presumably through the cyclic generation of inflammatory molecules.
The relationship between chronic pain and adhesions is further complicated by ensuing questions about the efficacy of adhesiolysis. The two randomized trials that have thus far examined the role of adhesiolysis in the reduction of chronic pelvic pain failed to demonstrate a significant improvement in pain after adhesiolysis; however, the high failure rates after follow-up may be due to adhesion reformation and de novo adhesion formation (Fertil. Steril. 2004;82:1483–91). Performance of more randomized comparisons in the future may yield improved outcomes when adhesiolysis is paired with postprocedure use of anti-adhesion adjuvants.
Despite the uncertainties, multiple studies support the current estimation that adhesions cause or significantly contribute to chronic pelvic pain in up to 30% of women with the problem. As the Ovarian Adhesion Study Group noted in one of its reports, adhesions have been reported as a primary cause of chronic pelvic pain in 13%-36% of women, depending on the study (Obstet. Gynecol. 1995;86:335–40). Economic analyses also have quantified the impact of adhesion-related hospital readmissions. A study done in the United Kingdom, for instance, concluded that 6% of all hospital readmissions in patients who had undergone abdominal or pelvic surgery were directly related to adhesions (Lancet 1999;353:1476–80).httother report on hospitalizations for lower abdominal adhesiolysis in the United States estimated that in 1988, the cost of adhesions stemming from gynecologic procedures alone was almost $1.2 billion. This estimate did not include outpatient and indirect costs (Surg. Gynecol. Obstet. 1993;176:271–6).
Why, How Adhesions Develop
Our current understanding is that adhesions develop as a result of injury to and devascularization of the peritoneum, and the subsequent inflammatory response and peritoneal wound healing process. Tissue hypoxia triggers a cascade of intracellular responses that, in combination with the fibrinous collection of blood and serosanguinous fluid at the tissue surface, may result in adhesion development.
In the initial postsurgical period, either overt bleeding or oozing may occur at the site(s) of tissue injury, forming clots. In combination with serosanguinous fluid, which may leak from damaged peritoneal surfaces, a fibrinous mass thus develops at the surgical sites and sites of tissue injury. This represents an initial step in peritoneal repair.
When surrounding tissue is normal and there is a sufficient amount of plasminogen activator present in the peritoneum — and when numerous other events and conditions are optimal — the resulting fibrinous mass can be degraded. As that occurs, and tissue healing continues, fibroblasts are recruited to the surface of the injury site from underlying tissues.
If the fibrinous mass is no longer present, fibroblasts “stop” at the tissue surfaces, and become covered by mesothelial cells which line the peritoneal surface as the process of remesothelialization occurs. This process appears to be initiated within hours after surgery and is generally believed to be completed in 3–5 days. (In such instances, healing would have occurred without adhesions, although subperitoneal fibrosis may have occurred.)
Various hypoxia-driven responses, however, such as a reduction in plasminogen activator activity, can cause the fibrinous mass to persist during the healing process, before remesothelialization occurs. In this case, fibroblasts migrate not only to, but through, the injury site, and into the persisting fibrinous mass. This is subsequently followed by deposition of collagen, fibronectin, and other extracellular matrix materials — creating the beginnings of a true adhesion.
In such cases, remesothelialization still occurs, but the mesothelial cells cover the adhesion as well as the normal tissue surfaces, forming adhesive bands and other types of connections between opposing serosal tissue surfaces. Angiogenesis then occurs as the hypoxic tissue in the adhesion sends signals (such as vascular endothelial growth factor) in an attempt to reestablish a supply of oxygen and nutrients to the injured and devascularized tissues. Subsequently, as the tissue remodels, there is a propensity for the adhesion to become more vascular and denser.
Understanding this process is important because the products currently available for reducing adhesions act as barriers during this critical period of remesothelialization, keeping peritoneal surfaces apart and minimizing the potential development of a fibrinous mass that bridges tissue surfaces. If an adhesion does not form during the 3–5-day period of remesothelialization, it is theorized that there will not be any adhesion development — unless there's new injury to the tissue surfaces.
Once an adhesion forms, however, it has acquired a particular “adhesion phenotype” — different from that of normal peritoneum — that appears to be irreversible. This is likely why it is so difficult to prevent adhesion reformation after adhesiolysis. Rates of adhesion reformation — even in the best of surgical hands — run between 80% and 90%, compared with a 50% chance of de novo adhesion development after surgery (at new sites of injury).
The identification of an adhesion phenotype came originally from comparisons of normal peritoneal and adhesion tissues harvested from the same patient, and were later confirmed in cell culture studies in which normal peritoneal fibroblasts were subjected to hypoxia (2% O2 conditions). Fibroblasts cultured under hypoxic conditions were subsequently found to have developed particular molecular biologic characterizations that are different from those of normal peritoneal fibroblasts.
When exposed to normal amounts of oxygen again, the fibroblasts did not go back to being normal fibroblasts — they continued to manifest the adhesion phenotype (J. Am Assoc. Gynecol. Laparosc. 2004;11:307–14). These findings have been confirmed in animal and human studies, and such relationships have also been identified in other peritoneal tissue types such as mesothelial cells and macrophages.
Further research on the pathogenesis of adhesions and the molecular biologic differences between normal peritoneum and adhesions may allow identification of which patients, and which sites within a patient, are most at risk for adhesion development, as well as the discovery of new ways to reduce the development of postoperative adhesions and their clinical sequelae.
It is possible that a future generation of barrier products not only will work as a barrier separating surfaces prior to remesothelialization, but will also have local biologic effects — delivering adhesion-reducing drugs or biologics, for instance, to specific localized tissue sites. A personalized approach to adhesion prevention also might be possible, with particular factors deemed to increase adhesion risk in individual patients (a deficiency of plasminogen activator, for instance) being corrected.
In the meantime, as we've learned more about the pathophysiological state under which adhesions develop, we have found that adhesion development may occur faster than we had thought. In one recent rodent study, we identified postoperative tissue attachments as early as 2 hours after cecal abrasion. We noted considerable local edema and vessel dilatation within 2 hours of injury, angiogenesis and fibrin deposition at 8 hours, and cell proliferation at 24 hours (Fertil. Steril. 2010;93:2734–7). And interestingly, recent studies in mice have shown that laparoscopic insufflation per se can induce peritoneal adhesions, with the adhesions increasing proportionally with both increasing duration of insufflation and an increase in intraperitoneal pressure.
Prevention in Practice
During the past decade a variety of surgical adjuvants — from procoagulants and fibrinolytic agents to anti-inflammatory drugs and antibiotics — have been investigated for use in reducing the occurrence, extent, and severity of adhesions. Unfortunately, most approaches seemingly have been futile. Some products have shown trends toward efficacy in animal or early human studies and need further investigation.
The three synthetic products that are approved by the Food and Drug Administration—Gynecare Interceed, Seprafilm, and Adept — can help reduce postoperative adhesions after gynecologic procedures, and should be considered as potentially useful surgical adjuvants. A meta-analysis of studies of Gynecare Interceed, for instance, found that approximately twice as many operative sites were adhesion free after use of the barrier than after surgery alone (J. Reprod. Med. 1999;44:325–31).
Gynecare Interceed (Johnson & Johnson) and Seprafilm (Genzyme) are approved for use only at laparotomy, while Adept (Baxter International), an icodextrin solution that disperses throughout the abdominopelvic cavity, is approved for use only in laparoscopic surgery.
The key consideration to make when using Interceed — a biodegradable woven fabric composed of oxidized, regenerated cellulose — is the importance of achieving meticulous hemostasis. Its efficacy is reduced, or can even be lost, in the presence of blood. Care also must be taken not to stretch the material or alter its shape and the spacing between the weaves. Otherwise, the material, once gelated, will have a greater potential for spaces in which the tissue surfaces would not be separated and thus a greater potential for blood coagulation and fibroblast in-growth. Multiple pieces of the material may be overlapped, but there have been no benefits demonstrated (at least in animal studies) to using double layers.
Care in application also is critically important for Seprafilm, a film composed of modified hyaluronic acid and carboxymethylcellulose. Seprafilm is brittle and is difficult to apply through small incisions. While it's not impossible to deliver the product laparoscopically, many surgeons have found this very difficult. And in the United States, it is approved for use with laparotomy only.
In applying Seprafilm, it is critical to first get good exposure of the field and then position the film very carefully. Attempts to reposition the product will often result in tears or breaks. Of course, just as with Interceed, this device is believed to work primarily by separating tissue surfaces, and thus it has little to no chance of success if it does not completely separate the surgically injured tissue from other tissue surfaces in the initial postoperative period while remesothelialization is occurring.
The use of adjuvants, moreover, is no substitute for good surgical technique that aims to minimize tissue injury, tissue devascularization, and inflammation. This is easier to achieve, of course, during a microsurgical procedure such as a tubal anastomosis than in a patient with severe endometriosis or many large fibroids. Still, to the extent possible for the procedure being conducted, the tenets of gynecologic microsurgery should always be considered:
▸ Handle as little tissue as possible, as minimally as possible. To the extent possible, handle only those portions that will subsequently be excised.
▸ Keep tissues moist. Tissue drying leads to injury and loss of mesothelial cells. Raw surfaces are more prone to develop adhesions.
▸ Take special care in the use of suture. Consider whether clinical situations will allow use of less reactive and smaller-caliber suture. When using suture to tie off blood vessels, skeletonize the vessels so as to minimize the amount of tissue distal to the suture that will become hypoxic and serve as a nidus to adhesion development.
▸ Target the use of electrosurgery and other energy sources. Use it in specific localized sites where it's needed, such as to stop bleeding, but avoid widely dispersed use, when possible, again to minimize the amount of residual devitalized tissue remaining in the pelvis at the conclusion of the surgical procedure.
Pelvic Adhesions — An Update
“A number of human interventional trials and animal studies have evaluated techniques and materials designed to prevent and reduce postsurgical adhesions. The results have been inconclusive and sometimes contradictory. Thus, preventing postsurgical adhesions remains an art, rather than a science.” So I began my introduction to the program on adhesion prevention at the 2010 Congress of the Society of Laparoscopic Surgeons in New York City.
Patients with adhesions can present with small bowel obstruction or with complaints of infertility, chronic pain, or dyspareunia. Unfortunately, adhesive disease is problematic. Four percent of the patients undergoing abdominal and pelvic surgery will be readmitted due to adhesion-related complications. In excess of 400,000 surgical procedures are performed annually in the United States for lysis of adhesions. In a Scottish National Health Service Study of nearly 9,000 women who previously underwent open gynecologic surgery, just less than 3% were readmitted secondary to adhesions; the highest readmit rate was ovarian surgery (BJOG 2000;107:855–62).
While one would expect a reduction in the number of patients undergoing laparoscopic surgery, in reality, the verdict is not yet clear. A 1998 meta-analysis showed a decrease in both reformed (26.6% vs. 14.3%) and de novo adhesions (45.2% vs. 37.2%) in the laparoscopic group, compared with laparotomy (Fertil. Steril. 1998;70:702–11).
Despite this, other authors cite pneumoperitoneum, prolonged surgery, high insufflation pressure, and overzealous use of energy to cut and coagulate as reasons why laparoscopic surgery increases risk of adhesions.
The economic impact of adhesions is staggering, in excess of $1.3 billion in the United States per year.
For this current excerpt of the Master Class in Gynecologic Surgery, I have solicited the wisdom of Dr. Michael Diamond. He is the Kamran S. Moghissi Professor of Obstetrics and Gynecology and associate chairman of the department of obstetrics and gynecology at Wayne State University, Detroit. Dr. Diamond also is director of the division of reproductive endocrinology and infertility and assistant dean for clinical and translational research at the university. Dr. Diamond has spent much of his academic career involved in the pathogenesis, prevention, and treatment of pelvic adhesions. He is truly considered the world's leader in this area, and we are honored to have Dr. Diamond as guest author of this important area of our surgical arena.
The prevention of postsurgical adhesions is one of the greatest unmet needs in medicine today. Surgical series have shown that adhesions are present after 80%-90% of abdominal and pelvic surgeries, and that these abnormal fibrous connections have a tremendous propensity to reform after adhesiolysis. (We will define adhesions here as “attachments between surfaces at nonanatomical locations.”)
In gynecologic surgery, postoperative adhesions are a frequent cause of infertility, pain, bowel obstruction, and difficulty in later procedures. Adhesions can occur after minimally invasive procedures, which have the potential for trocar injury to structures adherent to the anterior abdominal wall. Other intraoperative injuries can occur due to obscured normal anatomy or restricted access. A significant number of patients also undergo second surgeries to treat sequelae that are directly related to adhesions.
The literature is replete with studies of adhesion development and reports of its incidence and its consequences. Still, the problem of postoperative adhesion development often goes underestimated or unrecognized. This is because we don't routinely perform early second-look operations to assess adhesion development, and because there are no serum markers or sensitive imaging techniques to allow their identification. In addition, we do not follow our patients who seek care from other providers as insurance coverage changes or as other health problems arise, such as bowel obstruction being treated by a general surgeon.
As gynecologic surgeons, we must appreciate that while infections, endometriosis, and other peritoneal insults may contribute to adhesion development, surgery is the most common cause. We also must appreciate how tissue injury leads to the development of adhesions, and why adhesion reformation so commonly occurs.
This understanding is critical to our consideration and use of the “barrier” products currently available for reducing postsurgical adhesions — and critical to our efforts to employ the tenets of gynecologic microsurgery and to achieve as optimal a surgical outcome as possible. At this point in time, use of approved surgical adjuvants in combination with good surgical technique offers the best chance at adhesion reduction and prevention.
Incidence of Adhesions
A series of reports published in the early to mid-1980s documented how commonly adhesions develop after various types of reproductive pelvic surgery. Through early second-look laparoscopy, postoperative adhesions were found to occur, in these studies, in 55%–100% of patients after their primary gynecologic surgery.
In a multicenter study published in 1987, my colleagues and I also showed that gynecologic surgeries performed at the time of laparotomy are frequently complicated by both adhesion reformation and de novo adhesion formation. More than half of the 161 women (51%) who had a second-look laparoscopy 1–12 weeks after reproductive pelvic surgery were found to have de novo adhesion formation (adhesions in at least one new location). Adhesion reformation was also widespread: At the initial laparotomy, 121 of the patients (all of whom were treated for infertility) were noted to have some form of adhesion, and adhesion reformation subsequently occurred at the site of adhesiolysis in 85% of these women, with no differences with respect to adhesion type (Fertil. Steril. 1987;47;864–6).
It was hoped, and largely expected, that the growth of laparoscopy and minimally invasive surgery approaches in more recent years would reduce postoperative adhesion development — that minimally invasive techniques would prove to be less adhesiogenic than laparotomy. Questions remain, but thus far, such hopes have diminished and our expectations for significant improvement have gone unsubstantiated.
One multicenter study on adhesion development after initial laparoscopic procedures found that the incidence of adhesions at an early second-look procedure was 97% — no lower than in prior reports of second-look laparoscopy after laparotomy.
In this study, 68 women underwent operative laparoscopic procedures, including adhesiolysis, and had second-look procedures within 90 days. The good news was that de novo adhesion formation between the two laparoscopic procedures occurred in only 8 of the women (12%) and at 11 of 47 possible sites — much less frequently than after laparotomy. Adhesion scores also decreased at the second look compared with the status of the pelvis at the initial procedure. Still, with the high rate of adhesion reformation, almost all of the women developed postoperative adhesions.
Thus, even when the initial procedure was performed laparoscopically, adhesion development was an all-too-common occurrence, and appeared to be independent of the character of the initial adhesion (Fertil. Steril. 1991;55:700–4).
More recently, data from randomized studies of various adhesion barriers and potential anti-adhesion adjuvants have further dashed hopes that laparoscopy per se can reduce adhesion development.
For instance, in a recent small pilot study of a fibrin-based product called Adhexil, “control” ovaries that were not treated had a 27% increase in the mean adhesion score between an initial laparoscopic procedure and second-look laparoscopy. The women in the study had undergone bilateral ovarian surgery, with ovaries randomized for application of the product or no treatment (Fertil. Steril. 2011;95:1086–90). Clearly, a laparoscopic approach to their procedures did not prevent the development of adhesions.
Many of the initial studies on adhesion development were comprised of patients with infertility, but more recent observations have been extended to women without infertility and to men. Studies have covered patients undergoing colectomies, for instance, as well as neonates undergoing cardiothoracic procedures.
In a recent review article on adhesion prevention and reduction, members of an interdisciplinary consensus conference stated that adhesions develop after “nearly all” abdominal and pelvic procedures performed through either standard laparotomy or laparoscopic approaches. With respect to gynecologic surgery, they point out, research has shown that the most common site for postsurgical adhesion development is the ovary (Surg. Innov. 2010;17:183–8).
Consequences
Pelvic adhesions are a well-recognized cause of infertility, contributing to up to an estimated 40% of the cases of infertility in women. Adhesions are also a leading cause of bowel obstruction and a significant cause of chronic or recurrent pelvic pain.
The contribution of pelvic adhesions to chronic pelvic pain is not completely understood. Adhesions may be the cause of pain in some women, and in other women, an incidental finding that is not contributing to pain. In patients who have endometriosis as well, the question remains as to the contribution of endometriosis per se, or adhesions, to the pain. Endometriosis can cause adhesions and chronic pelvic pain, presumably through the cyclic generation of inflammatory molecules.
The relationship between chronic pain and adhesions is further complicated by ensuing questions about the efficacy of adhesiolysis. The two randomized trials that have thus far examined the role of adhesiolysis in the reduction of chronic pelvic pain failed to demonstrate a significant improvement in pain after adhesiolysis; however, the high failure rates after follow-up may be due to adhesion reformation and de novo adhesion formation (Fertil. Steril. 2004;82:1483–91). Performance of more randomized comparisons in the future may yield improved outcomes when adhesiolysis is paired with postprocedure use of anti-adhesion adjuvants.
Despite the uncertainties, multiple studies support the current estimation that adhesions cause or significantly contribute to chronic pelvic pain in up to 30% of women with the problem. As the Ovarian Adhesion Study Group noted in one of its reports, adhesions have been reported as a primary cause of chronic pelvic pain in 13%-36% of women, depending on the study (Obstet. Gynecol. 1995;86:335–40). Economic analyses also have quantified the impact of adhesion-related hospital readmissions. A study done in the United Kingdom, for instance, concluded that 6% of all hospital readmissions in patients who had undergone abdominal or pelvic surgery were directly related to adhesions (Lancet 1999;353:1476–80).httother report on hospitalizations for lower abdominal adhesiolysis in the United States estimated that in 1988, the cost of adhesions stemming from gynecologic procedures alone was almost $1.2 billion. This estimate did not include outpatient and indirect costs (Surg. Gynecol. Obstet. 1993;176:271–6).
Why, How Adhesions Develop
Our current understanding is that adhesions develop as a result of injury to and devascularization of the peritoneum, and the subsequent inflammatory response and peritoneal wound healing process. Tissue hypoxia triggers a cascade of intracellular responses that, in combination with the fibrinous collection of blood and serosanguinous fluid at the tissue surface, may result in adhesion development.
In the initial postsurgical period, either overt bleeding or oozing may occur at the site(s) of tissue injury, forming clots. In combination with serosanguinous fluid, which may leak from damaged peritoneal surfaces, a fibrinous mass thus develops at the surgical sites and sites of tissue injury. This represents an initial step in peritoneal repair.
When surrounding tissue is normal and there is a sufficient amount of plasminogen activator present in the peritoneum — and when numerous other events and conditions are optimal — the resulting fibrinous mass can be degraded. As that occurs, and tissue healing continues, fibroblasts are recruited to the surface of the injury site from underlying tissues.
If the fibrinous mass is no longer present, fibroblasts “stop” at the tissue surfaces, and become covered by mesothelial cells which line the peritoneal surface as the process of remesothelialization occurs. This process appears to be initiated within hours after surgery and is generally believed to be completed in 3–5 days. (In such instances, healing would have occurred without adhesions, although subperitoneal fibrosis may have occurred.)
Various hypoxia-driven responses, however, such as a reduction in plasminogen activator activity, can cause the fibrinous mass to persist during the healing process, before remesothelialization occurs. In this case, fibroblasts migrate not only to, but through, the injury site, and into the persisting fibrinous mass. This is subsequently followed by deposition of collagen, fibronectin, and other extracellular matrix materials — creating the beginnings of a true adhesion.
In such cases, remesothelialization still occurs, but the mesothelial cells cover the adhesion as well as the normal tissue surfaces, forming adhesive bands and other types of connections between opposing serosal tissue surfaces. Angiogenesis then occurs as the hypoxic tissue in the adhesion sends signals (such as vascular endothelial growth factor) in an attempt to reestablish a supply of oxygen and nutrients to the injured and devascularized tissues. Subsequently, as the tissue remodels, there is a propensity for the adhesion to become more vascular and denser.
Understanding this process is important because the products currently available for reducing adhesions act as barriers during this critical period of remesothelialization, keeping peritoneal surfaces apart and minimizing the potential development of a fibrinous mass that bridges tissue surfaces. If an adhesion does not form during the 3–5-day period of remesothelialization, it is theorized that there will not be any adhesion development — unless there's new injury to the tissue surfaces.
Once an adhesion forms, however, it has acquired a particular “adhesion phenotype” — different from that of normal peritoneum — that appears to be irreversible. This is likely why it is so difficult to prevent adhesion reformation after adhesiolysis. Rates of adhesion reformation — even in the best of surgical hands — run between 80% and 90%, compared with a 50% chance of de novo adhesion development after surgery (at new sites of injury).
The identification of an adhesion phenotype came originally from comparisons of normal peritoneal and adhesion tissues harvested from the same patient, and were later confirmed in cell culture studies in which normal peritoneal fibroblasts were subjected to hypoxia (2% O2 conditions). Fibroblasts cultured under hypoxic conditions were subsequently found to have developed particular molecular biologic characterizations that are different from those of normal peritoneal fibroblasts.
When exposed to normal amounts of oxygen again, the fibroblasts did not go back to being normal fibroblasts — they continued to manifest the adhesion phenotype (J. Am Assoc. Gynecol. Laparosc. 2004;11:307–14). These findings have been confirmed in animal and human studies, and such relationships have also been identified in other peritoneal tissue types such as mesothelial cells and macrophages.
Further research on the pathogenesis of adhesions and the molecular biologic differences between normal peritoneum and adhesions may allow identification of which patients, and which sites within a patient, are most at risk for adhesion development, as well as the discovery of new ways to reduce the development of postoperative adhesions and their clinical sequelae.
It is possible that a future generation of barrier products not only will work as a barrier separating surfaces prior to remesothelialization, but will also have local biologic effects — delivering adhesion-reducing drugs or biologics, for instance, to specific localized tissue sites. A personalized approach to adhesion prevention also might be possible, with particular factors deemed to increase adhesion risk in individual patients (a deficiency of plasminogen activator, for instance) being corrected.
In the meantime, as we've learned more about the pathophysiological state under which adhesions develop, we have found that adhesion development may occur faster than we had thought. In one recent rodent study, we identified postoperative tissue attachments as early as 2 hours after cecal abrasion. We noted considerable local edema and vessel dilatation within 2 hours of injury, angiogenesis and fibrin deposition at 8 hours, and cell proliferation at 24 hours (Fertil. Steril. 2010;93:2734–7). And interestingly, recent studies in mice have shown that laparoscopic insufflation per se can induce peritoneal adhesions, with the adhesions increasing proportionally with both increasing duration of insufflation and an increase in intraperitoneal pressure.
Prevention in Practice
During the past decade a variety of surgical adjuvants — from procoagulants and fibrinolytic agents to anti-inflammatory drugs and antibiotics — have been investigated for use in reducing the occurrence, extent, and severity of adhesions. Unfortunately, most approaches seemingly have been futile. Some products have shown trends toward efficacy in animal or early human studies and need further investigation.
The three synthetic products that are approved by the Food and Drug Administration—Gynecare Interceed, Seprafilm, and Adept — can help reduce postoperative adhesions after gynecologic procedures, and should be considered as potentially useful surgical adjuvants. A meta-analysis of studies of Gynecare Interceed, for instance, found that approximately twice as many operative sites were adhesion free after use of the barrier than after surgery alone (J. Reprod. Med. 1999;44:325–31).
Gynecare Interceed (Johnson & Johnson) and Seprafilm (Genzyme) are approved for use only at laparotomy, while Adept (Baxter International), an icodextrin solution that disperses throughout the abdominopelvic cavity, is approved for use only in laparoscopic surgery.
The key consideration to make when using Interceed — a biodegradable woven fabric composed of oxidized, regenerated cellulose — is the importance of achieving meticulous hemostasis. Its efficacy is reduced, or can even be lost, in the presence of blood. Care also must be taken not to stretch the material or alter its shape and the spacing between the weaves. Otherwise, the material, once gelated, will have a greater potential for spaces in which the tissue surfaces would not be separated and thus a greater potential for blood coagulation and fibroblast in-growth. Multiple pieces of the material may be overlapped, but there have been no benefits demonstrated (at least in animal studies) to using double layers.
Care in application also is critically important for Seprafilm, a film composed of modified hyaluronic acid and carboxymethylcellulose. Seprafilm is brittle and is difficult to apply through small incisions. While it's not impossible to deliver the product laparoscopically, many surgeons have found this very difficult. And in the United States, it is approved for use with laparotomy only.
In applying Seprafilm, it is critical to first get good exposure of the field and then position the film very carefully. Attempts to reposition the product will often result in tears or breaks. Of course, just as with Interceed, this device is believed to work primarily by separating tissue surfaces, and thus it has little to no chance of success if it does not completely separate the surgically injured tissue from other tissue surfaces in the initial postoperative period while remesothelialization is occurring.
The use of adjuvants, moreover, is no substitute for good surgical technique that aims to minimize tissue injury, tissue devascularization, and inflammation. This is easier to achieve, of course, during a microsurgical procedure such as a tubal anastomosis than in a patient with severe endometriosis or many large fibroids. Still, to the extent possible for the procedure being conducted, the tenets of gynecologic microsurgery should always be considered:
▸ Handle as little tissue as possible, as minimally as possible. To the extent possible, handle only those portions that will subsequently be excised.
▸ Keep tissues moist. Tissue drying leads to injury and loss of mesothelial cells. Raw surfaces are more prone to develop adhesions.
▸ Take special care in the use of suture. Consider whether clinical situations will allow use of less reactive and smaller-caliber suture. When using suture to tie off blood vessels, skeletonize the vessels so as to minimize the amount of tissue distal to the suture that will become hypoxic and serve as a nidus to adhesion development.
▸ Target the use of electrosurgery and other energy sources. Use it in specific localized sites where it's needed, such as to stop bleeding, but avoid widely dispersed use, when possible, again to minimize the amount of residual devitalized tissue remaining in the pelvis at the conclusion of the surgical procedure.
Pelvic Adhesions — An Update
“A number of human interventional trials and animal studies have evaluated techniques and materials designed to prevent and reduce postsurgical adhesions. The results have been inconclusive and sometimes contradictory. Thus, preventing postsurgical adhesions remains an art, rather than a science.” So I began my introduction to the program on adhesion prevention at the 2010 Congress of the Society of Laparoscopic Surgeons in New York City.
Patients with adhesions can present with small bowel obstruction or with complaints of infertility, chronic pain, or dyspareunia. Unfortunately, adhesive disease is problematic. Four percent of the patients undergoing abdominal and pelvic surgery will be readmitted due to adhesion-related complications. In excess of 400,000 surgical procedures are performed annually in the United States for lysis of adhesions. In a Scottish National Health Service Study of nearly 9,000 women who previously underwent open gynecologic surgery, just less than 3% were readmitted secondary to adhesions; the highest readmit rate was ovarian surgery (BJOG 2000;107:855–62).
While one would expect a reduction in the number of patients undergoing laparoscopic surgery, in reality, the verdict is not yet clear. A 1998 meta-analysis showed a decrease in both reformed (26.6% vs. 14.3%) and de novo adhesions (45.2% vs. 37.2%) in the laparoscopic group, compared with laparotomy (Fertil. Steril. 1998;70:702–11).
Despite this, other authors cite pneumoperitoneum, prolonged surgery, high insufflation pressure, and overzealous use of energy to cut and coagulate as reasons why laparoscopic surgery increases risk of adhesions.
The economic impact of adhesions is staggering, in excess of $1.3 billion in the United States per year.
For this current excerpt of the Master Class in Gynecologic Surgery, I have solicited the wisdom of Dr. Michael Diamond. He is the Kamran S. Moghissi Professor of Obstetrics and Gynecology and associate chairman of the department of obstetrics and gynecology at Wayne State University, Detroit. Dr. Diamond also is director of the division of reproductive endocrinology and infertility and assistant dean for clinical and translational research at the university. Dr. Diamond has spent much of his academic career involved in the pathogenesis, prevention, and treatment of pelvic adhesions. He is truly considered the world's leader in this area, and we are honored to have Dr. Diamond as guest author of this important area of our surgical arena.
The prevention of postsurgical adhesions is one of the greatest unmet needs in medicine today. Surgical series have shown that adhesions are present after 80%-90% of abdominal and pelvic surgeries, and that these abnormal fibrous connections have a tremendous propensity to reform after adhesiolysis. (We will define adhesions here as “attachments between surfaces at nonanatomical locations.”)
In gynecologic surgery, postoperative adhesions are a frequent cause of infertility, pain, bowel obstruction, and difficulty in later procedures. Adhesions can occur after minimally invasive procedures, which have the potential for trocar injury to structures adherent to the anterior abdominal wall. Other intraoperative injuries can occur due to obscured normal anatomy or restricted access. A significant number of patients also undergo second surgeries to treat sequelae that are directly related to adhesions.
The literature is replete with studies of adhesion development and reports of its incidence and its consequences. Still, the problem of postoperative adhesion development often goes underestimated or unrecognized. This is because we don't routinely perform early second-look operations to assess adhesion development, and because there are no serum markers or sensitive imaging techniques to allow their identification. In addition, we do not follow our patients who seek care from other providers as insurance coverage changes or as other health problems arise, such as bowel obstruction being treated by a general surgeon.
As gynecologic surgeons, we must appreciate that while infections, endometriosis, and other peritoneal insults may contribute to adhesion development, surgery is the most common cause. We also must appreciate how tissue injury leads to the development of adhesions, and why adhesion reformation so commonly occurs.
This understanding is critical to our consideration and use of the “barrier” products currently available for reducing postsurgical adhesions — and critical to our efforts to employ the tenets of gynecologic microsurgery and to achieve as optimal a surgical outcome as possible. At this point in time, use of approved surgical adjuvants in combination with good surgical technique offers the best chance at adhesion reduction and prevention.
Incidence of Adhesions
A series of reports published in the early to mid-1980s documented how commonly adhesions develop after various types of reproductive pelvic surgery. Through early second-look laparoscopy, postoperative adhesions were found to occur, in these studies, in 55%–100% of patients after their primary gynecologic surgery.
In a multicenter study published in 1987, my colleagues and I also showed that gynecologic surgeries performed at the time of laparotomy are frequently complicated by both adhesion reformation and de novo adhesion formation. More than half of the 161 women (51%) who had a second-look laparoscopy 1–12 weeks after reproductive pelvic surgery were found to have de novo adhesion formation (adhesions in at least one new location). Adhesion reformation was also widespread: At the initial laparotomy, 121 of the patients (all of whom were treated for infertility) were noted to have some form of adhesion, and adhesion reformation subsequently occurred at the site of adhesiolysis in 85% of these women, with no differences with respect to adhesion type (Fertil. Steril. 1987;47;864–6).
It was hoped, and largely expected, that the growth of laparoscopy and minimally invasive surgery approaches in more recent years would reduce postoperative adhesion development — that minimally invasive techniques would prove to be less adhesiogenic than laparotomy. Questions remain, but thus far, such hopes have diminished and our expectations for significant improvement have gone unsubstantiated.
One multicenter study on adhesion development after initial laparoscopic procedures found that the incidence of adhesions at an early second-look procedure was 97% — no lower than in prior reports of second-look laparoscopy after laparotomy.
In this study, 68 women underwent operative laparoscopic procedures, including adhesiolysis, and had second-look procedures within 90 days. The good news was that de novo adhesion formation between the two laparoscopic procedures occurred in only 8 of the women (12%) and at 11 of 47 possible sites — much less frequently than after laparotomy. Adhesion scores also decreased at the second look compared with the status of the pelvis at the initial procedure. Still, with the high rate of adhesion reformation, almost all of the women developed postoperative adhesions.
Thus, even when the initial procedure was performed laparoscopically, adhesion development was an all-too-common occurrence, and appeared to be independent of the character of the initial adhesion (Fertil. Steril. 1991;55:700–4).
More recently, data from randomized studies of various adhesion barriers and potential anti-adhesion adjuvants have further dashed hopes that laparoscopy per se can reduce adhesion development.
For instance, in a recent small pilot study of a fibrin-based product called Adhexil, “control” ovaries that were not treated had a 27% increase in the mean adhesion score between an initial laparoscopic procedure and second-look laparoscopy. The women in the study had undergone bilateral ovarian surgery, with ovaries randomized for application of the product or no treatment (Fertil. Steril. 2011;95:1086–90). Clearly, a laparoscopic approach to their procedures did not prevent the development of adhesions.
Many of the initial studies on adhesion development were comprised of patients with infertility, but more recent observations have been extended to women without infertility and to men. Studies have covered patients undergoing colectomies, for instance, as well as neonates undergoing cardiothoracic procedures.
In a recent review article on adhesion prevention and reduction, members of an interdisciplinary consensus conference stated that adhesions develop after “nearly all” abdominal and pelvic procedures performed through either standard laparotomy or laparoscopic approaches. With respect to gynecologic surgery, they point out, research has shown that the most common site for postsurgical adhesion development is the ovary (Surg. Innov. 2010;17:183–8).
Consequences
Pelvic adhesions are a well-recognized cause of infertility, contributing to up to an estimated 40% of the cases of infertility in women. Adhesions are also a leading cause of bowel obstruction and a significant cause of chronic or recurrent pelvic pain.
The contribution of pelvic adhesions to chronic pelvic pain is not completely understood. Adhesions may be the cause of pain in some women, and in other women, an incidental finding that is not contributing to pain. In patients who have endometriosis as well, the question remains as to the contribution of endometriosis per se, or adhesions, to the pain. Endometriosis can cause adhesions and chronic pelvic pain, presumably through the cyclic generation of inflammatory molecules.
The relationship between chronic pain and adhesions is further complicated by ensuing questions about the efficacy of adhesiolysis. The two randomized trials that have thus far examined the role of adhesiolysis in the reduction of chronic pelvic pain failed to demonstrate a significant improvement in pain after adhesiolysis; however, the high failure rates after follow-up may be due to adhesion reformation and de novo adhesion formation (Fertil. Steril. 2004;82:1483–91). Performance of more randomized comparisons in the future may yield improved outcomes when adhesiolysis is paired with postprocedure use of anti-adhesion adjuvants.
Despite the uncertainties, multiple studies support the current estimation that adhesions cause or significantly contribute to chronic pelvic pain in up to 30% of women with the problem. As the Ovarian Adhesion Study Group noted in one of its reports, adhesions have been reported as a primary cause of chronic pelvic pain in 13%-36% of women, depending on the study (Obstet. Gynecol. 1995;86:335–40). Economic analyses also have quantified the impact of adhesion-related hospital readmissions. A study done in the United Kingdom, for instance, concluded that 6% of all hospital readmissions in patients who had undergone abdominal or pelvic surgery were directly related to adhesions (Lancet 1999;353:1476–80).httother report on hospitalizations for lower abdominal adhesiolysis in the United States estimated that in 1988, the cost of adhesions stemming from gynecologic procedures alone was almost $1.2 billion. This estimate did not include outpatient and indirect costs (Surg. Gynecol. Obstet. 1993;176:271–6).
Why, How Adhesions Develop
Our current understanding is that adhesions develop as a result of injury to and devascularization of the peritoneum, and the subsequent inflammatory response and peritoneal wound healing process. Tissue hypoxia triggers a cascade of intracellular responses that, in combination with the fibrinous collection of blood and serosanguinous fluid at the tissue surface, may result in adhesion development.
In the initial postsurgical period, either overt bleeding or oozing may occur at the site(s) of tissue injury, forming clots. In combination with serosanguinous fluid, which may leak from damaged peritoneal surfaces, a fibrinous mass thus develops at the surgical sites and sites of tissue injury. This represents an initial step in peritoneal repair.
When surrounding tissue is normal and there is a sufficient amount of plasminogen activator present in the peritoneum — and when numerous other events and conditions are optimal — the resulting fibrinous mass can be degraded. As that occurs, and tissue healing continues, fibroblasts are recruited to the surface of the injury site from underlying tissues.
If the fibrinous mass is no longer present, fibroblasts “stop” at the tissue surfaces, and become covered by mesothelial cells which line the peritoneal surface as the process of remesothelialization occurs. This process appears to be initiated within hours after surgery and is generally believed to be completed in 3–5 days. (In such instances, healing would have occurred without adhesions, although subperitoneal fibrosis may have occurred.)
Various hypoxia-driven responses, however, such as a reduction in plasminogen activator activity, can cause the fibrinous mass to persist during the healing process, before remesothelialization occurs. In this case, fibroblasts migrate not only to, but through, the injury site, and into the persisting fibrinous mass. This is subsequently followed by deposition of collagen, fibronectin, and other extracellular matrix materials — creating the beginnings of a true adhesion.
In such cases, remesothelialization still occurs, but the mesothelial cells cover the adhesion as well as the normal tissue surfaces, forming adhesive bands and other types of connections between opposing serosal tissue surfaces. Angiogenesis then occurs as the hypoxic tissue in the adhesion sends signals (such as vascular endothelial growth factor) in an attempt to reestablish a supply of oxygen and nutrients to the injured and devascularized tissues. Subsequently, as the tissue remodels, there is a propensity for the adhesion to become more vascular and denser.
Understanding this process is important because the products currently available for reducing adhesions act as barriers during this critical period of remesothelialization, keeping peritoneal surfaces apart and minimizing the potential development of a fibrinous mass that bridges tissue surfaces. If an adhesion does not form during the 3–5-day period of remesothelialization, it is theorized that there will not be any adhesion development — unless there's new injury to the tissue surfaces.
Once an adhesion forms, however, it has acquired a particular “adhesion phenotype” — different from that of normal peritoneum — that appears to be irreversible. This is likely why it is so difficult to prevent adhesion reformation after adhesiolysis. Rates of adhesion reformation — even in the best of surgical hands — run between 80% and 90%, compared with a 50% chance of de novo adhesion development after surgery (at new sites of injury).
The identification of an adhesion phenotype came originally from comparisons of normal peritoneal and adhesion tissues harvested from the same patient, and were later confirmed in cell culture studies in which normal peritoneal fibroblasts were subjected to hypoxia (2% O2 conditions). Fibroblasts cultured under hypoxic conditions were subsequently found to have developed particular molecular biologic characterizations that are different from those of normal peritoneal fibroblasts.
When exposed to normal amounts of oxygen again, the fibroblasts did not go back to being normal fibroblasts — they continued to manifest the adhesion phenotype (J. Am Assoc. Gynecol. Laparosc. 2004;11:307–14). These findings have been confirmed in animal and human studies, and such relationships have also been identified in other peritoneal tissue types such as mesothelial cells and macrophages.
Further research on the pathogenesis of adhesions and the molecular biologic differences between normal peritoneum and adhesions may allow identification of which patients, and which sites within a patient, are most at risk for adhesion development, as well as the discovery of new ways to reduce the development of postoperative adhesions and their clinical sequelae.
It is possible that a future generation of barrier products not only will work as a barrier separating surfaces prior to remesothelialization, but will also have local biologic effects — delivering adhesion-reducing drugs or biologics, for instance, to specific localized tissue sites. A personalized approach to adhesion prevention also might be possible, with particular factors deemed to increase adhesion risk in individual patients (a deficiency of plasminogen activator, for instance) being corrected.
In the meantime, as we've learned more about the pathophysiological state under which adhesions develop, we have found that adhesion development may occur faster than we had thought. In one recent rodent study, we identified postoperative tissue attachments as early as 2 hours after cecal abrasion. We noted considerable local edema and vessel dilatation within 2 hours of injury, angiogenesis and fibrin deposition at 8 hours, and cell proliferation at 24 hours (Fertil. Steril. 2010;93:2734–7). And interestingly, recent studies in mice have shown that laparoscopic insufflation per se can induce peritoneal adhesions, with the adhesions increasing proportionally with both increasing duration of insufflation and an increase in intraperitoneal pressure.
Prevention in Practice
During the past decade a variety of surgical adjuvants — from procoagulants and fibrinolytic agents to anti-inflammatory drugs and antibiotics — have been investigated for use in reducing the occurrence, extent, and severity of adhesions. Unfortunately, most approaches seemingly have been futile. Some products have shown trends toward efficacy in animal or early human studies and need further investigation.
The three synthetic products that are approved by the Food and Drug Administration—Gynecare Interceed, Seprafilm, and Adept — can help reduce postoperative adhesions after gynecologic procedures, and should be considered as potentially useful surgical adjuvants. A meta-analysis of studies of Gynecare Interceed, for instance, found that approximately twice as many operative sites were adhesion free after use of the barrier than after surgery alone (J. Reprod. Med. 1999;44:325–31).
Gynecare Interceed (Johnson & Johnson) and Seprafilm (Genzyme) are approved for use only at laparotomy, while Adept (Baxter International), an icodextrin solution that disperses throughout the abdominopelvic cavity, is approved for use only in laparoscopic surgery.
The key consideration to make when using Interceed — a biodegradable woven fabric composed of oxidized, regenerated cellulose — is the importance of achieving meticulous hemostasis. Its efficacy is reduced, or can even be lost, in the presence of blood. Care also must be taken not to stretch the material or alter its shape and the spacing between the weaves. Otherwise, the material, once gelated, will have a greater potential for spaces in which the tissue surfaces would not be separated and thus a greater potential for blood coagulation and fibroblast in-growth. Multiple pieces of the material may be overlapped, but there have been no benefits demonstrated (at least in animal studies) to using double layers.
Care in application also is critically important for Seprafilm, a film composed of modified hyaluronic acid and carboxymethylcellulose. Seprafilm is brittle and is difficult to apply through small incisions. While it's not impossible to deliver the product laparoscopically, many surgeons have found this very difficult. And in the United States, it is approved for use with laparotomy only.
In applying Seprafilm, it is critical to first get good exposure of the field and then position the film very carefully. Attempts to reposition the product will often result in tears or breaks. Of course, just as with Interceed, this device is believed to work primarily by separating tissue surfaces, and thus it has little to no chance of success if it does not completely separate the surgically injured tissue from other tissue surfaces in the initial postoperative period while remesothelialization is occurring.
The use of adjuvants, moreover, is no substitute for good surgical technique that aims to minimize tissue injury, tissue devascularization, and inflammation. This is easier to achieve, of course, during a microsurgical procedure such as a tubal anastomosis than in a patient with severe endometriosis or many large fibroids. Still, to the extent possible for the procedure being conducted, the tenets of gynecologic microsurgery should always be considered:
▸ Handle as little tissue as possible, as minimally as possible. To the extent possible, handle only those portions that will subsequently be excised.
▸ Keep tissues moist. Tissue drying leads to injury and loss of mesothelial cells. Raw surfaces are more prone to develop adhesions.
▸ Take special care in the use of suture. Consider whether clinical situations will allow use of less reactive and smaller-caliber suture. When using suture to tie off blood vessels, skeletonize the vessels so as to minimize the amount of tissue distal to the suture that will become hypoxic and serve as a nidus to adhesion development.
▸ Target the use of electrosurgery and other energy sources. Use it in specific localized sites where it's needed, such as to stop bleeding, but avoid widely dispersed use, when possible, again to minimize the amount of residual devitalized tissue remaining in the pelvis at the conclusion of the surgical procedure.
Pelvic Adhesions — An Update
“A number of human interventional trials and animal studies have evaluated techniques and materials designed to prevent and reduce postsurgical adhesions. The results have been inconclusive and sometimes contradictory. Thus, preventing postsurgical adhesions remains an art, rather than a science.” So I began my introduction to the program on adhesion prevention at the 2010 Congress of the Society of Laparoscopic Surgeons in New York City.
Patients with adhesions can present with small bowel obstruction or with complaints of infertility, chronic pain, or dyspareunia. Unfortunately, adhesive disease is problematic. Four percent of the patients undergoing abdominal and pelvic surgery will be readmitted due to adhesion-related complications. In excess of 400,000 surgical procedures are performed annually in the United States for lysis of adhesions. In a Scottish National Health Service Study of nearly 9,000 women who previously underwent open gynecologic surgery, just less than 3% were readmitted secondary to adhesions; the highest readmit rate was ovarian surgery (BJOG 2000;107:855–62).
While one would expect a reduction in the number of patients undergoing laparoscopic surgery, in reality, the verdict is not yet clear. A 1998 meta-analysis showed a decrease in both reformed (26.6% vs. 14.3%) and de novo adhesions (45.2% vs. 37.2%) in the laparoscopic group, compared with laparotomy (Fertil. Steril. 1998;70:702–11).
Despite this, other authors cite pneumoperitoneum, prolonged surgery, high insufflation pressure, and overzealous use of energy to cut and coagulate as reasons why laparoscopic surgery increases risk of adhesions.
The economic impact of adhesions is staggering, in excess of $1.3 billion in the United States per year.
For this current excerpt of the Master Class in Gynecologic Surgery, I have solicited the wisdom of Dr. Michael Diamond. He is the Kamran S. Moghissi Professor of Obstetrics and Gynecology and associate chairman of the department of obstetrics and gynecology at Wayne State University, Detroit. Dr. Diamond also is director of the division of reproductive endocrinology and infertility and assistant dean for clinical and translational research at the university. Dr. Diamond has spent much of his academic career involved in the pathogenesis, prevention, and treatment of pelvic adhesions. He is truly considered the world's leader in this area, and we are honored to have Dr. Diamond as guest author of this important area of our surgical arena.
Endometriosis: Current Diagnosis and Treatment
A disease that affects 10%-15% of women of reproductive age, endometriosis is quite prevalent. In 1990, investigators in Belgium first described deep endometriosis to highlight the diagnostic and therapeutic aspects of the disease (Fertil. Steril. 1990;53:978–83). In contrast to superficial disease, deep endometriosis constitutes the most severe form of endometriosis and includes nodules affecting the pouch of Douglas, retrocervical area, bladder, ureter, or the intestinal wall. Less frequently, the rectovaginal septum is involved (Arq. Gastroenterol. 2003;40:192–7). The treatment of bowel endometriosis is challenging, as it is a benign disease that may infiltrate the bowel, requiring a surgical treatment with increased risks.
Preoperative Diagnosis Using Imaging
The definitive diagnosis of deep endometriosis with bowel involvement is reached principally at the time of surgery. However, some clinical characteristics identified by history and physical examination, laboratory tests, and diagnostic imaging may raise suspicion for this form of endometriosis. A surgical approach is still recommended for confirmation and treatment.
Transvaginal ultrasonography (TVUS) still appears to be the superior imaging technique, providing the best cost-benefit ratio for cases of ovarian or deep endometriosis. The presence of a hypoechoic lesion located in the posterior pelvic compartment (see
When performed after complete bowel preparation and during the perimenstrual phase, TVUS carried out by a trained professional provides useful information for therapeutic management.
MRI can be performed to identify deep lesions. (See
Excretory urography or uro-MRI also is useful for evaluating whether the ureters are involved. When urinary tract involvement is suspected, one of these types of imaging should be performed to fully document the state of the urinary tract before surgery.
If we have doubts about the bowel involvement even after TVUS with bowel preparation, we recommend rectal echoendoscopy. (See
Rectal echoendoscopy also permits identification of the distance between the lesion and the rectal lumen, as well as identification of extrinsic compression and lesions of the rectal submucosa. This information can be critical in the preoperative planning of the type of surgery required and the need to have the help of a colorectal surgeon. The chart on page 19 shows the algorithm for preoperative work-up depending on clinical and TVUS findings.
Treatment: Clinical or Surgical?
Medical treatment of deep endometriosis, as opposed to surgical treatment, remains controversial. Dr. Luigi Fedele and his associates in Italy reported a substantial improvement in pain during 6 months of treatment with GnRH analogs (Am. J. Obstet. Gynecol. 2000;183:1462–7). Similar improvements in pain were also observed by our group with both an intrauterine device medicated with levonorgestrel and with a GnRH analog (Hum. Reprod. 2005;20:1993–8). In Dr. Fedele's study, however, an early relapse occurred following discontinuation of treatment. In addition, the endometriotic lesions underwent a discrete but significant reduction in size as detected by TVUS during treatment, but returned to their original size 6 months after suspension of GnRH treatment.
In cases of intractable pain (measured by scores greater than 7 in the visual analog scale) and/or two previously failed IVF cycles, surgical treatment is required. Access for surgical treatment may be by laparotomy or laparoscopy, depending on the surgeon's experience; however, laparoscopy can provide a better visualization of the lesions, allowing a more precise excision.
Surgical Preparation and Technique
Whenever there is clinical suspicion of deep endometriosis, adequate presurgical bowel preparation is indicated. We recommend the use of 3–4 liters of an oral solution of polyethylene glycol (PEG) the day before surgery, followed by one or two Fleet enemas or a mannitol preparation.
Administration of antibiotics should be carried out during anesthetic induction, preferably using a second-generation cephalosporin (2 g intravenously).
When the preoperative rectal ultrasound permits identification of the depth of the lesion, this information can be used to define the type of surgery that will be performed. In the case of unifocal lesions less than 3 cm in size (major diameter) and affecting the serous and external muscular layers of the rectum or sigmoid, resection of the nodule alone may be indicated. This procedure may be done manually or with the help of a circular stapler. (
Our technique approached laparoscopically is as follows:
▸ The lesion on the rectosigmoid is delineated, and adhesions are lysed from contiguous organs such as adnexae, the uterus, or other loops of bowel. We prefer to use scissors or a hook.
▸ To resect the lesion manually (without the use of a disposable stapler), the endometriotic nodule is excised, taking care not to leave any residual disease behind. The defect is then repaired in a double-layer fashion. On the mucosal layer, 3–0 absorbable suture is used in a running and transverse manner to avoid bowel constriction. On the seromuscular layer, 3–0 permanent suture is used in a running manner to imbricate over the first layer.
▸ If a circular stapler is used, the following steps are followed: A stitch is placed in the lesion in order to invaginate it into the stapler. (See
▸ The anastomosis is tested by gently injecting air and/or methylene blue through the rectum (with an Asepto, or large bulb syringe) while the surgeon occludes the proximal sigmoid with an atraumatic instrument. Absence of air bubbles and/or methylene blue while the anastomotic site is submerged in sterile water in the pelvis confirms a tight anastomosis.
If, on the other hand, the lesion is deeper, affecting the deep muscle or the submucosal or mucosal layers, then segmental resection of the bowel is recommended. Complete surgical resection of endometrial foci has been shown to result in improved quality of life and decreased rates of recurrence (Fertil. Steril. 2004;82:878–84).
Segmental resection of the rectosigmoid can be performed laparoscopically (J. Minim. Invasive Gynecol. 2008;15:280–5). Our technique involves the following steps:
▸ Both ureters are identified (see
▸ The mesosigmoid is divided with an ultrasonic device.
▸ A linear stapler is utilized on the rectosigmoid distal to the lesion.
▸ After excision of all endometriotic implants, the right-lower trocar site is extended to 4 cm in order to remove the surgical specimen(s) and to prepare the proximal stump. (See
▸ An incision is made on the proximal stump in order to insert the anvil of the circular stapler.
▸ A purse-string suture holding the anvil in place is performed prior to replacement of the sigmoid into the abdominal cavity.
▸ The 4-cm fascial incision is closed in order to finish the procedure laparoscopically.
▸ The circular stapler is inserted through the anus in order to complete the end-to-end reanastomosis. The anastomosis is tested by gently injecting air and/or methylene blue through the rectum (with an Asepto, or large bulb syringe) while the surgeon occludes the proximal sigmoid with an atraumatic instrument. Absence of air bubbles and/or methylene blue while the anastomotic site is submerged in sterile water in the pelvis confirms a tight anastomosis.
▸ A large drain is left adjacent to the anastomosis prior to closure of trocar sites. The drain is generally removed 4 days postoperatively.
Deep endometriosis is associated with more severe pain and significantly greater rates of infertility, compared with superficial endometriosis. Because of the high risks of surgical intervention, preoperative diagnosis using imaging modalities can be helpful in planning surgical strategy. Improved outcomes are achieved with complete surgical resection, which can be performed through minimally invasive techniques.
Download a mobile quick response (QR) code reader from your smartphone's app store to view a video by Dr. Abrão, or visit
Vitals
Rectal Endometriosis
Deep endometriosis compromising the rectum continues to be a diagnostic and therapeutic challenge. The resultant pelvic pain, dyspareunia, dysmenorrhea, and infertility risk are well documented in literature. Despite the fact that there are numerous studies to evaluate deep endometriosis, including colonoscopy, MRI, vaginal and rectal ultrasound, and barium enema, there continues to be no standard road map for evaluation. In addition, there continues to be debate in the literature when patients should undergo shaving of the endometrioma, discoid resection of the endometrioma, or complete bowel resection.
Since the inception of the Master Class in Gynecologic Surgery, as Editor, I have used only experts who practice within the confines of the United States. However, given the internationally recognized expertise in both the diagnosis and treatment of deep and extensive endometriosis, I believed it was imperative to invite Dr. Mauricio S. Abrão to discuss the diagnosis and treatment of deep endometriosis compromising the rectum.
Dr. Abrão was born in São Paulo, Brazil in 1962, where he went on to complete medical school, and in 1988, his residency in obstetrics and gynecology. In 1989, Dr. Abrão founded the endometriosis division within the department of the teaching hospital of the University of São Paulo School of Medicine, where he currently is Docent Professor.
Since 2007, Dr. Abrão has been president of the Brazilian Society of Endometriosis and Minimally Invasive Endoscopy, and has been a board member of the World Endometriosis Society since 1998. He currently is on the board of trustees of the AAGL and is the chairman of the society's special interest group on endometriosis. Dr. Abrão is leading the AAGL initiative on producing a new classification on endometriosis. A prolific author, Dr. Abrão has nearly 100 papers published in peer-reviewed journals, the majority dealing with endometriosis.
It is with great admiration and respect that I introduce my friend, Dr. Abrão, to this edition of the Master Class in gynecologic surgery.
A disease that affects 10%-15% of women of reproductive age, endometriosis is quite prevalent. In 1990, investigators in Belgium first described deep endometriosis to highlight the diagnostic and therapeutic aspects of the disease (Fertil. Steril. 1990;53:978–83). In contrast to superficial disease, deep endometriosis constitutes the most severe form of endometriosis and includes nodules affecting the pouch of Douglas, retrocervical area, bladder, ureter, or the intestinal wall. Less frequently, the rectovaginal septum is involved (Arq. Gastroenterol. 2003;40:192–7). The treatment of bowel endometriosis is challenging, as it is a benign disease that may infiltrate the bowel, requiring a surgical treatment with increased risks.
Preoperative Diagnosis Using Imaging
The definitive diagnosis of deep endometriosis with bowel involvement is reached principally at the time of surgery. However, some clinical characteristics identified by history and physical examination, laboratory tests, and diagnostic imaging may raise suspicion for this form of endometriosis. A surgical approach is still recommended for confirmation and treatment.
Transvaginal ultrasonography (TVUS) still appears to be the superior imaging technique, providing the best cost-benefit ratio for cases of ovarian or deep endometriosis. The presence of a hypoechoic lesion located in the posterior pelvic compartment (see
When performed after complete bowel preparation and during the perimenstrual phase, TVUS carried out by a trained professional provides useful information for therapeutic management.
MRI can be performed to identify deep lesions. (See
Excretory urography or uro-MRI also is useful for evaluating whether the ureters are involved. When urinary tract involvement is suspected, one of these types of imaging should be performed to fully document the state of the urinary tract before surgery.
If we have doubts about the bowel involvement even after TVUS with bowel preparation, we recommend rectal echoendoscopy. (See
Rectal echoendoscopy also permits identification of the distance between the lesion and the rectal lumen, as well as identification of extrinsic compression and lesions of the rectal submucosa. This information can be critical in the preoperative planning of the type of surgery required and the need to have the help of a colorectal surgeon. The chart on page 19 shows the algorithm for preoperative work-up depending on clinical and TVUS findings.
Treatment: Clinical or Surgical?
Medical treatment of deep endometriosis, as opposed to surgical treatment, remains controversial. Dr. Luigi Fedele and his associates in Italy reported a substantial improvement in pain during 6 months of treatment with GnRH analogs (Am. J. Obstet. Gynecol. 2000;183:1462–7). Similar improvements in pain were also observed by our group with both an intrauterine device medicated with levonorgestrel and with a GnRH analog (Hum. Reprod. 2005;20:1993–8). In Dr. Fedele's study, however, an early relapse occurred following discontinuation of treatment. In addition, the endometriotic lesions underwent a discrete but significant reduction in size as detected by TVUS during treatment, but returned to their original size 6 months after suspension of GnRH treatment.
In cases of intractable pain (measured by scores greater than 7 in the visual analog scale) and/or two previously failed IVF cycles, surgical treatment is required. Access for surgical treatment may be by laparotomy or laparoscopy, depending on the surgeon's experience; however, laparoscopy can provide a better visualization of the lesions, allowing a more precise excision.
Surgical Preparation and Technique
Whenever there is clinical suspicion of deep endometriosis, adequate presurgical bowel preparation is indicated. We recommend the use of 3–4 liters of an oral solution of polyethylene glycol (PEG) the day before surgery, followed by one or two Fleet enemas or a mannitol preparation.
Administration of antibiotics should be carried out during anesthetic induction, preferably using a second-generation cephalosporin (2 g intravenously).
When the preoperative rectal ultrasound permits identification of the depth of the lesion, this information can be used to define the type of surgery that will be performed. In the case of unifocal lesions less than 3 cm in size (major diameter) and affecting the serous and external muscular layers of the rectum or sigmoid, resection of the nodule alone may be indicated. This procedure may be done manually or with the help of a circular stapler. (
Our technique approached laparoscopically is as follows:
▸ The lesion on the rectosigmoid is delineated, and adhesions are lysed from contiguous organs such as adnexae, the uterus, or other loops of bowel. We prefer to use scissors or a hook.
▸ To resect the lesion manually (without the use of a disposable stapler), the endometriotic nodule is excised, taking care not to leave any residual disease behind. The defect is then repaired in a double-layer fashion. On the mucosal layer, 3–0 absorbable suture is used in a running and transverse manner to avoid bowel constriction. On the seromuscular layer, 3–0 permanent suture is used in a running manner to imbricate over the first layer.
▸ If a circular stapler is used, the following steps are followed: A stitch is placed in the lesion in order to invaginate it into the stapler. (See
▸ The anastomosis is tested by gently injecting air and/or methylene blue through the rectum (with an Asepto, or large bulb syringe) while the surgeon occludes the proximal sigmoid with an atraumatic instrument. Absence of air bubbles and/or methylene blue while the anastomotic site is submerged in sterile water in the pelvis confirms a tight anastomosis.
If, on the other hand, the lesion is deeper, affecting the deep muscle or the submucosal or mucosal layers, then segmental resection of the bowel is recommended. Complete surgical resection of endometrial foci has been shown to result in improved quality of life and decreased rates of recurrence (Fertil. Steril. 2004;82:878–84).
Segmental resection of the rectosigmoid can be performed laparoscopically (J. Minim. Invasive Gynecol. 2008;15:280–5). Our technique involves the following steps:
▸ Both ureters are identified (see
▸ The mesosigmoid is divided with an ultrasonic device.
▸ A linear stapler is utilized on the rectosigmoid distal to the lesion.
▸ After excision of all endometriotic implants, the right-lower trocar site is extended to 4 cm in order to remove the surgical specimen(s) and to prepare the proximal stump. (See
▸ An incision is made on the proximal stump in order to insert the anvil of the circular stapler.
▸ A purse-string suture holding the anvil in place is performed prior to replacement of the sigmoid into the abdominal cavity.
▸ The 4-cm fascial incision is closed in order to finish the procedure laparoscopically.
▸ The circular stapler is inserted through the anus in order to complete the end-to-end reanastomosis. The anastomosis is tested by gently injecting air and/or methylene blue through the rectum (with an Asepto, or large bulb syringe) while the surgeon occludes the proximal sigmoid with an atraumatic instrument. Absence of air bubbles and/or methylene blue while the anastomotic site is submerged in sterile water in the pelvis confirms a tight anastomosis.
▸ A large drain is left adjacent to the anastomosis prior to closure of trocar sites. The drain is generally removed 4 days postoperatively.
Deep endometriosis is associated with more severe pain and significantly greater rates of infertility, compared with superficial endometriosis. Because of the high risks of surgical intervention, preoperative diagnosis using imaging modalities can be helpful in planning surgical strategy. Improved outcomes are achieved with complete surgical resection, which can be performed through minimally invasive techniques.
Download a mobile quick response (QR) code reader from your smartphone's app store to view a video by Dr. Abrão, or visit
Vitals
Rectal Endometriosis
Deep endometriosis compromising the rectum continues to be a diagnostic and therapeutic challenge. The resultant pelvic pain, dyspareunia, dysmenorrhea, and infertility risk are well documented in literature. Despite the fact that there are numerous studies to evaluate deep endometriosis, including colonoscopy, MRI, vaginal and rectal ultrasound, and barium enema, there continues to be no standard road map for evaluation. In addition, there continues to be debate in the literature when patients should undergo shaving of the endometrioma, discoid resection of the endometrioma, or complete bowel resection.
Since the inception of the Master Class in Gynecologic Surgery, as Editor, I have used only experts who practice within the confines of the United States. However, given the internationally recognized expertise in both the diagnosis and treatment of deep and extensive endometriosis, I believed it was imperative to invite Dr. Mauricio S. Abrão to discuss the diagnosis and treatment of deep endometriosis compromising the rectum.
Dr. Abrão was born in São Paulo, Brazil in 1962, where he went on to complete medical school, and in 1988, his residency in obstetrics and gynecology. In 1989, Dr. Abrão founded the endometriosis division within the department of the teaching hospital of the University of São Paulo School of Medicine, where he currently is Docent Professor.
Since 2007, Dr. Abrão has been president of the Brazilian Society of Endometriosis and Minimally Invasive Endoscopy, and has been a board member of the World Endometriosis Society since 1998. He currently is on the board of trustees of the AAGL and is the chairman of the society's special interest group on endometriosis. Dr. Abrão is leading the AAGL initiative on producing a new classification on endometriosis. A prolific author, Dr. Abrão has nearly 100 papers published in peer-reviewed journals, the majority dealing with endometriosis.
It is with great admiration and respect that I introduce my friend, Dr. Abrão, to this edition of the Master Class in gynecologic surgery.
A disease that affects 10%-15% of women of reproductive age, endometriosis is quite prevalent. In 1990, investigators in Belgium first described deep endometriosis to highlight the diagnostic and therapeutic aspects of the disease (Fertil. Steril. 1990;53:978–83). In contrast to superficial disease, deep endometriosis constitutes the most severe form of endometriosis and includes nodules affecting the pouch of Douglas, retrocervical area, bladder, ureter, or the intestinal wall. Less frequently, the rectovaginal septum is involved (Arq. Gastroenterol. 2003;40:192–7). The treatment of bowel endometriosis is challenging, as it is a benign disease that may infiltrate the bowel, requiring a surgical treatment with increased risks.
Preoperative Diagnosis Using Imaging
The definitive diagnosis of deep endometriosis with bowel involvement is reached principally at the time of surgery. However, some clinical characteristics identified by history and physical examination, laboratory tests, and diagnostic imaging may raise suspicion for this form of endometriosis. A surgical approach is still recommended for confirmation and treatment.
Transvaginal ultrasonography (TVUS) still appears to be the superior imaging technique, providing the best cost-benefit ratio for cases of ovarian or deep endometriosis. The presence of a hypoechoic lesion located in the posterior pelvic compartment (see
When performed after complete bowel preparation and during the perimenstrual phase, TVUS carried out by a trained professional provides useful information for therapeutic management.
MRI can be performed to identify deep lesions. (See
Excretory urography or uro-MRI also is useful for evaluating whether the ureters are involved. When urinary tract involvement is suspected, one of these types of imaging should be performed to fully document the state of the urinary tract before surgery.
If we have doubts about the bowel involvement even after TVUS with bowel preparation, we recommend rectal echoendoscopy. (See
Rectal echoendoscopy also permits identification of the distance between the lesion and the rectal lumen, as well as identification of extrinsic compression and lesions of the rectal submucosa. This information can be critical in the preoperative planning of the type of surgery required and the need to have the help of a colorectal surgeon. The chart on page 19 shows the algorithm for preoperative work-up depending on clinical and TVUS findings.
Treatment: Clinical or Surgical?
Medical treatment of deep endometriosis, as opposed to surgical treatment, remains controversial. Dr. Luigi Fedele and his associates in Italy reported a substantial improvement in pain during 6 months of treatment with GnRH analogs (Am. J. Obstet. Gynecol. 2000;183:1462–7). Similar improvements in pain were also observed by our group with both an intrauterine device medicated with levonorgestrel and with a GnRH analog (Hum. Reprod. 2005;20:1993–8). In Dr. Fedele's study, however, an early relapse occurred following discontinuation of treatment. In addition, the endometriotic lesions underwent a discrete but significant reduction in size as detected by TVUS during treatment, but returned to their original size 6 months after suspension of GnRH treatment.
In cases of intractable pain (measured by scores greater than 7 in the visual analog scale) and/or two previously failed IVF cycles, surgical treatment is required. Access for surgical treatment may be by laparotomy or laparoscopy, depending on the surgeon's experience; however, laparoscopy can provide a better visualization of the lesions, allowing a more precise excision.
Surgical Preparation and Technique
Whenever there is clinical suspicion of deep endometriosis, adequate presurgical bowel preparation is indicated. We recommend the use of 3–4 liters of an oral solution of polyethylene glycol (PEG) the day before surgery, followed by one or two Fleet enemas or a mannitol preparation.
Administration of antibiotics should be carried out during anesthetic induction, preferably using a second-generation cephalosporin (2 g intravenously).
When the preoperative rectal ultrasound permits identification of the depth of the lesion, this information can be used to define the type of surgery that will be performed. In the case of unifocal lesions less than 3 cm in size (major diameter) and affecting the serous and external muscular layers of the rectum or sigmoid, resection of the nodule alone may be indicated. This procedure may be done manually or with the help of a circular stapler. (
Our technique approached laparoscopically is as follows:
▸ The lesion on the rectosigmoid is delineated, and adhesions are lysed from contiguous organs such as adnexae, the uterus, or other loops of bowel. We prefer to use scissors or a hook.
▸ To resect the lesion manually (without the use of a disposable stapler), the endometriotic nodule is excised, taking care not to leave any residual disease behind. The defect is then repaired in a double-layer fashion. On the mucosal layer, 3–0 absorbable suture is used in a running and transverse manner to avoid bowel constriction. On the seromuscular layer, 3–0 permanent suture is used in a running manner to imbricate over the first layer.
▸ If a circular stapler is used, the following steps are followed: A stitch is placed in the lesion in order to invaginate it into the stapler. (See
▸ The anastomosis is tested by gently injecting air and/or methylene blue through the rectum (with an Asepto, or large bulb syringe) while the surgeon occludes the proximal sigmoid with an atraumatic instrument. Absence of air bubbles and/or methylene blue while the anastomotic site is submerged in sterile water in the pelvis confirms a tight anastomosis.
If, on the other hand, the lesion is deeper, affecting the deep muscle or the submucosal or mucosal layers, then segmental resection of the bowel is recommended. Complete surgical resection of endometrial foci has been shown to result in improved quality of life and decreased rates of recurrence (Fertil. Steril. 2004;82:878–84).
Segmental resection of the rectosigmoid can be performed laparoscopically (J. Minim. Invasive Gynecol. 2008;15:280–5). Our technique involves the following steps:
▸ Both ureters are identified (see
▸ The mesosigmoid is divided with an ultrasonic device.
▸ A linear stapler is utilized on the rectosigmoid distal to the lesion.
▸ After excision of all endometriotic implants, the right-lower trocar site is extended to 4 cm in order to remove the surgical specimen(s) and to prepare the proximal stump. (See
▸ An incision is made on the proximal stump in order to insert the anvil of the circular stapler.
▸ A purse-string suture holding the anvil in place is performed prior to replacement of the sigmoid into the abdominal cavity.
▸ The 4-cm fascial incision is closed in order to finish the procedure laparoscopically.
▸ The circular stapler is inserted through the anus in order to complete the end-to-end reanastomosis. The anastomosis is tested by gently injecting air and/or methylene blue through the rectum (with an Asepto, or large bulb syringe) while the surgeon occludes the proximal sigmoid with an atraumatic instrument. Absence of air bubbles and/or methylene blue while the anastomotic site is submerged in sterile water in the pelvis confirms a tight anastomosis.
▸ A large drain is left adjacent to the anastomosis prior to closure of trocar sites. The drain is generally removed 4 days postoperatively.
Deep endometriosis is associated with more severe pain and significantly greater rates of infertility, compared with superficial endometriosis. Because of the high risks of surgical intervention, preoperative diagnosis using imaging modalities can be helpful in planning surgical strategy. Improved outcomes are achieved with complete surgical resection, which can be performed through minimally invasive techniques.
Download a mobile quick response (QR) code reader from your smartphone's app store to view a video by Dr. Abrão, or visit
Vitals
Rectal Endometriosis
Deep endometriosis compromising the rectum continues to be a diagnostic and therapeutic challenge. The resultant pelvic pain, dyspareunia, dysmenorrhea, and infertility risk are well documented in literature. Despite the fact that there are numerous studies to evaluate deep endometriosis, including colonoscopy, MRI, vaginal and rectal ultrasound, and barium enema, there continues to be no standard road map for evaluation. In addition, there continues to be debate in the literature when patients should undergo shaving of the endometrioma, discoid resection of the endometrioma, or complete bowel resection.
Since the inception of the Master Class in Gynecologic Surgery, as Editor, I have used only experts who practice within the confines of the United States. However, given the internationally recognized expertise in both the diagnosis and treatment of deep and extensive endometriosis, I believed it was imperative to invite Dr. Mauricio S. Abrão to discuss the diagnosis and treatment of deep endometriosis compromising the rectum.
Dr. Abrão was born in São Paulo, Brazil in 1962, where he went on to complete medical school, and in 1988, his residency in obstetrics and gynecology. In 1989, Dr. Abrão founded the endometriosis division within the department of the teaching hospital of the University of São Paulo School of Medicine, where he currently is Docent Professor.
Since 2007, Dr. Abrão has been president of the Brazilian Society of Endometriosis and Minimally Invasive Endoscopy, and has been a board member of the World Endometriosis Society since 1998. He currently is on the board of trustees of the AAGL and is the chairman of the society's special interest group on endometriosis. Dr. Abrão is leading the AAGL initiative on producing a new classification on endometriosis. A prolific author, Dr. Abrão has nearly 100 papers published in peer-reviewed journals, the majority dealing with endometriosis.
It is with great admiration and respect that I introduce my friend, Dr. Abrão, to this edition of the Master Class in gynecologic surgery.
The Benefits of Robot-Assisted Myomectomy
Myomectomy offers an alternative to hysterectomy for the treatment of uterine fibroids whether or not future fertility is an issue. While many women chose a uterine-sparing approach to maintain their fertility options, there still are many women who prefer myomectomy for reasons other than fertility preservation.
The procedure is an important one for gynecologic surgeons and their patients, as it conveys a high rate of symptom resolution: Eighty-one percent of women who undergo a myomectomy experience complete resolution of their symptoms (Fertil. Steril. 1981;36:433-45).
Robot-assisted laparoscopic myomectomy was first described in 2004 by Dr. Arnold P. Advincula and his colleagues (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).
Their report played a pivotal role in the Food and Drug Administration's approval in 2005 for use of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for gynecologic surgical procedures.
While myomectomy still is most commonly performed via laparotomy, a significant number of surgeons have adopted the robotic approach. According to data from Solucient, a health care information company managed by Thomson Reuters, approximately 4,000 robotic myomectomies were performed in the United States in 2010. This represents 10% of the approximately 40,000 myomectomies performed each year, a significant proportion considering that robotics had been introduced to gynecology only 5 years earlier.
Myomectomy is a suture-intensive procedure, and suturing by a conventional laparoscopic approach has proved to be extremely challenging. The robotic platform gives surgeons greater capability of successfully repairing deep hysterotomy defects and provides them with a more achievable minimally invasive option to offer patients.
Interestingly, utilization of the laparoscopic approach for hysterectomy also has increased with the introduction of robotics. Current statistics show that only 16% of all hysterectomy procedures performed in the United States are done via conventional laparoscopy (20 years, approximately, after the techniques were developed), while another 20% are now being performed with robot assistance. A new AAGL position statement saying that surgeons who offer hysterectomy should be able to perform either vaginal hysterectomy (the preferred approach) or laparoscopic hysterectomy (the second best approach) – or refer their patients to a surgeon who can (J. Minim. Invasive Gynecol. 2011;18:1-3) – is indicative of the growing belief that the benefits of minimally invasive surgery over open procedures should be considered where possible in aspects of gynecologic surgery.
At our institution, we saw a significant improvement in operative time after the first 20 cases of robot-assisted myomectomy and hysterectomy. Our operative time went from a mean of 212 min. for cases 1–20 to a mean of 151 min. for cases 21–40 (Int. J. Med. Robot. 2008;4:114-20).
Others have reported similar findings on the learning curve for robot-assisted gynecologic surgery: Another case series published several years ago, for instance, showed operative times for various surgical procedures for benign gynecologic problems stabilizing within 50 cases (J. Minim. Invasive Gynecol. 2008;15:589-94). In general, these data are indicative of a significantly shorter learning curve than seen with traditional laparoscopic surgery.
Incorporation of MRI
The main drawback to robotics always has been the absence of haptics or tactile feedback. This limitation has, however, spurred the development of creative techniques to compensate, including the use of real-time magnetic resonance imaging.
MR images can now be incorporated in a real-time, 3-dimensional fashion into the surgeon's console for use in mapping, detecting, locating, and enucleating myomas. All three views – axial, coronal, and sagittal – can be seen during the surgery. This enables the surgeon both to overcome the haptic limitations and to remove multiple fibroids. (See images 1 and 2.)
Certainly, the gynecologic surgeon employing this technique must be comfortable reading and interpreting MR images. The necessary comfort level can be achieved, on an individual basis, with time spent reviewing series of pelvic MR images with a radiologist.
MR imaging also has proved, of course, to be an excellent preoperative tool for determining ahead of time the size, number, and location of myomas, and for ruling out adenomyosis. In my experience, MR imaging can be useful preoperatively in conjunction with pelvic exams to effectively screen for patients who are likely to have successful outcomes with robotic myomectomy.
For example, a patient with a 12- to 14-week-size uterus may not be a good candidate for robotic myomectomy if on the MR image the uterus has innumerable myomas without a clearly defined cleavage plane between the tumors. A woman with a significantly larger uterus may be an excellent candidate, on the other hand, if the number and location of leiomyomas is determined by MRI.
Set-Up, Technique
The three basic components of the da Vinci system are a patient-side cart, a vision system, and a surgeon's console. The patient-side cart has four robotic arms that are attached or “docked” to trocars that are placed in the abdomen in strategic locations. One arm holds the endoscope (either an 8.5-mm or 12-mm diameter, with a 0-degree or 30-degree configuration) and the other three arms hold miniaturized 8-mm (or 5-mm) instruments. Some surgeons employ only two of these arms. The vision system delivers a high-definition 3D image to the viewer in the surgeon's console, and 2D images to other monitors in the operating room.
From the console, the surgeon uses hand controllers and foot pedals to move the instrument and camera robotic arms of the patient cart via a process of computer algorithms that reduce tremor and employ motion scaling to deliver precise movements within the surgical field. The robotic instruments have seven degrees of freedom that replicate or surpass the motions of the human hand, allowing the surgeon to essentially perform open surgery through laparoscopic access.
A uterine manipulator is typically used for traditional laparoscopic myomectomy procedures, and robotic myomectomy is no exception. I typically use a standard HUMI manipulator (Harris-Kronner Uterine Manipulator Injector by CooperSurgical), and I dock the patient-side cart between the patient's legs rather than on the side. This placement of the patient cart enables me to employ a four-arm approach for robotic myomectomy, which I prefer, rather than a three-arm approach. With this configuration, I can use one of the instrument arms to manipulate the uterus instead of relying on a bedside assistant having vaginal access to do this task.
One arm, at or above the umbilicus, holds the endoscope. At the beginning of the procedure, an instrument arm on the left side holds a bipolar device (a PK Dissector that is made by Gyrus ACMI for Intuitive Surgical), and one of two instrument arms on the right side holds the robotic scissors (the da Vinci HotShears). The other right-handed instrument arm holds tenaculum forceps, which can be used to manipulate the uterus or fibroid in any direction. At the end of the procedure, for closure of the hysterotomy incision, needle drivers may be substituted for the PK Dissector and HotShears and the ProGrasp (part of the da Vinci Surgical System) substituted for the tenaculum.
The ports or trocar sites are placed after establishing pneumoperitoneum, typically starting with a Veress needle at the primary or camera site. The camera site is chosen based on the size of the uterus, and an attempt is made to keep at least 10 cm (one handbreadth) between the fundus or top of the presenting fibroid and the camera trocar site.
The left lower quadrant port is placed at least 4–5 cm (three fingerbreadth) directly cephalad to the anterior superior iliac spine. The right lower quadrant port is similarly placed, and then the right upper quadrant port, with the distance between the two right ports being at least one handbreadth (10 cm) in a medial direction. The assistant's port is placed in the left upper quadrant near Palmer's point (the point 3 cm below the last rib in the left midclavicular line). (See image 3.)
One can also “side dock” the patient cart using this configuration to provide more access to the vagina when necessary, and the ports can be adjusted higher or lower on the abdomen depending on the size of the uterus. Clearly, there is a limit to how high one may traverse on the abdomen before entering the thoracic cavity using these principles. There are cases, though, in which the camera port may end up below the fundus of the uterus.
Spacing of the arms also can be negatively affected by a lower body mass index (BMI), but every attempt should be made to obtain at least 8–10 cm of spacing between the robotic port sites to minimize or prevent collision of the instrument and camera arms externally and internally. Caution also must be employed to place the trocars perpendicular to the plane of the abdominal wall; this prevents tunneling of the port, which would defeat the purpose of the strategic placement of the arms externally.
The use of two robotic instruments on the patient's right side is key. Having two right-handed instruments gives the surgeon the ability, at any point in the operation, to manipulate the uterus or the fibroid(s) with two graspers, and to be fairly self-sufficient in enucleating and retracting the fibroid(s) as well as in closing the myometrium.
Prior to the hysterotomy, a vasopressin solution of 20 U diluted in 60 cc of normal saline is injected transcutaneously into the myometrium surrounding the myomas using a 22-gauge 3½-inch or 7-inch spinal needle. This is done by direct vision under endoscopic guidance while using MR imagery. (See image 4.)
An incision is then made over the serosa overlying the fibroid to the level of the pseudocapsule. Whenever possible, and especially when the woman plans to have children, we make a transverse incision, as cesarean-section data of vertical versus low transverse incisions demonstrate that the strongest closure is obtained from transverse incisions. (See image 5.)
The myoma is grasped with the robotic tenaculum, and traction/counter-traction is then used to enucleate the myoma, with the tenaculum pulling away from a push-spread motion created with the scissor and a curved bipolar device in the opposite direction. The push-spread technique is preferable over significant use of cautery for two reasons: It reduces the amount of necrosis that occurs within the myometrium as a result of excessive thermal injury, and it promotes healing within the myometrium after the surgery is completed. Any vessels present at the base of the myoma can be addressed with use of the bipolar device. (See image 6.)
Indigo carmine dye may be injected through the uterine manipulator to help discern the location of the endometrial cavity, but the presence of the inflated balloon of the HUMI manipulator is also sufficient for that purpose.
The removed myoma is stored in the cul-de-sac or in the right upper quadrant, and must be counted upon removal just as any other sponge or instrument would be counted. Alternatively, the myomas can be attached on a suture, as a string of pearls, using a needle introduced laparoscopically.
Robotic needle drivers, one standard large and one Mega SutureCut, are then placed. Closure of the hysterotomy incision can currently be achieved with the use of barbed suture, a recently developed type of product that enables consistent tension on the suture line and does not need to be tied. Closure of the deep hysterotomy defect should be done in layers, especially if the defect is greater than 4–5 cm, using at least a 2–0 barbed suture. The myomas are subsequently removed from the abdomen by a process of morcellation. (See images 7 and 8.)
I recommend not using barbed suture on the serosa, but instead using a monofilament, nonbarbed suture of a smaller gauge such as 3–0. This is because exposure of the barbs on the serosa of the uterus may lead to adhesion formation by catching bowel or omentum.
Closure of the serosa can be achieved with either a running, imbricating stitch, or a baseball stitch. Morcellation is performed under direct vision (after undocking the robotic patient side-cart) using a 15-mm mechanical device placed either in the camera port or the left upper quadrant assistant port. A traditional 5-mm laparoscope or a robotic 8.5-mm endoscope can be used to facilitate this process.
Patients and Outcomes
Based on the published literature to date, and on MRI mapping, I recommend that the number of myomas removed not exceed five, and that the uterus be no larger than a 20-week gestational size. One can certainly exceed these limits, but these criteria are advisable for a surgeon with an average level of experience with robotics.
Although the cost of robotic myomectomy may be greater than that of myomectomy performed by laparotomy, a standardization of the type and number of instruments used, as well as a reduction in the number of disposables used per case, may result in significant cost savings in an institution that already has a robotic system.
Regarding pregnancies achieved after robotic myomectomies, preliminary data have been positive. We will report studies of long-term experience this fall.
Download a mobile quick response (QR) code reader from your smartphone's app store to view a video by Dr. Pitter, or visit
Image 1 (left): Below the endoscopic view of the fibroid uterus (top), MR images are superimposed in the surgeon's console viewer. The upper left MR image is a sagittal pelvic view indicating the presence of fibroids (left to right) in the posterior fundal, submucosal, and posterior midportion of the uterus. The upper right and lower left images are axial views showing fibroids (top to bottom) in the anterior left, submucosal left midportion, and posterior midportion of the uterus. In Image 2, the relative size of the images are adjusted to the surgeon's needs.
Source Images courtesy Dr. Michael C. Pitter
Image 3 shows robotic trocar placement in a 4-arm approach.
Image 4 (top): A spinal needle injects a dilute vasopressin solution into the fibroid pseudocapsule. Image 5: An initial incision is made to find the fibroid, using the PK Dissector (left) and HotShears (right).
Image 6 (left): The fibroid is enucleated using three robotic instruments and a suction irrigator from the assistant port. Clockwise from 12 o'clock are HotShears, robotic tenaculum, laparoscopic suction irrigator, and PK Dissector. Image 7 (middle): Closure of the hysterotomy incision is done using a 2–0 V-Loc suture to close the myometrium in two layers. Instruments (from left, upward, to right) are the standard large robotic needle driver; the Prograsp, which holds the suture and supports the uterus while the layers are being closed; and the Mega SutureCut needle driver, used to drive the needle through the myometrium. Image 8 (right): The final layer is closed with a monofilament suture, with optimal leveraging of all three robotic instruments.
Source Images courtesy Dr. Michael C. Pitter
Myomectomy – The Robotic Way
As noted in my AAGL Presidential Address in 2008, while cholecystectomies, hernia repairs, and bariatric surgeries are generally performed via minimally invasive techniques, only a small percentage of hysterectomies are executed by a laparoscopic technique. As pointed out in the text of this edition of the Master Class in gynecologic surgery by guest author Dr. Michael C. Pitter, there has been a recent increase in the percentage of minimally invasive hysterectomies due to robotic assistance.
Even more difficult to master laparoscopically than hysterectomy is myomectomy. Despite numerous opportunities for gynecologists to learn the technique of laparoscopic suturing, laparoscopic myomectomy remains in the domain of a few minimally invasive gynecologic surgeons worldwide. As Dr. Pitter so ably demonstrates in his discourse, for the gynecologist who is challenged by a pure laparoscopic approach, myomectomy can still be performed in a minimally invasive manner with use of robotic assistance. The difficulty of suturing at bedside is simplified with use of the robot due to 3-D visualization and articulating instrumentation.
Dr. Pitter is the chief of gynecologic robotic and minimally invasive surgery and a clinical assistant professor of obstetrics and gynecology at Newark (N.J.) Beth Israel Medical Center. Dr. Pitter is vice chair of the Robotics Special Interest Group of the AAGL and is a charter member of the Society of Robotic Surgery. He has publications both on establishing training criteria in robotic assisted gynecologic surgery, as well as robotic assisted hysterectomy in patients with large uteri. It is a pleasure and honor to welcome Dr. Pitter to this edition of the Master Class in gynecologic surgery.
Myomectomy offers an alternative to hysterectomy for the treatment of uterine fibroids whether or not future fertility is an issue. While many women chose a uterine-sparing approach to maintain their fertility options, there still are many women who prefer myomectomy for reasons other than fertility preservation.
The procedure is an important one for gynecologic surgeons and their patients, as it conveys a high rate of symptom resolution: Eighty-one percent of women who undergo a myomectomy experience complete resolution of their symptoms (Fertil. Steril. 1981;36:433-45).
Robot-assisted laparoscopic myomectomy was first described in 2004 by Dr. Arnold P. Advincula and his colleagues (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).
Their report played a pivotal role in the Food and Drug Administration's approval in 2005 for use of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for gynecologic surgical procedures.
While myomectomy still is most commonly performed via laparotomy, a significant number of surgeons have adopted the robotic approach. According to data from Solucient, a health care information company managed by Thomson Reuters, approximately 4,000 robotic myomectomies were performed in the United States in 2010. This represents 10% of the approximately 40,000 myomectomies performed each year, a significant proportion considering that robotics had been introduced to gynecology only 5 years earlier.
Myomectomy is a suture-intensive procedure, and suturing by a conventional laparoscopic approach has proved to be extremely challenging. The robotic platform gives surgeons greater capability of successfully repairing deep hysterotomy defects and provides them with a more achievable minimally invasive option to offer patients.
Interestingly, utilization of the laparoscopic approach for hysterectomy also has increased with the introduction of robotics. Current statistics show that only 16% of all hysterectomy procedures performed in the United States are done via conventional laparoscopy (20 years, approximately, after the techniques were developed), while another 20% are now being performed with robot assistance. A new AAGL position statement saying that surgeons who offer hysterectomy should be able to perform either vaginal hysterectomy (the preferred approach) or laparoscopic hysterectomy (the second best approach) – or refer their patients to a surgeon who can (J. Minim. Invasive Gynecol. 2011;18:1-3) – is indicative of the growing belief that the benefits of minimally invasive surgery over open procedures should be considered where possible in aspects of gynecologic surgery.
At our institution, we saw a significant improvement in operative time after the first 20 cases of robot-assisted myomectomy and hysterectomy. Our operative time went from a mean of 212 min. for cases 1–20 to a mean of 151 min. for cases 21–40 (Int. J. Med. Robot. 2008;4:114-20).
Others have reported similar findings on the learning curve for robot-assisted gynecologic surgery: Another case series published several years ago, for instance, showed operative times for various surgical procedures for benign gynecologic problems stabilizing within 50 cases (J. Minim. Invasive Gynecol. 2008;15:589-94). In general, these data are indicative of a significantly shorter learning curve than seen with traditional laparoscopic surgery.
Incorporation of MRI
The main drawback to robotics always has been the absence of haptics or tactile feedback. This limitation has, however, spurred the development of creative techniques to compensate, including the use of real-time magnetic resonance imaging.
MR images can now be incorporated in a real-time, 3-dimensional fashion into the surgeon's console for use in mapping, detecting, locating, and enucleating myomas. All three views – axial, coronal, and sagittal – can be seen during the surgery. This enables the surgeon both to overcome the haptic limitations and to remove multiple fibroids. (See images 1 and 2.)
Certainly, the gynecologic surgeon employing this technique must be comfortable reading and interpreting MR images. The necessary comfort level can be achieved, on an individual basis, with time spent reviewing series of pelvic MR images with a radiologist.
MR imaging also has proved, of course, to be an excellent preoperative tool for determining ahead of time the size, number, and location of myomas, and for ruling out adenomyosis. In my experience, MR imaging can be useful preoperatively in conjunction with pelvic exams to effectively screen for patients who are likely to have successful outcomes with robotic myomectomy.
For example, a patient with a 12- to 14-week-size uterus may not be a good candidate for robotic myomectomy if on the MR image the uterus has innumerable myomas without a clearly defined cleavage plane between the tumors. A woman with a significantly larger uterus may be an excellent candidate, on the other hand, if the number and location of leiomyomas is determined by MRI.
Set-Up, Technique
The three basic components of the da Vinci system are a patient-side cart, a vision system, and a surgeon's console. The patient-side cart has four robotic arms that are attached or “docked” to trocars that are placed in the abdomen in strategic locations. One arm holds the endoscope (either an 8.5-mm or 12-mm diameter, with a 0-degree or 30-degree configuration) and the other three arms hold miniaturized 8-mm (or 5-mm) instruments. Some surgeons employ only two of these arms. The vision system delivers a high-definition 3D image to the viewer in the surgeon's console, and 2D images to other monitors in the operating room.
From the console, the surgeon uses hand controllers and foot pedals to move the instrument and camera robotic arms of the patient cart via a process of computer algorithms that reduce tremor and employ motion scaling to deliver precise movements within the surgical field. The robotic instruments have seven degrees of freedom that replicate or surpass the motions of the human hand, allowing the surgeon to essentially perform open surgery through laparoscopic access.
A uterine manipulator is typically used for traditional laparoscopic myomectomy procedures, and robotic myomectomy is no exception. I typically use a standard HUMI manipulator (Harris-Kronner Uterine Manipulator Injector by CooperSurgical), and I dock the patient-side cart between the patient's legs rather than on the side. This placement of the patient cart enables me to employ a four-arm approach for robotic myomectomy, which I prefer, rather than a three-arm approach. With this configuration, I can use one of the instrument arms to manipulate the uterus instead of relying on a bedside assistant having vaginal access to do this task.
One arm, at or above the umbilicus, holds the endoscope. At the beginning of the procedure, an instrument arm on the left side holds a bipolar device (a PK Dissector that is made by Gyrus ACMI for Intuitive Surgical), and one of two instrument arms on the right side holds the robotic scissors (the da Vinci HotShears). The other right-handed instrument arm holds tenaculum forceps, which can be used to manipulate the uterus or fibroid in any direction. At the end of the procedure, for closure of the hysterotomy incision, needle drivers may be substituted for the PK Dissector and HotShears and the ProGrasp (part of the da Vinci Surgical System) substituted for the tenaculum.
The ports or trocar sites are placed after establishing pneumoperitoneum, typically starting with a Veress needle at the primary or camera site. The camera site is chosen based on the size of the uterus, and an attempt is made to keep at least 10 cm (one handbreadth) between the fundus or top of the presenting fibroid and the camera trocar site.
The left lower quadrant port is placed at least 4–5 cm (three fingerbreadth) directly cephalad to the anterior superior iliac spine. The right lower quadrant port is similarly placed, and then the right upper quadrant port, with the distance between the two right ports being at least one handbreadth (10 cm) in a medial direction. The assistant's port is placed in the left upper quadrant near Palmer's point (the point 3 cm below the last rib in the left midclavicular line). (See image 3.)
One can also “side dock” the patient cart using this configuration to provide more access to the vagina when necessary, and the ports can be adjusted higher or lower on the abdomen depending on the size of the uterus. Clearly, there is a limit to how high one may traverse on the abdomen before entering the thoracic cavity using these principles. There are cases, though, in which the camera port may end up below the fundus of the uterus.
Spacing of the arms also can be negatively affected by a lower body mass index (BMI), but every attempt should be made to obtain at least 8–10 cm of spacing between the robotic port sites to minimize or prevent collision of the instrument and camera arms externally and internally. Caution also must be employed to place the trocars perpendicular to the plane of the abdominal wall; this prevents tunneling of the port, which would defeat the purpose of the strategic placement of the arms externally.
The use of two robotic instruments on the patient's right side is key. Having two right-handed instruments gives the surgeon the ability, at any point in the operation, to manipulate the uterus or the fibroid(s) with two graspers, and to be fairly self-sufficient in enucleating and retracting the fibroid(s) as well as in closing the myometrium.
Prior to the hysterotomy, a vasopressin solution of 20 U diluted in 60 cc of normal saline is injected transcutaneously into the myometrium surrounding the myomas using a 22-gauge 3½-inch or 7-inch spinal needle. This is done by direct vision under endoscopic guidance while using MR imagery. (See image 4.)
An incision is then made over the serosa overlying the fibroid to the level of the pseudocapsule. Whenever possible, and especially when the woman plans to have children, we make a transverse incision, as cesarean-section data of vertical versus low transverse incisions demonstrate that the strongest closure is obtained from transverse incisions. (See image 5.)
The myoma is grasped with the robotic tenaculum, and traction/counter-traction is then used to enucleate the myoma, with the tenaculum pulling away from a push-spread motion created with the scissor and a curved bipolar device in the opposite direction. The push-spread technique is preferable over significant use of cautery for two reasons: It reduces the amount of necrosis that occurs within the myometrium as a result of excessive thermal injury, and it promotes healing within the myometrium after the surgery is completed. Any vessels present at the base of the myoma can be addressed with use of the bipolar device. (See image 6.)
Indigo carmine dye may be injected through the uterine manipulator to help discern the location of the endometrial cavity, but the presence of the inflated balloon of the HUMI manipulator is also sufficient for that purpose.
The removed myoma is stored in the cul-de-sac or in the right upper quadrant, and must be counted upon removal just as any other sponge or instrument would be counted. Alternatively, the myomas can be attached on a suture, as a string of pearls, using a needle introduced laparoscopically.
Robotic needle drivers, one standard large and one Mega SutureCut, are then placed. Closure of the hysterotomy incision can currently be achieved with the use of barbed suture, a recently developed type of product that enables consistent tension on the suture line and does not need to be tied. Closure of the deep hysterotomy defect should be done in layers, especially if the defect is greater than 4–5 cm, using at least a 2–0 barbed suture. The myomas are subsequently removed from the abdomen by a process of morcellation. (See images 7 and 8.)
I recommend not using barbed suture on the serosa, but instead using a monofilament, nonbarbed suture of a smaller gauge such as 3–0. This is because exposure of the barbs on the serosa of the uterus may lead to adhesion formation by catching bowel or omentum.
Closure of the serosa can be achieved with either a running, imbricating stitch, or a baseball stitch. Morcellation is performed under direct vision (after undocking the robotic patient side-cart) using a 15-mm mechanical device placed either in the camera port or the left upper quadrant assistant port. A traditional 5-mm laparoscope or a robotic 8.5-mm endoscope can be used to facilitate this process.
Patients and Outcomes
Based on the published literature to date, and on MRI mapping, I recommend that the number of myomas removed not exceed five, and that the uterus be no larger than a 20-week gestational size. One can certainly exceed these limits, but these criteria are advisable for a surgeon with an average level of experience with robotics.
Although the cost of robotic myomectomy may be greater than that of myomectomy performed by laparotomy, a standardization of the type and number of instruments used, as well as a reduction in the number of disposables used per case, may result in significant cost savings in an institution that already has a robotic system.
Regarding pregnancies achieved after robotic myomectomies, preliminary data have been positive. We will report studies of long-term experience this fall.
Download a mobile quick response (QR) code reader from your smartphone's app store to view a video by Dr. Pitter, or visit
Image 1 (left): Below the endoscopic view of the fibroid uterus (top), MR images are superimposed in the surgeon's console viewer. The upper left MR image is a sagittal pelvic view indicating the presence of fibroids (left to right) in the posterior fundal, submucosal, and posterior midportion of the uterus. The upper right and lower left images are axial views showing fibroids (top to bottom) in the anterior left, submucosal left midportion, and posterior midportion of the uterus. In Image 2, the relative size of the images are adjusted to the surgeon's needs.
Source Images courtesy Dr. Michael C. Pitter
Image 3 shows robotic trocar placement in a 4-arm approach.
Image 4 (top): A spinal needle injects a dilute vasopressin solution into the fibroid pseudocapsule. Image 5: An initial incision is made to find the fibroid, using the PK Dissector (left) and HotShears (right).
Image 6 (left): The fibroid is enucleated using three robotic instruments and a suction irrigator from the assistant port. Clockwise from 12 o'clock are HotShears, robotic tenaculum, laparoscopic suction irrigator, and PK Dissector. Image 7 (middle): Closure of the hysterotomy incision is done using a 2–0 V-Loc suture to close the myometrium in two layers. Instruments (from left, upward, to right) are the standard large robotic needle driver; the Prograsp, which holds the suture and supports the uterus while the layers are being closed; and the Mega SutureCut needle driver, used to drive the needle through the myometrium. Image 8 (right): The final layer is closed with a monofilament suture, with optimal leveraging of all three robotic instruments.
Source Images courtesy Dr. Michael C. Pitter
Myomectomy – The Robotic Way
As noted in my AAGL Presidential Address in 2008, while cholecystectomies, hernia repairs, and bariatric surgeries are generally performed via minimally invasive techniques, only a small percentage of hysterectomies are executed by a laparoscopic technique. As pointed out in the text of this edition of the Master Class in gynecologic surgery by guest author Dr. Michael C. Pitter, there has been a recent increase in the percentage of minimally invasive hysterectomies due to robotic assistance.
Even more difficult to master laparoscopically than hysterectomy is myomectomy. Despite numerous opportunities for gynecologists to learn the technique of laparoscopic suturing, laparoscopic myomectomy remains in the domain of a few minimally invasive gynecologic surgeons worldwide. As Dr. Pitter so ably demonstrates in his discourse, for the gynecologist who is challenged by a pure laparoscopic approach, myomectomy can still be performed in a minimally invasive manner with use of robotic assistance. The difficulty of suturing at bedside is simplified with use of the robot due to 3-D visualization and articulating instrumentation.
Dr. Pitter is the chief of gynecologic robotic and minimally invasive surgery and a clinical assistant professor of obstetrics and gynecology at Newark (N.J.) Beth Israel Medical Center. Dr. Pitter is vice chair of the Robotics Special Interest Group of the AAGL and is a charter member of the Society of Robotic Surgery. He has publications both on establishing training criteria in robotic assisted gynecologic surgery, as well as robotic assisted hysterectomy in patients with large uteri. It is a pleasure and honor to welcome Dr. Pitter to this edition of the Master Class in gynecologic surgery.
Myomectomy offers an alternative to hysterectomy for the treatment of uterine fibroids whether or not future fertility is an issue. While many women chose a uterine-sparing approach to maintain their fertility options, there still are many women who prefer myomectomy for reasons other than fertility preservation.
The procedure is an important one for gynecologic surgeons and their patients, as it conveys a high rate of symptom resolution: Eighty-one percent of women who undergo a myomectomy experience complete resolution of their symptoms (Fertil. Steril. 1981;36:433-45).
Robot-assisted laparoscopic myomectomy was first described in 2004 by Dr. Arnold P. Advincula and his colleagues (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).
Their report played a pivotal role in the Food and Drug Administration's approval in 2005 for use of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for gynecologic surgical procedures.
While myomectomy still is most commonly performed via laparotomy, a significant number of surgeons have adopted the robotic approach. According to data from Solucient, a health care information company managed by Thomson Reuters, approximately 4,000 robotic myomectomies were performed in the United States in 2010. This represents 10% of the approximately 40,000 myomectomies performed each year, a significant proportion considering that robotics had been introduced to gynecology only 5 years earlier.
Myomectomy is a suture-intensive procedure, and suturing by a conventional laparoscopic approach has proved to be extremely challenging. The robotic platform gives surgeons greater capability of successfully repairing deep hysterotomy defects and provides them with a more achievable minimally invasive option to offer patients.
Interestingly, utilization of the laparoscopic approach for hysterectomy also has increased with the introduction of robotics. Current statistics show that only 16% of all hysterectomy procedures performed in the United States are done via conventional laparoscopy (20 years, approximately, after the techniques were developed), while another 20% are now being performed with robot assistance. A new AAGL position statement saying that surgeons who offer hysterectomy should be able to perform either vaginal hysterectomy (the preferred approach) or laparoscopic hysterectomy (the second best approach) – or refer their patients to a surgeon who can (J. Minim. Invasive Gynecol. 2011;18:1-3) – is indicative of the growing belief that the benefits of minimally invasive surgery over open procedures should be considered where possible in aspects of gynecologic surgery.
At our institution, we saw a significant improvement in operative time after the first 20 cases of robot-assisted myomectomy and hysterectomy. Our operative time went from a mean of 212 min. for cases 1–20 to a mean of 151 min. for cases 21–40 (Int. J. Med. Robot. 2008;4:114-20).
Others have reported similar findings on the learning curve for robot-assisted gynecologic surgery: Another case series published several years ago, for instance, showed operative times for various surgical procedures for benign gynecologic problems stabilizing within 50 cases (J. Minim. Invasive Gynecol. 2008;15:589-94). In general, these data are indicative of a significantly shorter learning curve than seen with traditional laparoscopic surgery.
Incorporation of MRI
The main drawback to robotics always has been the absence of haptics or tactile feedback. This limitation has, however, spurred the development of creative techniques to compensate, including the use of real-time magnetic resonance imaging.
MR images can now be incorporated in a real-time, 3-dimensional fashion into the surgeon's console for use in mapping, detecting, locating, and enucleating myomas. All three views – axial, coronal, and sagittal – can be seen during the surgery. This enables the surgeon both to overcome the haptic limitations and to remove multiple fibroids. (See images 1 and 2.)
Certainly, the gynecologic surgeon employing this technique must be comfortable reading and interpreting MR images. The necessary comfort level can be achieved, on an individual basis, with time spent reviewing series of pelvic MR images with a radiologist.
MR imaging also has proved, of course, to be an excellent preoperative tool for determining ahead of time the size, number, and location of myomas, and for ruling out adenomyosis. In my experience, MR imaging can be useful preoperatively in conjunction with pelvic exams to effectively screen for patients who are likely to have successful outcomes with robotic myomectomy.
For example, a patient with a 12- to 14-week-size uterus may not be a good candidate for robotic myomectomy if on the MR image the uterus has innumerable myomas without a clearly defined cleavage plane between the tumors. A woman with a significantly larger uterus may be an excellent candidate, on the other hand, if the number and location of leiomyomas is determined by MRI.
Set-Up, Technique
The three basic components of the da Vinci system are a patient-side cart, a vision system, and a surgeon's console. The patient-side cart has four robotic arms that are attached or “docked” to trocars that are placed in the abdomen in strategic locations. One arm holds the endoscope (either an 8.5-mm or 12-mm diameter, with a 0-degree or 30-degree configuration) and the other three arms hold miniaturized 8-mm (or 5-mm) instruments. Some surgeons employ only two of these arms. The vision system delivers a high-definition 3D image to the viewer in the surgeon's console, and 2D images to other monitors in the operating room.
From the console, the surgeon uses hand controllers and foot pedals to move the instrument and camera robotic arms of the patient cart via a process of computer algorithms that reduce tremor and employ motion scaling to deliver precise movements within the surgical field. The robotic instruments have seven degrees of freedom that replicate or surpass the motions of the human hand, allowing the surgeon to essentially perform open surgery through laparoscopic access.
A uterine manipulator is typically used for traditional laparoscopic myomectomy procedures, and robotic myomectomy is no exception. I typically use a standard HUMI manipulator (Harris-Kronner Uterine Manipulator Injector by CooperSurgical), and I dock the patient-side cart between the patient's legs rather than on the side. This placement of the patient cart enables me to employ a four-arm approach for robotic myomectomy, which I prefer, rather than a three-arm approach. With this configuration, I can use one of the instrument arms to manipulate the uterus instead of relying on a bedside assistant having vaginal access to do this task.
One arm, at or above the umbilicus, holds the endoscope. At the beginning of the procedure, an instrument arm on the left side holds a bipolar device (a PK Dissector that is made by Gyrus ACMI for Intuitive Surgical), and one of two instrument arms on the right side holds the robotic scissors (the da Vinci HotShears). The other right-handed instrument arm holds tenaculum forceps, which can be used to manipulate the uterus or fibroid in any direction. At the end of the procedure, for closure of the hysterotomy incision, needle drivers may be substituted for the PK Dissector and HotShears and the ProGrasp (part of the da Vinci Surgical System) substituted for the tenaculum.
The ports or trocar sites are placed after establishing pneumoperitoneum, typically starting with a Veress needle at the primary or camera site. The camera site is chosen based on the size of the uterus, and an attempt is made to keep at least 10 cm (one handbreadth) between the fundus or top of the presenting fibroid and the camera trocar site.
The left lower quadrant port is placed at least 4–5 cm (three fingerbreadth) directly cephalad to the anterior superior iliac spine. The right lower quadrant port is similarly placed, and then the right upper quadrant port, with the distance between the two right ports being at least one handbreadth (10 cm) in a medial direction. The assistant's port is placed in the left upper quadrant near Palmer's point (the point 3 cm below the last rib in the left midclavicular line). (See image 3.)
One can also “side dock” the patient cart using this configuration to provide more access to the vagina when necessary, and the ports can be adjusted higher or lower on the abdomen depending on the size of the uterus. Clearly, there is a limit to how high one may traverse on the abdomen before entering the thoracic cavity using these principles. There are cases, though, in which the camera port may end up below the fundus of the uterus.
Spacing of the arms also can be negatively affected by a lower body mass index (BMI), but every attempt should be made to obtain at least 8–10 cm of spacing between the robotic port sites to minimize or prevent collision of the instrument and camera arms externally and internally. Caution also must be employed to place the trocars perpendicular to the plane of the abdominal wall; this prevents tunneling of the port, which would defeat the purpose of the strategic placement of the arms externally.
The use of two robotic instruments on the patient's right side is key. Having two right-handed instruments gives the surgeon the ability, at any point in the operation, to manipulate the uterus or the fibroid(s) with two graspers, and to be fairly self-sufficient in enucleating and retracting the fibroid(s) as well as in closing the myometrium.
Prior to the hysterotomy, a vasopressin solution of 20 U diluted in 60 cc of normal saline is injected transcutaneously into the myometrium surrounding the myomas using a 22-gauge 3½-inch or 7-inch spinal needle. This is done by direct vision under endoscopic guidance while using MR imagery. (See image 4.)
An incision is then made over the serosa overlying the fibroid to the level of the pseudocapsule. Whenever possible, and especially when the woman plans to have children, we make a transverse incision, as cesarean-section data of vertical versus low transverse incisions demonstrate that the strongest closure is obtained from transverse incisions. (See image 5.)
The myoma is grasped with the robotic tenaculum, and traction/counter-traction is then used to enucleate the myoma, with the tenaculum pulling away from a push-spread motion created with the scissor and a curved bipolar device in the opposite direction. The push-spread technique is preferable over significant use of cautery for two reasons: It reduces the amount of necrosis that occurs within the myometrium as a result of excessive thermal injury, and it promotes healing within the myometrium after the surgery is completed. Any vessels present at the base of the myoma can be addressed with use of the bipolar device. (See image 6.)
Indigo carmine dye may be injected through the uterine manipulator to help discern the location of the endometrial cavity, but the presence of the inflated balloon of the HUMI manipulator is also sufficient for that purpose.
The removed myoma is stored in the cul-de-sac or in the right upper quadrant, and must be counted upon removal just as any other sponge or instrument would be counted. Alternatively, the myomas can be attached on a suture, as a string of pearls, using a needle introduced laparoscopically.
Robotic needle drivers, one standard large and one Mega SutureCut, are then placed. Closure of the hysterotomy incision can currently be achieved with the use of barbed suture, a recently developed type of product that enables consistent tension on the suture line and does not need to be tied. Closure of the deep hysterotomy defect should be done in layers, especially if the defect is greater than 4–5 cm, using at least a 2–0 barbed suture. The myomas are subsequently removed from the abdomen by a process of morcellation. (See images 7 and 8.)
I recommend not using barbed suture on the serosa, but instead using a monofilament, nonbarbed suture of a smaller gauge such as 3–0. This is because exposure of the barbs on the serosa of the uterus may lead to adhesion formation by catching bowel or omentum.
Closure of the serosa can be achieved with either a running, imbricating stitch, or a baseball stitch. Morcellation is performed under direct vision (after undocking the robotic patient side-cart) using a 15-mm mechanical device placed either in the camera port or the left upper quadrant assistant port. A traditional 5-mm laparoscope or a robotic 8.5-mm endoscope can be used to facilitate this process.
Patients and Outcomes
Based on the published literature to date, and on MRI mapping, I recommend that the number of myomas removed not exceed five, and that the uterus be no larger than a 20-week gestational size. One can certainly exceed these limits, but these criteria are advisable for a surgeon with an average level of experience with robotics.
Although the cost of robotic myomectomy may be greater than that of myomectomy performed by laparotomy, a standardization of the type and number of instruments used, as well as a reduction in the number of disposables used per case, may result in significant cost savings in an institution that already has a robotic system.
Regarding pregnancies achieved after robotic myomectomies, preliminary data have been positive. We will report studies of long-term experience this fall.
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Image 1 (left): Below the endoscopic view of the fibroid uterus (top), MR images are superimposed in the surgeon's console viewer. The upper left MR image is a sagittal pelvic view indicating the presence of fibroids (left to right) in the posterior fundal, submucosal, and posterior midportion of the uterus. The upper right and lower left images are axial views showing fibroids (top to bottom) in the anterior left, submucosal left midportion, and posterior midportion of the uterus. In Image 2, the relative size of the images are adjusted to the surgeon's needs.
Source Images courtesy Dr. Michael C. Pitter
Image 3 shows robotic trocar placement in a 4-arm approach.
Image 4 (top): A spinal needle injects a dilute vasopressin solution into the fibroid pseudocapsule. Image 5: An initial incision is made to find the fibroid, using the PK Dissector (left) and HotShears (right).
Image 6 (left): The fibroid is enucleated using three robotic instruments and a suction irrigator from the assistant port. Clockwise from 12 o'clock are HotShears, robotic tenaculum, laparoscopic suction irrigator, and PK Dissector. Image 7 (middle): Closure of the hysterotomy incision is done using a 2–0 V-Loc suture to close the myometrium in two layers. Instruments (from left, upward, to right) are the standard large robotic needle driver; the Prograsp, which holds the suture and supports the uterus while the layers are being closed; and the Mega SutureCut needle driver, used to drive the needle through the myometrium. Image 8 (right): The final layer is closed with a monofilament suture, with optimal leveraging of all three robotic instruments.
Source Images courtesy Dr. Michael C. Pitter
Myomectomy – The Robotic Way
As noted in my AAGL Presidential Address in 2008, while cholecystectomies, hernia repairs, and bariatric surgeries are generally performed via minimally invasive techniques, only a small percentage of hysterectomies are executed by a laparoscopic technique. As pointed out in the text of this edition of the Master Class in gynecologic surgery by guest author Dr. Michael C. Pitter, there has been a recent increase in the percentage of minimally invasive hysterectomies due to robotic assistance.
Even more difficult to master laparoscopically than hysterectomy is myomectomy. Despite numerous opportunities for gynecologists to learn the technique of laparoscopic suturing, laparoscopic myomectomy remains in the domain of a few minimally invasive gynecologic surgeons worldwide. As Dr. Pitter so ably demonstrates in his discourse, for the gynecologist who is challenged by a pure laparoscopic approach, myomectomy can still be performed in a minimally invasive manner with use of robotic assistance. The difficulty of suturing at bedside is simplified with use of the robot due to 3-D visualization and articulating instrumentation.
Dr. Pitter is the chief of gynecologic robotic and minimally invasive surgery and a clinical assistant professor of obstetrics and gynecology at Newark (N.J.) Beth Israel Medical Center. Dr. Pitter is vice chair of the Robotics Special Interest Group of the AAGL and is a charter member of the Society of Robotic Surgery. He has publications both on establishing training criteria in robotic assisted gynecologic surgery, as well as robotic assisted hysterectomy in patients with large uteri. It is a pleasure and honor to welcome Dr. Pitter to this edition of the Master Class in gynecologic surgery.
Bowel Resection With Invasive Endometriosis
Deep endometriosis involving the bowel is uncommon, but not rare, among patients with pelvic endometriosis. There is a growing body of literature describing minimally invasive colorectal resection for invasive endometriosis, and a growing feeling among gynecologic surgeons that endometriosis involving the rectal wall is better treated with rectal resection than with a shaving, or scraping, technique.
In our experience of working within a multispecialty surgical team, addressing endometriosis in a systematic fashion has led to a higher rate of patient satisfaction and quality of life, a lower rate of recurrent symptoms, and less surgical morbidity than has been seen with other approaches. While still infrequent, the greatest impact of this multispecialty approach has been the more liberal inclusion of bowel resection as part of the treatment for deep pelvic endometriosis.
It is our belief that patients who have evidence of bowel involvement and have a colorectal resection as part of their endometriosis treatment ultimately have a better surgical outcome. The opposite also appears to hold true. Those patients who have endometriosis involving the bowel wall and who do not receive a bowel resection have been more prone to recurrent disease and symptoms resulting in subsequent reoperations that are often more difficult to perform than a planned colorectal resection would have been.
Furthermore, surgery involving premeditated bowel resection is often safer than treatment employing a scraping technique when endometriosis is deep seated. In cases in which endometriosis has infiltrated the rectal wall, scraping techniques often result in unidentified bowel perforation, which leads to operations that are much more difficult to perform than planned elective resections. In addition, delayed missed injuries often will result in multiple trips to the operating room that frequently include the use of a colostomy in an otherwise young, healthy female patient.
Diagnosing Rectal Involvement
The full extent of disease, including the precise involvement of the bowel, sometimes can be difficult to determine prior to surgery. In many cases, however, physical examination combined with endoscopy and ultrasonography is enough to diagnose bowel involvement that would best be treated with segmental resection.
Pain associated with defecation, rectal bleeding around menses, and constipation often are found on history. On physical exam, endometriosis involving the rectal wall is most commonly associated with pain on both vaginal and rectal examination. Nodularity of the rectal wall, as well as distortion of the rectal folds, often is palpated.
The presence of either nodularity or rectal wall distortion raises the likelihood that there is significant rectal wall involvement. Conversely, if there is minimal or no nodularity of the rectal wall, the likelihood of rectal involvement is low.
When physical examination is abnormal, we proceed with colonoscopy, which enables us to visualize external compression on the rectal wall, nodularity, or other signs of endometriosis infiltrating the bowel wall. Colonoscopy is preferred because endometriosis is often found in the cecum, which would be missed on flexible sigmoidoscopy. Rarely will endometriosis actually penetrate the bowel wall. Most of the time, wall distortion with what is often seen as a submucosal mass is the only positive finding. Biopsy of the abnormality is typically unsatisfying, with normal colonic mucosa being the most common finding on microscopy.
When there are positive endoscopic findings, we prefer endorectal ultrasonography (ERUS) over transvaginal ultrasound to further evaluate rectal wall involvement of endometriosis. Using a 10-megahertz, 3-D ultrasound, we are able to visualize if endometriosis is attached to the bowel wall and to what degree.
The most important finding is whether or not endometriosis is invading the muscularis propria by the presence or absence of a space between the lesion(s) and the muscularis propria. If a space is visualized, there is a fairly good chance that the endometriosis may be safely scraped off the rectum.
If we see, on the other hand, that the endometriosis is either invading or firmly attached to the rectal muscularis propria, we know that chances of successfully scraping the lesion(s) off the rectum will be very low. In that case, a segmental resection of the rectum can be scheduled in conjunction with the rest of the endometriosis removal. Previous endometriosis surgery, it must be noted, leads to scar tissue which will often distort ERUS images and make the exam less accurate.
Surgical Planning
When the preoperative work-up is confirmatory, a combined surgical approach is scheduled. When the work-up is negative and the patient is scheduled for removal of endometriosis from the nongastrointestinal organs, we remain on surgical standby because bowel involvement of endometriosis is occasionally discovered in symptomatic patients despite a negative work-up.
Standby status also allows the gynecologist to be more aggressive because rectal wall injury can be corrected at the time of surgery. Flexible sigmoidoscopy always should be performed at the end of any endometriosis operation in which bowel proximity is encountered. By submerging the bowel under water and inflating air via the sigmoidoscope, the presence of air bubbles often will identify a missed bowel injury.
Segmental resection usually involves no more than 5-6 cm of the rectum. We do, however, extend the resection a bit proximally if the patient has a history of chronic constipation. Resecting more of the rectum and sigmoid colon to straighten out the left side of the large bowel and shorten the overall length will better alleviate the patient's constipation symptoms. Combined with improvement in the patient's defecation-related symptoms associated with the endometriosis, patient satisfaction regarding the elimination of constipation symptoms is often quite high.
Basic Surgical Technique
Rectal resection for deep endometriosis is comparable to resection of a T4 rectal cancer (one that has invaded outside the rectal wall), except that in the case of endometriosis, we typically are treating young, otherwise healthy patients. In these patients, the risk of complications – mainly, the risk of a permanent colostomy – is all the more concerning. It is important that patients understand the risk and benefits of the surgery and that the colorectal surgeon has the proper expertise for such a technically demanding, risky operation.
The operation is performed in a modified lithotomy position. A laparoscopic or hand-assisted laparoscopic approach can be used. We have performed both techniques, but find a hand-assisted laparoscopic approach faster. A robotic-assisted approach also is being developed.
Depending upon the type of camera used, a 5- or 10-mm port is placed in the umbilicus. The only other ancillary ports needed are 5-mm dissecting ports placed in the right and left lower quadrants. A mini-Pfannenstiel incision is needed to remove the rectal specimen. By extending this incision 3 centimeters, a hand port for hand-assisted laparoscopic surgery can be placed.
Surgery is initiated by the gynecologic surgeon, who resects endometriosis off all nongastrointestinal organs. Endometriosis involving the colon and rectum is left intact. If indicated, hysterectomy with salpingo-oophorectomy is performed at this time.
Next is the laparoscopic colorectal portion of the surgery. First, the inferior mesenteric artery is ligated at the root of the aorta so that various collateral vessels within the marginal branches and Riolan's arch are not sacrificed. Usually, this ligation alone will adequately free up the sigmoid colon enough for a tension-free anastomosis. If the sigmoid colon still cannot be lowered into the rectum without undue tension, we also will ligate the rectal tributary of the inferior mesenteric vein, one of the two main tributaries of the mesenteric vein.
The remainder of the mobilization involves dissecting along the White line of Toldt until the colon falls freely into the rectum. Rarely will we need to mobilize the splenic flexure of the colon to achieve adequate length.
With the left side of the colon freely mobilized, we turn our attention to the pelvis and subsequent rectal dissection. We do not remove the lesion from the rectum, since we have already confirmed that the lesion is firmly attached to the rectal wall. The endometriosis is removed en bloc with the rectum, similar to what is done for rectal cancer.
While the lateral and posterior dissection of the mesorectum can be easily done laparoscopically or robotically, we believe the anterior dissection of the rectum – removal of the endometriosis off the posterior aspect of the vagina while leaving it attached to the rectum – is more easily performed using a hand-assisted laparoscopic approach or even a hybrid open approach through the mini-Pfannenstiel incision.
Dissection is carried out distally until a soft, normal section of rectum is identified. At least 2 cm of normal rectum is needed for a safe anastomosis.
Endometriosis involving the bowel usually appears as a white fibrotic, submucosal mass and feels similar to invasive rectal cancer. The difference, of course, is that rectal cancer is mostly intraluminal, whereas endometriosis usually originates outside the bowel wall and invades inward. Occasionally, one will find “chocolate”-filled cysts within the endometriotic mass, but this is rare.
Endometriosis with bowel involvement is typically anterior to the rectum and posterior to the vagina, but lesions posterior to the rectum have been found, which would denote a nonanatomical spreading distribution.
There are two techniques for a low colorectal anastomosis: The hand-sewn anastomosis technique and the end-to-end anastomosis (EEA) stapler technique. The hand-sewn anastomosis has largely been replaced by the EEA stapler because stapling the proximal colon to the lower rectum is easier to perform, faster, and results in a similar anastomotic leak rate when compared to a hand-sewn anastomosis.
An anastomosis in the upper or mid-rectum has a low risk of leaking (less than 2%). Sometimes, in patients with a deep cul-de-sac, the lesion is attached to the mid-rectum and the anastomosis must be performed in the lower rectum, within a few centimeters of the anus. Low rectal anastomoses have leak rates as high as 10%. A flexible sigmoidoscopy must be performed to check for an air leak. If one is found, the anastomosis should be reconstructed or repaired. Temporary diverting ileostomy should be considered if the anastomosis is suboptimal.
An endorectal ultrasound shows endometriosis invading the muscularis propria (1 o'clock position).
Source Courtesy Dr. John J. Park
Endometriosis invades the rectal wall. The mucosa is distorted, but intact.
The inferior mesenteric artery (left) is ligated at the root of the aorta so that various collateral vessels within the marginal branches and Riolan's arch are not sacrificed. This ligation alone often will adequately free up the sigmoid colon enough for a tension-free anastomosis. If the sigmoid colon still cannot be lowered into the rectum without undue tension, the surgeon also will ligate the rectal tributary of the inferior mesenteric vein (right), one of the two main tributaries of the mesenteric vein.
The colon is being attached to the distal rectum using an end-to-end anastomosis stapler.
Source Images Courtesy Dr. John J. Park
Deeply Invasive Rectosigmoid Endometriosis
Deeply invasive rectosigmoid endometriosis can be associated with a severe – and at times incapacitating – symptom complex. This includes dysmenorrhea – both premenstrual and menstrual – deep dyspareunia, dyschezia, and rectal bleeding at time of menses. There also can be an impact on fertility as well, which can be rectified with bowel resection. In the accompanying graphic (right), a number of studies revealing pregnancy post bowel resection for rectosigmoid endometriosis are noted.
As bowel resection is generally not in the armamentarium of the gynecologic surgeon treating benign disease, the proper treatment of deep infiltrated rectosigmoid endometriosis must involve a cooperative effort with a colorectal surgeon who is capable of performing advanced minimally invasive surgery. This collaboration permits the minimally invasive gynecologist to laparoscopically excise endometriosis, lyse pelvic adhesions, resect ovarian endometriomata, and where indicated, perform ureterolysis and total laparoscopic hysterectomy. The colorectal or general surgeon can then proceed with the bowel resection via a minimally invasive approach.
For this current Master Class in Gynecologic Surgery, I have solicited the expertise of Dr. John J. Park. Dr. Park is a clinical assistant professor of surgery in the division of colorectal surgery at the University of Illinois at Chicago, as well as attending surgeon at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Park completed his residency in general surgery at the University of Illinois and his colorectal surgery residency at Mayo Clinic, Rochester, Minn. Dr. Park is board certified in general surgery and colon and rectal surgery.
Deep endometriosis involving the bowel is uncommon, but not rare, among patients with pelvic endometriosis. There is a growing body of literature describing minimally invasive colorectal resection for invasive endometriosis, and a growing feeling among gynecologic surgeons that endometriosis involving the rectal wall is better treated with rectal resection than with a shaving, or scraping, technique.
In our experience of working within a multispecialty surgical team, addressing endometriosis in a systematic fashion has led to a higher rate of patient satisfaction and quality of life, a lower rate of recurrent symptoms, and less surgical morbidity than has been seen with other approaches. While still infrequent, the greatest impact of this multispecialty approach has been the more liberal inclusion of bowel resection as part of the treatment for deep pelvic endometriosis.
It is our belief that patients who have evidence of bowel involvement and have a colorectal resection as part of their endometriosis treatment ultimately have a better surgical outcome. The opposite also appears to hold true. Those patients who have endometriosis involving the bowel wall and who do not receive a bowel resection have been more prone to recurrent disease and symptoms resulting in subsequent reoperations that are often more difficult to perform than a planned colorectal resection would have been.
Furthermore, surgery involving premeditated bowel resection is often safer than treatment employing a scraping technique when endometriosis is deep seated. In cases in which endometriosis has infiltrated the rectal wall, scraping techniques often result in unidentified bowel perforation, which leads to operations that are much more difficult to perform than planned elective resections. In addition, delayed missed injuries often will result in multiple trips to the operating room that frequently include the use of a colostomy in an otherwise young, healthy female patient.
Diagnosing Rectal Involvement
The full extent of disease, including the precise involvement of the bowel, sometimes can be difficult to determine prior to surgery. In many cases, however, physical examination combined with endoscopy and ultrasonography is enough to diagnose bowel involvement that would best be treated with segmental resection.
Pain associated with defecation, rectal bleeding around menses, and constipation often are found on history. On physical exam, endometriosis involving the rectal wall is most commonly associated with pain on both vaginal and rectal examination. Nodularity of the rectal wall, as well as distortion of the rectal folds, often is palpated.
The presence of either nodularity or rectal wall distortion raises the likelihood that there is significant rectal wall involvement. Conversely, if there is minimal or no nodularity of the rectal wall, the likelihood of rectal involvement is low.
When physical examination is abnormal, we proceed with colonoscopy, which enables us to visualize external compression on the rectal wall, nodularity, or other signs of endometriosis infiltrating the bowel wall. Colonoscopy is preferred because endometriosis is often found in the cecum, which would be missed on flexible sigmoidoscopy. Rarely will endometriosis actually penetrate the bowel wall. Most of the time, wall distortion with what is often seen as a submucosal mass is the only positive finding. Biopsy of the abnormality is typically unsatisfying, with normal colonic mucosa being the most common finding on microscopy.
When there are positive endoscopic findings, we prefer endorectal ultrasonography (ERUS) over transvaginal ultrasound to further evaluate rectal wall involvement of endometriosis. Using a 10-megahertz, 3-D ultrasound, we are able to visualize if endometriosis is attached to the bowel wall and to what degree.
The most important finding is whether or not endometriosis is invading the muscularis propria by the presence or absence of a space between the lesion(s) and the muscularis propria. If a space is visualized, there is a fairly good chance that the endometriosis may be safely scraped off the rectum.
If we see, on the other hand, that the endometriosis is either invading or firmly attached to the rectal muscularis propria, we know that chances of successfully scraping the lesion(s) off the rectum will be very low. In that case, a segmental resection of the rectum can be scheduled in conjunction with the rest of the endometriosis removal. Previous endometriosis surgery, it must be noted, leads to scar tissue which will often distort ERUS images and make the exam less accurate.
Surgical Planning
When the preoperative work-up is confirmatory, a combined surgical approach is scheduled. When the work-up is negative and the patient is scheduled for removal of endometriosis from the nongastrointestinal organs, we remain on surgical standby because bowel involvement of endometriosis is occasionally discovered in symptomatic patients despite a negative work-up.
Standby status also allows the gynecologist to be more aggressive because rectal wall injury can be corrected at the time of surgery. Flexible sigmoidoscopy always should be performed at the end of any endometriosis operation in which bowel proximity is encountered. By submerging the bowel under water and inflating air via the sigmoidoscope, the presence of air bubbles often will identify a missed bowel injury.
Segmental resection usually involves no more than 5-6 cm of the rectum. We do, however, extend the resection a bit proximally if the patient has a history of chronic constipation. Resecting more of the rectum and sigmoid colon to straighten out the left side of the large bowel and shorten the overall length will better alleviate the patient's constipation symptoms. Combined with improvement in the patient's defecation-related symptoms associated with the endometriosis, patient satisfaction regarding the elimination of constipation symptoms is often quite high.
Basic Surgical Technique
Rectal resection for deep endometriosis is comparable to resection of a T4 rectal cancer (one that has invaded outside the rectal wall), except that in the case of endometriosis, we typically are treating young, otherwise healthy patients. In these patients, the risk of complications – mainly, the risk of a permanent colostomy – is all the more concerning. It is important that patients understand the risk and benefits of the surgery and that the colorectal surgeon has the proper expertise for such a technically demanding, risky operation.
The operation is performed in a modified lithotomy position. A laparoscopic or hand-assisted laparoscopic approach can be used. We have performed both techniques, but find a hand-assisted laparoscopic approach faster. A robotic-assisted approach also is being developed.
Depending upon the type of camera used, a 5- or 10-mm port is placed in the umbilicus. The only other ancillary ports needed are 5-mm dissecting ports placed in the right and left lower quadrants. A mini-Pfannenstiel incision is needed to remove the rectal specimen. By extending this incision 3 centimeters, a hand port for hand-assisted laparoscopic surgery can be placed.
Surgery is initiated by the gynecologic surgeon, who resects endometriosis off all nongastrointestinal organs. Endometriosis involving the colon and rectum is left intact. If indicated, hysterectomy with salpingo-oophorectomy is performed at this time.
Next is the laparoscopic colorectal portion of the surgery. First, the inferior mesenteric artery is ligated at the root of the aorta so that various collateral vessels within the marginal branches and Riolan's arch are not sacrificed. Usually, this ligation alone will adequately free up the sigmoid colon enough for a tension-free anastomosis. If the sigmoid colon still cannot be lowered into the rectum without undue tension, we also will ligate the rectal tributary of the inferior mesenteric vein, one of the two main tributaries of the mesenteric vein.
The remainder of the mobilization involves dissecting along the White line of Toldt until the colon falls freely into the rectum. Rarely will we need to mobilize the splenic flexure of the colon to achieve adequate length.
With the left side of the colon freely mobilized, we turn our attention to the pelvis and subsequent rectal dissection. We do not remove the lesion from the rectum, since we have already confirmed that the lesion is firmly attached to the rectal wall. The endometriosis is removed en bloc with the rectum, similar to what is done for rectal cancer.
While the lateral and posterior dissection of the mesorectum can be easily done laparoscopically or robotically, we believe the anterior dissection of the rectum – removal of the endometriosis off the posterior aspect of the vagina while leaving it attached to the rectum – is more easily performed using a hand-assisted laparoscopic approach or even a hybrid open approach through the mini-Pfannenstiel incision.
Dissection is carried out distally until a soft, normal section of rectum is identified. At least 2 cm of normal rectum is needed for a safe anastomosis.
Endometriosis involving the bowel usually appears as a white fibrotic, submucosal mass and feels similar to invasive rectal cancer. The difference, of course, is that rectal cancer is mostly intraluminal, whereas endometriosis usually originates outside the bowel wall and invades inward. Occasionally, one will find “chocolate”-filled cysts within the endometriotic mass, but this is rare.
Endometriosis with bowel involvement is typically anterior to the rectum and posterior to the vagina, but lesions posterior to the rectum have been found, which would denote a nonanatomical spreading distribution.
There are two techniques for a low colorectal anastomosis: The hand-sewn anastomosis technique and the end-to-end anastomosis (EEA) stapler technique. The hand-sewn anastomosis has largely been replaced by the EEA stapler because stapling the proximal colon to the lower rectum is easier to perform, faster, and results in a similar anastomotic leak rate when compared to a hand-sewn anastomosis.
An anastomosis in the upper or mid-rectum has a low risk of leaking (less than 2%). Sometimes, in patients with a deep cul-de-sac, the lesion is attached to the mid-rectum and the anastomosis must be performed in the lower rectum, within a few centimeters of the anus. Low rectal anastomoses have leak rates as high as 10%. A flexible sigmoidoscopy must be performed to check for an air leak. If one is found, the anastomosis should be reconstructed or repaired. Temporary diverting ileostomy should be considered if the anastomosis is suboptimal.
An endorectal ultrasound shows endometriosis invading the muscularis propria (1 o'clock position).
Source Courtesy Dr. John J. Park
Endometriosis invades the rectal wall. The mucosa is distorted, but intact.
The inferior mesenteric artery (left) is ligated at the root of the aorta so that various collateral vessels within the marginal branches and Riolan's arch are not sacrificed. This ligation alone often will adequately free up the sigmoid colon enough for a tension-free anastomosis. If the sigmoid colon still cannot be lowered into the rectum without undue tension, the surgeon also will ligate the rectal tributary of the inferior mesenteric vein (right), one of the two main tributaries of the mesenteric vein.
The colon is being attached to the distal rectum using an end-to-end anastomosis stapler.
Source Images Courtesy Dr. John J. Park
Deeply Invasive Rectosigmoid Endometriosis
Deeply invasive rectosigmoid endometriosis can be associated with a severe – and at times incapacitating – symptom complex. This includes dysmenorrhea – both premenstrual and menstrual – deep dyspareunia, dyschezia, and rectal bleeding at time of menses. There also can be an impact on fertility as well, which can be rectified with bowel resection. In the accompanying graphic (right), a number of studies revealing pregnancy post bowel resection for rectosigmoid endometriosis are noted.
As bowel resection is generally not in the armamentarium of the gynecologic surgeon treating benign disease, the proper treatment of deep infiltrated rectosigmoid endometriosis must involve a cooperative effort with a colorectal surgeon who is capable of performing advanced minimally invasive surgery. This collaboration permits the minimally invasive gynecologist to laparoscopically excise endometriosis, lyse pelvic adhesions, resect ovarian endometriomata, and where indicated, perform ureterolysis and total laparoscopic hysterectomy. The colorectal or general surgeon can then proceed with the bowel resection via a minimally invasive approach.
For this current Master Class in Gynecologic Surgery, I have solicited the expertise of Dr. John J. Park. Dr. Park is a clinical assistant professor of surgery in the division of colorectal surgery at the University of Illinois at Chicago, as well as attending surgeon at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Park completed his residency in general surgery at the University of Illinois and his colorectal surgery residency at Mayo Clinic, Rochester, Minn. Dr. Park is board certified in general surgery and colon and rectal surgery.
Deep endometriosis involving the bowel is uncommon, but not rare, among patients with pelvic endometriosis. There is a growing body of literature describing minimally invasive colorectal resection for invasive endometriosis, and a growing feeling among gynecologic surgeons that endometriosis involving the rectal wall is better treated with rectal resection than with a shaving, or scraping, technique.
In our experience of working within a multispecialty surgical team, addressing endometriosis in a systematic fashion has led to a higher rate of patient satisfaction and quality of life, a lower rate of recurrent symptoms, and less surgical morbidity than has been seen with other approaches. While still infrequent, the greatest impact of this multispecialty approach has been the more liberal inclusion of bowel resection as part of the treatment for deep pelvic endometriosis.
It is our belief that patients who have evidence of bowel involvement and have a colorectal resection as part of their endometriosis treatment ultimately have a better surgical outcome. The opposite also appears to hold true. Those patients who have endometriosis involving the bowel wall and who do not receive a bowel resection have been more prone to recurrent disease and symptoms resulting in subsequent reoperations that are often more difficult to perform than a planned colorectal resection would have been.
Furthermore, surgery involving premeditated bowel resection is often safer than treatment employing a scraping technique when endometriosis is deep seated. In cases in which endometriosis has infiltrated the rectal wall, scraping techniques often result in unidentified bowel perforation, which leads to operations that are much more difficult to perform than planned elective resections. In addition, delayed missed injuries often will result in multiple trips to the operating room that frequently include the use of a colostomy in an otherwise young, healthy female patient.
Diagnosing Rectal Involvement
The full extent of disease, including the precise involvement of the bowel, sometimes can be difficult to determine prior to surgery. In many cases, however, physical examination combined with endoscopy and ultrasonography is enough to diagnose bowel involvement that would best be treated with segmental resection.
Pain associated with defecation, rectal bleeding around menses, and constipation often are found on history. On physical exam, endometriosis involving the rectal wall is most commonly associated with pain on both vaginal and rectal examination. Nodularity of the rectal wall, as well as distortion of the rectal folds, often is palpated.
The presence of either nodularity or rectal wall distortion raises the likelihood that there is significant rectal wall involvement. Conversely, if there is minimal or no nodularity of the rectal wall, the likelihood of rectal involvement is low.
When physical examination is abnormal, we proceed with colonoscopy, which enables us to visualize external compression on the rectal wall, nodularity, or other signs of endometriosis infiltrating the bowel wall. Colonoscopy is preferred because endometriosis is often found in the cecum, which would be missed on flexible sigmoidoscopy. Rarely will endometriosis actually penetrate the bowel wall. Most of the time, wall distortion with what is often seen as a submucosal mass is the only positive finding. Biopsy of the abnormality is typically unsatisfying, with normal colonic mucosa being the most common finding on microscopy.
When there are positive endoscopic findings, we prefer endorectal ultrasonography (ERUS) over transvaginal ultrasound to further evaluate rectal wall involvement of endometriosis. Using a 10-megahertz, 3-D ultrasound, we are able to visualize if endometriosis is attached to the bowel wall and to what degree.
The most important finding is whether or not endometriosis is invading the muscularis propria by the presence or absence of a space between the lesion(s) and the muscularis propria. If a space is visualized, there is a fairly good chance that the endometriosis may be safely scraped off the rectum.
If we see, on the other hand, that the endometriosis is either invading or firmly attached to the rectal muscularis propria, we know that chances of successfully scraping the lesion(s) off the rectum will be very low. In that case, a segmental resection of the rectum can be scheduled in conjunction with the rest of the endometriosis removal. Previous endometriosis surgery, it must be noted, leads to scar tissue which will often distort ERUS images and make the exam less accurate.
Surgical Planning
When the preoperative work-up is confirmatory, a combined surgical approach is scheduled. When the work-up is negative and the patient is scheduled for removal of endometriosis from the nongastrointestinal organs, we remain on surgical standby because bowel involvement of endometriosis is occasionally discovered in symptomatic patients despite a negative work-up.
Standby status also allows the gynecologist to be more aggressive because rectal wall injury can be corrected at the time of surgery. Flexible sigmoidoscopy always should be performed at the end of any endometriosis operation in which bowel proximity is encountered. By submerging the bowel under water and inflating air via the sigmoidoscope, the presence of air bubbles often will identify a missed bowel injury.
Segmental resection usually involves no more than 5-6 cm of the rectum. We do, however, extend the resection a bit proximally if the patient has a history of chronic constipation. Resecting more of the rectum and sigmoid colon to straighten out the left side of the large bowel and shorten the overall length will better alleviate the patient's constipation symptoms. Combined with improvement in the patient's defecation-related symptoms associated with the endometriosis, patient satisfaction regarding the elimination of constipation symptoms is often quite high.
Basic Surgical Technique
Rectal resection for deep endometriosis is comparable to resection of a T4 rectal cancer (one that has invaded outside the rectal wall), except that in the case of endometriosis, we typically are treating young, otherwise healthy patients. In these patients, the risk of complications – mainly, the risk of a permanent colostomy – is all the more concerning. It is important that patients understand the risk and benefits of the surgery and that the colorectal surgeon has the proper expertise for such a technically demanding, risky operation.
The operation is performed in a modified lithotomy position. A laparoscopic or hand-assisted laparoscopic approach can be used. We have performed both techniques, but find a hand-assisted laparoscopic approach faster. A robotic-assisted approach also is being developed.
Depending upon the type of camera used, a 5- or 10-mm port is placed in the umbilicus. The only other ancillary ports needed are 5-mm dissecting ports placed in the right and left lower quadrants. A mini-Pfannenstiel incision is needed to remove the rectal specimen. By extending this incision 3 centimeters, a hand port for hand-assisted laparoscopic surgery can be placed.
Surgery is initiated by the gynecologic surgeon, who resects endometriosis off all nongastrointestinal organs. Endometriosis involving the colon and rectum is left intact. If indicated, hysterectomy with salpingo-oophorectomy is performed at this time.
Next is the laparoscopic colorectal portion of the surgery. First, the inferior mesenteric artery is ligated at the root of the aorta so that various collateral vessels within the marginal branches and Riolan's arch are not sacrificed. Usually, this ligation alone will adequately free up the sigmoid colon enough for a tension-free anastomosis. If the sigmoid colon still cannot be lowered into the rectum without undue tension, we also will ligate the rectal tributary of the inferior mesenteric vein, one of the two main tributaries of the mesenteric vein.
The remainder of the mobilization involves dissecting along the White line of Toldt until the colon falls freely into the rectum. Rarely will we need to mobilize the splenic flexure of the colon to achieve adequate length.
With the left side of the colon freely mobilized, we turn our attention to the pelvis and subsequent rectal dissection. We do not remove the lesion from the rectum, since we have already confirmed that the lesion is firmly attached to the rectal wall. The endometriosis is removed en bloc with the rectum, similar to what is done for rectal cancer.
While the lateral and posterior dissection of the mesorectum can be easily done laparoscopically or robotically, we believe the anterior dissection of the rectum – removal of the endometriosis off the posterior aspect of the vagina while leaving it attached to the rectum – is more easily performed using a hand-assisted laparoscopic approach or even a hybrid open approach through the mini-Pfannenstiel incision.
Dissection is carried out distally until a soft, normal section of rectum is identified. At least 2 cm of normal rectum is needed for a safe anastomosis.
Endometriosis involving the bowel usually appears as a white fibrotic, submucosal mass and feels similar to invasive rectal cancer. The difference, of course, is that rectal cancer is mostly intraluminal, whereas endometriosis usually originates outside the bowel wall and invades inward. Occasionally, one will find “chocolate”-filled cysts within the endometriotic mass, but this is rare.
Endometriosis with bowel involvement is typically anterior to the rectum and posterior to the vagina, but lesions posterior to the rectum have been found, which would denote a nonanatomical spreading distribution.
There are two techniques for a low colorectal anastomosis: The hand-sewn anastomosis technique and the end-to-end anastomosis (EEA) stapler technique. The hand-sewn anastomosis has largely been replaced by the EEA stapler because stapling the proximal colon to the lower rectum is easier to perform, faster, and results in a similar anastomotic leak rate when compared to a hand-sewn anastomosis.
An anastomosis in the upper or mid-rectum has a low risk of leaking (less than 2%). Sometimes, in patients with a deep cul-de-sac, the lesion is attached to the mid-rectum and the anastomosis must be performed in the lower rectum, within a few centimeters of the anus. Low rectal anastomoses have leak rates as high as 10%. A flexible sigmoidoscopy must be performed to check for an air leak. If one is found, the anastomosis should be reconstructed or repaired. Temporary diverting ileostomy should be considered if the anastomosis is suboptimal.
An endorectal ultrasound shows endometriosis invading the muscularis propria (1 o'clock position).
Source Courtesy Dr. John J. Park
Endometriosis invades the rectal wall. The mucosa is distorted, but intact.
The inferior mesenteric artery (left) is ligated at the root of the aorta so that various collateral vessels within the marginal branches and Riolan's arch are not sacrificed. This ligation alone often will adequately free up the sigmoid colon enough for a tension-free anastomosis. If the sigmoid colon still cannot be lowered into the rectum without undue tension, the surgeon also will ligate the rectal tributary of the inferior mesenteric vein (right), one of the two main tributaries of the mesenteric vein.
The colon is being attached to the distal rectum using an end-to-end anastomosis stapler.
Source Images Courtesy Dr. John J. Park
Deeply Invasive Rectosigmoid Endometriosis
Deeply invasive rectosigmoid endometriosis can be associated with a severe – and at times incapacitating – symptom complex. This includes dysmenorrhea – both premenstrual and menstrual – deep dyspareunia, dyschezia, and rectal bleeding at time of menses. There also can be an impact on fertility as well, which can be rectified with bowel resection. In the accompanying graphic (right), a number of studies revealing pregnancy post bowel resection for rectosigmoid endometriosis are noted.
As bowel resection is generally not in the armamentarium of the gynecologic surgeon treating benign disease, the proper treatment of deep infiltrated rectosigmoid endometriosis must involve a cooperative effort with a colorectal surgeon who is capable of performing advanced minimally invasive surgery. This collaboration permits the minimally invasive gynecologist to laparoscopically excise endometriosis, lyse pelvic adhesions, resect ovarian endometriomata, and where indicated, perform ureterolysis and total laparoscopic hysterectomy. The colorectal or general surgeon can then proceed with the bowel resection via a minimally invasive approach.
For this current Master Class in Gynecologic Surgery, I have solicited the expertise of Dr. John J. Park. Dr. Park is a clinical assistant professor of surgery in the division of colorectal surgery at the University of Illinois at Chicago, as well as attending surgeon at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Park completed his residency in general surgery at the University of Illinois and his colorectal surgery residency at Mayo Clinic, Rochester, Minn. Dr. Park is board certified in general surgery and colon and rectal surgery.
Robot-Assisted Laparoscopic Tubal Reanastomosis
Surgery has an important role in the management of a patient's regret following tubal sterilization. While assisted reproductive technologies (ART) have made great strides in efficacy and patient acceptability, reanastomosis of the tubal segments remains an attractive option for couples who have no other fertility issues and who find the risk of multiple pregnancies unacceptable or the extensive medical treatment of ART impractical or undesirable. The re-establishment of some degree of reproductive tract function also can have important psychological and/or religious implications.
As with all gynecologic operations, there has been a trend toward the development and diffusion of minimally invasive (laparoscopic) versions of the classic microsurgical tubal reanastomosis.
The biggest problem with conventional laparoscopic tubal reanastomosis is that it is one of the most technically challenging gynecologic operations ever conceived. Before the full introduction of robotics at our institution, I have observed the struggle of skilled reproductive surgeons with every step of this operation.
It is no surprise, therefore, that laparoscopic tubal reanastomosis was among the first gynecologic operations for which robotic assistance was described. In fact, a feasibility study for tubal reanastomosis using the da Vinci surgical system (Intuitive Surgical Inc.) was published in 2000 by Dr. Michel Degueldre and colleagues in Belgium – 5 years before the Food and Drug Administration approved this surgical platform for gynecologic applications in the United States (Fertil. Steril. 2000;74:1020-3).
Two more recent case series compared robot-assisted tubal reanastomosis performed with the da Vinci surgical system to the “gold standard” of microsurgical reanastomosis by minilaparotomy. In a 2007 case-control study by Dr. Allison K. Rodgers and colleagues at the Cleveland Clinic, surgical times were significantly longer, and costs were higher, for the robot compared with open surgery. Hospitalization times were not significantly different, as patients undergoing minilaparotomy were discharged home on the day of surgery. Pregnancy rates also were similar (61% for robotic vs. 79% for minilaparotomy), as were ectopic pregnancy rates. Complications occurred less frequently in the robotic group, however, and the return to normal activity was shorter in this group by approximately 1 week (Obstet. Gynecol. 2007;109:1375-80).
A 2008 prospective cohort study by Dr. Sejal P. Dharia Patel and colleagues confirmed that surgical times are significantly longer for the robot group. This team did not practice outpatient minilaparotomy as did Dr. Rodgers' team, and patients undergoing robot-assisted laparoscopic surgery were discharged on the day of surgery. Hence, hospitalization times were significantly shorter in the robot-assisted group. Time to recovery was also significantly shorter. Pregnancy rates (62.5% for robotic vs. 50% for open) and ectopic pregnancy rates were not significantly different. Cost per delivery was similar between the two procedures (Fertil. Steril. 2008;90:1175-9).
These data indicate that robot-assisted tubal reanastomosis is safe and that its results are comparable to those obtained by classic tubal microsurgery performed by trained subspecialists. In terms of cost, it appears that even at the current high operating costs for the robot, open surgery is cost effective only if patients are sent home on the day of surgery, but not if they are admitted to the hospital.
Our robotic team performed the first successful robot-assisted tubal reanastomosis (with postoperative delivery) in New England in February 2007, and has since completely converted to the robotic approach. In our 4 years of experience, we have successfully completed approximately 350 robot-assisted reproductive surgeries, including robot-assisted tubal reanastomosis.
Setup
As in all laparoscopic procedures, patient positioning and port placement are vital. Robotic tubal reanastomosis is performed with the patient in dorsal lithotomy position on Allen stirrups. Preferably, all four robotic arms of the da Vinci patient-side cart are employed. The camera port is always placed within the umbilicus. The three 8-mm da Vinci ports are positioned as follows: Port 1 is 8-10 cm to the right of the camera port, port 2 is 8-10 cm to the left of the camera port, and port 3 is 8-10 cm to the left of port 2 (
Ports 1 and 2 are safely located in an area of the abdominal wall that is between the epigastric vessels (superficial and inferior) and the superficial circumflex vessels, making injury of any of these vessels extremely unlikely. Port 3 is located in the left lateral portion of the anterior abdominal wall. In women with a smaller abdomen, it is necessary to slide port 3 about 15-30 degrees caudal to port 2, while keeping the distance of 8-10 cm.
Optimal placement of robotic port 3 is undoubtedly the most challenging of the three 8-mm ports. Due to the obtrusive nature of the da Vinci patient-side cart, external interference between robotic arms 2 and 3 and between robotic arm 3 and the patient arm support systems (such as arm toboggans) is common during the learning curve of this operation. Moreover, internal interference between instruments in port 2 and port 3 is also possible (particularly if the degree of caudal shift of port 3 is excessive and the instrument crosses the pelvis transversely).
One also should be cognizant of the fact that placement of robotic port 3 in the lateral abdominal wall introduces the risk of a rarely observed complication of gynecologic laparoscopy: injury of the deep circumflex artery and vein (stemming from the external iliac artery and vein). The course of these vessels is significantly lateral to that of the inferior as well as superficial epigastric vessels, and is usually lateral to typical port sites in gynecologic surgery. Therefore, at the end of any robotic case employing a third instrument port in such a lateral location, all port sites (particularly the site of robotic port 3) should be re-evaluated laparoscopically for possible occult vessel injury after removal of the trocars, since the release of tamponade from the trocar may allow reactivation of bleeding.
To help prevent injury to the deep circumflex vessels, we also recommend exclusive use of blunt nondisposable robotic trocar obturators (instead of semisharp single-use obturators) for all robot-assisted procedures employing lateral placement of the third instrument arm.
Placement of the bedside surgical assistant port in robotic surgery has traditionally been high in the abdominal wall at either side of the umbilicus. However, we feel strongly that for the main reproductive surgery applications (namely, tubal reanastomosis and uterine myomectomy), the assistant port must be placed in one of the lower quadrants. Such placement is based on considerations of patient safety, assistant safety, and surgical ergonomics.
Reproductive microsurgery is suture intensive, and needle exchanges should never occur beyond the visual field of the console surgeon; loss of a 6.0 or an 8.0 needle between loops of bowel in the upper abdomen can turn an elegant procedure into a surgical nightmare.
In terms of assistant safety, placement of the assistant port as the most lateral port (instead of between the robotic camera arm and a robotic instrument arm) avoids the possibility that the assistant's hand could be caught between colliding robotic arms.
Finally, placing the assistant port in the lower quadrant allows for an overall port configuration that is compatible with any advanced conventional laparoscopic maneuvers that may be needed during the case (approximating the “ultralateral” port placement previously described for conventional laparoscopy).
Our right lower quadrant assistant port is always a 12-mm port. Even though it may be tempting to use a small-caliber assistant port in a microsurgical case like this, we have experienced problems with micro-needles becoming stuck in the plastic valve of assistant ports smaller than 12 mm in diameter. Ideally, a valve-free assistant port should be used for these cases.
Tubal reanastomosis is often performed best with the uterus in anteversion, so it is essential to employ a manipulator that allows the uterus to be fixed in any desired position between 0 and 90 degrees of anteversion. Such a manipulator should provide reliable chromopertubation. Several nondisposable devices work perfectly for this application, such as the Hayden Uterine Manipulator (Hayden Medical Inc.), the Pelosi Uterine Manipulator (Apple Medical Corp.), the Valtchev Uterine Mobilizer (Conkin Surgical Instruments Ltd.), and the RUMI Uterine Manipulator (CooperSurgical Inc.).
In our experience, the degree of anteversion provided by these devices is more than enough to complete a reanastomosis procedure without the need for an assistant to actively support the manipulator. Clearly, a vaginal delineator is never required for this procedure, and all of these manipulators can be assembled without the delineator.
As in all robot-assisted reproductive surgery techniques, we prefer lateral docking of the patient-side cart: This allows ample space for access to uterine positioning devices (
Surgical Technique
Our philosophy in transitioning from the gold-standard minilaparotomy approach to the laparoscopic approach has been that three essential aspects of the operation could not be compromised: 1) Reanastomosis should occur over a tubal stent; 2) secure orientation should be achieved by applying more than two reanastomosis sutures per tube; and 3) the thinnest safely employable suture should be chosen. At this point, our surgical protocol for robot-assisted laparoscopic tubal reanastomosis is identical to the one that we used for minilaparotomy.
The robotic microinstruments employed in this operation are shown in
The choice of whether to use the Potts scissors in port 1 (right-sided) or port 2 (left-sided) depends on how important it is for the surgeon to have the opportunity to use two graspers at the same time for tissue manipulation. With the robotic arm configuration described here (one robotic port on the patient's right, and two robotic ports on the patient's left), the surgeon has to toggle between instruments 2 and 3 on the left side. By keeping the scissors on the left side, the surgeon can have the ProGrasp and the micro-bipolar forceps at his disposal at the same time when needed. This means, however, that most surgeons would have to operate the robotic Potts scissors with the nondominant hand. In our experience, the accuracy of operation is not compromised as long as the robotic console scaling setting is at very fine (1:3) or ultrafine (1:5) (the latter is preferred for this operation but is not available at this time on the latest version of the da Vinci system).
A dilute solution of vasopressin is injected into the mesosalpinx in order to decrease blood loss during mobilization of the proximal and distal tubal segments. Potts scissors and micro-bipolar graspers are used to mobilize tubal segments and to deperitonealize the edges of the mesosalpinx. Even though we have bipolar electrocautery (micro-bipolar forceps) at our disposal, we employ it sparingly to avoid occult thermal damage to the tubal epithelium.
A graduated-tip ERCP (endoscopic retrograde cholangiopancreatography) cannula (Contour 3-4-5 Tip ERCP Cannula, Boston Scientific, Natick, Mass.) is inserted through the fimbriated end of the distal tubal segment; it exits through the newly opened proximal lumen of this distal segment and enters the newly created opening of the proximal tubal segment. This stent provides anatomic orientation and helps to identify the tubal lumen.
Preparation of the tubal edges and placement of the ERCP cannula are performed with the assistance of chromopertubation. It is particularly important to note abundant spillage of indigo carmine solution when the proximal tubal stump is opened.
From this point in the operation, the main role of the robotic ProGrasp operated through port 3 is to hold the ERCP cannula in place, thereby providing a steady and reliable stent.
The second stage of the procedure involves the suturing of the proximal and distal tubal stumps together (
Once the reapproximation is complete, the ERCP catheter is removed from the tube and immediately removed from the abdominal cavity, and prompt fill and spill of indigo carmine is observed, indicating patency. The same procedure is performed on the contralateral side, with great care taken to avoid inadvertently damaging the delicate reanastomosis line in the first tube.
This procedure invariably involves minimal or no blood loss. We gently irrigate the pelvis at regular intervals during the case to avoid desiccation, and carefully remove any small blood clots that may form. We do not employ any other adhesion-prevention strategies.
Patients leave the hospital within 3 hours of surgery and expect complete recovery within 2 weeks. Pelvic rest is recommended for the first month after surgery, and contraception is recommended until after their hysterosalpingogram 2 months after surgery.
A 'Swift Learning Curve'
Robotic assistance allows easy performance of classic microsurgical reanastomosis through laparoscopic access. Aside from shorter recovery time and a lower chance of complications, the robotic approach does not provide major clinical advantages over classic minilaparotomy. However, having performed and taught all three types of tubal reanastomosis (classic microsurgical, laparoscopic, and robot-assisted laparoscopic), I have been impressed by a unique quality of robotic reanastomosis: its eminent reproducibility and swift learning curve.
The enabling nature of robotic technology makes tubal reanastomosis a perfect example of an operation that is more safely learned and performed robotically. At our institution, we have developed a protocol for fast-track teaching of robot-assisted laparoscopic tubal reanastomosis that involves several hours of inanimate training at the console to get familiar with microrobotic instruments and sutures, as well as a chance to assist on these cases at bedside.
This is followed by an intensive use of Telestration, a technology specific to the da Vinci surgical system that greatly improves communication between the teacher and apprentice during surgery. The apprentice sits at the console while the attending surgeon remains by his/her side and communicates precise instructions by direct verbal cues and by drawing on a dedicated monitor that shows the operator's right field of vision. The drawings are transmitted in real time to the console, where they superimpose on the operator's visual field so that he/she may incorporate them into the current surgical act.
Aside from the expected differences in speed of performance, the quality and the safety of the operations performed by the teacher and the apprentice are absolutely comparable even on the first case. Coupled with a simple teaching strategy, robotic technology thus dramatically shortens the learning curve of a complex microsurgical operation. It is hard to deny the value of a procedure that can be safely taught and reliably reproduced in a single session.
The Ultimate Microsurgical Procedure
For this current excerpt of Master Class in Gynecologic Surgery, I have solicited the expertise of Dr. Antonio Rosario Gargiulo. Dr. Gargiulo is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. He is also the director of robotic surgery at the Center for Infertility and Reproductive Surgery at Brigham and Women's Hospital in Boston. After completing his subspecialty training in reproductive endocrinology and infertility at Brigham and Women's Hospital, Dr. Gargiulo rapidly built a busy reproductive surgery practice and has become a well-known expert in minimally invasive gynecologic surgery. Since 2007, Dr. Gargiulo has worked in robot-assisted reproductive surgery, and he performed the first robotic tubal anastomosis in New England. It is a pleasure to watch such a young and gifted surgeon successfully and safely pushing the envelope in gynecologic robot-assisted microsurgery.
In 1999, Dr. Tommaso Falcone and his Cleveland Clinic team published the first report on robot-assisted tubal anastomosis. Using the Zeus robotic surgical system (Computer Motion Inc.), a far less sophisticated tool than the currently available da Vinci surgical system (Intuitive Surgical), the procedure lasted more than 5 hours.
Only a decade later, Dr. Martin Caillet presented a study on robot-assisted laparoscopic microsurgical tubal reanastomosis at the First European Symposium in Robotic Gynecological Surgery in Milan, Italy (Fertil. Steril. 2010;94:1844-7). In 97 patients who underwent robot-assisted microsurgical tubal reanastomosis, using the da Vinci surgical system, the overall pregnancy and birth rates were 71% and 62%, respectively. Not surprisingly, pregnancy and delivery rates were age related. In patients less than 35 years of age, 91% became pregnant and 88% delivered. By the time a patient reached 36-39 years of age, pregnancy and delivery rates were 75% and 66%, respectively, while patients aged 40-42 years had a 50% pregnancy rate and 43.8% delivery rate. Importantly, the success rate is similar to rates reported in the most successful studies using the open microsurgical tubal reanastomosis technique.
Dr. Gargiulo will discuss his technique in this Gynecologic Surgery Master Class.
Surgery has an important role in the management of a patient's regret following tubal sterilization. While assisted reproductive technologies (ART) have made great strides in efficacy and patient acceptability, reanastomosis of the tubal segments remains an attractive option for couples who have no other fertility issues and who find the risk of multiple pregnancies unacceptable or the extensive medical treatment of ART impractical or undesirable. The re-establishment of some degree of reproductive tract function also can have important psychological and/or religious implications.
As with all gynecologic operations, there has been a trend toward the development and diffusion of minimally invasive (laparoscopic) versions of the classic microsurgical tubal reanastomosis.
The biggest problem with conventional laparoscopic tubal reanastomosis is that it is one of the most technically challenging gynecologic operations ever conceived. Before the full introduction of robotics at our institution, I have observed the struggle of skilled reproductive surgeons with every step of this operation.
It is no surprise, therefore, that laparoscopic tubal reanastomosis was among the first gynecologic operations for which robotic assistance was described. In fact, a feasibility study for tubal reanastomosis using the da Vinci surgical system (Intuitive Surgical Inc.) was published in 2000 by Dr. Michel Degueldre and colleagues in Belgium – 5 years before the Food and Drug Administration approved this surgical platform for gynecologic applications in the United States (Fertil. Steril. 2000;74:1020-3).
Two more recent case series compared robot-assisted tubal reanastomosis performed with the da Vinci surgical system to the “gold standard” of microsurgical reanastomosis by minilaparotomy. In a 2007 case-control study by Dr. Allison K. Rodgers and colleagues at the Cleveland Clinic, surgical times were significantly longer, and costs were higher, for the robot compared with open surgery. Hospitalization times were not significantly different, as patients undergoing minilaparotomy were discharged home on the day of surgery. Pregnancy rates also were similar (61% for robotic vs. 79% for minilaparotomy), as were ectopic pregnancy rates. Complications occurred less frequently in the robotic group, however, and the return to normal activity was shorter in this group by approximately 1 week (Obstet. Gynecol. 2007;109:1375-80).
A 2008 prospective cohort study by Dr. Sejal P. Dharia Patel and colleagues confirmed that surgical times are significantly longer for the robot group. This team did not practice outpatient minilaparotomy as did Dr. Rodgers' team, and patients undergoing robot-assisted laparoscopic surgery were discharged on the day of surgery. Hence, hospitalization times were significantly shorter in the robot-assisted group. Time to recovery was also significantly shorter. Pregnancy rates (62.5% for robotic vs. 50% for open) and ectopic pregnancy rates were not significantly different. Cost per delivery was similar between the two procedures (Fertil. Steril. 2008;90:1175-9).
These data indicate that robot-assisted tubal reanastomosis is safe and that its results are comparable to those obtained by classic tubal microsurgery performed by trained subspecialists. In terms of cost, it appears that even at the current high operating costs for the robot, open surgery is cost effective only if patients are sent home on the day of surgery, but not if they are admitted to the hospital.
Our robotic team performed the first successful robot-assisted tubal reanastomosis (with postoperative delivery) in New England in February 2007, and has since completely converted to the robotic approach. In our 4 years of experience, we have successfully completed approximately 350 robot-assisted reproductive surgeries, including robot-assisted tubal reanastomosis.
Setup
As in all laparoscopic procedures, patient positioning and port placement are vital. Robotic tubal reanastomosis is performed with the patient in dorsal lithotomy position on Allen stirrups. Preferably, all four robotic arms of the da Vinci patient-side cart are employed. The camera port is always placed within the umbilicus. The three 8-mm da Vinci ports are positioned as follows: Port 1 is 8-10 cm to the right of the camera port, port 2 is 8-10 cm to the left of the camera port, and port 3 is 8-10 cm to the left of port 2 (
Ports 1 and 2 are safely located in an area of the abdominal wall that is between the epigastric vessels (superficial and inferior) and the superficial circumflex vessels, making injury of any of these vessels extremely unlikely. Port 3 is located in the left lateral portion of the anterior abdominal wall. In women with a smaller abdomen, it is necessary to slide port 3 about 15-30 degrees caudal to port 2, while keeping the distance of 8-10 cm.
Optimal placement of robotic port 3 is undoubtedly the most challenging of the three 8-mm ports. Due to the obtrusive nature of the da Vinci patient-side cart, external interference between robotic arms 2 and 3 and between robotic arm 3 and the patient arm support systems (such as arm toboggans) is common during the learning curve of this operation. Moreover, internal interference between instruments in port 2 and port 3 is also possible (particularly if the degree of caudal shift of port 3 is excessive and the instrument crosses the pelvis transversely).
One also should be cognizant of the fact that placement of robotic port 3 in the lateral abdominal wall introduces the risk of a rarely observed complication of gynecologic laparoscopy: injury of the deep circumflex artery and vein (stemming from the external iliac artery and vein). The course of these vessels is significantly lateral to that of the inferior as well as superficial epigastric vessels, and is usually lateral to typical port sites in gynecologic surgery. Therefore, at the end of any robotic case employing a third instrument port in such a lateral location, all port sites (particularly the site of robotic port 3) should be re-evaluated laparoscopically for possible occult vessel injury after removal of the trocars, since the release of tamponade from the trocar may allow reactivation of bleeding.
To help prevent injury to the deep circumflex vessels, we also recommend exclusive use of blunt nondisposable robotic trocar obturators (instead of semisharp single-use obturators) for all robot-assisted procedures employing lateral placement of the third instrument arm.
Placement of the bedside surgical assistant port in robotic surgery has traditionally been high in the abdominal wall at either side of the umbilicus. However, we feel strongly that for the main reproductive surgery applications (namely, tubal reanastomosis and uterine myomectomy), the assistant port must be placed in one of the lower quadrants. Such placement is based on considerations of patient safety, assistant safety, and surgical ergonomics.
Reproductive microsurgery is suture intensive, and needle exchanges should never occur beyond the visual field of the console surgeon; loss of a 6.0 or an 8.0 needle between loops of bowel in the upper abdomen can turn an elegant procedure into a surgical nightmare.
In terms of assistant safety, placement of the assistant port as the most lateral port (instead of between the robotic camera arm and a robotic instrument arm) avoids the possibility that the assistant's hand could be caught between colliding robotic arms.
Finally, placing the assistant port in the lower quadrant allows for an overall port configuration that is compatible with any advanced conventional laparoscopic maneuvers that may be needed during the case (approximating the “ultralateral” port placement previously described for conventional laparoscopy).
Our right lower quadrant assistant port is always a 12-mm port. Even though it may be tempting to use a small-caliber assistant port in a microsurgical case like this, we have experienced problems with micro-needles becoming stuck in the plastic valve of assistant ports smaller than 12 mm in diameter. Ideally, a valve-free assistant port should be used for these cases.
Tubal reanastomosis is often performed best with the uterus in anteversion, so it is essential to employ a manipulator that allows the uterus to be fixed in any desired position between 0 and 90 degrees of anteversion. Such a manipulator should provide reliable chromopertubation. Several nondisposable devices work perfectly for this application, such as the Hayden Uterine Manipulator (Hayden Medical Inc.), the Pelosi Uterine Manipulator (Apple Medical Corp.), the Valtchev Uterine Mobilizer (Conkin Surgical Instruments Ltd.), and the RUMI Uterine Manipulator (CooperSurgical Inc.).
In our experience, the degree of anteversion provided by these devices is more than enough to complete a reanastomosis procedure without the need for an assistant to actively support the manipulator. Clearly, a vaginal delineator is never required for this procedure, and all of these manipulators can be assembled without the delineator.
As in all robot-assisted reproductive surgery techniques, we prefer lateral docking of the patient-side cart: This allows ample space for access to uterine positioning devices (
Surgical Technique
Our philosophy in transitioning from the gold-standard minilaparotomy approach to the laparoscopic approach has been that three essential aspects of the operation could not be compromised: 1) Reanastomosis should occur over a tubal stent; 2) secure orientation should be achieved by applying more than two reanastomosis sutures per tube; and 3) the thinnest safely employable suture should be chosen. At this point, our surgical protocol for robot-assisted laparoscopic tubal reanastomosis is identical to the one that we used for minilaparotomy.
The robotic microinstruments employed in this operation are shown in
The choice of whether to use the Potts scissors in port 1 (right-sided) or port 2 (left-sided) depends on how important it is for the surgeon to have the opportunity to use two graspers at the same time for tissue manipulation. With the robotic arm configuration described here (one robotic port on the patient's right, and two robotic ports on the patient's left), the surgeon has to toggle between instruments 2 and 3 on the left side. By keeping the scissors on the left side, the surgeon can have the ProGrasp and the micro-bipolar forceps at his disposal at the same time when needed. This means, however, that most surgeons would have to operate the robotic Potts scissors with the nondominant hand. In our experience, the accuracy of operation is not compromised as long as the robotic console scaling setting is at very fine (1:3) or ultrafine (1:5) (the latter is preferred for this operation but is not available at this time on the latest version of the da Vinci system).
A dilute solution of vasopressin is injected into the mesosalpinx in order to decrease blood loss during mobilization of the proximal and distal tubal segments. Potts scissors and micro-bipolar graspers are used to mobilize tubal segments and to deperitonealize the edges of the mesosalpinx. Even though we have bipolar electrocautery (micro-bipolar forceps) at our disposal, we employ it sparingly to avoid occult thermal damage to the tubal epithelium.
A graduated-tip ERCP (endoscopic retrograde cholangiopancreatography) cannula (Contour 3-4-5 Tip ERCP Cannula, Boston Scientific, Natick, Mass.) is inserted through the fimbriated end of the distal tubal segment; it exits through the newly opened proximal lumen of this distal segment and enters the newly created opening of the proximal tubal segment. This stent provides anatomic orientation and helps to identify the tubal lumen.
Preparation of the tubal edges and placement of the ERCP cannula are performed with the assistance of chromopertubation. It is particularly important to note abundant spillage of indigo carmine solution when the proximal tubal stump is opened.
From this point in the operation, the main role of the robotic ProGrasp operated through port 3 is to hold the ERCP cannula in place, thereby providing a steady and reliable stent.
The second stage of the procedure involves the suturing of the proximal and distal tubal stumps together (
Once the reapproximation is complete, the ERCP catheter is removed from the tube and immediately removed from the abdominal cavity, and prompt fill and spill of indigo carmine is observed, indicating patency. The same procedure is performed on the contralateral side, with great care taken to avoid inadvertently damaging the delicate reanastomosis line in the first tube.
This procedure invariably involves minimal or no blood loss. We gently irrigate the pelvis at regular intervals during the case to avoid desiccation, and carefully remove any small blood clots that may form. We do not employ any other adhesion-prevention strategies.
Patients leave the hospital within 3 hours of surgery and expect complete recovery within 2 weeks. Pelvic rest is recommended for the first month after surgery, and contraception is recommended until after their hysterosalpingogram 2 months after surgery.
A 'Swift Learning Curve'
Robotic assistance allows easy performance of classic microsurgical reanastomosis through laparoscopic access. Aside from shorter recovery time and a lower chance of complications, the robotic approach does not provide major clinical advantages over classic minilaparotomy. However, having performed and taught all three types of tubal reanastomosis (classic microsurgical, laparoscopic, and robot-assisted laparoscopic), I have been impressed by a unique quality of robotic reanastomosis: its eminent reproducibility and swift learning curve.
The enabling nature of robotic technology makes tubal reanastomosis a perfect example of an operation that is more safely learned and performed robotically. At our institution, we have developed a protocol for fast-track teaching of robot-assisted laparoscopic tubal reanastomosis that involves several hours of inanimate training at the console to get familiar with microrobotic instruments and sutures, as well as a chance to assist on these cases at bedside.
This is followed by an intensive use of Telestration, a technology specific to the da Vinci surgical system that greatly improves communication between the teacher and apprentice during surgery. The apprentice sits at the console while the attending surgeon remains by his/her side and communicates precise instructions by direct verbal cues and by drawing on a dedicated monitor that shows the operator's right field of vision. The drawings are transmitted in real time to the console, where they superimpose on the operator's visual field so that he/she may incorporate them into the current surgical act.
Aside from the expected differences in speed of performance, the quality and the safety of the operations performed by the teacher and the apprentice are absolutely comparable even on the first case. Coupled with a simple teaching strategy, robotic technology thus dramatically shortens the learning curve of a complex microsurgical operation. It is hard to deny the value of a procedure that can be safely taught and reliably reproduced in a single session.
The Ultimate Microsurgical Procedure
For this current excerpt of Master Class in Gynecologic Surgery, I have solicited the expertise of Dr. Antonio Rosario Gargiulo. Dr. Gargiulo is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. He is also the director of robotic surgery at the Center for Infertility and Reproductive Surgery at Brigham and Women's Hospital in Boston. After completing his subspecialty training in reproductive endocrinology and infertility at Brigham and Women's Hospital, Dr. Gargiulo rapidly built a busy reproductive surgery practice and has become a well-known expert in minimally invasive gynecologic surgery. Since 2007, Dr. Gargiulo has worked in robot-assisted reproductive surgery, and he performed the first robotic tubal anastomosis in New England. It is a pleasure to watch such a young and gifted surgeon successfully and safely pushing the envelope in gynecologic robot-assisted microsurgery.
In 1999, Dr. Tommaso Falcone and his Cleveland Clinic team published the first report on robot-assisted tubal anastomosis. Using the Zeus robotic surgical system (Computer Motion Inc.), a far less sophisticated tool than the currently available da Vinci surgical system (Intuitive Surgical), the procedure lasted more than 5 hours.
Only a decade later, Dr. Martin Caillet presented a study on robot-assisted laparoscopic microsurgical tubal reanastomosis at the First European Symposium in Robotic Gynecological Surgery in Milan, Italy (Fertil. Steril. 2010;94:1844-7). In 97 patients who underwent robot-assisted microsurgical tubal reanastomosis, using the da Vinci surgical system, the overall pregnancy and birth rates were 71% and 62%, respectively. Not surprisingly, pregnancy and delivery rates were age related. In patients less than 35 years of age, 91% became pregnant and 88% delivered. By the time a patient reached 36-39 years of age, pregnancy and delivery rates were 75% and 66%, respectively, while patients aged 40-42 years had a 50% pregnancy rate and 43.8% delivery rate. Importantly, the success rate is similar to rates reported in the most successful studies using the open microsurgical tubal reanastomosis technique.
Dr. Gargiulo will discuss his technique in this Gynecologic Surgery Master Class.
Surgery has an important role in the management of a patient's regret following tubal sterilization. While assisted reproductive technologies (ART) have made great strides in efficacy and patient acceptability, reanastomosis of the tubal segments remains an attractive option for couples who have no other fertility issues and who find the risk of multiple pregnancies unacceptable or the extensive medical treatment of ART impractical or undesirable. The re-establishment of some degree of reproductive tract function also can have important psychological and/or religious implications.
As with all gynecologic operations, there has been a trend toward the development and diffusion of minimally invasive (laparoscopic) versions of the classic microsurgical tubal reanastomosis.
The biggest problem with conventional laparoscopic tubal reanastomosis is that it is one of the most technically challenging gynecologic operations ever conceived. Before the full introduction of robotics at our institution, I have observed the struggle of skilled reproductive surgeons with every step of this operation.
It is no surprise, therefore, that laparoscopic tubal reanastomosis was among the first gynecologic operations for which robotic assistance was described. In fact, a feasibility study for tubal reanastomosis using the da Vinci surgical system (Intuitive Surgical Inc.) was published in 2000 by Dr. Michel Degueldre and colleagues in Belgium – 5 years before the Food and Drug Administration approved this surgical platform for gynecologic applications in the United States (Fertil. Steril. 2000;74:1020-3).
Two more recent case series compared robot-assisted tubal reanastomosis performed with the da Vinci surgical system to the “gold standard” of microsurgical reanastomosis by minilaparotomy. In a 2007 case-control study by Dr. Allison K. Rodgers and colleagues at the Cleveland Clinic, surgical times were significantly longer, and costs were higher, for the robot compared with open surgery. Hospitalization times were not significantly different, as patients undergoing minilaparotomy were discharged home on the day of surgery. Pregnancy rates also were similar (61% for robotic vs. 79% for minilaparotomy), as were ectopic pregnancy rates. Complications occurred less frequently in the robotic group, however, and the return to normal activity was shorter in this group by approximately 1 week (Obstet. Gynecol. 2007;109:1375-80).
A 2008 prospective cohort study by Dr. Sejal P. Dharia Patel and colleagues confirmed that surgical times are significantly longer for the robot group. This team did not practice outpatient minilaparotomy as did Dr. Rodgers' team, and patients undergoing robot-assisted laparoscopic surgery were discharged on the day of surgery. Hence, hospitalization times were significantly shorter in the robot-assisted group. Time to recovery was also significantly shorter. Pregnancy rates (62.5% for robotic vs. 50% for open) and ectopic pregnancy rates were not significantly different. Cost per delivery was similar between the two procedures (Fertil. Steril. 2008;90:1175-9).
These data indicate that robot-assisted tubal reanastomosis is safe and that its results are comparable to those obtained by classic tubal microsurgery performed by trained subspecialists. In terms of cost, it appears that even at the current high operating costs for the robot, open surgery is cost effective only if patients are sent home on the day of surgery, but not if they are admitted to the hospital.
Our robotic team performed the first successful robot-assisted tubal reanastomosis (with postoperative delivery) in New England in February 2007, and has since completely converted to the robotic approach. In our 4 years of experience, we have successfully completed approximately 350 robot-assisted reproductive surgeries, including robot-assisted tubal reanastomosis.
Setup
As in all laparoscopic procedures, patient positioning and port placement are vital. Robotic tubal reanastomosis is performed with the patient in dorsal lithotomy position on Allen stirrups. Preferably, all four robotic arms of the da Vinci patient-side cart are employed. The camera port is always placed within the umbilicus. The three 8-mm da Vinci ports are positioned as follows: Port 1 is 8-10 cm to the right of the camera port, port 2 is 8-10 cm to the left of the camera port, and port 3 is 8-10 cm to the left of port 2 (
Ports 1 and 2 are safely located in an area of the abdominal wall that is between the epigastric vessels (superficial and inferior) and the superficial circumflex vessels, making injury of any of these vessels extremely unlikely. Port 3 is located in the left lateral portion of the anterior abdominal wall. In women with a smaller abdomen, it is necessary to slide port 3 about 15-30 degrees caudal to port 2, while keeping the distance of 8-10 cm.
Optimal placement of robotic port 3 is undoubtedly the most challenging of the three 8-mm ports. Due to the obtrusive nature of the da Vinci patient-side cart, external interference between robotic arms 2 and 3 and between robotic arm 3 and the patient arm support systems (such as arm toboggans) is common during the learning curve of this operation. Moreover, internal interference between instruments in port 2 and port 3 is also possible (particularly if the degree of caudal shift of port 3 is excessive and the instrument crosses the pelvis transversely).
One also should be cognizant of the fact that placement of robotic port 3 in the lateral abdominal wall introduces the risk of a rarely observed complication of gynecologic laparoscopy: injury of the deep circumflex artery and vein (stemming from the external iliac artery and vein). The course of these vessels is significantly lateral to that of the inferior as well as superficial epigastric vessels, and is usually lateral to typical port sites in gynecologic surgery. Therefore, at the end of any robotic case employing a third instrument port in such a lateral location, all port sites (particularly the site of robotic port 3) should be re-evaluated laparoscopically for possible occult vessel injury after removal of the trocars, since the release of tamponade from the trocar may allow reactivation of bleeding.
To help prevent injury to the deep circumflex vessels, we also recommend exclusive use of blunt nondisposable robotic trocar obturators (instead of semisharp single-use obturators) for all robot-assisted procedures employing lateral placement of the third instrument arm.
Placement of the bedside surgical assistant port in robotic surgery has traditionally been high in the abdominal wall at either side of the umbilicus. However, we feel strongly that for the main reproductive surgery applications (namely, tubal reanastomosis and uterine myomectomy), the assistant port must be placed in one of the lower quadrants. Such placement is based on considerations of patient safety, assistant safety, and surgical ergonomics.
Reproductive microsurgery is suture intensive, and needle exchanges should never occur beyond the visual field of the console surgeon; loss of a 6.0 or an 8.0 needle between loops of bowel in the upper abdomen can turn an elegant procedure into a surgical nightmare.
In terms of assistant safety, placement of the assistant port as the most lateral port (instead of between the robotic camera arm and a robotic instrument arm) avoids the possibility that the assistant's hand could be caught between colliding robotic arms.
Finally, placing the assistant port in the lower quadrant allows for an overall port configuration that is compatible with any advanced conventional laparoscopic maneuvers that may be needed during the case (approximating the “ultralateral” port placement previously described for conventional laparoscopy).
Our right lower quadrant assistant port is always a 12-mm port. Even though it may be tempting to use a small-caliber assistant port in a microsurgical case like this, we have experienced problems with micro-needles becoming stuck in the plastic valve of assistant ports smaller than 12 mm in diameter. Ideally, a valve-free assistant port should be used for these cases.
Tubal reanastomosis is often performed best with the uterus in anteversion, so it is essential to employ a manipulator that allows the uterus to be fixed in any desired position between 0 and 90 degrees of anteversion. Such a manipulator should provide reliable chromopertubation. Several nondisposable devices work perfectly for this application, such as the Hayden Uterine Manipulator (Hayden Medical Inc.), the Pelosi Uterine Manipulator (Apple Medical Corp.), the Valtchev Uterine Mobilizer (Conkin Surgical Instruments Ltd.), and the RUMI Uterine Manipulator (CooperSurgical Inc.).
In our experience, the degree of anteversion provided by these devices is more than enough to complete a reanastomosis procedure without the need for an assistant to actively support the manipulator. Clearly, a vaginal delineator is never required for this procedure, and all of these manipulators can be assembled without the delineator.
As in all robot-assisted reproductive surgery techniques, we prefer lateral docking of the patient-side cart: This allows ample space for access to uterine positioning devices (
Surgical Technique
Our philosophy in transitioning from the gold-standard minilaparotomy approach to the laparoscopic approach has been that three essential aspects of the operation could not be compromised: 1) Reanastomosis should occur over a tubal stent; 2) secure orientation should be achieved by applying more than two reanastomosis sutures per tube; and 3) the thinnest safely employable suture should be chosen. At this point, our surgical protocol for robot-assisted laparoscopic tubal reanastomosis is identical to the one that we used for minilaparotomy.
The robotic microinstruments employed in this operation are shown in
The choice of whether to use the Potts scissors in port 1 (right-sided) or port 2 (left-sided) depends on how important it is for the surgeon to have the opportunity to use two graspers at the same time for tissue manipulation. With the robotic arm configuration described here (one robotic port on the patient's right, and two robotic ports on the patient's left), the surgeon has to toggle between instruments 2 and 3 on the left side. By keeping the scissors on the left side, the surgeon can have the ProGrasp and the micro-bipolar forceps at his disposal at the same time when needed. This means, however, that most surgeons would have to operate the robotic Potts scissors with the nondominant hand. In our experience, the accuracy of operation is not compromised as long as the robotic console scaling setting is at very fine (1:3) or ultrafine (1:5) (the latter is preferred for this operation but is not available at this time on the latest version of the da Vinci system).
A dilute solution of vasopressin is injected into the mesosalpinx in order to decrease blood loss during mobilization of the proximal and distal tubal segments. Potts scissors and micro-bipolar graspers are used to mobilize tubal segments and to deperitonealize the edges of the mesosalpinx. Even though we have bipolar electrocautery (micro-bipolar forceps) at our disposal, we employ it sparingly to avoid occult thermal damage to the tubal epithelium.
A graduated-tip ERCP (endoscopic retrograde cholangiopancreatography) cannula (Contour 3-4-5 Tip ERCP Cannula, Boston Scientific, Natick, Mass.) is inserted through the fimbriated end of the distal tubal segment; it exits through the newly opened proximal lumen of this distal segment and enters the newly created opening of the proximal tubal segment. This stent provides anatomic orientation and helps to identify the tubal lumen.
Preparation of the tubal edges and placement of the ERCP cannula are performed with the assistance of chromopertubation. It is particularly important to note abundant spillage of indigo carmine solution when the proximal tubal stump is opened.
From this point in the operation, the main role of the robotic ProGrasp operated through port 3 is to hold the ERCP cannula in place, thereby providing a steady and reliable stent.
The second stage of the procedure involves the suturing of the proximal and distal tubal stumps together (
Once the reapproximation is complete, the ERCP catheter is removed from the tube and immediately removed from the abdominal cavity, and prompt fill and spill of indigo carmine is observed, indicating patency. The same procedure is performed on the contralateral side, with great care taken to avoid inadvertently damaging the delicate reanastomosis line in the first tube.
This procedure invariably involves minimal or no blood loss. We gently irrigate the pelvis at regular intervals during the case to avoid desiccation, and carefully remove any small blood clots that may form. We do not employ any other adhesion-prevention strategies.
Patients leave the hospital within 3 hours of surgery and expect complete recovery within 2 weeks. Pelvic rest is recommended for the first month after surgery, and contraception is recommended until after their hysterosalpingogram 2 months after surgery.
A 'Swift Learning Curve'
Robotic assistance allows easy performance of classic microsurgical reanastomosis through laparoscopic access. Aside from shorter recovery time and a lower chance of complications, the robotic approach does not provide major clinical advantages over classic minilaparotomy. However, having performed and taught all three types of tubal reanastomosis (classic microsurgical, laparoscopic, and robot-assisted laparoscopic), I have been impressed by a unique quality of robotic reanastomosis: its eminent reproducibility and swift learning curve.
The enabling nature of robotic technology makes tubal reanastomosis a perfect example of an operation that is more safely learned and performed robotically. At our institution, we have developed a protocol for fast-track teaching of robot-assisted laparoscopic tubal reanastomosis that involves several hours of inanimate training at the console to get familiar with microrobotic instruments and sutures, as well as a chance to assist on these cases at bedside.
This is followed by an intensive use of Telestration, a technology specific to the da Vinci surgical system that greatly improves communication between the teacher and apprentice during surgery. The apprentice sits at the console while the attending surgeon remains by his/her side and communicates precise instructions by direct verbal cues and by drawing on a dedicated monitor that shows the operator's right field of vision. The drawings are transmitted in real time to the console, where they superimpose on the operator's visual field so that he/she may incorporate them into the current surgical act.
Aside from the expected differences in speed of performance, the quality and the safety of the operations performed by the teacher and the apprentice are absolutely comparable even on the first case. Coupled with a simple teaching strategy, robotic technology thus dramatically shortens the learning curve of a complex microsurgical operation. It is hard to deny the value of a procedure that can be safely taught and reliably reproduced in a single session.
The Ultimate Microsurgical Procedure
For this current excerpt of Master Class in Gynecologic Surgery, I have solicited the expertise of Dr. Antonio Rosario Gargiulo. Dr. Gargiulo is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston. He is also the director of robotic surgery at the Center for Infertility and Reproductive Surgery at Brigham and Women's Hospital in Boston. After completing his subspecialty training in reproductive endocrinology and infertility at Brigham and Women's Hospital, Dr. Gargiulo rapidly built a busy reproductive surgery practice and has become a well-known expert in minimally invasive gynecologic surgery. Since 2007, Dr. Gargiulo has worked in robot-assisted reproductive surgery, and he performed the first robotic tubal anastomosis in New England. It is a pleasure to watch such a young and gifted surgeon successfully and safely pushing the envelope in gynecologic robot-assisted microsurgery.
In 1999, Dr. Tommaso Falcone and his Cleveland Clinic team published the first report on robot-assisted tubal anastomosis. Using the Zeus robotic surgical system (Computer Motion Inc.), a far less sophisticated tool than the currently available da Vinci surgical system (Intuitive Surgical), the procedure lasted more than 5 hours.
Only a decade later, Dr. Martin Caillet presented a study on robot-assisted laparoscopic microsurgical tubal reanastomosis at the First European Symposium in Robotic Gynecological Surgery in Milan, Italy (Fertil. Steril. 2010;94:1844-7). In 97 patients who underwent robot-assisted microsurgical tubal reanastomosis, using the da Vinci surgical system, the overall pregnancy and birth rates were 71% and 62%, respectively. Not surprisingly, pregnancy and delivery rates were age related. In patients less than 35 years of age, 91% became pregnant and 88% delivered. By the time a patient reached 36-39 years of age, pregnancy and delivery rates were 75% and 66%, respectively, while patients aged 40-42 years had a 50% pregnancy rate and 43.8% delivery rate. Importantly, the success rate is similar to rates reported in the most successful studies using the open microsurgical tubal reanastomosis technique.
Dr. Gargiulo will discuss his technique in this Gynecologic Surgery Master Class.
Sacrospinous Ligament Suspension, With and Without Mesh
The sacrospinous ligament suspension technique was first described by Karl Richter in 1968 and later introduced into the United States by David H. Nichols and Clyde L. Randall in 1971. It has been and continues to be an effective technique for apical suspension via the vaginal route, and is a valuable addition to the surgical armamentarium of the gynecologic surgeon.
In the 1990s, the procedure was done less frequently because of the popularity of uterosacral ligament suspension. Recently, however, sacrospinous ligament suspension has regained popularity for various reasons. The uterosacral ligament technique, for one, requires peritoneal entry, and the ligament is often of variable strength and also can sometimes be difficult to identify.
In addition, new tools and variations in technique, such as use of the Capio needle driver, have made sacrospinous ligament suspension easier and safer. Finally, the popularity of vaginal mesh procedures has created renewed interest in sacrospinous suspension as a direct visualization attachment technique for apical mesh, compared with trocar/needle-based techniques, which involve blind passage and possible injury to the bowel and bladder.
With proper technique, the procedure is safe, effective, and durable and has few complications related to future sexual function. Long-term success rates have been excellent in properly selected patients.
Indications
Various techniques of apical suspension are available to the gynecologic surgeon. Sacrospinous suspension is indicated in patients with adequate vaginal length who desire a vaginal procedure. An office-based exam should be performed to assess vaginal length and location/severity of prolapse.
Oftentimes, the procedure can be performed using the traditional technique with attachment of the vaginal mucosa or with mesh augmentation using the sacrospinous sutures as the apical mesh attachment points. In my practice, the procedure is contraindicated in patients with a short vagina, chronic pelvic pain, or any history of sciatica.
Prior to Surgery
Vaginal exam prior to initial dissection is helpful in ensuring that the vagina is of adequate length to reach the sacrospinous ligament. Marking of the vaginal apex for placement of suspension sutures sites also is helpful. The vagina is reapproximated to either or both sacrospinous ligaments using an Allis clamp, which is then adjusted in order to maximize vaginal length and reapproximation to the corresponding ligament. The location of the Allis clamp is then tagged with a full thickness marking suture.
Surgical Dissection
The procedure begins with entry into the sacrospinous space. Traditionally, this dissection has been described through a posterior vaginal mucosal incision associated with rectocele repair. A midline incision is made from the perineal body to the vaginal apex. The vaginal mucosa is then dissected off the underlying rectovaginal septum distally and any enterocele proximally. In the upper third of the vagina, lateral dissection is extended in the pararectal space until areolar tissue is encountered. Blunt dissection is then performed toward the ischial spine in a back-and-forth manner.
The relevant anatomy including the ischial spine, the sacrospinous ligament, the coccygeus muscle, and the lateral side wall with White's line, is identified (Fig. A). An identical dissection is performed on the contralateral side.
An anterior approach to sacrospinous suspension was described by Peter K. Sands et al. in 2000. This is especially helpful if the patient has only anterior and apical defects without the need for rectocele dissection or is undergoing an anterior mesh augmentation procedure. The anterior vaginal wall is opened, and the endopelvic connective tissue is separated from the pubic ramus at the level of the bladder neck to the ischial spine, exposing the paravesical and pararectal space. The sacrospinous ligament is identified and isolated through this defect.
Perhaps the easiest method of entering the sacrospinous space is through a midcompartment approach just lateral to the enterocele. This is often described with isolated apical/enterocele defects. The vaginal mucosa over the apex/enterocele is incised in the midline. The edges of the incision are grasped using Allis clamps, and lateral dissection is performed between the vaginal mucosa and enterocele sac until loose areolar tissue is noted. Blunt finger dissection in a back-and-forth motion is performed to the ischial spine.
An identical procedure is then performed on the contralateral side. Such midcompartment dissection is associated with very little bleeding and quick access to the sacrospinous space.
Suture Placement
A variety of tools and techniques have been described to place the sacrospinous suspension sutures. Traditionally, suture placement has been described using a standard needle holder, Miya hook, Des-Champs ligature, Shutt punch, or Nichols-Veronikis ligature carrier. Each device is loaded with the suture/needle.
Vaginal retractors (I prefer the Breisky-Navratril retractors) are used to gain exposure to the sacrospinous space until the ligament is visualized. The suture is placed around the sacrospinous ligament approximately two fingerbreadths medial to the ischial spine, with care given to avoid injury to the pudendal neurovascular bundle (Fig. B).
A permanent suture (Ethibond or Gore-Tex) is used for a pulley stitch attachment, while a delayed absorbable suture such as polydioxanone (PDS) is used for a full thickness vaginal attachment. A second suture may be placed just slightly medial to the first at the surgeon's discretion. Bilateral sacrospinous sutures also could be placed. Bilateral suspension sutures are especially useful when considering mesh augmentation of the anterior and/or posterior segment.
More recently, traditional devices have been replaced with the Capio needle driver. This is a disposable multiuse suture retrieval device which makes sacrospinous ligament suspension significantly easier, faster, and safer. The device has a medium caliber shaft with a plunger for suture application. The end has a hook which allows push-catch retrieval of a small needle-based suture. Various permanent and delayed absorbable sutures are available. Under direct finger guidance, the device is used to hook the sacrospinous ligament at the appropriate location. Depression of the plunger passes the needle through the ligament, and the needle is then retrieved by fins on the other side. Removal of the device completes placement of the suture.
One of the true benefits of the Capio needle driver is the ability to perform suture placement under direct finger guidance without the need for visualization using retractors – a benefit that minimizes the extent of dissection and the time involved. In my opinion, this device has revolutionized sacrospinous suspension by allowing more physicians to perform the procedure safely and effectively.
The next evolution in sacrospinous suspension will include anchor-based single-point attachment – an approach that has recently become available and may supplant traditional suture placement, which can potentially strangulate tissue and result in postoperative pain. Additional clinical experience is required before this technique can be supported, but initial results are encouraging, especially with respect to postoperative sacrospinous pain.
Completion of Procedure
Once the suture(s) are in place, a rectal exam is recommended to exclude unintentional rectal injury or suture placement. Once confirmed, tie-down of the sutures can be completed. In cases of simple sacrospinous suspension, the suture is taken through the vagina at the apex marked prior to initial incision. Two techniques are available for this.
The traditional pulley technique with permanent suture is taken through full thickness vagina excluding the epithelium, and then tied down prior to closure of the mucosal incision, thereby burying the knot under the mucosa. This sometimes can be technically confusing and difficult, and may reduce the strength of vaginal attachment. The benefit of this technique is use of a permanent suspension suture.
An alternative technique utilizes delayed absorbable suture and involves both arms of the suture being taken through the full thickness vaginal mucosa at the apex (Fig. C, D). The mucosal incision is then closed followed by suture(s) tie-down (Fig. E, F)F I prefer this technique as it is technically easier and allows full thickness attachment of the vagina. More importantly, it gives the surgeon easy access to the suspension sutures if the sutures need to be removed in the postoperative period in cases of persistent postoperative pain.
Regardless of technique, it is important to tie down the suture securely, but not tightly, as strangulation of the sacrospinous tissue may increase the chances of postoperative pain.
I prefer bilateral sacrospinous suspension sutures with only one attachment on each side in order to minimize deviation of the vagina to one side as well as to maximize support. A single suture on each side also removes any confusion over which suture may be involved in uncommon intraoperative complications such as rectal penetration or ureteral kinking.
If mesh/graft augmentation is being performed, the bilateral sacrospinous suspension sutures are taken through the apical lateral extensions of the trapezoid-shaped mesh and tied down. Although permanent suture can be used for this technique, I would recommend the use of delayed absorbable suture; permanent suture can sometimes strangulate the sacrospinous ligament with contraction of the mesh/graft over time.
After initial tie-down, these suspension sutures then can be taken through the vaginal apex as described above for further apical support. The distal ends of the mesh are then attached to the pubocervical fascia lateral to the bladder neck or the perineal body, depending on whether the procedure involves anterior or posterior mesh placement, respectively.
If mesh is used, hemostasis should be ensured when the vagina is closed using interrupted suture with little or no mucosal excision, thereby minimizing tension at the suture line and hopefully reducing the risk of postoperative mesh exposure.
A rectal exam should be done to exclude rectal injury/stitch penetration. In addition, it's important to assess the tissue bridge spanning the sacrospinous ligaments to make sure this is not too tight. A tight bridge may cause significant postoperative pain as well as defecatory dysfunction by partially obstructing the rectosigmoid. When using a mesh, this bridge can be minimized by cutting the apical transverse distance to at least 10 cm.
Cystoscopy with IV indigo carmine is performed at the end of the procedure to exclude unintentional urethral extraction/kinking. The vagina is packed at the surgeon's discretion.
Preventing, Managing Complications
With proper technique, complications associated with the sacrospinous suspension are relatively uncommon.
They can be broadly categorized as occurring intraoperatively and postoperatively, and can be largely avoided by minimizing wide dissection, by placing sutures at least 2 cm medial to the ischial spine to avoid injury to the pudendal neurovascular bundle, and by always performing a rectal exam as well as cystoscopy with IV indigo carmine following the surgical procedure.
Intraoperative Complications
Intraoperative complications can be associated with dissection into the sacrospinous space and placement of the suspension suture. Dissection-related complications include injury to the rectosigmoid as well as bleeding during dissection. It is important to make sure that dissection of the endopelvic fascia is performed sharply until a relatively avascular and areolar space is created; at this time, blunt dissection with the surgeon's finger can be easily accomplished.
Hugging the lateral side wall on each side should minimize risk of injury to the bowel. Rectal exam after placement of the suture is essential to the diagnosis of any unintentional bowel injury or suture penetration. Any confirmed rectal injury would need repair at the time of surgery.
Use of finger dissection in a back-and-forth motion rather than a sweeping up-down or side-side motion will minimize injury to the surrounding vasculature while still creating a tract large enough to place the suture. Placement of the suture can occasionally be associated with bleeding if there is any injury to the pudendal neurovascular bundle or its associated branches.
Oftentimes, tie-down of the suspension suture will control the bleeder. If there is persistent and uncontrollable bleeding, it is best not to be overly aggressive with hemostatic sutures or surgical clips, as these may result in increasing injury to the pudendal neurovascular bundle. Adequate exposure and suction are essential. Initial control of the hemostasis with pressure and tapenade for several minutes is usually successful. Placement of hemostatic agents such as Surgicel or Flo-Seal is often effective, followed by suture/clip placement if needed. Postoperative embolization for persistent bleeders has also been reported.
Placement of the suture also can sometimes be associated with ureteral kinking/obstruction. Following tie-down of the suspension sutures, cystoscopy with IV indigo carmine is recommended. If the ureter fails to spill on either side, repeat IV indigo carmine followed by ureteral stent placement is suggested. Stent placement will allow one to determine the relative site of obstruction based on how far the stent can be inserted. Typically, obstruction associated with sacrospinous sutures allows the stent to be passed 5-9 cm.
Removal of the suspension suture almost always results in resolution of the obstruction with resulting ureteral spill. A repeat suspension suture could then be placed slightly more medial at the surgeon's discretion. Repeat cystoscopy should be performed to confirm continued ureteral patency.
Postoperative Complications
Postoperative complications include hematoma/bleeding and complaints of buttock pain secondary to the involvement of the pudendal nerve branches. Bleeding should be banished accordingly. If bleeding is significant, reoperation or embolization is generally the best option. Small self-limited hematomas can be expectantly managed or drained via vaginal access as needed. It may be best to drain hematomas in cases in which mesh was placed at the time of sacrospinous suspension so as to prevent significant abscess and postoperative infection.
Mild buttock discomfort following sacrospinous suspension is not uncommon, and it is usually managed conservatively with observation, nonsteroidals, and muscle relaxants such as baclofen. The patient should be monitored on a weekly basis to ensure continued improvement.
For severe or persistent pain, removal of the suture should be considered; this is easiest if the suture was tied transvaginally rather than with the traditional pulley stitch technique. (In the latter case, suture removal involves opening the vagina.) Transvaginal excision of the suspension sutures can often be performed in the office or at the bedside with a lighted speculum and long scissors. Most patients report almost immediate relief after removal of the suture.
A. Here Briesky-Navratil retractors are used to retract the rectum medially and the bladder superiorly. B. Here is the technique of passage of a Miya hook through the ligament. Inset is the technique of retrieval of the suture.
Source Atlas of Pelvic Anatomy and Gynecologic Surgery (Philadelphia: Elsevier Health Sciences, 2006)
C. Here two sutures have been passed through the complex. D. Technique of fixing the vaginal apex to the coccygeus-sacrospinous ligament complex (C-SSL). If a pulley stitch is performed, then permanent sutures should be used. If the sutures are passed through the vaginal epithelium and tied in the vaginal lumen, then delayed absorbable sutures should be used. E. The vagina is closed prior to tying the suspension sutures. F. Tied sacrospinous sutures.
Source Atlas of Pelvic Anatomy and Gynecologic Surgery (Philadelphia: Elsevier Health Sciences, 2006)
Treating Advanced Pelvic Prolapse
It is estimated that 50% of parous women have evidence of loss of pelvic support.
Today, women with advanced pelvic organ prolapse have a number of surgical options. In a 1997 study by Olsen et al., the authors included 13 different procedures to treat advanced pelvic organ prolapse (Obstet. Gynecol. 1997;89:501-6). Since the date of that article, many more procedures – laparoscopic, robot-assisted, and vaginal – have been described and utilized to treat advanced organ prolapse. Even with the ability to use minimally invasive abdominal techniques, many physicians continue to prefer a vaginal route to correct advanced pelvic organ prolapse. They cite the fact that a vaginal approach is associated with reduced hospitalization, less postoperative pain, a faster return to normal activity, and a superior cosmetic result.
Over the past 40 years, one of the most popular procedures in the vaginal surgeon's armamentarium has been the sacrospinous ligament suspension. More recently, the procedure has been described with mesh placement as well.
We have asked an expert on this surgical technique, Dr. Neeraj Kohli, to write this Gynecologic Surgery Master Class. Dr. Kohli is a leader in the field of minimally invasive pelvic surgery and the treatment of pelvic prolapse and urinary incontinence. He is director of the division of urogynecology at Brigham and Women's Hospital and assistant professor of obstetrics and gynecology at Harvard Medical School, both in Boston.
The sacrospinous ligament suspension technique was first described by Karl Richter in 1968 and later introduced into the United States by David H. Nichols and Clyde L. Randall in 1971. It has been and continues to be an effective technique for apical suspension via the vaginal route, and is a valuable addition to the surgical armamentarium of the gynecologic surgeon.
In the 1990s, the procedure was done less frequently because of the popularity of uterosacral ligament suspension. Recently, however, sacrospinous ligament suspension has regained popularity for various reasons. The uterosacral ligament technique, for one, requires peritoneal entry, and the ligament is often of variable strength and also can sometimes be difficult to identify.
In addition, new tools and variations in technique, such as use of the Capio needle driver, have made sacrospinous ligament suspension easier and safer. Finally, the popularity of vaginal mesh procedures has created renewed interest in sacrospinous suspension as a direct visualization attachment technique for apical mesh, compared with trocar/needle-based techniques, which involve blind passage and possible injury to the bowel and bladder.
With proper technique, the procedure is safe, effective, and durable and has few complications related to future sexual function. Long-term success rates have been excellent in properly selected patients.
Indications
Various techniques of apical suspension are available to the gynecologic surgeon. Sacrospinous suspension is indicated in patients with adequate vaginal length who desire a vaginal procedure. An office-based exam should be performed to assess vaginal length and location/severity of prolapse.
Oftentimes, the procedure can be performed using the traditional technique with attachment of the vaginal mucosa or with mesh augmentation using the sacrospinous sutures as the apical mesh attachment points. In my practice, the procedure is contraindicated in patients with a short vagina, chronic pelvic pain, or any history of sciatica.
Prior to Surgery
Vaginal exam prior to initial dissection is helpful in ensuring that the vagina is of adequate length to reach the sacrospinous ligament. Marking of the vaginal apex for placement of suspension sutures sites also is helpful. The vagina is reapproximated to either or both sacrospinous ligaments using an Allis clamp, which is then adjusted in order to maximize vaginal length and reapproximation to the corresponding ligament. The location of the Allis clamp is then tagged with a full thickness marking suture.
Surgical Dissection
The procedure begins with entry into the sacrospinous space. Traditionally, this dissection has been described through a posterior vaginal mucosal incision associated with rectocele repair. A midline incision is made from the perineal body to the vaginal apex. The vaginal mucosa is then dissected off the underlying rectovaginal septum distally and any enterocele proximally. In the upper third of the vagina, lateral dissection is extended in the pararectal space until areolar tissue is encountered. Blunt dissection is then performed toward the ischial spine in a back-and-forth manner.
The relevant anatomy including the ischial spine, the sacrospinous ligament, the coccygeus muscle, and the lateral side wall with White's line, is identified (Fig. A). An identical dissection is performed on the contralateral side.
An anterior approach to sacrospinous suspension was described by Peter K. Sands et al. in 2000. This is especially helpful if the patient has only anterior and apical defects without the need for rectocele dissection or is undergoing an anterior mesh augmentation procedure. The anterior vaginal wall is opened, and the endopelvic connective tissue is separated from the pubic ramus at the level of the bladder neck to the ischial spine, exposing the paravesical and pararectal space. The sacrospinous ligament is identified and isolated through this defect.
Perhaps the easiest method of entering the sacrospinous space is through a midcompartment approach just lateral to the enterocele. This is often described with isolated apical/enterocele defects. The vaginal mucosa over the apex/enterocele is incised in the midline. The edges of the incision are grasped using Allis clamps, and lateral dissection is performed between the vaginal mucosa and enterocele sac until loose areolar tissue is noted. Blunt finger dissection in a back-and-forth motion is performed to the ischial spine.
An identical procedure is then performed on the contralateral side. Such midcompartment dissection is associated with very little bleeding and quick access to the sacrospinous space.
Suture Placement
A variety of tools and techniques have been described to place the sacrospinous suspension sutures. Traditionally, suture placement has been described using a standard needle holder, Miya hook, Des-Champs ligature, Shutt punch, or Nichols-Veronikis ligature carrier. Each device is loaded with the suture/needle.
Vaginal retractors (I prefer the Breisky-Navratril retractors) are used to gain exposure to the sacrospinous space until the ligament is visualized. The suture is placed around the sacrospinous ligament approximately two fingerbreadths medial to the ischial spine, with care given to avoid injury to the pudendal neurovascular bundle (Fig. B).
A permanent suture (Ethibond or Gore-Tex) is used for a pulley stitch attachment, while a delayed absorbable suture such as polydioxanone (PDS) is used for a full thickness vaginal attachment. A second suture may be placed just slightly medial to the first at the surgeon's discretion. Bilateral sacrospinous sutures also could be placed. Bilateral suspension sutures are especially useful when considering mesh augmentation of the anterior and/or posterior segment.
More recently, traditional devices have been replaced with the Capio needle driver. This is a disposable multiuse suture retrieval device which makes sacrospinous ligament suspension significantly easier, faster, and safer. The device has a medium caliber shaft with a plunger for suture application. The end has a hook which allows push-catch retrieval of a small needle-based suture. Various permanent and delayed absorbable sutures are available. Under direct finger guidance, the device is used to hook the sacrospinous ligament at the appropriate location. Depression of the plunger passes the needle through the ligament, and the needle is then retrieved by fins on the other side. Removal of the device completes placement of the suture.
One of the true benefits of the Capio needle driver is the ability to perform suture placement under direct finger guidance without the need for visualization using retractors – a benefit that minimizes the extent of dissection and the time involved. In my opinion, this device has revolutionized sacrospinous suspension by allowing more physicians to perform the procedure safely and effectively.
The next evolution in sacrospinous suspension will include anchor-based single-point attachment – an approach that has recently become available and may supplant traditional suture placement, which can potentially strangulate tissue and result in postoperative pain. Additional clinical experience is required before this technique can be supported, but initial results are encouraging, especially with respect to postoperative sacrospinous pain.
Completion of Procedure
Once the suture(s) are in place, a rectal exam is recommended to exclude unintentional rectal injury or suture placement. Once confirmed, tie-down of the sutures can be completed. In cases of simple sacrospinous suspension, the suture is taken through the vagina at the apex marked prior to initial incision. Two techniques are available for this.
The traditional pulley technique with permanent suture is taken through full thickness vagina excluding the epithelium, and then tied down prior to closure of the mucosal incision, thereby burying the knot under the mucosa. This sometimes can be technically confusing and difficult, and may reduce the strength of vaginal attachment. The benefit of this technique is use of a permanent suspension suture.
An alternative technique utilizes delayed absorbable suture and involves both arms of the suture being taken through the full thickness vaginal mucosa at the apex (Fig. C, D). The mucosal incision is then closed followed by suture(s) tie-down (Fig. E, F)F I prefer this technique as it is technically easier and allows full thickness attachment of the vagina. More importantly, it gives the surgeon easy access to the suspension sutures if the sutures need to be removed in the postoperative period in cases of persistent postoperative pain.
Regardless of technique, it is important to tie down the suture securely, but not tightly, as strangulation of the sacrospinous tissue may increase the chances of postoperative pain.
I prefer bilateral sacrospinous suspension sutures with only one attachment on each side in order to minimize deviation of the vagina to one side as well as to maximize support. A single suture on each side also removes any confusion over which suture may be involved in uncommon intraoperative complications such as rectal penetration or ureteral kinking.
If mesh/graft augmentation is being performed, the bilateral sacrospinous suspension sutures are taken through the apical lateral extensions of the trapezoid-shaped mesh and tied down. Although permanent suture can be used for this technique, I would recommend the use of delayed absorbable suture; permanent suture can sometimes strangulate the sacrospinous ligament with contraction of the mesh/graft over time.
After initial tie-down, these suspension sutures then can be taken through the vaginal apex as described above for further apical support. The distal ends of the mesh are then attached to the pubocervical fascia lateral to the bladder neck or the perineal body, depending on whether the procedure involves anterior or posterior mesh placement, respectively.
If mesh is used, hemostasis should be ensured when the vagina is closed using interrupted suture with little or no mucosal excision, thereby minimizing tension at the suture line and hopefully reducing the risk of postoperative mesh exposure.
A rectal exam should be done to exclude rectal injury/stitch penetration. In addition, it's important to assess the tissue bridge spanning the sacrospinous ligaments to make sure this is not too tight. A tight bridge may cause significant postoperative pain as well as defecatory dysfunction by partially obstructing the rectosigmoid. When using a mesh, this bridge can be minimized by cutting the apical transverse distance to at least 10 cm.
Cystoscopy with IV indigo carmine is performed at the end of the procedure to exclude unintentional urethral extraction/kinking. The vagina is packed at the surgeon's discretion.
Preventing, Managing Complications
With proper technique, complications associated with the sacrospinous suspension are relatively uncommon.
They can be broadly categorized as occurring intraoperatively and postoperatively, and can be largely avoided by minimizing wide dissection, by placing sutures at least 2 cm medial to the ischial spine to avoid injury to the pudendal neurovascular bundle, and by always performing a rectal exam as well as cystoscopy with IV indigo carmine following the surgical procedure.
Intraoperative Complications
Intraoperative complications can be associated with dissection into the sacrospinous space and placement of the suspension suture. Dissection-related complications include injury to the rectosigmoid as well as bleeding during dissection. It is important to make sure that dissection of the endopelvic fascia is performed sharply until a relatively avascular and areolar space is created; at this time, blunt dissection with the surgeon's finger can be easily accomplished.
Hugging the lateral side wall on each side should minimize risk of injury to the bowel. Rectal exam after placement of the suture is essential to the diagnosis of any unintentional bowel injury or suture penetration. Any confirmed rectal injury would need repair at the time of surgery.
Use of finger dissection in a back-and-forth motion rather than a sweeping up-down or side-side motion will minimize injury to the surrounding vasculature while still creating a tract large enough to place the suture. Placement of the suture can occasionally be associated with bleeding if there is any injury to the pudendal neurovascular bundle or its associated branches.
Oftentimes, tie-down of the suspension suture will control the bleeder. If there is persistent and uncontrollable bleeding, it is best not to be overly aggressive with hemostatic sutures or surgical clips, as these may result in increasing injury to the pudendal neurovascular bundle. Adequate exposure and suction are essential. Initial control of the hemostasis with pressure and tapenade for several minutes is usually successful. Placement of hemostatic agents such as Surgicel or Flo-Seal is often effective, followed by suture/clip placement if needed. Postoperative embolization for persistent bleeders has also been reported.
Placement of the suture also can sometimes be associated with ureteral kinking/obstruction. Following tie-down of the suspension sutures, cystoscopy with IV indigo carmine is recommended. If the ureter fails to spill on either side, repeat IV indigo carmine followed by ureteral stent placement is suggested. Stent placement will allow one to determine the relative site of obstruction based on how far the stent can be inserted. Typically, obstruction associated with sacrospinous sutures allows the stent to be passed 5-9 cm.
Removal of the suspension suture almost always results in resolution of the obstruction with resulting ureteral spill. A repeat suspension suture could then be placed slightly more medial at the surgeon's discretion. Repeat cystoscopy should be performed to confirm continued ureteral patency.
Postoperative Complications
Postoperative complications include hematoma/bleeding and complaints of buttock pain secondary to the involvement of the pudendal nerve branches. Bleeding should be banished accordingly. If bleeding is significant, reoperation or embolization is generally the best option. Small self-limited hematomas can be expectantly managed or drained via vaginal access as needed. It may be best to drain hematomas in cases in which mesh was placed at the time of sacrospinous suspension so as to prevent significant abscess and postoperative infection.
Mild buttock discomfort following sacrospinous suspension is not uncommon, and it is usually managed conservatively with observation, nonsteroidals, and muscle relaxants such as baclofen. The patient should be monitored on a weekly basis to ensure continued improvement.
For severe or persistent pain, removal of the suture should be considered; this is easiest if the suture was tied transvaginally rather than with the traditional pulley stitch technique. (In the latter case, suture removal involves opening the vagina.) Transvaginal excision of the suspension sutures can often be performed in the office or at the bedside with a lighted speculum and long scissors. Most patients report almost immediate relief after removal of the suture.
A. Here Briesky-Navratil retractors are used to retract the rectum medially and the bladder superiorly. B. Here is the technique of passage of a Miya hook through the ligament. Inset is the technique of retrieval of the suture.
Source Atlas of Pelvic Anatomy and Gynecologic Surgery (Philadelphia: Elsevier Health Sciences, 2006)
C. Here two sutures have been passed through the complex. D. Technique of fixing the vaginal apex to the coccygeus-sacrospinous ligament complex (C-SSL). If a pulley stitch is performed, then permanent sutures should be used. If the sutures are passed through the vaginal epithelium and tied in the vaginal lumen, then delayed absorbable sutures should be used. E. The vagina is closed prior to tying the suspension sutures. F. Tied sacrospinous sutures.
Source Atlas of Pelvic Anatomy and Gynecologic Surgery (Philadelphia: Elsevier Health Sciences, 2006)
Treating Advanced Pelvic Prolapse
It is estimated that 50% of parous women have evidence of loss of pelvic support.
Today, women with advanced pelvic organ prolapse have a number of surgical options. In a 1997 study by Olsen et al., the authors included 13 different procedures to treat advanced pelvic organ prolapse (Obstet. Gynecol. 1997;89:501-6). Since the date of that article, many more procedures – laparoscopic, robot-assisted, and vaginal – have been described and utilized to treat advanced organ prolapse. Even with the ability to use minimally invasive abdominal techniques, many physicians continue to prefer a vaginal route to correct advanced pelvic organ prolapse. They cite the fact that a vaginal approach is associated with reduced hospitalization, less postoperative pain, a faster return to normal activity, and a superior cosmetic result.
Over the past 40 years, one of the most popular procedures in the vaginal surgeon's armamentarium has been the sacrospinous ligament suspension. More recently, the procedure has been described with mesh placement as well.
We have asked an expert on this surgical technique, Dr. Neeraj Kohli, to write this Gynecologic Surgery Master Class. Dr. Kohli is a leader in the field of minimally invasive pelvic surgery and the treatment of pelvic prolapse and urinary incontinence. He is director of the division of urogynecology at Brigham and Women's Hospital and assistant professor of obstetrics and gynecology at Harvard Medical School, both in Boston.
The sacrospinous ligament suspension technique was first described by Karl Richter in 1968 and later introduced into the United States by David H. Nichols and Clyde L. Randall in 1971. It has been and continues to be an effective technique for apical suspension via the vaginal route, and is a valuable addition to the surgical armamentarium of the gynecologic surgeon.
In the 1990s, the procedure was done less frequently because of the popularity of uterosacral ligament suspension. Recently, however, sacrospinous ligament suspension has regained popularity for various reasons. The uterosacral ligament technique, for one, requires peritoneal entry, and the ligament is often of variable strength and also can sometimes be difficult to identify.
In addition, new tools and variations in technique, such as use of the Capio needle driver, have made sacrospinous ligament suspension easier and safer. Finally, the popularity of vaginal mesh procedures has created renewed interest in sacrospinous suspension as a direct visualization attachment technique for apical mesh, compared with trocar/needle-based techniques, which involve blind passage and possible injury to the bowel and bladder.
With proper technique, the procedure is safe, effective, and durable and has few complications related to future sexual function. Long-term success rates have been excellent in properly selected patients.
Indications
Various techniques of apical suspension are available to the gynecologic surgeon. Sacrospinous suspension is indicated in patients with adequate vaginal length who desire a vaginal procedure. An office-based exam should be performed to assess vaginal length and location/severity of prolapse.
Oftentimes, the procedure can be performed using the traditional technique with attachment of the vaginal mucosa or with mesh augmentation using the sacrospinous sutures as the apical mesh attachment points. In my practice, the procedure is contraindicated in patients with a short vagina, chronic pelvic pain, or any history of sciatica.
Prior to Surgery
Vaginal exam prior to initial dissection is helpful in ensuring that the vagina is of adequate length to reach the sacrospinous ligament. Marking of the vaginal apex for placement of suspension sutures sites also is helpful. The vagina is reapproximated to either or both sacrospinous ligaments using an Allis clamp, which is then adjusted in order to maximize vaginal length and reapproximation to the corresponding ligament. The location of the Allis clamp is then tagged with a full thickness marking suture.
Surgical Dissection
The procedure begins with entry into the sacrospinous space. Traditionally, this dissection has been described through a posterior vaginal mucosal incision associated with rectocele repair. A midline incision is made from the perineal body to the vaginal apex. The vaginal mucosa is then dissected off the underlying rectovaginal septum distally and any enterocele proximally. In the upper third of the vagina, lateral dissection is extended in the pararectal space until areolar tissue is encountered. Blunt dissection is then performed toward the ischial spine in a back-and-forth manner.
The relevant anatomy including the ischial spine, the sacrospinous ligament, the coccygeus muscle, and the lateral side wall with White's line, is identified (Fig. A). An identical dissection is performed on the contralateral side.
An anterior approach to sacrospinous suspension was described by Peter K. Sands et al. in 2000. This is especially helpful if the patient has only anterior and apical defects without the need for rectocele dissection or is undergoing an anterior mesh augmentation procedure. The anterior vaginal wall is opened, and the endopelvic connective tissue is separated from the pubic ramus at the level of the bladder neck to the ischial spine, exposing the paravesical and pararectal space. The sacrospinous ligament is identified and isolated through this defect.
Perhaps the easiest method of entering the sacrospinous space is through a midcompartment approach just lateral to the enterocele. This is often described with isolated apical/enterocele defects. The vaginal mucosa over the apex/enterocele is incised in the midline. The edges of the incision are grasped using Allis clamps, and lateral dissection is performed between the vaginal mucosa and enterocele sac until loose areolar tissue is noted. Blunt finger dissection in a back-and-forth motion is performed to the ischial spine.
An identical procedure is then performed on the contralateral side. Such midcompartment dissection is associated with very little bleeding and quick access to the sacrospinous space.
Suture Placement
A variety of tools and techniques have been described to place the sacrospinous suspension sutures. Traditionally, suture placement has been described using a standard needle holder, Miya hook, Des-Champs ligature, Shutt punch, or Nichols-Veronikis ligature carrier. Each device is loaded with the suture/needle.
Vaginal retractors (I prefer the Breisky-Navratril retractors) are used to gain exposure to the sacrospinous space until the ligament is visualized. The suture is placed around the sacrospinous ligament approximately two fingerbreadths medial to the ischial spine, with care given to avoid injury to the pudendal neurovascular bundle (Fig. B).
A permanent suture (Ethibond or Gore-Tex) is used for a pulley stitch attachment, while a delayed absorbable suture such as polydioxanone (PDS) is used for a full thickness vaginal attachment. A second suture may be placed just slightly medial to the first at the surgeon's discretion. Bilateral sacrospinous sutures also could be placed. Bilateral suspension sutures are especially useful when considering mesh augmentation of the anterior and/or posterior segment.
More recently, traditional devices have been replaced with the Capio needle driver. This is a disposable multiuse suture retrieval device which makes sacrospinous ligament suspension significantly easier, faster, and safer. The device has a medium caliber shaft with a plunger for suture application. The end has a hook which allows push-catch retrieval of a small needle-based suture. Various permanent and delayed absorbable sutures are available. Under direct finger guidance, the device is used to hook the sacrospinous ligament at the appropriate location. Depression of the plunger passes the needle through the ligament, and the needle is then retrieved by fins on the other side. Removal of the device completes placement of the suture.
One of the true benefits of the Capio needle driver is the ability to perform suture placement under direct finger guidance without the need for visualization using retractors – a benefit that minimizes the extent of dissection and the time involved. In my opinion, this device has revolutionized sacrospinous suspension by allowing more physicians to perform the procedure safely and effectively.
The next evolution in sacrospinous suspension will include anchor-based single-point attachment – an approach that has recently become available and may supplant traditional suture placement, which can potentially strangulate tissue and result in postoperative pain. Additional clinical experience is required before this technique can be supported, but initial results are encouraging, especially with respect to postoperative sacrospinous pain.
Completion of Procedure
Once the suture(s) are in place, a rectal exam is recommended to exclude unintentional rectal injury or suture placement. Once confirmed, tie-down of the sutures can be completed. In cases of simple sacrospinous suspension, the suture is taken through the vagina at the apex marked prior to initial incision. Two techniques are available for this.
The traditional pulley technique with permanent suture is taken through full thickness vagina excluding the epithelium, and then tied down prior to closure of the mucosal incision, thereby burying the knot under the mucosa. This sometimes can be technically confusing and difficult, and may reduce the strength of vaginal attachment. The benefit of this technique is use of a permanent suspension suture.
An alternative technique utilizes delayed absorbable suture and involves both arms of the suture being taken through the full thickness vaginal mucosa at the apex (Fig. C, D). The mucosal incision is then closed followed by suture(s) tie-down (Fig. E, F)F I prefer this technique as it is technically easier and allows full thickness attachment of the vagina. More importantly, it gives the surgeon easy access to the suspension sutures if the sutures need to be removed in the postoperative period in cases of persistent postoperative pain.
Regardless of technique, it is important to tie down the suture securely, but not tightly, as strangulation of the sacrospinous tissue may increase the chances of postoperative pain.
I prefer bilateral sacrospinous suspension sutures with only one attachment on each side in order to minimize deviation of the vagina to one side as well as to maximize support. A single suture on each side also removes any confusion over which suture may be involved in uncommon intraoperative complications such as rectal penetration or ureteral kinking.
If mesh/graft augmentation is being performed, the bilateral sacrospinous suspension sutures are taken through the apical lateral extensions of the trapezoid-shaped mesh and tied down. Although permanent suture can be used for this technique, I would recommend the use of delayed absorbable suture; permanent suture can sometimes strangulate the sacrospinous ligament with contraction of the mesh/graft over time.
After initial tie-down, these suspension sutures then can be taken through the vaginal apex as described above for further apical support. The distal ends of the mesh are then attached to the pubocervical fascia lateral to the bladder neck or the perineal body, depending on whether the procedure involves anterior or posterior mesh placement, respectively.
If mesh is used, hemostasis should be ensured when the vagina is closed using interrupted suture with little or no mucosal excision, thereby minimizing tension at the suture line and hopefully reducing the risk of postoperative mesh exposure.
A rectal exam should be done to exclude rectal injury/stitch penetration. In addition, it's important to assess the tissue bridge spanning the sacrospinous ligaments to make sure this is not too tight. A tight bridge may cause significant postoperative pain as well as defecatory dysfunction by partially obstructing the rectosigmoid. When using a mesh, this bridge can be minimized by cutting the apical transverse distance to at least 10 cm.
Cystoscopy with IV indigo carmine is performed at the end of the procedure to exclude unintentional urethral extraction/kinking. The vagina is packed at the surgeon's discretion.
Preventing, Managing Complications
With proper technique, complications associated with the sacrospinous suspension are relatively uncommon.
They can be broadly categorized as occurring intraoperatively and postoperatively, and can be largely avoided by minimizing wide dissection, by placing sutures at least 2 cm medial to the ischial spine to avoid injury to the pudendal neurovascular bundle, and by always performing a rectal exam as well as cystoscopy with IV indigo carmine following the surgical procedure.
Intraoperative Complications
Intraoperative complications can be associated with dissection into the sacrospinous space and placement of the suspension suture. Dissection-related complications include injury to the rectosigmoid as well as bleeding during dissection. It is important to make sure that dissection of the endopelvic fascia is performed sharply until a relatively avascular and areolar space is created; at this time, blunt dissection with the surgeon's finger can be easily accomplished.
Hugging the lateral side wall on each side should minimize risk of injury to the bowel. Rectal exam after placement of the suture is essential to the diagnosis of any unintentional bowel injury or suture penetration. Any confirmed rectal injury would need repair at the time of surgery.
Use of finger dissection in a back-and-forth motion rather than a sweeping up-down or side-side motion will minimize injury to the surrounding vasculature while still creating a tract large enough to place the suture. Placement of the suture can occasionally be associated with bleeding if there is any injury to the pudendal neurovascular bundle or its associated branches.
Oftentimes, tie-down of the suspension suture will control the bleeder. If there is persistent and uncontrollable bleeding, it is best not to be overly aggressive with hemostatic sutures or surgical clips, as these may result in increasing injury to the pudendal neurovascular bundle. Adequate exposure and suction are essential. Initial control of the hemostasis with pressure and tapenade for several minutes is usually successful. Placement of hemostatic agents such as Surgicel or Flo-Seal is often effective, followed by suture/clip placement if needed. Postoperative embolization for persistent bleeders has also been reported.
Placement of the suture also can sometimes be associated with ureteral kinking/obstruction. Following tie-down of the suspension sutures, cystoscopy with IV indigo carmine is recommended. If the ureter fails to spill on either side, repeat IV indigo carmine followed by ureteral stent placement is suggested. Stent placement will allow one to determine the relative site of obstruction based on how far the stent can be inserted. Typically, obstruction associated with sacrospinous sutures allows the stent to be passed 5-9 cm.
Removal of the suspension suture almost always results in resolution of the obstruction with resulting ureteral spill. A repeat suspension suture could then be placed slightly more medial at the surgeon's discretion. Repeat cystoscopy should be performed to confirm continued ureteral patency.
Postoperative Complications
Postoperative complications include hematoma/bleeding and complaints of buttock pain secondary to the involvement of the pudendal nerve branches. Bleeding should be banished accordingly. If bleeding is significant, reoperation or embolization is generally the best option. Small self-limited hematomas can be expectantly managed or drained via vaginal access as needed. It may be best to drain hematomas in cases in which mesh was placed at the time of sacrospinous suspension so as to prevent significant abscess and postoperative infection.
Mild buttock discomfort following sacrospinous suspension is not uncommon, and it is usually managed conservatively with observation, nonsteroidals, and muscle relaxants such as baclofen. The patient should be monitored on a weekly basis to ensure continued improvement.
For severe or persistent pain, removal of the suture should be considered; this is easiest if the suture was tied transvaginally rather than with the traditional pulley stitch technique. (In the latter case, suture removal involves opening the vagina.) Transvaginal excision of the suspension sutures can often be performed in the office or at the bedside with a lighted speculum and long scissors. Most patients report almost immediate relief after removal of the suture.
A. Here Briesky-Navratil retractors are used to retract the rectum medially and the bladder superiorly. B. Here is the technique of passage of a Miya hook through the ligament. Inset is the technique of retrieval of the suture.
Source Atlas of Pelvic Anatomy and Gynecologic Surgery (Philadelphia: Elsevier Health Sciences, 2006)
C. Here two sutures have been passed through the complex. D. Technique of fixing the vaginal apex to the coccygeus-sacrospinous ligament complex (C-SSL). If a pulley stitch is performed, then permanent sutures should be used. If the sutures are passed through the vaginal epithelium and tied in the vaginal lumen, then delayed absorbable sutures should be used. E. The vagina is closed prior to tying the suspension sutures. F. Tied sacrospinous sutures.
Source Atlas of Pelvic Anatomy and Gynecologic Surgery (Philadelphia: Elsevier Health Sciences, 2006)
Treating Advanced Pelvic Prolapse
It is estimated that 50% of parous women have evidence of loss of pelvic support.
Today, women with advanced pelvic organ prolapse have a number of surgical options. In a 1997 study by Olsen et al., the authors included 13 different procedures to treat advanced pelvic organ prolapse (Obstet. Gynecol. 1997;89:501-6). Since the date of that article, many more procedures – laparoscopic, robot-assisted, and vaginal – have been described and utilized to treat advanced organ prolapse. Even with the ability to use minimally invasive abdominal techniques, many physicians continue to prefer a vaginal route to correct advanced pelvic organ prolapse. They cite the fact that a vaginal approach is associated with reduced hospitalization, less postoperative pain, a faster return to normal activity, and a superior cosmetic result.
Over the past 40 years, one of the most popular procedures in the vaginal surgeon's armamentarium has been the sacrospinous ligament suspension. More recently, the procedure has been described with mesh placement as well.
We have asked an expert on this surgical technique, Dr. Neeraj Kohli, to write this Gynecologic Surgery Master Class. Dr. Kohli is a leader in the field of minimally invasive pelvic surgery and the treatment of pelvic prolapse and urinary incontinence. He is director of the division of urogynecology at Brigham and Women's Hospital and assistant professor of obstetrics and gynecology at Harvard Medical School, both in Boston.
Obliterated Cul-de-Sac Dissection
Endometriosis affects about 2.5%-3.3% of reproductive-aged women and is characterized by extrauterine growth of endometrial tissue consisting of endometrial glands and stroma. Its depth ranges from superficial to deep infiltration.
When described as deep infiltrating endometriosis (DIE), the disease involves lesions that are invasive and that extend into areas or organs that are in direct contact with already affected areas. Although the theory of migration of endometrial glands may help to explain endometriosis in general and superficial disease in particular, the prevailing opinion currently is that DIE may result from metaplasia of remnants of Müllerian tissue.
DIE lesions penetrate greater than 5 mm under the peritoneal surface and can cause severe pelvic pain. The lesions are mainly composed of smooth muscle with active glandular epithelium, which causes fibrosis and eventually their nodular characteristics.
In cases in which the DIE lesions affect areas such as the rectovaginal space (as well as the uterosacral ligaments and the rectocervical area), treatment is more successful with a surgical approach.
Although rectovaginal lesions are eventually diagnosed through surgical methods, clinical examinations and imaging should be performed to support the surgical approach.
On medical history, many of these patients present with pelvic pain, dysmenorrhea, dyspareunia, or infertility.
Clinical examination must be done to help appreciate the location of the nodular lesion. The size of the nodule may be palpated on bimanual exam and can involve uterosacral ligaments, the posterior vaginal wall, the anterior rectal wall, and the posterior fornix.
Preoperative imaging, especially transvaginal and transrectal ultrasound and MRI, will establish the distribution and depth of the deep lesions.
The presence of deeply infiltrative endometriosis and the resulting alteration of normal anatomical planes make this one of the most challenging surgical cases that gynecologists encounter. Laparoscopic treatment requires an intimate understanding and application of pelvic anatomy, and the surgical fundamentals of visualization and traction-counter-traction, as well as electrosurgery.
Pathophysiology
The presence of deep endometriotic lesions in the posterior cul-de-sac is, again, likely a consequence of metaplasia of Müllerian rests, and the nodules are composed of smooth muscle proliferation and fibrosis, which is a result of infiltration.
The endometriotic foci migrate to the rectovaginal area, where hyperplasia of smooth muscle incites an inflammatory response; this evolves into retraction, which then leads to pelvic fibrosis and a subsequent reduction in uterine mobility and distortion of the pelvic anatomy.
DIE lesions have been classified through studies by Dr. Philippe Koninckx and his colleagues into three types based on their depth of invasion and location.
Type I lesions are conically shaped rectovaginal septum nodules and are located between the posterior and anterior walls of the vaginal mucosa and rectal muscularis, respectively. Lesions categorized as type II are deeply located and form from the posterior fornix to the rectovaginal region. They are typically covered by extensive adhesions causing retraction. The most severe lesions—type III—are composed of spherical nodules. The largest dimension of these lesions is located under the peritoneal fold of the rectouterine pouch of Douglas. The cranial movement of these posterior fornix lesions eventually causes the nodules to join the anterior rectal wall and creates an “hourglass”-like appearance.
Anatomy
It is important to appreciate the relationships of the avascular spaces and their relevance to the dissection of the obliterated cul-de-sac and excision of rectovaginal endometriosis. Also remember that the ureter enters the pelvis over the bifurcation of the common iliac and medial to the infundibulopelvic ligament (see photo below).
The pararectal space is bordered laterally by the pelvic sidewall, anterolaterally by the cardinal ligament, and medially by the rectal pillars. The ureter courses beneath the peritoneum and through the rectal pillar.
The rectovaginal space is bordered laterally by the uterosacral ligaments, anteriorly by the vaginal fascia, and posteriorly by the rectal fascia.
The potential surgical space between the ureter and uterosacral ligament is utilized to transect the uterosacral ligament, which provides a means of access from the pararectal space into the rectovaginal space.
Instrumentation and Process
Surgical management of DIE is essential for restoring pelvic anatomy, relieving debilitating pelvic pain, and eliminating endometriotic nodular foci. Laparoscopic surgery provides magnified views of the posterior cul-de-sac and its pathology, and results in less postoperative pain and decreased recurrence of adhesions.
Instruments typically utilized during these procedures include monopolar scissors, bipolar coagulation, and the Harmonic scalpel.
Energy sources that provide the least amount of lateral spread are key in these procedures as the relationships of the pelvic organs, ureters, and rectum are exceptionally close.
The systematic approach of resecting these nodules entails restoring the normal anatomic relationships of the adnexa and sigmoid, then dissecting the obliterated cul-de-sac and performing a thorough excision of the rectovaginal endometriotic lesions.
We have divided the procedure into four parts: ureterolysis, dissection of the rectovaginal septum, excision of the rectovaginal nodule, and reconstruction.
When the ureters and bowel are involved with the disease process, the surgical approach should take into account the importance of restoring normal anatomy. The use of uterine manipulators with a colpotomy cup can help delineate the posterior vaginal fornix and the rectum. The introduction of rectal and vaginal probes during the surgery will improve the exposition and excision of the lesions (see figure above).
After pneumoperitoneum is established and maintained at 15 mm Hg, we have used a standard technique of placing a 10-mm trocar in the umbilicus for the laparoscope and three 5-mm ancillary trocars. One 5-mm trocar is placed to the right at 10 cm lateral to the umbilicus, and two 5-mm trocars are placed to the left (10 cm lateral to the umbilicus and in the left lower quadrant).
A thorough examination of the abdomen and pelvis should be performed to assess the disease and degree of dissection needed to successfully access the rectovaginal space. To excise the lesions, we have used the bipolar RoBi forceps (Karl Storz), monopolar scissors, and the Harmonic scalpel.
Ureterolysis
In all of our cases thus far, ureterolysis was performed before resection of any DIE nodules. The ureter crosses the pelvic brim close to the bifurcation of the common iliac artery, at which point it becomes the pelvic ureter. It continues on the pelvic sidewall medial to the infundibulopelvic ligament as it crosses the external iliac artery. Branches of the internal iliac artery supply the descending portion of the ureter and move along the course of the ureter from the lateral aspect.
The dissection of the ureter begins at the pelvic brim where the anatomy is normal. The peritoneum superior to the ureter is grasped and entered, and the incision is extended. Medial traction is placed on the inferior edge of the peritoneal incision, and dissection is continued in the fat/nonfat interface until the ureter is identified.
The ureter is surrounded by a layer of loose areolar tissue; this layer is entered by using a blunt dissector to dissect parallel to the ureter. Small vessels should be coagulated in the process to ensure visibility. The ureterolysis is directed toward the uterosacral ligaments and continued until the ureter enters the cardinal ligament (see photo above).
When complete obliteration of the cul- de-sac is present and the uterosacral ligaments are obscured bilaterally, ureterolysis is carried out on the opposite side to improve pelvic anatomic restoration. The dissection is sufficient when both ureters are mobilized completely and when each can be traced from the pelvic brim to its insertion into the bladder (see photo above).
Dissection of Rectovaginal Septum
The next step is to enter and dissect the rectovaginal septum. Prior to excision of the nodule, the pouch of Douglas is first accessed by freeing the area from any adhesions or ovarian endometriomas.
After the successful bilateral ureterolysis, the ureters can be identified and the posterior fornix can be delineated with the rectal probe and colpotomizer.
The posterior fornix is then pushed upward, and a transverse incision is made over the posterior cervix superior to the rectum—an area also known as the prerectal fascia (see photo above).
The rectovaginal septum extends laterally from the posterior cervix and uterosacral ligaments to the pelvic sidewall, where it then courses caudally to insert in the perineal body. This area is dissected inferiorly until the uterosacral ligaments (also known as the medial rectal pillars) are identified. At this stage, the ureter, the pararectal space, the lateral rectal pillar with associated nerves, and the medial rectal pillar are seen. The rectal probe will then help identify the rectum and the dissected uterosacral ligaments in their respective planes.
The potential space medial to the ureter is used to transect the uterosacral ligament and thus enter the rectovaginal space from the lateral aspect to medial. The uterosacral ligament is again transected, and the rectovaginal space entered (see photo above).
If the dissection is continued too superiorly, the prerectal fascia is transected and the vagina may be entered. If this occurs, then the fascia is retracted superiorly and the rectum is retracted inferiorly to help identify the correct dissection plane.
By understanding the anatomic principle that fat belongs to the rectum, one can identify the fat/nonfat interface; this facilitates dissection superior to this plane. It is also important to maintain the integrity of the vaginal and rectal spaces as much as possible to decrease the risk of bowel perforation. The dissection is continued until the space is fully developed.
Excision of the Nodule
When the uterosacral ligament is transected, this permits a closer inspection of the posterior vaginal wall and the ability to assess the need for further rectal dissection. The posterior fornix is then incised along the rectovaginal margin, allowing the space to be opened. The nodule is then excised by continuing along the original shape (triangular) of the pouch of Douglas (see photo at bottom of column).
One might find that the nodule extends into the pararectal fascia, the muscularis layer of the rectum, the posterior vagina, or the rectal wall. The rectal probe is used to help delineate the rectum from the remaining lesion. Such lesions can often be dissected with sharp scissors or may require excision with a Harmonic scalpel.
Reconstruction
The last step is the reconstruction of any structures that were compromised during the dissection. The patient is given IV indigo carmine to ensure the ureters are not compromised, and a cystoscopy is performed at the conclusion of the case to confirm function. The rectal wall integrity is confirmed with the injection of dilute indigo carmine through an 18 french foley catheter placed in the rectum or via an air leak test performed with the aide of a proctoscope.
Because the fibers of rectovaginal septum run vertically and blend with the muscular wall of the vagina, some deep-infiltrating lesions are part of the vaginal wall, and in these cases excision of the affected area of the vagina is necessary. Once these lesions are fully resected, the vagina is reattached to the cervix by means of an interrupted figure of eight suture, and the anterior rectal wall is also reinforced with sutures. The pneumoperitoneum can be maintained by using a blue suction bulb in the vagina.
Once the reconstruction is completed, the restoration of the pelvic anatomy should be apparent and additional attention should be paid to defects to ensure proper closure.
The surgical management of rectovaginal endometriosis nodules can be technically demanding as it can include the repair of the vagina, bowel, bladder, and ureters. A systematic approach and adequate endoscopic experience, however, can significantly decrease the risk of injury, Taking the time to perform the ureterolysis before the beginning of the case, moreover, is beneficial in providing landmarks and protecting the integrity of the ureters. Although long-term experience is forthcoming, the surgical intervention of DIE has proven to be beneficial in the short term by decreasing patients' pain and improving their quality of lifestyle.
The yellow-shaded region represents the ureter, the blue represents the infundibulopelvic ligament, and the red represents the bifurcation of the right common iliac artery.
The pararectal space is bordered by the pelvic sidewall, the cardinal ligament, and the rectal pillars.
The rectovaginal space is bordered by the uterosacral ligaments, the vaginal fascia, and the rectal fascia.
The space between the ureter and uterosacral ligament is utilized to transect the uterosacral ligament.
Source Images provided by Dr. Resad Pasic
Use of a rectal probe and vaginal tenaculum allows for proper plane appreciation when dissecting lesions in the rectovaginal space.
The right ureter is seen here on the medial aspect of the peritoneum. Ureterolysis can be done bluntly with the graspers and scissors, or with the Harmonic scalpel as shown here.
Bilateral ureterolysis is done before dissection of the rectovaginal septum.
To transect the rectovaginal septum, place the uterus on stretch in the anteverted position. The rectal probe is placed in the rectum and the uterosacral septum is identified and transected with the harmonic scalpel.
Transection of the uterosacral ligament is done after ureterolysis is completed. (Ureter is visible in the left upper portion; rectum is in lower right corner.)
The rectal nodule is grasped and placed on tension. The rectal probe is used to help delineate the rectal borders.
Source Images provided by Dr. Resad Pasic
Keys to the Obliterated Cul-de-Sac
Although the best approach to treatment of the obliterated cul-de-sac and excision of rectovaginal endometriosis is surgical, this laparoscopic procedure can be a daunting task for even the most experienced minimally invasive gynecologic surgeon. The potential risk to the rectum and ureter must be immediately recognized. It is for this reason that Dr. Harry Reich, one of the legendary pioneers in minimally invasive gynecologic surgery, stated over 20 years ago that dissection of the obliterated cul-de-sac and excision of deep rectovaginal endometriosis was the most difficult procedure in the gynecologist's armamentarium.
Obviously, the anatomy has remained unchanged, but safety has been enhanced through the creation of a strategic approach for dealing with this unique surgical dilemma. For this current issue of the Master Class in Gynecologic Surgery, I have called upon Dr. Resad Pasic, who was my vice president during my tenure as president of the AAGL and who is now the immediate past president of that organization. Dr. Pasic is professor of obstetrics and gynecology, the director of the section of operative gynecologic endoscopy, and a codirector of the fellowship in laparoscopy and minimally invasive surgery at the department of ob.gyn. and women's health at the University of Louisville (Ky.).
As the director of the postgraduate course on advanced laparoscopic anatomy, dissection, and reparative pelvic surgery on unembalmed female cadavers, Dr. Pasic's expertise in anatomy and minimally invasive gynecologic surgery makes him an excellent candidate to lead the discussion of the systematic approach to the obliterated cul-de-sac and excision of rectovaginal endometriosis.
Joining Dr. Pasic as coauthors for this Master Class are Dr. Jessica A. Shepherd and Dr. Joseph L. Hudgens, the current clinical fellows in the division of gynecologic endoscopy at the University of Louisville.
Dr. Shepherd obtained her medical degree from Ross University in Roseau, Dominica, in 2005 and then completed her internship and residency at Drexel University in Philadelphia. In addition to her current involvement as a fellow in gynecologic endoscopy, Dr. Shepherd is also completing her MBA at the University of Louisville. She is currently a member of the AAGL and serves on the ad hoc review committee for the Journal of Minimally Invasive Gynecology.
Dr. Hudgens obtained his medical degree from the University of Arkansas, Little Rock, in 2005. He completed his residency training in ob.gyn. at the University of Louisville in 2009. Dr. Hudgens recently completed a fellowship in minimally invasive gynecology in 2010 and has joined the Center for Women's Health at Owensboro Medical Health System in Owensboro, Ky. Dr. Hudgens also is currently an active member of the AAGL and serves as a member of the ad hoc review committee for the Journal of Minimally Invasive Gynecology.
Endometriosis affects about 2.5%-3.3% of reproductive-aged women and is characterized by extrauterine growth of endometrial tissue consisting of endometrial glands and stroma. Its depth ranges from superficial to deep infiltration.
When described as deep infiltrating endometriosis (DIE), the disease involves lesions that are invasive and that extend into areas or organs that are in direct contact with already affected areas. Although the theory of migration of endometrial glands may help to explain endometriosis in general and superficial disease in particular, the prevailing opinion currently is that DIE may result from metaplasia of remnants of Müllerian tissue.
DIE lesions penetrate greater than 5 mm under the peritoneal surface and can cause severe pelvic pain. The lesions are mainly composed of smooth muscle with active glandular epithelium, which causes fibrosis and eventually their nodular characteristics.
In cases in which the DIE lesions affect areas such as the rectovaginal space (as well as the uterosacral ligaments and the rectocervical area), treatment is more successful with a surgical approach.
Although rectovaginal lesions are eventually diagnosed through surgical methods, clinical examinations and imaging should be performed to support the surgical approach.
On medical history, many of these patients present with pelvic pain, dysmenorrhea, dyspareunia, or infertility.
Clinical examination must be done to help appreciate the location of the nodular lesion. The size of the nodule may be palpated on bimanual exam and can involve uterosacral ligaments, the posterior vaginal wall, the anterior rectal wall, and the posterior fornix.
Preoperative imaging, especially transvaginal and transrectal ultrasound and MRI, will establish the distribution and depth of the deep lesions.
The presence of deeply infiltrative endometriosis and the resulting alteration of normal anatomical planes make this one of the most challenging surgical cases that gynecologists encounter. Laparoscopic treatment requires an intimate understanding and application of pelvic anatomy, and the surgical fundamentals of visualization and traction-counter-traction, as well as electrosurgery.
Pathophysiology
The presence of deep endometriotic lesions in the posterior cul-de-sac is, again, likely a consequence of metaplasia of Müllerian rests, and the nodules are composed of smooth muscle proliferation and fibrosis, which is a result of infiltration.
The endometriotic foci migrate to the rectovaginal area, where hyperplasia of smooth muscle incites an inflammatory response; this evolves into retraction, which then leads to pelvic fibrosis and a subsequent reduction in uterine mobility and distortion of the pelvic anatomy.
DIE lesions have been classified through studies by Dr. Philippe Koninckx and his colleagues into three types based on their depth of invasion and location.
Type I lesions are conically shaped rectovaginal septum nodules and are located between the posterior and anterior walls of the vaginal mucosa and rectal muscularis, respectively. Lesions categorized as type II are deeply located and form from the posterior fornix to the rectovaginal region. They are typically covered by extensive adhesions causing retraction. The most severe lesions—type III—are composed of spherical nodules. The largest dimension of these lesions is located under the peritoneal fold of the rectouterine pouch of Douglas. The cranial movement of these posterior fornix lesions eventually causes the nodules to join the anterior rectal wall and creates an “hourglass”-like appearance.
Anatomy
It is important to appreciate the relationships of the avascular spaces and their relevance to the dissection of the obliterated cul-de-sac and excision of rectovaginal endometriosis. Also remember that the ureter enters the pelvis over the bifurcation of the common iliac and medial to the infundibulopelvic ligament (see photo below).
The pararectal space is bordered laterally by the pelvic sidewall, anterolaterally by the cardinal ligament, and medially by the rectal pillars. The ureter courses beneath the peritoneum and through the rectal pillar.
The rectovaginal space is bordered laterally by the uterosacral ligaments, anteriorly by the vaginal fascia, and posteriorly by the rectal fascia.
The potential surgical space between the ureter and uterosacral ligament is utilized to transect the uterosacral ligament, which provides a means of access from the pararectal space into the rectovaginal space.
Instrumentation and Process
Surgical management of DIE is essential for restoring pelvic anatomy, relieving debilitating pelvic pain, and eliminating endometriotic nodular foci. Laparoscopic surgery provides magnified views of the posterior cul-de-sac and its pathology, and results in less postoperative pain and decreased recurrence of adhesions.
Instruments typically utilized during these procedures include monopolar scissors, bipolar coagulation, and the Harmonic scalpel.
Energy sources that provide the least amount of lateral spread are key in these procedures as the relationships of the pelvic organs, ureters, and rectum are exceptionally close.
The systematic approach of resecting these nodules entails restoring the normal anatomic relationships of the adnexa and sigmoid, then dissecting the obliterated cul-de-sac and performing a thorough excision of the rectovaginal endometriotic lesions.
We have divided the procedure into four parts: ureterolysis, dissection of the rectovaginal septum, excision of the rectovaginal nodule, and reconstruction.
When the ureters and bowel are involved with the disease process, the surgical approach should take into account the importance of restoring normal anatomy. The use of uterine manipulators with a colpotomy cup can help delineate the posterior vaginal fornix and the rectum. The introduction of rectal and vaginal probes during the surgery will improve the exposition and excision of the lesions (see figure above).
After pneumoperitoneum is established and maintained at 15 mm Hg, we have used a standard technique of placing a 10-mm trocar in the umbilicus for the laparoscope and three 5-mm ancillary trocars. One 5-mm trocar is placed to the right at 10 cm lateral to the umbilicus, and two 5-mm trocars are placed to the left (10 cm lateral to the umbilicus and in the left lower quadrant).
A thorough examination of the abdomen and pelvis should be performed to assess the disease and degree of dissection needed to successfully access the rectovaginal space. To excise the lesions, we have used the bipolar RoBi forceps (Karl Storz), monopolar scissors, and the Harmonic scalpel.
Ureterolysis
In all of our cases thus far, ureterolysis was performed before resection of any DIE nodules. The ureter crosses the pelvic brim close to the bifurcation of the common iliac artery, at which point it becomes the pelvic ureter. It continues on the pelvic sidewall medial to the infundibulopelvic ligament as it crosses the external iliac artery. Branches of the internal iliac artery supply the descending portion of the ureter and move along the course of the ureter from the lateral aspect.
The dissection of the ureter begins at the pelvic brim where the anatomy is normal. The peritoneum superior to the ureter is grasped and entered, and the incision is extended. Medial traction is placed on the inferior edge of the peritoneal incision, and dissection is continued in the fat/nonfat interface until the ureter is identified.
The ureter is surrounded by a layer of loose areolar tissue; this layer is entered by using a blunt dissector to dissect parallel to the ureter. Small vessels should be coagulated in the process to ensure visibility. The ureterolysis is directed toward the uterosacral ligaments and continued until the ureter enters the cardinal ligament (see photo above).
When complete obliteration of the cul- de-sac is present and the uterosacral ligaments are obscured bilaterally, ureterolysis is carried out on the opposite side to improve pelvic anatomic restoration. The dissection is sufficient when both ureters are mobilized completely and when each can be traced from the pelvic brim to its insertion into the bladder (see photo above).
Dissection of Rectovaginal Septum
The next step is to enter and dissect the rectovaginal septum. Prior to excision of the nodule, the pouch of Douglas is first accessed by freeing the area from any adhesions or ovarian endometriomas.
After the successful bilateral ureterolysis, the ureters can be identified and the posterior fornix can be delineated with the rectal probe and colpotomizer.
The posterior fornix is then pushed upward, and a transverse incision is made over the posterior cervix superior to the rectum—an area also known as the prerectal fascia (see photo above).
The rectovaginal septum extends laterally from the posterior cervix and uterosacral ligaments to the pelvic sidewall, where it then courses caudally to insert in the perineal body. This area is dissected inferiorly until the uterosacral ligaments (also known as the medial rectal pillars) are identified. At this stage, the ureter, the pararectal space, the lateral rectal pillar with associated nerves, and the medial rectal pillar are seen. The rectal probe will then help identify the rectum and the dissected uterosacral ligaments in their respective planes.
The potential space medial to the ureter is used to transect the uterosacral ligament and thus enter the rectovaginal space from the lateral aspect to medial. The uterosacral ligament is again transected, and the rectovaginal space entered (see photo above).
If the dissection is continued too superiorly, the prerectal fascia is transected and the vagina may be entered. If this occurs, then the fascia is retracted superiorly and the rectum is retracted inferiorly to help identify the correct dissection plane.
By understanding the anatomic principle that fat belongs to the rectum, one can identify the fat/nonfat interface; this facilitates dissection superior to this plane. It is also important to maintain the integrity of the vaginal and rectal spaces as much as possible to decrease the risk of bowel perforation. The dissection is continued until the space is fully developed.
Excision of the Nodule
When the uterosacral ligament is transected, this permits a closer inspection of the posterior vaginal wall and the ability to assess the need for further rectal dissection. The posterior fornix is then incised along the rectovaginal margin, allowing the space to be opened. The nodule is then excised by continuing along the original shape (triangular) of the pouch of Douglas (see photo at bottom of column).
One might find that the nodule extends into the pararectal fascia, the muscularis layer of the rectum, the posterior vagina, or the rectal wall. The rectal probe is used to help delineate the rectum from the remaining lesion. Such lesions can often be dissected with sharp scissors or may require excision with a Harmonic scalpel.
Reconstruction
The last step is the reconstruction of any structures that were compromised during the dissection. The patient is given IV indigo carmine to ensure the ureters are not compromised, and a cystoscopy is performed at the conclusion of the case to confirm function. The rectal wall integrity is confirmed with the injection of dilute indigo carmine through an 18 french foley catheter placed in the rectum or via an air leak test performed with the aide of a proctoscope.
Because the fibers of rectovaginal septum run vertically and blend with the muscular wall of the vagina, some deep-infiltrating lesions are part of the vaginal wall, and in these cases excision of the affected area of the vagina is necessary. Once these lesions are fully resected, the vagina is reattached to the cervix by means of an interrupted figure of eight suture, and the anterior rectal wall is also reinforced with sutures. The pneumoperitoneum can be maintained by using a blue suction bulb in the vagina.
Once the reconstruction is completed, the restoration of the pelvic anatomy should be apparent and additional attention should be paid to defects to ensure proper closure.
The surgical management of rectovaginal endometriosis nodules can be technically demanding as it can include the repair of the vagina, bowel, bladder, and ureters. A systematic approach and adequate endoscopic experience, however, can significantly decrease the risk of injury, Taking the time to perform the ureterolysis before the beginning of the case, moreover, is beneficial in providing landmarks and protecting the integrity of the ureters. Although long-term experience is forthcoming, the surgical intervention of DIE has proven to be beneficial in the short term by decreasing patients' pain and improving their quality of lifestyle.
The yellow-shaded region represents the ureter, the blue represents the infundibulopelvic ligament, and the red represents the bifurcation of the right common iliac artery.
The pararectal space is bordered by the pelvic sidewall, the cardinal ligament, and the rectal pillars.
The rectovaginal space is bordered by the uterosacral ligaments, the vaginal fascia, and the rectal fascia.
The space between the ureter and uterosacral ligament is utilized to transect the uterosacral ligament.
Source Images provided by Dr. Resad Pasic
Use of a rectal probe and vaginal tenaculum allows for proper plane appreciation when dissecting lesions in the rectovaginal space.
The right ureter is seen here on the medial aspect of the peritoneum. Ureterolysis can be done bluntly with the graspers and scissors, or with the Harmonic scalpel as shown here.
Bilateral ureterolysis is done before dissection of the rectovaginal septum.
To transect the rectovaginal septum, place the uterus on stretch in the anteverted position. The rectal probe is placed in the rectum and the uterosacral septum is identified and transected with the harmonic scalpel.
Transection of the uterosacral ligament is done after ureterolysis is completed. (Ureter is visible in the left upper portion; rectum is in lower right corner.)
The rectal nodule is grasped and placed on tension. The rectal probe is used to help delineate the rectal borders.
Source Images provided by Dr. Resad Pasic
Keys to the Obliterated Cul-de-Sac
Although the best approach to treatment of the obliterated cul-de-sac and excision of rectovaginal endometriosis is surgical, this laparoscopic procedure can be a daunting task for even the most experienced minimally invasive gynecologic surgeon. The potential risk to the rectum and ureter must be immediately recognized. It is for this reason that Dr. Harry Reich, one of the legendary pioneers in minimally invasive gynecologic surgery, stated over 20 years ago that dissection of the obliterated cul-de-sac and excision of deep rectovaginal endometriosis was the most difficult procedure in the gynecologist's armamentarium.
Obviously, the anatomy has remained unchanged, but safety has been enhanced through the creation of a strategic approach for dealing with this unique surgical dilemma. For this current issue of the Master Class in Gynecologic Surgery, I have called upon Dr. Resad Pasic, who was my vice president during my tenure as president of the AAGL and who is now the immediate past president of that organization. Dr. Pasic is professor of obstetrics and gynecology, the director of the section of operative gynecologic endoscopy, and a codirector of the fellowship in laparoscopy and minimally invasive surgery at the department of ob.gyn. and women's health at the University of Louisville (Ky.).
As the director of the postgraduate course on advanced laparoscopic anatomy, dissection, and reparative pelvic surgery on unembalmed female cadavers, Dr. Pasic's expertise in anatomy and minimally invasive gynecologic surgery makes him an excellent candidate to lead the discussion of the systematic approach to the obliterated cul-de-sac and excision of rectovaginal endometriosis.
Joining Dr. Pasic as coauthors for this Master Class are Dr. Jessica A. Shepherd and Dr. Joseph L. Hudgens, the current clinical fellows in the division of gynecologic endoscopy at the University of Louisville.
Dr. Shepherd obtained her medical degree from Ross University in Roseau, Dominica, in 2005 and then completed her internship and residency at Drexel University in Philadelphia. In addition to her current involvement as a fellow in gynecologic endoscopy, Dr. Shepherd is also completing her MBA at the University of Louisville. She is currently a member of the AAGL and serves on the ad hoc review committee for the Journal of Minimally Invasive Gynecology.
Dr. Hudgens obtained his medical degree from the University of Arkansas, Little Rock, in 2005. He completed his residency training in ob.gyn. at the University of Louisville in 2009. Dr. Hudgens recently completed a fellowship in minimally invasive gynecology in 2010 and has joined the Center for Women's Health at Owensboro Medical Health System in Owensboro, Ky. Dr. Hudgens also is currently an active member of the AAGL and serves as a member of the ad hoc review committee for the Journal of Minimally Invasive Gynecology.
Endometriosis affects about 2.5%-3.3% of reproductive-aged women and is characterized by extrauterine growth of endometrial tissue consisting of endometrial glands and stroma. Its depth ranges from superficial to deep infiltration.
When described as deep infiltrating endometriosis (DIE), the disease involves lesions that are invasive and that extend into areas or organs that are in direct contact with already affected areas. Although the theory of migration of endometrial glands may help to explain endometriosis in general and superficial disease in particular, the prevailing opinion currently is that DIE may result from metaplasia of remnants of Müllerian tissue.
DIE lesions penetrate greater than 5 mm under the peritoneal surface and can cause severe pelvic pain. The lesions are mainly composed of smooth muscle with active glandular epithelium, which causes fibrosis and eventually their nodular characteristics.
In cases in which the DIE lesions affect areas such as the rectovaginal space (as well as the uterosacral ligaments and the rectocervical area), treatment is more successful with a surgical approach.
Although rectovaginal lesions are eventually diagnosed through surgical methods, clinical examinations and imaging should be performed to support the surgical approach.
On medical history, many of these patients present with pelvic pain, dysmenorrhea, dyspareunia, or infertility.
Clinical examination must be done to help appreciate the location of the nodular lesion. The size of the nodule may be palpated on bimanual exam and can involve uterosacral ligaments, the posterior vaginal wall, the anterior rectal wall, and the posterior fornix.
Preoperative imaging, especially transvaginal and transrectal ultrasound and MRI, will establish the distribution and depth of the deep lesions.
The presence of deeply infiltrative endometriosis and the resulting alteration of normal anatomical planes make this one of the most challenging surgical cases that gynecologists encounter. Laparoscopic treatment requires an intimate understanding and application of pelvic anatomy, and the surgical fundamentals of visualization and traction-counter-traction, as well as electrosurgery.
Pathophysiology
The presence of deep endometriotic lesions in the posterior cul-de-sac is, again, likely a consequence of metaplasia of Müllerian rests, and the nodules are composed of smooth muscle proliferation and fibrosis, which is a result of infiltration.
The endometriotic foci migrate to the rectovaginal area, where hyperplasia of smooth muscle incites an inflammatory response; this evolves into retraction, which then leads to pelvic fibrosis and a subsequent reduction in uterine mobility and distortion of the pelvic anatomy.
DIE lesions have been classified through studies by Dr. Philippe Koninckx and his colleagues into three types based on their depth of invasion and location.
Type I lesions are conically shaped rectovaginal septum nodules and are located between the posterior and anterior walls of the vaginal mucosa and rectal muscularis, respectively. Lesions categorized as type II are deeply located and form from the posterior fornix to the rectovaginal region. They are typically covered by extensive adhesions causing retraction. The most severe lesions—type III—are composed of spherical nodules. The largest dimension of these lesions is located under the peritoneal fold of the rectouterine pouch of Douglas. The cranial movement of these posterior fornix lesions eventually causes the nodules to join the anterior rectal wall and creates an “hourglass”-like appearance.
Anatomy
It is important to appreciate the relationships of the avascular spaces and their relevance to the dissection of the obliterated cul-de-sac and excision of rectovaginal endometriosis. Also remember that the ureter enters the pelvis over the bifurcation of the common iliac and medial to the infundibulopelvic ligament (see photo below).
The pararectal space is bordered laterally by the pelvic sidewall, anterolaterally by the cardinal ligament, and medially by the rectal pillars. The ureter courses beneath the peritoneum and through the rectal pillar.
The rectovaginal space is bordered laterally by the uterosacral ligaments, anteriorly by the vaginal fascia, and posteriorly by the rectal fascia.
The potential surgical space between the ureter and uterosacral ligament is utilized to transect the uterosacral ligament, which provides a means of access from the pararectal space into the rectovaginal space.
Instrumentation and Process
Surgical management of DIE is essential for restoring pelvic anatomy, relieving debilitating pelvic pain, and eliminating endometriotic nodular foci. Laparoscopic surgery provides magnified views of the posterior cul-de-sac and its pathology, and results in less postoperative pain and decreased recurrence of adhesions.
Instruments typically utilized during these procedures include monopolar scissors, bipolar coagulation, and the Harmonic scalpel.
Energy sources that provide the least amount of lateral spread are key in these procedures as the relationships of the pelvic organs, ureters, and rectum are exceptionally close.
The systematic approach of resecting these nodules entails restoring the normal anatomic relationships of the adnexa and sigmoid, then dissecting the obliterated cul-de-sac and performing a thorough excision of the rectovaginal endometriotic lesions.
We have divided the procedure into four parts: ureterolysis, dissection of the rectovaginal septum, excision of the rectovaginal nodule, and reconstruction.
When the ureters and bowel are involved with the disease process, the surgical approach should take into account the importance of restoring normal anatomy. The use of uterine manipulators with a colpotomy cup can help delineate the posterior vaginal fornix and the rectum. The introduction of rectal and vaginal probes during the surgery will improve the exposition and excision of the lesions (see figure above).
After pneumoperitoneum is established and maintained at 15 mm Hg, we have used a standard technique of placing a 10-mm trocar in the umbilicus for the laparoscope and three 5-mm ancillary trocars. One 5-mm trocar is placed to the right at 10 cm lateral to the umbilicus, and two 5-mm trocars are placed to the left (10 cm lateral to the umbilicus and in the left lower quadrant).
A thorough examination of the abdomen and pelvis should be performed to assess the disease and degree of dissection needed to successfully access the rectovaginal space. To excise the lesions, we have used the bipolar RoBi forceps (Karl Storz), monopolar scissors, and the Harmonic scalpel.
Ureterolysis
In all of our cases thus far, ureterolysis was performed before resection of any DIE nodules. The ureter crosses the pelvic brim close to the bifurcation of the common iliac artery, at which point it becomes the pelvic ureter. It continues on the pelvic sidewall medial to the infundibulopelvic ligament as it crosses the external iliac artery. Branches of the internal iliac artery supply the descending portion of the ureter and move along the course of the ureter from the lateral aspect.
The dissection of the ureter begins at the pelvic brim where the anatomy is normal. The peritoneum superior to the ureter is grasped and entered, and the incision is extended. Medial traction is placed on the inferior edge of the peritoneal incision, and dissection is continued in the fat/nonfat interface until the ureter is identified.
The ureter is surrounded by a layer of loose areolar tissue; this layer is entered by using a blunt dissector to dissect parallel to the ureter. Small vessels should be coagulated in the process to ensure visibility. The ureterolysis is directed toward the uterosacral ligaments and continued until the ureter enters the cardinal ligament (see photo above).
When complete obliteration of the cul- de-sac is present and the uterosacral ligaments are obscured bilaterally, ureterolysis is carried out on the opposite side to improve pelvic anatomic restoration. The dissection is sufficient when both ureters are mobilized completely and when each can be traced from the pelvic brim to its insertion into the bladder (see photo above).
Dissection of Rectovaginal Septum
The next step is to enter and dissect the rectovaginal septum. Prior to excision of the nodule, the pouch of Douglas is first accessed by freeing the area from any adhesions or ovarian endometriomas.
After the successful bilateral ureterolysis, the ureters can be identified and the posterior fornix can be delineated with the rectal probe and colpotomizer.
The posterior fornix is then pushed upward, and a transverse incision is made over the posterior cervix superior to the rectum—an area also known as the prerectal fascia (see photo above).
The rectovaginal septum extends laterally from the posterior cervix and uterosacral ligaments to the pelvic sidewall, where it then courses caudally to insert in the perineal body. This area is dissected inferiorly until the uterosacral ligaments (also known as the medial rectal pillars) are identified. At this stage, the ureter, the pararectal space, the lateral rectal pillar with associated nerves, and the medial rectal pillar are seen. The rectal probe will then help identify the rectum and the dissected uterosacral ligaments in their respective planes.
The potential space medial to the ureter is used to transect the uterosacral ligament and thus enter the rectovaginal space from the lateral aspect to medial. The uterosacral ligament is again transected, and the rectovaginal space entered (see photo above).
If the dissection is continued too superiorly, the prerectal fascia is transected and the vagina may be entered. If this occurs, then the fascia is retracted superiorly and the rectum is retracted inferiorly to help identify the correct dissection plane.
By understanding the anatomic principle that fat belongs to the rectum, one can identify the fat/nonfat interface; this facilitates dissection superior to this plane. It is also important to maintain the integrity of the vaginal and rectal spaces as much as possible to decrease the risk of bowel perforation. The dissection is continued until the space is fully developed.
Excision of the Nodule
When the uterosacral ligament is transected, this permits a closer inspection of the posterior vaginal wall and the ability to assess the need for further rectal dissection. The posterior fornix is then incised along the rectovaginal margin, allowing the space to be opened. The nodule is then excised by continuing along the original shape (triangular) of the pouch of Douglas (see photo at bottom of column).
One might find that the nodule extends into the pararectal fascia, the muscularis layer of the rectum, the posterior vagina, or the rectal wall. The rectal probe is used to help delineate the rectum from the remaining lesion. Such lesions can often be dissected with sharp scissors or may require excision with a Harmonic scalpel.
Reconstruction
The last step is the reconstruction of any structures that were compromised during the dissection. The patient is given IV indigo carmine to ensure the ureters are not compromised, and a cystoscopy is performed at the conclusion of the case to confirm function. The rectal wall integrity is confirmed with the injection of dilute indigo carmine through an 18 french foley catheter placed in the rectum or via an air leak test performed with the aide of a proctoscope.
Because the fibers of rectovaginal septum run vertically and blend with the muscular wall of the vagina, some deep-infiltrating lesions are part of the vaginal wall, and in these cases excision of the affected area of the vagina is necessary. Once these lesions are fully resected, the vagina is reattached to the cervix by means of an interrupted figure of eight suture, and the anterior rectal wall is also reinforced with sutures. The pneumoperitoneum can be maintained by using a blue suction bulb in the vagina.
Once the reconstruction is completed, the restoration of the pelvic anatomy should be apparent and additional attention should be paid to defects to ensure proper closure.
The surgical management of rectovaginal endometriosis nodules can be technically demanding as it can include the repair of the vagina, bowel, bladder, and ureters. A systematic approach and adequate endoscopic experience, however, can significantly decrease the risk of injury, Taking the time to perform the ureterolysis before the beginning of the case, moreover, is beneficial in providing landmarks and protecting the integrity of the ureters. Although long-term experience is forthcoming, the surgical intervention of DIE has proven to be beneficial in the short term by decreasing patients' pain and improving their quality of lifestyle.
The yellow-shaded region represents the ureter, the blue represents the infundibulopelvic ligament, and the red represents the bifurcation of the right common iliac artery.
The pararectal space is bordered by the pelvic sidewall, the cardinal ligament, and the rectal pillars.
The rectovaginal space is bordered by the uterosacral ligaments, the vaginal fascia, and the rectal fascia.
The space between the ureter and uterosacral ligament is utilized to transect the uterosacral ligament.
Source Images provided by Dr. Resad Pasic
Use of a rectal probe and vaginal tenaculum allows for proper plane appreciation when dissecting lesions in the rectovaginal space.
The right ureter is seen here on the medial aspect of the peritoneum. Ureterolysis can be done bluntly with the graspers and scissors, or with the Harmonic scalpel as shown here.
Bilateral ureterolysis is done before dissection of the rectovaginal septum.
To transect the rectovaginal septum, place the uterus on stretch in the anteverted position. The rectal probe is placed in the rectum and the uterosacral septum is identified and transected with the harmonic scalpel.
Transection of the uterosacral ligament is done after ureterolysis is completed. (Ureter is visible in the left upper portion; rectum is in lower right corner.)
The rectal nodule is grasped and placed on tension. The rectal probe is used to help delineate the rectal borders.
Source Images provided by Dr. Resad Pasic
Keys to the Obliterated Cul-de-Sac
Although the best approach to treatment of the obliterated cul-de-sac and excision of rectovaginal endometriosis is surgical, this laparoscopic procedure can be a daunting task for even the most experienced minimally invasive gynecologic surgeon. The potential risk to the rectum and ureter must be immediately recognized. It is for this reason that Dr. Harry Reich, one of the legendary pioneers in minimally invasive gynecologic surgery, stated over 20 years ago that dissection of the obliterated cul-de-sac and excision of deep rectovaginal endometriosis was the most difficult procedure in the gynecologist's armamentarium.
Obviously, the anatomy has remained unchanged, but safety has been enhanced through the creation of a strategic approach for dealing with this unique surgical dilemma. For this current issue of the Master Class in Gynecologic Surgery, I have called upon Dr. Resad Pasic, who was my vice president during my tenure as president of the AAGL and who is now the immediate past president of that organization. Dr. Pasic is professor of obstetrics and gynecology, the director of the section of operative gynecologic endoscopy, and a codirector of the fellowship in laparoscopy and minimally invasive surgery at the department of ob.gyn. and women's health at the University of Louisville (Ky.).
As the director of the postgraduate course on advanced laparoscopic anatomy, dissection, and reparative pelvic surgery on unembalmed female cadavers, Dr. Pasic's expertise in anatomy and minimally invasive gynecologic surgery makes him an excellent candidate to lead the discussion of the systematic approach to the obliterated cul-de-sac and excision of rectovaginal endometriosis.
Joining Dr. Pasic as coauthors for this Master Class are Dr. Jessica A. Shepherd and Dr. Joseph L. Hudgens, the current clinical fellows in the division of gynecologic endoscopy at the University of Louisville.
Dr. Shepherd obtained her medical degree from Ross University in Roseau, Dominica, in 2005 and then completed her internship and residency at Drexel University in Philadelphia. In addition to her current involvement as a fellow in gynecologic endoscopy, Dr. Shepherd is also completing her MBA at the University of Louisville. She is currently a member of the AAGL and serves on the ad hoc review committee for the Journal of Minimally Invasive Gynecology.
Dr. Hudgens obtained his medical degree from the University of Arkansas, Little Rock, in 2005. He completed his residency training in ob.gyn. at the University of Louisville in 2009. Dr. Hudgens recently completed a fellowship in minimally invasive gynecology in 2010 and has joined the Center for Women's Health at Owensboro Medical Health System in Owensboro, Ky. Dr. Hudgens also is currently an active member of the AAGL and serves as a member of the ad hoc review committee for the Journal of Minimally Invasive Gynecology.
Treating Anterior Vaginal Wall Prolapse
The anterior vaginal wall is the most common site of initial pelvic organ prolapse. It is estimated that 80% of surgical repairs for vaginal wall prolapse involve the anterior compartment. It is also the most frequent site of operative failure. Reported rates of operative failure have run as high as 40%—much higher than rates of failure after posterior wall repairs.
There are several possible reasons the anterior vaginal wall may be more susceptible to prolapse and more difficult to repair. It could be that the anterior wall is not as well supported by the levator plate that counters the effects of gravity and abdominal pressure. Normally the anterior wall rests horizontally on the posterior wall, and the posterior wall rests on the levator plate. When levator muscles weaken and increasing force is placed on the connective tissue supports, the anterior wall may be the first compartment to fall. It is also possible that the attachments of the anterior compartment to the pelvic sidewall or to the apex are weaker, or that the anterior wall itself is more elastic or less dense, or perhaps it is more susceptible to damage during childbirth or weakening with aging. For most women, anterior vaginal wall prolapse is probably the result of a combination of these factors.
Management of anterior wall prolapse is consequently a significant challenge—one that has led surgeons to use various graft materials to reduce the rate of failure of transvaginal repair and subsequent prolapse recurrence. Several studies have shown improvements in short-term recurrence rates, but long-term durability and safety of mesh-reinforced repair is unclear. We need a more complete assessment of the anatomic and symptomatic efficacy of graft use in transvaginal repair.
The traditional anterior colporrhaphy with attention to apical suspension remains the preferred method for primary repairs. Apical attachment can be accomplished through a sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension. Sacrocolpopexy provides both apical and midline support for the anterior wall. For many surgeons, including myself, a sacrocolpopexy is the procedure of choice for women with a cystocele and apical descent.
Anatomy and Evaluation
Understanding pelvic floor anatomy—and the trapezoidal anatomy of the anterior vaginal wall—is critical to understanding the various types of cystocele and their repair. The trapezoidal plane of the anterior wall results from the ventral and more medial attachments near the pubic symphysis and the dorsal and more lateral attachments near the ischial spine. The wall is suspended on both sides to the parietal fascia overlying the levator ani muscles at the arcus tendineus fascia pelvis (ATFP).
The type of cystocele is defined by where there is a break in the fascial attachments to the pelvic sidewall. A loss of lateral attachment causes what we know as a paravaginal defect, or displacement cystocele. The goal of the paravaginal repair, therefore, is to reattach the lateral vaginal walls to the ATFP.
A transverse cystocele occurs when the top of the pubocervical fascia detaches from the cervix or vaginal apex; it is evidenced by the loss of anterior fornix. (When a transverse cystocele occurs following a hysterectomy, the prolapse frequently includes an enterocele and loss of apical support that must also be repaired.) Central or distal cystoceles involve a loss of support near the pubis and tend to manifest as urethral hypermobility.
When one considers the trapezoidal anatomy of the anterior vaginal wall, the importance of restoring apical support is clear. Several studies have shown that variations in cystocele type and severity are often determined by the degree of apical support. Dr. John O.L. DeLancey and his associates, for instance, found that anterior wall prolapse was due to loss of apical support in one-half of women whose prolapse was measured on MRI scans (Am. J. Obstet. Gynecol. 2006;194:1438-43).
In another evaluation—a cohort study of 325 women—investigators similarly found that anterior vaginal wall prolapse was strongly associated with apical prolapse, and concluded that anterior vaginal wall defects that are surgically repaired usually require concomitant repair of the apex (Am. J. Obstet. Gynecol. 2006;195:1837-40).
Just as with posterior vaginal wall prolapse, one must first determine which part of the patient's support mechanism has failed. A careful physical evaluation must be done to identify the sites of defects and detachments. By supporting the lateral anterior walls at the level of the ATFP with a ring forceps, one can identify paravaginal defects and determine the role of apical failure.
While supporting the apex with a ring forceps, I ask the patient to bear down or cough. If her anterior wall remains in place and her cystocele disappears, I know an apical suspension is needed at the time of surgery. If she still has some relaxation, an apical suspension as well as an anterior colporrhaphy are needed.
One must also understand which symptoms are bothering the patient, if they are related to the physical findings, and if surgical correction of the anatomy will improve her symptoms. Each woman should then be appropriately counseled about the possible impact of prolapse surgery on both bladder and sexual function.
It is a common misperception that most patients with cystoceles also have stress urinary incontinence. Descent of the midvagina under the bladder base may actually reduce the chance of stress urinary incontinence occurring. Instead, voiding dysfunction is more common, as straining and increased abdominal pressure can cause the cystocele to be pushed to the point that it creates an outlet obstruction by kinking or compressing the urethra.
In a review we conducted of 35 women with stage 3 or 4 anterior wall prolapse and elevated postvoid residuals greater than 100 mL on two separate occasions, 31 women (89%) had normal postvoid residuals following reconstructive surgery and correction of their anterior wall prolapse (Am. J. Obstet. Gynecol. 2000;183:1361-4).
Paradoxically, correction of the cystocele can unmask “occult” stress urinary incontinence. Prior to surgery, a full bladder stress test with the prolapse reduced may indicate that the patient is at risk for stress incontinence symptoms after her prolapsed repair. If a sacrocolpopexy is planned, the CARE (Colpopexy and Urinary Reduction Efforts) trial recommends the placement of a Burch colposuspension at the time of surgery, regardless of preoperative urodynamics. Whether this recommendation is true for vaginal repairs is currently unknown.
Preoperative discussions with the patient concerning her risks of incontinence after cystocele repair, the benefits and risks of prophylactic anti-incontinence surgery, and the need for future surgical correction should be had as part of the surgical decision-making process.
Technique for Anterior Colporrhaphy
Traditional anterior colporrhaphy involves plication of the “endopelvic fascia” or fibromuscular layer of the vaginal wall after the vaginal wall is split. Buttressing of the bladder neck with a Kelly plication stitch was originally described by Howard Kelly in 1913.
The anterior vaginal wall is grasped on each side of the midline with Allis clamps. The cuff is grasped if a vaginal hysterectomy has been performed. If the uterus is in situ, the Allis clamps are used to grasp the vagina approximately 1 cm from the cervicovaginal junction, and an initial transverse incision is made.
The anterior wall, between the mucosa and bladder, is injected with 10 cc of vasopressin solution, 20 U in 50 cc of normal saline. This improves hemostasis and hydrodissects the space. A midline incision to within 1-2 cm of the urethrovesical neck is made.
The use of “three-point” traction can help with the dissection of the muscularis. The vagina is then grasped with several Allis clamps. The surgeon's index finger distends the vaginal wall and allows the surgeon to determine the thickness of the dissection with the Metzenbaum scissors. The assistant can provide countertraction with a tonsil clamp or DeBakey forceps. The fibromuscular layer is split to the level of the inferior pubic ramus. The procedure is repeated on the opposite side of the vagina.
One modification I prefer is to begin the plication at the apex instead of the bladder neck. This way, I avoid the pitfall of stopping short of the apex and leaving a “gap” or weakness in the repair. It is the apical portion of the repair that is most important. I use permanent sutures, preferably 2-0 Ethibond.
If the vaginal wall is the length needed to reach the apical supports, I use a transverse mattress stitch to plicate the fascia. If the vaginal wall needs to be shortened, I use a vertical mattress stitch. This will generally shorten the anterior wall 2-3 cm. For a large cystocele, two layers of plication can be used. The excess vaginal tissue is excised and closed with interrupted or running fine absorbable sutures.
When an apical repair procedure such as uterosacral ligament suspension or sacrospinous ligament suspension is performed in conjunction with anterior colporrhaphy—which is more often than not—the sutures for the apical repair should be placed and held prior to initiating the anterior colporrhaphy.
At the end of the anterior repair, the apical sutures are then incorporated into the vaginal cuff. Regardless of the type of transvaginal suspension, it is beneficial to bring one arm of the suspension suture through the anterior wall of the cuff and the other arm through the posterior cuff. This way, the anterior and posterior walls are brought together and suspended when the suture is tied.
Graft Use
In 2008, the Society of Gynecologic Surgeons (SGS) systematically reviewed the literature and published clinical practice guidelines on vaginal graft use. The SGS group concluded that nonabsorbable synthetic graft use may improve anatomic outcomes of the anterior vaginal wall, but that there are trade-offs in regard to additional risk. While more randomized studies on new mesh products are being conducted and reported, the data simply are insufficient to determine the anatomic or symptomatic efficacy of these types of grafts, the group said (Obstet. Gynecol. 2008;112:1131-42).
Similar to the SGS review, the Cochrane Collaboration completed a systematic review and concluded that the use of mesh or graft inlays at the time of anterior vaginal wall repair may reduce the risk of recurrent cystocele but that there was insufficient evidence to make recommendations for anterior vaginal wall or apical repair (Cochrane Database Syst. Rev. 2010;CD004014 [doi: 10.1002/14651858.CD004014.pub4]).
Overall, the few randomized trials that have been done illustrate the balance of risks and benefits that the surgeon and patient must weigh prior to considering the use of vaginal mesh or graft for the treatment of anterior wall prolapse.
One study that randomized 202 women to anterior colporrhaphy with or without a low-weight polypropylene mesh showed lower recurrence of anterior wall prolapse at 1 year with mesh than without mesh on physical examination using the Pelvic Organ Prolapse Quantification (POP-Q) system, but no differences in patient symptoms.
In this trial, the cure rate 1 year after surgery (defined as POP-Q stage 0 or 1) was significantly higher after the mesh-augmented repair compared with standard anterior colporrhaphy (62% vs. 93%). The use of mesh was, however, associated more often with stress urinary incontinence (23% vs. 10%). There were no differences in symptomatic outcomes. Mesh exposure was significant in the augmented group, 17% vs. 0% (Obstet. Gynecol. 2007;110:455-62).
In a one-surgeon, randomized controlled trial of 38 women who had traditional anterior colporrhaphy and 37 who had polypropylene mesh repair using the Perigee Transobturator Prolapse Repair System, Dr. John N. Nguyen concluded that repair with polypropylene mesh reinforcement offered lower anatomic recurrence rates at 1 year than did anterior colporrhaphy without mesh reinforcement (Obstet. Gynecol. 2008;111:891-8).
In this study, prolapse and incontinence symptoms improved significantly in both treatment groups.
Overall, the current evidence seems to support the use of synthetic mesh to augment repairs of anterior vaginal prolapse but at the expense of an increased rate of complications, particularly mesh exposure.
In my practice, most recurrent anterior wall prolapses are associated with apical descent as well. In those patients, I recommend a sacrocolpopexy performed laparoscopically. I would reserve the use of transvaginal mesh for women who have recurrent isolated anterior vaginal prolapse with a well-supported apex.
Three-point countertraction aids in the dissection of the vaginal wall.
The first vertical mattress stitch is placed at the vaginal apex during the surgery.
The second horizontal mattress stitch is placed, plicating the fibromuscular wall of the anterior wall.
The plication is complete. Minimal vaginal wall is trimmed prior to closing.
Source Photos courtesy Dr. Dee E. Fenner
Revisiting Anterior Colporrhaphy
According to Dr. Sangeeta Mahajan, any descent of the anterior wall of the vagina or base of the bladder, whether provoked or without straining, can be considered clinically an anterior vaginal wall defect. However, the International Continence Society uses a more precise definition: An anterior vaginal wall defect exists when the urethrovesical junction or any other part of the anterior vaginal wall is less than 3 cm from the hymenal ring.
It is now recognized that anterior vaginal wall prolapse occurs as a result of a specific defect in the vagina's support structure. Epidemiologically, aging, parity, obesity, cigarette smoking, chronic lung disease, congenital defects, white ancestry, and prior hysterectomy or prolapse surgery have been identified as risk factors associated with pelvic organ prolapse. Ultimately, management of anterior wall defects, which may be conservative or surgical, is indicated for the following reasons: discomfort, urinary retention, or genuine stress urinary incontinence.
Although retrospective case series, with a minimum of 1-year follow-up, by R. Porges, S.L. Stanton, and Walter and C. Maher, have documented success rates following anterior colporrhaphy for the treatment of anterior vaginal wall defects, in the range of 80%-100%; prospective studies by P.K. Sand and A.M. Weber demonstrate rates of success at 37%-57%.
Given the obvious challenge in providing success to our patient suffering with an anterior vaginal support defect with resulting prolapse, it is important to review the anatomy, perform proper evaluation, and provide appropriate surgical treatment, including use of graft materials.
In this edition of the Master Class in Gynecologic Surgery, I have once again called upon Dr. Dee E. Fenner, the Harold A. Furlong Professor of Women's Health and director of gynecology at the University of Michigan, Ann Arbor. This time Dr. Fenner will revisit anterior colporrhaphy for the treatment of anterior vaginal wall prolapse. Dr. Fenner provided her insight on the technique of posterior colporrhaphy and perineorrhaphy, that is, transvaginal rectocele repair, in the last installment of
The anterior vaginal wall is the most common site of initial pelvic organ prolapse. It is estimated that 80% of surgical repairs for vaginal wall prolapse involve the anterior compartment. It is also the most frequent site of operative failure. Reported rates of operative failure have run as high as 40%—much higher than rates of failure after posterior wall repairs.
There are several possible reasons the anterior vaginal wall may be more susceptible to prolapse and more difficult to repair. It could be that the anterior wall is not as well supported by the levator plate that counters the effects of gravity and abdominal pressure. Normally the anterior wall rests horizontally on the posterior wall, and the posterior wall rests on the levator plate. When levator muscles weaken and increasing force is placed on the connective tissue supports, the anterior wall may be the first compartment to fall. It is also possible that the attachments of the anterior compartment to the pelvic sidewall or to the apex are weaker, or that the anterior wall itself is more elastic or less dense, or perhaps it is more susceptible to damage during childbirth or weakening with aging. For most women, anterior vaginal wall prolapse is probably the result of a combination of these factors.
Management of anterior wall prolapse is consequently a significant challenge—one that has led surgeons to use various graft materials to reduce the rate of failure of transvaginal repair and subsequent prolapse recurrence. Several studies have shown improvements in short-term recurrence rates, but long-term durability and safety of mesh-reinforced repair is unclear. We need a more complete assessment of the anatomic and symptomatic efficacy of graft use in transvaginal repair.
The traditional anterior colporrhaphy with attention to apical suspension remains the preferred method for primary repairs. Apical attachment can be accomplished through a sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension. Sacrocolpopexy provides both apical and midline support for the anterior wall. For many surgeons, including myself, a sacrocolpopexy is the procedure of choice for women with a cystocele and apical descent.
Anatomy and Evaluation
Understanding pelvic floor anatomy—and the trapezoidal anatomy of the anterior vaginal wall—is critical to understanding the various types of cystocele and their repair. The trapezoidal plane of the anterior wall results from the ventral and more medial attachments near the pubic symphysis and the dorsal and more lateral attachments near the ischial spine. The wall is suspended on both sides to the parietal fascia overlying the levator ani muscles at the arcus tendineus fascia pelvis (ATFP).
The type of cystocele is defined by where there is a break in the fascial attachments to the pelvic sidewall. A loss of lateral attachment causes what we know as a paravaginal defect, or displacement cystocele. The goal of the paravaginal repair, therefore, is to reattach the lateral vaginal walls to the ATFP.
A transverse cystocele occurs when the top of the pubocervical fascia detaches from the cervix or vaginal apex; it is evidenced by the loss of anterior fornix. (When a transverse cystocele occurs following a hysterectomy, the prolapse frequently includes an enterocele and loss of apical support that must also be repaired.) Central or distal cystoceles involve a loss of support near the pubis and tend to manifest as urethral hypermobility.
When one considers the trapezoidal anatomy of the anterior vaginal wall, the importance of restoring apical support is clear. Several studies have shown that variations in cystocele type and severity are often determined by the degree of apical support. Dr. John O.L. DeLancey and his associates, for instance, found that anterior wall prolapse was due to loss of apical support in one-half of women whose prolapse was measured on MRI scans (Am. J. Obstet. Gynecol. 2006;194:1438-43).
In another evaluation—a cohort study of 325 women—investigators similarly found that anterior vaginal wall prolapse was strongly associated with apical prolapse, and concluded that anterior vaginal wall defects that are surgically repaired usually require concomitant repair of the apex (Am. J. Obstet. Gynecol. 2006;195:1837-40).
Just as with posterior vaginal wall prolapse, one must first determine which part of the patient's support mechanism has failed. A careful physical evaluation must be done to identify the sites of defects and detachments. By supporting the lateral anterior walls at the level of the ATFP with a ring forceps, one can identify paravaginal defects and determine the role of apical failure.
While supporting the apex with a ring forceps, I ask the patient to bear down or cough. If her anterior wall remains in place and her cystocele disappears, I know an apical suspension is needed at the time of surgery. If she still has some relaxation, an apical suspension as well as an anterior colporrhaphy are needed.
One must also understand which symptoms are bothering the patient, if they are related to the physical findings, and if surgical correction of the anatomy will improve her symptoms. Each woman should then be appropriately counseled about the possible impact of prolapse surgery on both bladder and sexual function.
It is a common misperception that most patients with cystoceles also have stress urinary incontinence. Descent of the midvagina under the bladder base may actually reduce the chance of stress urinary incontinence occurring. Instead, voiding dysfunction is more common, as straining and increased abdominal pressure can cause the cystocele to be pushed to the point that it creates an outlet obstruction by kinking or compressing the urethra.
In a review we conducted of 35 women with stage 3 or 4 anterior wall prolapse and elevated postvoid residuals greater than 100 mL on two separate occasions, 31 women (89%) had normal postvoid residuals following reconstructive surgery and correction of their anterior wall prolapse (Am. J. Obstet. Gynecol. 2000;183:1361-4).
Paradoxically, correction of the cystocele can unmask “occult” stress urinary incontinence. Prior to surgery, a full bladder stress test with the prolapse reduced may indicate that the patient is at risk for stress incontinence symptoms after her prolapsed repair. If a sacrocolpopexy is planned, the CARE (Colpopexy and Urinary Reduction Efforts) trial recommends the placement of a Burch colposuspension at the time of surgery, regardless of preoperative urodynamics. Whether this recommendation is true for vaginal repairs is currently unknown.
Preoperative discussions with the patient concerning her risks of incontinence after cystocele repair, the benefits and risks of prophylactic anti-incontinence surgery, and the need for future surgical correction should be had as part of the surgical decision-making process.
Technique for Anterior Colporrhaphy
Traditional anterior colporrhaphy involves plication of the “endopelvic fascia” or fibromuscular layer of the vaginal wall after the vaginal wall is split. Buttressing of the bladder neck with a Kelly plication stitch was originally described by Howard Kelly in 1913.
The anterior vaginal wall is grasped on each side of the midline with Allis clamps. The cuff is grasped if a vaginal hysterectomy has been performed. If the uterus is in situ, the Allis clamps are used to grasp the vagina approximately 1 cm from the cervicovaginal junction, and an initial transverse incision is made.
The anterior wall, between the mucosa and bladder, is injected with 10 cc of vasopressin solution, 20 U in 50 cc of normal saline. This improves hemostasis and hydrodissects the space. A midline incision to within 1-2 cm of the urethrovesical neck is made.
The use of “three-point” traction can help with the dissection of the muscularis. The vagina is then grasped with several Allis clamps. The surgeon's index finger distends the vaginal wall and allows the surgeon to determine the thickness of the dissection with the Metzenbaum scissors. The assistant can provide countertraction with a tonsil clamp or DeBakey forceps. The fibromuscular layer is split to the level of the inferior pubic ramus. The procedure is repeated on the opposite side of the vagina.
One modification I prefer is to begin the plication at the apex instead of the bladder neck. This way, I avoid the pitfall of stopping short of the apex and leaving a “gap” or weakness in the repair. It is the apical portion of the repair that is most important. I use permanent sutures, preferably 2-0 Ethibond.
If the vaginal wall is the length needed to reach the apical supports, I use a transverse mattress stitch to plicate the fascia. If the vaginal wall needs to be shortened, I use a vertical mattress stitch. This will generally shorten the anterior wall 2-3 cm. For a large cystocele, two layers of plication can be used. The excess vaginal tissue is excised and closed with interrupted or running fine absorbable sutures.
When an apical repair procedure such as uterosacral ligament suspension or sacrospinous ligament suspension is performed in conjunction with anterior colporrhaphy—which is more often than not—the sutures for the apical repair should be placed and held prior to initiating the anterior colporrhaphy.
At the end of the anterior repair, the apical sutures are then incorporated into the vaginal cuff. Regardless of the type of transvaginal suspension, it is beneficial to bring one arm of the suspension suture through the anterior wall of the cuff and the other arm through the posterior cuff. This way, the anterior and posterior walls are brought together and suspended when the suture is tied.
Graft Use
In 2008, the Society of Gynecologic Surgeons (SGS) systematically reviewed the literature and published clinical practice guidelines on vaginal graft use. The SGS group concluded that nonabsorbable synthetic graft use may improve anatomic outcomes of the anterior vaginal wall, but that there are trade-offs in regard to additional risk. While more randomized studies on new mesh products are being conducted and reported, the data simply are insufficient to determine the anatomic or symptomatic efficacy of these types of grafts, the group said (Obstet. Gynecol. 2008;112:1131-42).
Similar to the SGS review, the Cochrane Collaboration completed a systematic review and concluded that the use of mesh or graft inlays at the time of anterior vaginal wall repair may reduce the risk of recurrent cystocele but that there was insufficient evidence to make recommendations for anterior vaginal wall or apical repair (Cochrane Database Syst. Rev. 2010;CD004014 [doi: 10.1002/14651858.CD004014.pub4]).
Overall, the few randomized trials that have been done illustrate the balance of risks and benefits that the surgeon and patient must weigh prior to considering the use of vaginal mesh or graft for the treatment of anterior wall prolapse.
One study that randomized 202 women to anterior colporrhaphy with or without a low-weight polypropylene mesh showed lower recurrence of anterior wall prolapse at 1 year with mesh than without mesh on physical examination using the Pelvic Organ Prolapse Quantification (POP-Q) system, but no differences in patient symptoms.
In this trial, the cure rate 1 year after surgery (defined as POP-Q stage 0 or 1) was significantly higher after the mesh-augmented repair compared with standard anterior colporrhaphy (62% vs. 93%). The use of mesh was, however, associated more often with stress urinary incontinence (23% vs. 10%). There were no differences in symptomatic outcomes. Mesh exposure was significant in the augmented group, 17% vs. 0% (Obstet. Gynecol. 2007;110:455-62).
In a one-surgeon, randomized controlled trial of 38 women who had traditional anterior colporrhaphy and 37 who had polypropylene mesh repair using the Perigee Transobturator Prolapse Repair System, Dr. John N. Nguyen concluded that repair with polypropylene mesh reinforcement offered lower anatomic recurrence rates at 1 year than did anterior colporrhaphy without mesh reinforcement (Obstet. Gynecol. 2008;111:891-8).
In this study, prolapse and incontinence symptoms improved significantly in both treatment groups.
Overall, the current evidence seems to support the use of synthetic mesh to augment repairs of anterior vaginal prolapse but at the expense of an increased rate of complications, particularly mesh exposure.
In my practice, most recurrent anterior wall prolapses are associated with apical descent as well. In those patients, I recommend a sacrocolpopexy performed laparoscopically. I would reserve the use of transvaginal mesh for women who have recurrent isolated anterior vaginal prolapse with a well-supported apex.
Three-point countertraction aids in the dissection of the vaginal wall.
The first vertical mattress stitch is placed at the vaginal apex during the surgery.
The second horizontal mattress stitch is placed, plicating the fibromuscular wall of the anterior wall.
The plication is complete. Minimal vaginal wall is trimmed prior to closing.
Source Photos courtesy Dr. Dee E. Fenner
Revisiting Anterior Colporrhaphy
According to Dr. Sangeeta Mahajan, any descent of the anterior wall of the vagina or base of the bladder, whether provoked or without straining, can be considered clinically an anterior vaginal wall defect. However, the International Continence Society uses a more precise definition: An anterior vaginal wall defect exists when the urethrovesical junction or any other part of the anterior vaginal wall is less than 3 cm from the hymenal ring.
It is now recognized that anterior vaginal wall prolapse occurs as a result of a specific defect in the vagina's support structure. Epidemiologically, aging, parity, obesity, cigarette smoking, chronic lung disease, congenital defects, white ancestry, and prior hysterectomy or prolapse surgery have been identified as risk factors associated with pelvic organ prolapse. Ultimately, management of anterior wall defects, which may be conservative or surgical, is indicated for the following reasons: discomfort, urinary retention, or genuine stress urinary incontinence.
Although retrospective case series, with a minimum of 1-year follow-up, by R. Porges, S.L. Stanton, and Walter and C. Maher, have documented success rates following anterior colporrhaphy for the treatment of anterior vaginal wall defects, in the range of 80%-100%; prospective studies by P.K. Sand and A.M. Weber demonstrate rates of success at 37%-57%.
Given the obvious challenge in providing success to our patient suffering with an anterior vaginal support defect with resulting prolapse, it is important to review the anatomy, perform proper evaluation, and provide appropriate surgical treatment, including use of graft materials.
In this edition of the Master Class in Gynecologic Surgery, I have once again called upon Dr. Dee E. Fenner, the Harold A. Furlong Professor of Women's Health and director of gynecology at the University of Michigan, Ann Arbor. This time Dr. Fenner will revisit anterior colporrhaphy for the treatment of anterior vaginal wall prolapse. Dr. Fenner provided her insight on the technique of posterior colporrhaphy and perineorrhaphy, that is, transvaginal rectocele repair, in the last installment of
The anterior vaginal wall is the most common site of initial pelvic organ prolapse. It is estimated that 80% of surgical repairs for vaginal wall prolapse involve the anterior compartment. It is also the most frequent site of operative failure. Reported rates of operative failure have run as high as 40%—much higher than rates of failure after posterior wall repairs.
There are several possible reasons the anterior vaginal wall may be more susceptible to prolapse and more difficult to repair. It could be that the anterior wall is not as well supported by the levator plate that counters the effects of gravity and abdominal pressure. Normally the anterior wall rests horizontally on the posterior wall, and the posterior wall rests on the levator plate. When levator muscles weaken and increasing force is placed on the connective tissue supports, the anterior wall may be the first compartment to fall. It is also possible that the attachments of the anterior compartment to the pelvic sidewall or to the apex are weaker, or that the anterior wall itself is more elastic or less dense, or perhaps it is more susceptible to damage during childbirth or weakening with aging. For most women, anterior vaginal wall prolapse is probably the result of a combination of these factors.
Management of anterior wall prolapse is consequently a significant challenge—one that has led surgeons to use various graft materials to reduce the rate of failure of transvaginal repair and subsequent prolapse recurrence. Several studies have shown improvements in short-term recurrence rates, but long-term durability and safety of mesh-reinforced repair is unclear. We need a more complete assessment of the anatomic and symptomatic efficacy of graft use in transvaginal repair.
The traditional anterior colporrhaphy with attention to apical suspension remains the preferred method for primary repairs. Apical attachment can be accomplished through a sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension. Sacrocolpopexy provides both apical and midline support for the anterior wall. For many surgeons, including myself, a sacrocolpopexy is the procedure of choice for women with a cystocele and apical descent.
Anatomy and Evaluation
Understanding pelvic floor anatomy—and the trapezoidal anatomy of the anterior vaginal wall—is critical to understanding the various types of cystocele and their repair. The trapezoidal plane of the anterior wall results from the ventral and more medial attachments near the pubic symphysis and the dorsal and more lateral attachments near the ischial spine. The wall is suspended on both sides to the parietal fascia overlying the levator ani muscles at the arcus tendineus fascia pelvis (ATFP).
The type of cystocele is defined by where there is a break in the fascial attachments to the pelvic sidewall. A loss of lateral attachment causes what we know as a paravaginal defect, or displacement cystocele. The goal of the paravaginal repair, therefore, is to reattach the lateral vaginal walls to the ATFP.
A transverse cystocele occurs when the top of the pubocervical fascia detaches from the cervix or vaginal apex; it is evidenced by the loss of anterior fornix. (When a transverse cystocele occurs following a hysterectomy, the prolapse frequently includes an enterocele and loss of apical support that must also be repaired.) Central or distal cystoceles involve a loss of support near the pubis and tend to manifest as urethral hypermobility.
When one considers the trapezoidal anatomy of the anterior vaginal wall, the importance of restoring apical support is clear. Several studies have shown that variations in cystocele type and severity are often determined by the degree of apical support. Dr. John O.L. DeLancey and his associates, for instance, found that anterior wall prolapse was due to loss of apical support in one-half of women whose prolapse was measured on MRI scans (Am. J. Obstet. Gynecol. 2006;194:1438-43).
In another evaluation—a cohort study of 325 women—investigators similarly found that anterior vaginal wall prolapse was strongly associated with apical prolapse, and concluded that anterior vaginal wall defects that are surgically repaired usually require concomitant repair of the apex (Am. J. Obstet. Gynecol. 2006;195:1837-40).
Just as with posterior vaginal wall prolapse, one must first determine which part of the patient's support mechanism has failed. A careful physical evaluation must be done to identify the sites of defects and detachments. By supporting the lateral anterior walls at the level of the ATFP with a ring forceps, one can identify paravaginal defects and determine the role of apical failure.
While supporting the apex with a ring forceps, I ask the patient to bear down or cough. If her anterior wall remains in place and her cystocele disappears, I know an apical suspension is needed at the time of surgery. If she still has some relaxation, an apical suspension as well as an anterior colporrhaphy are needed.
One must also understand which symptoms are bothering the patient, if they are related to the physical findings, and if surgical correction of the anatomy will improve her symptoms. Each woman should then be appropriately counseled about the possible impact of prolapse surgery on both bladder and sexual function.
It is a common misperception that most patients with cystoceles also have stress urinary incontinence. Descent of the midvagina under the bladder base may actually reduce the chance of stress urinary incontinence occurring. Instead, voiding dysfunction is more common, as straining and increased abdominal pressure can cause the cystocele to be pushed to the point that it creates an outlet obstruction by kinking or compressing the urethra.
In a review we conducted of 35 women with stage 3 or 4 anterior wall prolapse and elevated postvoid residuals greater than 100 mL on two separate occasions, 31 women (89%) had normal postvoid residuals following reconstructive surgery and correction of their anterior wall prolapse (Am. J. Obstet. Gynecol. 2000;183:1361-4).
Paradoxically, correction of the cystocele can unmask “occult” stress urinary incontinence. Prior to surgery, a full bladder stress test with the prolapse reduced may indicate that the patient is at risk for stress incontinence symptoms after her prolapsed repair. If a sacrocolpopexy is planned, the CARE (Colpopexy and Urinary Reduction Efforts) trial recommends the placement of a Burch colposuspension at the time of surgery, regardless of preoperative urodynamics. Whether this recommendation is true for vaginal repairs is currently unknown.
Preoperative discussions with the patient concerning her risks of incontinence after cystocele repair, the benefits and risks of prophylactic anti-incontinence surgery, and the need for future surgical correction should be had as part of the surgical decision-making process.
Technique for Anterior Colporrhaphy
Traditional anterior colporrhaphy involves plication of the “endopelvic fascia” or fibromuscular layer of the vaginal wall after the vaginal wall is split. Buttressing of the bladder neck with a Kelly plication stitch was originally described by Howard Kelly in 1913.
The anterior vaginal wall is grasped on each side of the midline with Allis clamps. The cuff is grasped if a vaginal hysterectomy has been performed. If the uterus is in situ, the Allis clamps are used to grasp the vagina approximately 1 cm from the cervicovaginal junction, and an initial transverse incision is made.
The anterior wall, between the mucosa and bladder, is injected with 10 cc of vasopressin solution, 20 U in 50 cc of normal saline. This improves hemostasis and hydrodissects the space. A midline incision to within 1-2 cm of the urethrovesical neck is made.
The use of “three-point” traction can help with the dissection of the muscularis. The vagina is then grasped with several Allis clamps. The surgeon's index finger distends the vaginal wall and allows the surgeon to determine the thickness of the dissection with the Metzenbaum scissors. The assistant can provide countertraction with a tonsil clamp or DeBakey forceps. The fibromuscular layer is split to the level of the inferior pubic ramus. The procedure is repeated on the opposite side of the vagina.
One modification I prefer is to begin the plication at the apex instead of the bladder neck. This way, I avoid the pitfall of stopping short of the apex and leaving a “gap” or weakness in the repair. It is the apical portion of the repair that is most important. I use permanent sutures, preferably 2-0 Ethibond.
If the vaginal wall is the length needed to reach the apical supports, I use a transverse mattress stitch to plicate the fascia. If the vaginal wall needs to be shortened, I use a vertical mattress stitch. This will generally shorten the anterior wall 2-3 cm. For a large cystocele, two layers of plication can be used. The excess vaginal tissue is excised and closed with interrupted or running fine absorbable sutures.
When an apical repair procedure such as uterosacral ligament suspension or sacrospinous ligament suspension is performed in conjunction with anterior colporrhaphy—which is more often than not—the sutures for the apical repair should be placed and held prior to initiating the anterior colporrhaphy.
At the end of the anterior repair, the apical sutures are then incorporated into the vaginal cuff. Regardless of the type of transvaginal suspension, it is beneficial to bring one arm of the suspension suture through the anterior wall of the cuff and the other arm through the posterior cuff. This way, the anterior and posterior walls are brought together and suspended when the suture is tied.
Graft Use
In 2008, the Society of Gynecologic Surgeons (SGS) systematically reviewed the literature and published clinical practice guidelines on vaginal graft use. The SGS group concluded that nonabsorbable synthetic graft use may improve anatomic outcomes of the anterior vaginal wall, but that there are trade-offs in regard to additional risk. While more randomized studies on new mesh products are being conducted and reported, the data simply are insufficient to determine the anatomic or symptomatic efficacy of these types of grafts, the group said (Obstet. Gynecol. 2008;112:1131-42).
Similar to the SGS review, the Cochrane Collaboration completed a systematic review and concluded that the use of mesh or graft inlays at the time of anterior vaginal wall repair may reduce the risk of recurrent cystocele but that there was insufficient evidence to make recommendations for anterior vaginal wall or apical repair (Cochrane Database Syst. Rev. 2010;CD004014 [doi: 10.1002/14651858.CD004014.pub4]).
Overall, the few randomized trials that have been done illustrate the balance of risks and benefits that the surgeon and patient must weigh prior to considering the use of vaginal mesh or graft for the treatment of anterior wall prolapse.
One study that randomized 202 women to anterior colporrhaphy with or without a low-weight polypropylene mesh showed lower recurrence of anterior wall prolapse at 1 year with mesh than without mesh on physical examination using the Pelvic Organ Prolapse Quantification (POP-Q) system, but no differences in patient symptoms.
In this trial, the cure rate 1 year after surgery (defined as POP-Q stage 0 or 1) was significantly higher after the mesh-augmented repair compared with standard anterior colporrhaphy (62% vs. 93%). The use of mesh was, however, associated more often with stress urinary incontinence (23% vs. 10%). There were no differences in symptomatic outcomes. Mesh exposure was significant in the augmented group, 17% vs. 0% (Obstet. Gynecol. 2007;110:455-62).
In a one-surgeon, randomized controlled trial of 38 women who had traditional anterior colporrhaphy and 37 who had polypropylene mesh repair using the Perigee Transobturator Prolapse Repair System, Dr. John N. Nguyen concluded that repair with polypropylene mesh reinforcement offered lower anatomic recurrence rates at 1 year than did anterior colporrhaphy without mesh reinforcement (Obstet. Gynecol. 2008;111:891-8).
In this study, prolapse and incontinence symptoms improved significantly in both treatment groups.
Overall, the current evidence seems to support the use of synthetic mesh to augment repairs of anterior vaginal prolapse but at the expense of an increased rate of complications, particularly mesh exposure.
In my practice, most recurrent anterior wall prolapses are associated with apical descent as well. In those patients, I recommend a sacrocolpopexy performed laparoscopically. I would reserve the use of transvaginal mesh for women who have recurrent isolated anterior vaginal prolapse with a well-supported apex.
Three-point countertraction aids in the dissection of the vaginal wall.
The first vertical mattress stitch is placed at the vaginal apex during the surgery.
The second horizontal mattress stitch is placed, plicating the fibromuscular wall of the anterior wall.
The plication is complete. Minimal vaginal wall is trimmed prior to closing.
Source Photos courtesy Dr. Dee E. Fenner
Revisiting Anterior Colporrhaphy
According to Dr. Sangeeta Mahajan, any descent of the anterior wall of the vagina or base of the bladder, whether provoked or without straining, can be considered clinically an anterior vaginal wall defect. However, the International Continence Society uses a more precise definition: An anterior vaginal wall defect exists when the urethrovesical junction or any other part of the anterior vaginal wall is less than 3 cm from the hymenal ring.
It is now recognized that anterior vaginal wall prolapse occurs as a result of a specific defect in the vagina's support structure. Epidemiologically, aging, parity, obesity, cigarette smoking, chronic lung disease, congenital defects, white ancestry, and prior hysterectomy or prolapse surgery have been identified as risk factors associated with pelvic organ prolapse. Ultimately, management of anterior wall defects, which may be conservative or surgical, is indicated for the following reasons: discomfort, urinary retention, or genuine stress urinary incontinence.
Although retrospective case series, with a minimum of 1-year follow-up, by R. Porges, S.L. Stanton, and Walter and C. Maher, have documented success rates following anterior colporrhaphy for the treatment of anterior vaginal wall defects, in the range of 80%-100%; prospective studies by P.K. Sand and A.M. Weber demonstrate rates of success at 37%-57%.
Given the obvious challenge in providing success to our patient suffering with an anterior vaginal support defect with resulting prolapse, it is important to review the anatomy, perform proper evaluation, and provide appropriate surgical treatment, including use of graft materials.
In this edition of the Master Class in Gynecologic Surgery, I have once again called upon Dr. Dee E. Fenner, the Harold A. Furlong Professor of Women's Health and director of gynecology at the University of Michigan, Ann Arbor. This time Dr. Fenner will revisit anterior colporrhaphy for the treatment of anterior vaginal wall prolapse. Dr. Fenner provided her insight on the technique of posterior colporrhaphy and perineorrhaphy, that is, transvaginal rectocele repair, in the last installment of