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Official Newspaper of the American College of Surgeons
Opioid reduction works after minimally invasive gynecologic surgery
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Diagnosis, treatment, and prevention of ovarian remnant syndrome
Ovarian remnant syndrome (ORS) is an uncommon problem, but one that seems to be increasing in incidence and one that is important to diagnose and treat properly, as well as prevent. Retrospective cohort studies published in the past 15 years or so have improved our understanding of its presentation and the outcomes of surgical management – and recent literature has demonstrated that a minimally invasive surgical approach with either conventional laparoscopy or robot-assisted laparoscopy yields improved outcomes in a skilled surgeon’s hands.
Diagnosis is based on clinical history and should be further supported with imaging and laboratory evaluation. A definitive diagnosis of the disease comes through surgical intervention and pathological findings.
Surgery therefore is technically challenging, usually requiring complete ureterolysis, careful adhesiolysis (often enterolysis), and excision of much of the pelvic sidewall peritoneum with extirpation of the remnant and endometriosis. High ligation of the ovarian vasculature also often is required.
This complexity and the consequent risk of intraoperative injury to the bowel, bladder, and ureters requires careful preoperative preparation. When an ovarian remnant is suspected, it may be important to have other surgeons – such as gynecologic oncologists, urologists, colorectal surgeons, or general surgeons – either present or on standby during the surgical intervention. In expert hands, surgical intervention has been shown to resolve or improve pain in the majority of patients, with no recurrence of the syndrome.
Diagnosis of ORS
Courtesy Dr. Charles E. Miller and Dr. Kirsten J. Sasaki
Patients with ORS have had previous oophorectomies with incomplete removal of ovarian tissue. Pelvic pain, either cyclical or most commonly chronic, is a common symptom. Other symptoms can include dyspareunia, dysuria and other urinary symptoms, and bowel symptoms. Ovarian remnants may have an expanding cystic structure – oftentimes secondary to endometriosis – that causes mass-like effects leading to pain and inflammation and to symptoms such as low back pain, constipation, and even urinary retention.
It also is important to discuss the patient’s history of menopausal symptoms, because the absence of these symptoms after oophorectomy may be a sign that ovarian tissue has been left behind. Menopausal symptoms do not exclude the diagnosis, however. Endometriosis, extensive surgical history, and other diseases that lead to significant adhesion formation – and a higher risk of incomplete removal of ovarian tissue, theoretically – also should be explored during history-taking.
Laboratory assessment of serum follicle-stimulating hormone (FSH) and estradiol can be helpful. Values that are indicative of ovarian function – FSH less than 30 mIU/mL and estradiol greater than 35 pg/mL – point towards ORS, but the absence of such premenopausal values should not rule out the possibility of an ovarian remnant.
The literature shows that FSH and estradiol levels are variable in women with ORS. A retrospective review published in 2005 by Paul M. Magtibay, MD, and colleagues at the Mayo Clinic, Scottsdale, Ariz., and Rochester, Minn., involved 186 patients treated surgically from 1985 to 2003 with a mean follow-up, via questionnaire, of 1.2 years. This is the largest series published thus far of patients with pathologically confirmed ORS. It reported premenopausal levels of FSH and estradiol in 69% and 63% of patients, respectively, who had preoperative hormonal evaluations.1
In another retrospective cohort study published in 2011 of 30 women – also with pathologically confirmed ovarian remnants – Deborah Arden, MD, and Ted Lee, MD, of the University of Pittsburgh Medical Center reported premenopausal levels of FSH and estradiol in 59% and 71%, respectively, of women whose concentrations were measured.2
ORS often involves a pelvic mass, and preoperative imaging is important in this regard. In Dr. Magtibay’s series, a pelvic mass was identified in 93%, 92%, and 78% of those who were imaged presurgically with ultrasonography, computed tomography, and magnetic resonance imaging, respectively.1 As with laboratory testing, however, a negative result does not rule out the presence of an ovarian remnant.
Some authors have advocated the use of clomiphene citrate stimulation before preoperative imaging – or before repeat imaging – to identify remnant ovarian tissue. Typically, clomiphene citrate 100 mg is administered for 10 days prior to imaging to potentially induce ovulation in patients with suspected ORS. Alternatively, at the Advanced Gynecologic Surgery Institute in Naperville and Park Ridge, Ill., ovarian stimulation is performed using FSH 300 IUs for 5 days. A finding of cystic structures consistent with ovarian follicles will help narrow the diagnosis.
Use of gonadotropins is superior in that an intact pituitary-ovarian axis is not required. Moreover, monitoring can be in real time; increasing estradiol levels and increasing mass size on ultrasound can be monitored as gonadotropin treatment is rendered. Again, however, negative findings should not necessarily rule out ORS. Unfortunately, there have been no clinical studies looking at the use of controlled ovarian stimulation as a definitive test.
The differential diagnosis includes supernumerary ovary (a rare gynecologic congenital anomaly) and residual ovary syndrome (a condition in which an ovary is intentionally or unintentionally left in place during a hysterectomy, as well as often an intended bilateral oophorectomy, and later causes pain). The latter occurs when surgical anatomy is poor and the surgery is consequently very difficult.
Surgical principles and approach
Previously, laparotomy was believed to be the best approach for minimizing intraoperative complications and achieving the extensive dissections necessary for effective treatment of ORS. In recent years, conventional laparoscopy and robot-assisted laparoscopy have been shown in retrospective reviews such as that by Arden et al.2 and a 2007 review by Rosanne M. Kho, MD,3 to be just as safe and effective provided that the same surgical principles – extensive retroperitoneal dissections and ureterolysis – are applied.
Good outcomes can be achieved with less blood loss, shorter operating room time, and less time in the hospital. The better visualization with greater magnification afforded by a minimally invasive approach offers a distinct advantage for such complex dissections.
A remnant of ovarian tissue can be located anywhere along the pelvic sidewall, which makes the surgical protocol largely individualized and based on the suspected location of the remnant.
Still, there are certain standard components of any surgical approach to ORS: The retroperitoneum should be entered at the level of the pelvic brim and the ureter must be clearly identified; usually, a partial or complete ureterolysis is necessary. Then, a window into the broad ligament inferior to the infundibulopelvic (IP) ligament is created, or the peritoneum of the broad ligament is removed, in order to completely isolate both the IP ligament and the ureter.
Once the ovarian remnant is isolated, a wide excision at least 2 cm from all ovarian tissue is performed. This wide surgical clearance is critical to prevent recurrence.
These standard components form the crux of the most basic and straightforward surgery for ORS. In some cases, more extensive dissections such as a cystectomy or even a bowel resection might be necessary. Ligation of the IP ligament as high because its connection to the aortic bifurcation also may be necessary – depending, again, on the location of the ovarian remnant.
The risk of intraoperative injury to the bowel, bladder, and ureters is not insignificant, but with careful planning and the involvement of other surgeons in the most complex cases, these risks can be minimized.
For patients who have a significant surgical history and do not want more surgery, pharmacologic therapy, such as leuprolide (Lupron) or danazol, is an option for ORS. It’s important to note, however, that no studies have been done to demonstrate that medical therapy is a curative option. In addition, one must consider the small risk that remnants may harbor or develop malignancy.
Malignancy has been reported in ovarian remnant tissue. While the risk is believed to be very small, 2 of the 20 patients in Dr. Kho’s cohort had malignancy in remnant tissue,3 and it is generally recommended that surgeons send frozen sections of suspected ovarian tissue to pathology. Frozen-section diagnosis of ovarian tissue is about 95% accurate.
Preventing ovarian remnants
Oophorectomy is a common procedure performed by gynecologic surgeons. While routine, it is imperative that it be performed correctly to prevent ovarian remnants from occurring. When performing a laparoscopic or robot-assisted laparoscopic oophorectomy, it is important to optimize visualization of the ovary and the IP ligament, and to account for the significant magnification provided by laparoscopic cameras.
Surgeons must make sure all adhesions are completely cleared in order to optimally transect the IP ligament. Furthermore, wide excision around ovarian tissue is critical. Accessory ovarian tissue has been found up to 1.4 cm away from the ovary itself, which is why we recommend that surgeons excise at least 2-3 cm away from the IP in order to safely ensure complete removal of ovarian tissue.
Dr. Kooperman completed the American Association of Gynecologic Laparoscopists (AAGL) Fellowship Program in Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., and will be starting practice at the Highland Park (Ill.) North Shore Hospital System in August 2019. He reported no relevant disclosures.
References
1. Am J Obstet Gynecol. 2005;193(6):2062-6.
2. J Minim Invasive Gynecol. 2011;18(2):194-9.
3. Fertil Steril. 2007;87(5):1005-9.
Ovarian remnant syndrome (ORS) is an uncommon problem, but one that seems to be increasing in incidence and one that is important to diagnose and treat properly, as well as prevent. Retrospective cohort studies published in the past 15 years or so have improved our understanding of its presentation and the outcomes of surgical management – and recent literature has demonstrated that a minimally invasive surgical approach with either conventional laparoscopy or robot-assisted laparoscopy yields improved outcomes in a skilled surgeon’s hands.
Diagnosis is based on clinical history and should be further supported with imaging and laboratory evaluation. A definitive diagnosis of the disease comes through surgical intervention and pathological findings.
Surgery therefore is technically challenging, usually requiring complete ureterolysis, careful adhesiolysis (often enterolysis), and excision of much of the pelvic sidewall peritoneum with extirpation of the remnant and endometriosis. High ligation of the ovarian vasculature also often is required.
This complexity and the consequent risk of intraoperative injury to the bowel, bladder, and ureters requires careful preoperative preparation. When an ovarian remnant is suspected, it may be important to have other surgeons – such as gynecologic oncologists, urologists, colorectal surgeons, or general surgeons – either present or on standby during the surgical intervention. In expert hands, surgical intervention has been shown to resolve or improve pain in the majority of patients, with no recurrence of the syndrome.
Diagnosis of ORS
Courtesy Dr. Charles E. Miller and Dr. Kirsten J. Sasaki
Patients with ORS have had previous oophorectomies with incomplete removal of ovarian tissue. Pelvic pain, either cyclical or most commonly chronic, is a common symptom. Other symptoms can include dyspareunia, dysuria and other urinary symptoms, and bowel symptoms. Ovarian remnants may have an expanding cystic structure – oftentimes secondary to endometriosis – that causes mass-like effects leading to pain and inflammation and to symptoms such as low back pain, constipation, and even urinary retention.
It also is important to discuss the patient’s history of menopausal symptoms, because the absence of these symptoms after oophorectomy may be a sign that ovarian tissue has been left behind. Menopausal symptoms do not exclude the diagnosis, however. Endometriosis, extensive surgical history, and other diseases that lead to significant adhesion formation – and a higher risk of incomplete removal of ovarian tissue, theoretically – also should be explored during history-taking.
Laboratory assessment of serum follicle-stimulating hormone (FSH) and estradiol can be helpful. Values that are indicative of ovarian function – FSH less than 30 mIU/mL and estradiol greater than 35 pg/mL – point towards ORS, but the absence of such premenopausal values should not rule out the possibility of an ovarian remnant.
The literature shows that FSH and estradiol levels are variable in women with ORS. A retrospective review published in 2005 by Paul M. Magtibay, MD, and colleagues at the Mayo Clinic, Scottsdale, Ariz., and Rochester, Minn., involved 186 patients treated surgically from 1985 to 2003 with a mean follow-up, via questionnaire, of 1.2 years. This is the largest series published thus far of patients with pathologically confirmed ORS. It reported premenopausal levels of FSH and estradiol in 69% and 63% of patients, respectively, who had preoperative hormonal evaluations.1
In another retrospective cohort study published in 2011 of 30 women – also with pathologically confirmed ovarian remnants – Deborah Arden, MD, and Ted Lee, MD, of the University of Pittsburgh Medical Center reported premenopausal levels of FSH and estradiol in 59% and 71%, respectively, of women whose concentrations were measured.2
ORS often involves a pelvic mass, and preoperative imaging is important in this regard. In Dr. Magtibay’s series, a pelvic mass was identified in 93%, 92%, and 78% of those who were imaged presurgically with ultrasonography, computed tomography, and magnetic resonance imaging, respectively.1 As with laboratory testing, however, a negative result does not rule out the presence of an ovarian remnant.
Some authors have advocated the use of clomiphene citrate stimulation before preoperative imaging – or before repeat imaging – to identify remnant ovarian tissue. Typically, clomiphene citrate 100 mg is administered for 10 days prior to imaging to potentially induce ovulation in patients with suspected ORS. Alternatively, at the Advanced Gynecologic Surgery Institute in Naperville and Park Ridge, Ill., ovarian stimulation is performed using FSH 300 IUs for 5 days. A finding of cystic structures consistent with ovarian follicles will help narrow the diagnosis.
Use of gonadotropins is superior in that an intact pituitary-ovarian axis is not required. Moreover, monitoring can be in real time; increasing estradiol levels and increasing mass size on ultrasound can be monitored as gonadotropin treatment is rendered. Again, however, negative findings should not necessarily rule out ORS. Unfortunately, there have been no clinical studies looking at the use of controlled ovarian stimulation as a definitive test.
The differential diagnosis includes supernumerary ovary (a rare gynecologic congenital anomaly) and residual ovary syndrome (a condition in which an ovary is intentionally or unintentionally left in place during a hysterectomy, as well as often an intended bilateral oophorectomy, and later causes pain). The latter occurs when surgical anatomy is poor and the surgery is consequently very difficult.
Surgical principles and approach
Previously, laparotomy was believed to be the best approach for minimizing intraoperative complications and achieving the extensive dissections necessary for effective treatment of ORS. In recent years, conventional laparoscopy and robot-assisted laparoscopy have been shown in retrospective reviews such as that by Arden et al.2 and a 2007 review by Rosanne M. Kho, MD,3 to be just as safe and effective provided that the same surgical principles – extensive retroperitoneal dissections and ureterolysis – are applied.
Good outcomes can be achieved with less blood loss, shorter operating room time, and less time in the hospital. The better visualization with greater magnification afforded by a minimally invasive approach offers a distinct advantage for such complex dissections.
A remnant of ovarian tissue can be located anywhere along the pelvic sidewall, which makes the surgical protocol largely individualized and based on the suspected location of the remnant.
Still, there are certain standard components of any surgical approach to ORS: The retroperitoneum should be entered at the level of the pelvic brim and the ureter must be clearly identified; usually, a partial or complete ureterolysis is necessary. Then, a window into the broad ligament inferior to the infundibulopelvic (IP) ligament is created, or the peritoneum of the broad ligament is removed, in order to completely isolate both the IP ligament and the ureter.
Once the ovarian remnant is isolated, a wide excision at least 2 cm from all ovarian tissue is performed. This wide surgical clearance is critical to prevent recurrence.
These standard components form the crux of the most basic and straightforward surgery for ORS. In some cases, more extensive dissections such as a cystectomy or even a bowel resection might be necessary. Ligation of the IP ligament as high because its connection to the aortic bifurcation also may be necessary – depending, again, on the location of the ovarian remnant.
The risk of intraoperative injury to the bowel, bladder, and ureters is not insignificant, but with careful planning and the involvement of other surgeons in the most complex cases, these risks can be minimized.
For patients who have a significant surgical history and do not want more surgery, pharmacologic therapy, such as leuprolide (Lupron) or danazol, is an option for ORS. It’s important to note, however, that no studies have been done to demonstrate that medical therapy is a curative option. In addition, one must consider the small risk that remnants may harbor or develop malignancy.
Malignancy has been reported in ovarian remnant tissue. While the risk is believed to be very small, 2 of the 20 patients in Dr. Kho’s cohort had malignancy in remnant tissue,3 and it is generally recommended that surgeons send frozen sections of suspected ovarian tissue to pathology. Frozen-section diagnosis of ovarian tissue is about 95% accurate.
Preventing ovarian remnants
Oophorectomy is a common procedure performed by gynecologic surgeons. While routine, it is imperative that it be performed correctly to prevent ovarian remnants from occurring. When performing a laparoscopic or robot-assisted laparoscopic oophorectomy, it is important to optimize visualization of the ovary and the IP ligament, and to account for the significant magnification provided by laparoscopic cameras.
Surgeons must make sure all adhesions are completely cleared in order to optimally transect the IP ligament. Furthermore, wide excision around ovarian tissue is critical. Accessory ovarian tissue has been found up to 1.4 cm away from the ovary itself, which is why we recommend that surgeons excise at least 2-3 cm away from the IP in order to safely ensure complete removal of ovarian tissue.
Dr. Kooperman completed the American Association of Gynecologic Laparoscopists (AAGL) Fellowship Program in Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., and will be starting practice at the Highland Park (Ill.) North Shore Hospital System in August 2019. He reported no relevant disclosures.
References
1. Am J Obstet Gynecol. 2005;193(6):2062-6.
2. J Minim Invasive Gynecol. 2011;18(2):194-9.
3. Fertil Steril. 2007;87(5):1005-9.
Ovarian remnant syndrome (ORS) is an uncommon problem, but one that seems to be increasing in incidence and one that is important to diagnose and treat properly, as well as prevent. Retrospective cohort studies published in the past 15 years or so have improved our understanding of its presentation and the outcomes of surgical management – and recent literature has demonstrated that a minimally invasive surgical approach with either conventional laparoscopy or robot-assisted laparoscopy yields improved outcomes in a skilled surgeon’s hands.
Diagnosis is based on clinical history and should be further supported with imaging and laboratory evaluation. A definitive diagnosis of the disease comes through surgical intervention and pathological findings.
Surgery therefore is technically challenging, usually requiring complete ureterolysis, careful adhesiolysis (often enterolysis), and excision of much of the pelvic sidewall peritoneum with extirpation of the remnant and endometriosis. High ligation of the ovarian vasculature also often is required.
This complexity and the consequent risk of intraoperative injury to the bowel, bladder, and ureters requires careful preoperative preparation. When an ovarian remnant is suspected, it may be important to have other surgeons – such as gynecologic oncologists, urologists, colorectal surgeons, or general surgeons – either present or on standby during the surgical intervention. In expert hands, surgical intervention has been shown to resolve or improve pain in the majority of patients, with no recurrence of the syndrome.
Diagnosis of ORS
Courtesy Dr. Charles E. Miller and Dr. Kirsten J. Sasaki
Patients with ORS have had previous oophorectomies with incomplete removal of ovarian tissue. Pelvic pain, either cyclical or most commonly chronic, is a common symptom. Other symptoms can include dyspareunia, dysuria and other urinary symptoms, and bowel symptoms. Ovarian remnants may have an expanding cystic structure – oftentimes secondary to endometriosis – that causes mass-like effects leading to pain and inflammation and to symptoms such as low back pain, constipation, and even urinary retention.
It also is important to discuss the patient’s history of menopausal symptoms, because the absence of these symptoms after oophorectomy may be a sign that ovarian tissue has been left behind. Menopausal symptoms do not exclude the diagnosis, however. Endometriosis, extensive surgical history, and other diseases that lead to significant adhesion formation – and a higher risk of incomplete removal of ovarian tissue, theoretically – also should be explored during history-taking.
Laboratory assessment of serum follicle-stimulating hormone (FSH) and estradiol can be helpful. Values that are indicative of ovarian function – FSH less than 30 mIU/mL and estradiol greater than 35 pg/mL – point towards ORS, but the absence of such premenopausal values should not rule out the possibility of an ovarian remnant.
The literature shows that FSH and estradiol levels are variable in women with ORS. A retrospective review published in 2005 by Paul M. Magtibay, MD, and colleagues at the Mayo Clinic, Scottsdale, Ariz., and Rochester, Minn., involved 186 patients treated surgically from 1985 to 2003 with a mean follow-up, via questionnaire, of 1.2 years. This is the largest series published thus far of patients with pathologically confirmed ORS. It reported premenopausal levels of FSH and estradiol in 69% and 63% of patients, respectively, who had preoperative hormonal evaluations.1
In another retrospective cohort study published in 2011 of 30 women – also with pathologically confirmed ovarian remnants – Deborah Arden, MD, and Ted Lee, MD, of the University of Pittsburgh Medical Center reported premenopausal levels of FSH and estradiol in 59% and 71%, respectively, of women whose concentrations were measured.2
ORS often involves a pelvic mass, and preoperative imaging is important in this regard. In Dr. Magtibay’s series, a pelvic mass was identified in 93%, 92%, and 78% of those who were imaged presurgically with ultrasonography, computed tomography, and magnetic resonance imaging, respectively.1 As with laboratory testing, however, a negative result does not rule out the presence of an ovarian remnant.
Some authors have advocated the use of clomiphene citrate stimulation before preoperative imaging – or before repeat imaging – to identify remnant ovarian tissue. Typically, clomiphene citrate 100 mg is administered for 10 days prior to imaging to potentially induce ovulation in patients with suspected ORS. Alternatively, at the Advanced Gynecologic Surgery Institute in Naperville and Park Ridge, Ill., ovarian stimulation is performed using FSH 300 IUs for 5 days. A finding of cystic structures consistent with ovarian follicles will help narrow the diagnosis.
Use of gonadotropins is superior in that an intact pituitary-ovarian axis is not required. Moreover, monitoring can be in real time; increasing estradiol levels and increasing mass size on ultrasound can be monitored as gonadotropin treatment is rendered. Again, however, negative findings should not necessarily rule out ORS. Unfortunately, there have been no clinical studies looking at the use of controlled ovarian stimulation as a definitive test.
The differential diagnosis includes supernumerary ovary (a rare gynecologic congenital anomaly) and residual ovary syndrome (a condition in which an ovary is intentionally or unintentionally left in place during a hysterectomy, as well as often an intended bilateral oophorectomy, and later causes pain). The latter occurs when surgical anatomy is poor and the surgery is consequently very difficult.
Surgical principles and approach
Previously, laparotomy was believed to be the best approach for minimizing intraoperative complications and achieving the extensive dissections necessary for effective treatment of ORS. In recent years, conventional laparoscopy and robot-assisted laparoscopy have been shown in retrospective reviews such as that by Arden et al.2 and a 2007 review by Rosanne M. Kho, MD,3 to be just as safe and effective provided that the same surgical principles – extensive retroperitoneal dissections and ureterolysis – are applied.
Good outcomes can be achieved with less blood loss, shorter operating room time, and less time in the hospital. The better visualization with greater magnification afforded by a minimally invasive approach offers a distinct advantage for such complex dissections.
A remnant of ovarian tissue can be located anywhere along the pelvic sidewall, which makes the surgical protocol largely individualized and based on the suspected location of the remnant.
Still, there are certain standard components of any surgical approach to ORS: The retroperitoneum should be entered at the level of the pelvic brim and the ureter must be clearly identified; usually, a partial or complete ureterolysis is necessary. Then, a window into the broad ligament inferior to the infundibulopelvic (IP) ligament is created, or the peritoneum of the broad ligament is removed, in order to completely isolate both the IP ligament and the ureter.
Once the ovarian remnant is isolated, a wide excision at least 2 cm from all ovarian tissue is performed. This wide surgical clearance is critical to prevent recurrence.
These standard components form the crux of the most basic and straightforward surgery for ORS. In some cases, more extensive dissections such as a cystectomy or even a bowel resection might be necessary. Ligation of the IP ligament as high because its connection to the aortic bifurcation also may be necessary – depending, again, on the location of the ovarian remnant.
The risk of intraoperative injury to the bowel, bladder, and ureters is not insignificant, but with careful planning and the involvement of other surgeons in the most complex cases, these risks can be minimized.
For patients who have a significant surgical history and do not want more surgery, pharmacologic therapy, such as leuprolide (Lupron) or danazol, is an option for ORS. It’s important to note, however, that no studies have been done to demonstrate that medical therapy is a curative option. In addition, one must consider the small risk that remnants may harbor or develop malignancy.
Malignancy has been reported in ovarian remnant tissue. While the risk is believed to be very small, 2 of the 20 patients in Dr. Kho’s cohort had malignancy in remnant tissue,3 and it is generally recommended that surgeons send frozen sections of suspected ovarian tissue to pathology. Frozen-section diagnosis of ovarian tissue is about 95% accurate.
Preventing ovarian remnants
Oophorectomy is a common procedure performed by gynecologic surgeons. While routine, it is imperative that it be performed correctly to prevent ovarian remnants from occurring. When performing a laparoscopic or robot-assisted laparoscopic oophorectomy, it is important to optimize visualization of the ovary and the IP ligament, and to account for the significant magnification provided by laparoscopic cameras.
Surgeons must make sure all adhesions are completely cleared in order to optimally transect the IP ligament. Furthermore, wide excision around ovarian tissue is critical. Accessory ovarian tissue has been found up to 1.4 cm away from the ovary itself, which is why we recommend that surgeons excise at least 2-3 cm away from the IP in order to safely ensure complete removal of ovarian tissue.
Dr. Kooperman completed the American Association of Gynecologic Laparoscopists (AAGL) Fellowship Program in Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital, Park Ridge, Ill., and will be starting practice at the Highland Park (Ill.) North Shore Hospital System in August 2019. He reported no relevant disclosures.
References
1. Am J Obstet Gynecol. 2005;193(6):2062-6.
2. J Minim Invasive Gynecol. 2011;18(2):194-9.
3. Fertil Steril. 2007;87(5):1005-9.
The ovarian remnant syndrome
A 45-year old woman was referred by her physician to my clinic for continued pain after total hysterectomy and bilateral salpingo-oophorectomy. The patient initially had undergone a robot-assisted total laparoscopic hysterectomy, bilateral salpingectomy, and excision of stage 1 endometriosis secondary to pelvic pain. Because of continued pain and new onset of persistent ovarian cysts, she once again underwent robotic-assisted laparoscopic surgery, this time to remove both ovaries. Interestingly, severe periadnexal adhesions were noted in the second surgical report. A hemorrhagic cyst and a corpus luteal cyst were noted. Unfortunately, the patient continued to have left lower abdominal pain; thus, the referral to my clinic.
Given the history of pelvic pain, especially in light of severe periadnexal adhesions at the second surgery, I voiced my concern about possible ovarian remnant syndrome. At the patient’s initial visit, an estradiol (E2), progesterone (P4) and follicle-stimulating hormone (FSH) test were ordered. Interestingly, while the E2 and P4 were quite low, the FSH was 10.9 IU/mL. Certainly, this was not consistent with menopause but could point to ovarian remnant syndrome.
A follow-up examination and ultrasound revealed a 15-mm exquisitely tender left adnexal mass, again consistent with ovarian remnant syndrome. My plan now is to proceed with surgery with the presumptive diagnosis of ovarian remnant syndrome.
Ovarian remnant syndrome (ORS), first described by Shemwell and Weed in 1970, is defined as a pelvic mass with residual ovarian tissue postoophorectomy.1-3 ORS may be associated with endometriosis or ovarian cancer. Remnant ovarian tissue also may stimulate endometriosis and cyclic pelvic pain, similar to symptoms of the remnant itself.4
Pelvic adhesions may be secondary to previous surgery, intraoperative bleeding, previous appendectomy, inflammatory bowel disease, pelvic inflammatory disease, or endometriosis, the latter of which is the most common cause of initial oophorectomy. Moreover, surgical technique may be causal. This includes inability to achieve adequate exposure, inability to restore normal anatomy, and imprecise site of surgical incision.5-7
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Ryan S. Kooperman, DO, who recently completed his 2-year American Association of Gynecologic Laparoscopists (AAGL) Fellowship in Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital in Park Ridge, Ill., where I am currently the program director.
In 2016, Dr. Kooperman was the recipient of the National Outstanding Resident of the Year in Obstetrics and Gynecology (American Osteopathic Foundation/Medical Education Foundation of the American College of Osteopathic Obstetricians and Gynecologists). Dr. Kooperman is a very skilled surgeon and adroit clinician. He will be starting practice at Highland Park (Ill.) North Shore Hospital System in August 2019. It is a pleasure to welcome Dr. Kooperman to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital. He has no disclosures relevant to this Master Class.
References
1. Obstet Gynecol. 1970 Aug;36(2):299-303.
2. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):433-5.
3. Curr Opin Obstet Gynecol. 2012 Aug;24(4):210-4.
4. Int J Gynaecol Obstet. 1988 Feb;26(1):93-103.
5. Oncol Lett. 2014 Jul;8(1):3-6.
6. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):194-9.
7. Fertil Steril. 2007 May;87(5):1005-9.
A 45-year old woman was referred by her physician to my clinic for continued pain after total hysterectomy and bilateral salpingo-oophorectomy. The patient initially had undergone a robot-assisted total laparoscopic hysterectomy, bilateral salpingectomy, and excision of stage 1 endometriosis secondary to pelvic pain. Because of continued pain and new onset of persistent ovarian cysts, she once again underwent robotic-assisted laparoscopic surgery, this time to remove both ovaries. Interestingly, severe periadnexal adhesions were noted in the second surgical report. A hemorrhagic cyst and a corpus luteal cyst were noted. Unfortunately, the patient continued to have left lower abdominal pain; thus, the referral to my clinic.
Given the history of pelvic pain, especially in light of severe periadnexal adhesions at the second surgery, I voiced my concern about possible ovarian remnant syndrome. At the patient’s initial visit, an estradiol (E2), progesterone (P4) and follicle-stimulating hormone (FSH) test were ordered. Interestingly, while the E2 and P4 were quite low, the FSH was 10.9 IU/mL. Certainly, this was not consistent with menopause but could point to ovarian remnant syndrome.
A follow-up examination and ultrasound revealed a 15-mm exquisitely tender left adnexal mass, again consistent with ovarian remnant syndrome. My plan now is to proceed with surgery with the presumptive diagnosis of ovarian remnant syndrome.
Ovarian remnant syndrome (ORS), first described by Shemwell and Weed in 1970, is defined as a pelvic mass with residual ovarian tissue postoophorectomy.1-3 ORS may be associated with endometriosis or ovarian cancer. Remnant ovarian tissue also may stimulate endometriosis and cyclic pelvic pain, similar to symptoms of the remnant itself.4
Pelvic adhesions may be secondary to previous surgery, intraoperative bleeding, previous appendectomy, inflammatory bowel disease, pelvic inflammatory disease, or endometriosis, the latter of which is the most common cause of initial oophorectomy. Moreover, surgical technique may be causal. This includes inability to achieve adequate exposure, inability to restore normal anatomy, and imprecise site of surgical incision.5-7
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Ryan S. Kooperman, DO, who recently completed his 2-year American Association of Gynecologic Laparoscopists (AAGL) Fellowship in Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital in Park Ridge, Ill., where I am currently the program director.
In 2016, Dr. Kooperman was the recipient of the National Outstanding Resident of the Year in Obstetrics and Gynecology (American Osteopathic Foundation/Medical Education Foundation of the American College of Osteopathic Obstetricians and Gynecologists). Dr. Kooperman is a very skilled surgeon and adroit clinician. He will be starting practice at Highland Park (Ill.) North Shore Hospital System in August 2019. It is a pleasure to welcome Dr. Kooperman to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital. He has no disclosures relevant to this Master Class.
References
1. Obstet Gynecol. 1970 Aug;36(2):299-303.
2. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):433-5.
3. Curr Opin Obstet Gynecol. 2012 Aug;24(4):210-4.
4. Int J Gynaecol Obstet. 1988 Feb;26(1):93-103.
5. Oncol Lett. 2014 Jul;8(1):3-6.
6. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):194-9.
7. Fertil Steril. 2007 May;87(5):1005-9.
A 45-year old woman was referred by her physician to my clinic for continued pain after total hysterectomy and bilateral salpingo-oophorectomy. The patient initially had undergone a robot-assisted total laparoscopic hysterectomy, bilateral salpingectomy, and excision of stage 1 endometriosis secondary to pelvic pain. Because of continued pain and new onset of persistent ovarian cysts, she once again underwent robotic-assisted laparoscopic surgery, this time to remove both ovaries. Interestingly, severe periadnexal adhesions were noted in the second surgical report. A hemorrhagic cyst and a corpus luteal cyst were noted. Unfortunately, the patient continued to have left lower abdominal pain; thus, the referral to my clinic.
Given the history of pelvic pain, especially in light of severe periadnexal adhesions at the second surgery, I voiced my concern about possible ovarian remnant syndrome. At the patient’s initial visit, an estradiol (E2), progesterone (P4) and follicle-stimulating hormone (FSH) test were ordered. Interestingly, while the E2 and P4 were quite low, the FSH was 10.9 IU/mL. Certainly, this was not consistent with menopause but could point to ovarian remnant syndrome.
A follow-up examination and ultrasound revealed a 15-mm exquisitely tender left adnexal mass, again consistent with ovarian remnant syndrome. My plan now is to proceed with surgery with the presumptive diagnosis of ovarian remnant syndrome.
Ovarian remnant syndrome (ORS), first described by Shemwell and Weed in 1970, is defined as a pelvic mass with residual ovarian tissue postoophorectomy.1-3 ORS may be associated with endometriosis or ovarian cancer. Remnant ovarian tissue also may stimulate endometriosis and cyclic pelvic pain, similar to symptoms of the remnant itself.4
Pelvic adhesions may be secondary to previous surgery, intraoperative bleeding, previous appendectomy, inflammatory bowel disease, pelvic inflammatory disease, or endometriosis, the latter of which is the most common cause of initial oophorectomy. Moreover, surgical technique may be causal. This includes inability to achieve adequate exposure, inability to restore normal anatomy, and imprecise site of surgical incision.5-7
For this edition of the Master Class in Gynecologic Surgery, I have enlisted the assistance of Ryan S. Kooperman, DO, who recently completed his 2-year American Association of Gynecologic Laparoscopists (AAGL) Fellowship in Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital in Park Ridge, Ill., where I am currently the program director.
In 2016, Dr. Kooperman was the recipient of the National Outstanding Resident of the Year in Obstetrics and Gynecology (American Osteopathic Foundation/Medical Education Foundation of the American College of Osteopathic Obstetricians and Gynecologists). Dr. Kooperman is a very skilled surgeon and adroit clinician. He will be starting practice at Highland Park (Ill.) North Shore Hospital System in August 2019. It is a pleasure to welcome Dr. Kooperman to this edition of the Master Class in Gynecologic Surgery.
Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital. He has no disclosures relevant to this Master Class.
References
1. Obstet Gynecol. 1970 Aug;36(2):299-303.
2. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):433-5.
3. Curr Opin Obstet Gynecol. 2012 Aug;24(4):210-4.
4. Int J Gynaecol Obstet. 1988 Feb;26(1):93-103.
5. Oncol Lett. 2014 Jul;8(1):3-6.
6. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):194-9.
7. Fertil Steril. 2007 May;87(5):1005-9.
What is the future of para-aortic lymphadenectomy for endometrial cancer?
A landmark study of advanced endometrial cancer, GOG 258, was published in the New England Journal of Medicine this summer.1 This clinical trial compared the use of carboplatin and paclitaxel chemotherapy with a combination of chemotherapy with external beam radiation, exploring the notion of “more is better.” The results of the trial revealed that the “more” (chemotherapy with external beam radiation) was no better than chemotherapy alone with respect to overall survival. These results have challenged a creeping dogma in gynecologic oncology, which has seen many providers embrace combination therapy, particularly for patients with stage III (node-positive) endometrial cancer, a group of patients who made up approximately three-quarters of GOG 258’s study population. Many have been left searching for justification of their early adoption of combination therapy before the results of a trial such as this were available. For me it also raised a slightly different question: In the light of these results, what IS the role of para-aortic lymphadenectomy in the staging of endometrial cancers? If radiation to the nodal basins is no longer part of adjuvant therapy, then
It was in the 1980s that the removal of clinically normal para-aortic lymph nodes (those residing between the renal and proximal common iliac vessels) became a part of surgical staging. This practice was endorsed by the International Federation of Gynecology and Obstetrics (FIGO) and the Gynecologic Oncology Group (GOG) surgical committee in response to findings that 11% of women with clinical stage I endometrial cancer had microscopic lymph node metastases which were discovered only with routine pathologic evaluation of these tissues. Among those with pelvic lymph node metastases (stage IIIC disease), approximately one-third also harbored disease in para-aortic nodal regions.2 Among all patients with endometrial cancer, including those with low-grade disease, only a small fraction (approximately 2%) have isolated para-aortic lymph nodes (positive para-aortic nodes, but negative pelvic nodes). However, among patients with deeply invasive higher-grade tumors, the likelihood of discovering isolated para-aortic metastases is higher at approximately 16%.3 Therefore, the dominant pattern of lymph node metastases and lymphatic dissemination of endometrial cancer appears to be via the parametrial channels laterally towards the pelvic basins, and then sequentially to the para-aortic regions. The direct lymphatic pathway to the para-aortic basins from the uterine fundus through the adnexal lymphatics misses the pelvic regions altogether and may seen logical, but actually is observed fairly infrequently.4
Over the subsequent decades, there have been debates and schools of thought regarding what is the optimal degree of lymphatic dissection for endometrial cancer staging. Some advocated for full pelvic and infrarenal para-aortic nodal dissections in all patients, including even those in the lowest risk for metastases. Others advocated for a more limited, inframesenteric para-aortic nodal dissection, although the origins of such a distinction appear to be largely arbitrary. The inferior mesenteric artery is not a physiologic landmark for lymphatic pathways, and approximately half of para-aortic metastases are located above the level of the inferior mesenteric artery. This limited sampling may have been preferred because of relative ease of dissection rather than diagnostic or therapeutic efficacy.
As the population became more obese, making para-aortic nodal dissections less feasible, and laparoscopic staging became accepted as the standard of care in endometrial cancer staging, there was a further push towards limiting the scope of lymphadenectomy. Selective algorithms, such as the so-called “Mayo clinic criteria,” were widely adopted. In this approach, gynecologic oncologists perform full pelvic and infrarenal para-aortic lymphadenectomies but only in the presence of a high-risk uterine feature such as tumor size greater than 2 cm, deep myometrial invasion, or grade 3 histology.3 While this reduced the number of para-aortic dissections being performed, it did not eliminate them, as approximately 40% of patients with endometrial cancer meet at least one of those criteria.
At this same time, we learned something else critical about the benefits, or lack thereof, of lymphadenectomy. Two landmark surgical-staging trials were published in 2009 which randomly assigned women to hysterectomy with lymphadenectomy or hysterectomy alone, and found no survival benefit for lymphadenectomy.5,6 While these trial results initially were met with noisy backlash, particularly from those who had legitimate concerns regarding study design and conclusions that reach beyond the scope of this column, ultimately their findings (that there is no therapeutic benefit to surgically removing clinically normal lymph nodes) has become largely accepted. The subsequent findings of the Laparoscopic Approach to Cancer of the Endometrium (LACE) trial further support this, as there was no difference in survival found between patients who were randomly assigned to laparoscopic versus open staging for endometrial cancer, even despite a significantly lower rate of lymphadenectomy among the laparoscopic arm.7
SLN biopsy, in which the specific nodes which drain the uterus are selectively removed, represents the most recent development in lymph node assessment for endometrial cancer. On average, only three lymph nodes are removed per patient, and para-aortic nodes infrequently are removed, because it is rare that lymphatic pathways drain directly into the aortic basins after cervical injection. Yet despite this more limited dissection of lymph nodes, especially para-aortic, with SLN biopsy, surgeons still observe similar rates of IIIC disease, compared with full lymphadenectomy, suggesting that the presence or absence of lymphatic metastases still is able to be adequately determined. SLN biopsy misses only 3% of lymphatic disease.8 What is of particular interest to practitioners of the SLN approach is that “atypical” pathways are discovered approximately 20% of the time, and nodes are harvested from locations such as the presacral space or medial to the internal iliac vessels. These nodes are in locations previously overlooked by even the most comprehensive pelvic and para-aortic lymphadenectomy. Therefore, while the para-aortic nodes may not be systematically removed with SLN biopsy, new and arguably more relevant regions are interrogated, which might explain its equivalent diagnostic virtue.
With this evolution in surgical-staging practice, what we have come to recognize is that the role of lymph node assessment is predominantly, if not exclusively, diagnostic. It can help us determine which patients are at risk for distant relapse and therefore candidates for systemic therapy (chemotherapy), versus those whose risk is predominantly of local relapse and can be adequately treated with local therapies alone, such as vaginal radiation. This brings us to the results of GOG 258. If defining the specific and complete extent of lymph node metastases (as if that was ever truly what surgeons were doing) is no longer necessary to guide the prescription and extent of external beam radiation, then lymph node dissection need only inform us of whether or not there are nodal metastases, not specifically the location of those nodal metastases. The prescription of chemotherapy is the same whether the disease is limited to the pelvic nodes or also includes the para-aortic nodes. While GOG 258 discovered more para-aortic failures among the chemotherapy-alone group, suggesting there may be some therapeutic role of radiation in preventing this, it should be noted that these para-aortic relapses did not negatively impact relapse-free survival, and these patients still can presumably be salvaged with external beam radiation to the site of para-aortic relapse.
It would seem logical that the results of GOG 258 further limit the potential role of para-aortic lymphadenectomy in women with clinical stage I disease. Perhaps para-aortic dissection can be limited to women who are at highest risk for isolated para-aortic disease, such as those with deeply invasive high-grade tumors not successfully mapped with the highly targeted sentinel node biopsy technique? Most clinicians look forward to an era in which we no longer rely on crude dissections of disease-free tissue just to prove they are disease free, but instead can utilize more sophisticated diagnostic methods to recognize disseminated disease.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Email her at [email protected].
References
1. N Engl J Med. 2019 Jun 13;380(24):2317-26.
2. Cancer. 1987 Oct 15;60(8 Suppl):2035-41.
3. Gynecol Oncol. 2008;109(1):11-8.
4. Int J Gynecol Cancer. 2019 Mar;29(3):613-21.
5. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16.
6. Lancet. 2009 Jan 10;373(9658):125-36.
7. JAMA. 2017 Mar 28;317(12):1224-33.
8. Lancet Oncol. 2017 Mar;18(3):384-92.
A landmark study of advanced endometrial cancer, GOG 258, was published in the New England Journal of Medicine this summer.1 This clinical trial compared the use of carboplatin and paclitaxel chemotherapy with a combination of chemotherapy with external beam radiation, exploring the notion of “more is better.” The results of the trial revealed that the “more” (chemotherapy with external beam radiation) was no better than chemotherapy alone with respect to overall survival. These results have challenged a creeping dogma in gynecologic oncology, which has seen many providers embrace combination therapy, particularly for patients with stage III (node-positive) endometrial cancer, a group of patients who made up approximately three-quarters of GOG 258’s study population. Many have been left searching for justification of their early adoption of combination therapy before the results of a trial such as this were available. For me it also raised a slightly different question: In the light of these results, what IS the role of para-aortic lymphadenectomy in the staging of endometrial cancers? If radiation to the nodal basins is no longer part of adjuvant therapy, then
It was in the 1980s that the removal of clinically normal para-aortic lymph nodes (those residing between the renal and proximal common iliac vessels) became a part of surgical staging. This practice was endorsed by the International Federation of Gynecology and Obstetrics (FIGO) and the Gynecologic Oncology Group (GOG) surgical committee in response to findings that 11% of women with clinical stage I endometrial cancer had microscopic lymph node metastases which were discovered only with routine pathologic evaluation of these tissues. Among those with pelvic lymph node metastases (stage IIIC disease), approximately one-third also harbored disease in para-aortic nodal regions.2 Among all patients with endometrial cancer, including those with low-grade disease, only a small fraction (approximately 2%) have isolated para-aortic lymph nodes (positive para-aortic nodes, but negative pelvic nodes). However, among patients with deeply invasive higher-grade tumors, the likelihood of discovering isolated para-aortic metastases is higher at approximately 16%.3 Therefore, the dominant pattern of lymph node metastases and lymphatic dissemination of endometrial cancer appears to be via the parametrial channels laterally towards the pelvic basins, and then sequentially to the para-aortic regions. The direct lymphatic pathway to the para-aortic basins from the uterine fundus through the adnexal lymphatics misses the pelvic regions altogether and may seen logical, but actually is observed fairly infrequently.4
Over the subsequent decades, there have been debates and schools of thought regarding what is the optimal degree of lymphatic dissection for endometrial cancer staging. Some advocated for full pelvic and infrarenal para-aortic nodal dissections in all patients, including even those in the lowest risk for metastases. Others advocated for a more limited, inframesenteric para-aortic nodal dissection, although the origins of such a distinction appear to be largely arbitrary. The inferior mesenteric artery is not a physiologic landmark for lymphatic pathways, and approximately half of para-aortic metastases are located above the level of the inferior mesenteric artery. This limited sampling may have been preferred because of relative ease of dissection rather than diagnostic or therapeutic efficacy.
As the population became more obese, making para-aortic nodal dissections less feasible, and laparoscopic staging became accepted as the standard of care in endometrial cancer staging, there was a further push towards limiting the scope of lymphadenectomy. Selective algorithms, such as the so-called “Mayo clinic criteria,” were widely adopted. In this approach, gynecologic oncologists perform full pelvic and infrarenal para-aortic lymphadenectomies but only in the presence of a high-risk uterine feature such as tumor size greater than 2 cm, deep myometrial invasion, or grade 3 histology.3 While this reduced the number of para-aortic dissections being performed, it did not eliminate them, as approximately 40% of patients with endometrial cancer meet at least one of those criteria.
At this same time, we learned something else critical about the benefits, or lack thereof, of lymphadenectomy. Two landmark surgical-staging trials were published in 2009 which randomly assigned women to hysterectomy with lymphadenectomy or hysterectomy alone, and found no survival benefit for lymphadenectomy.5,6 While these trial results initially were met with noisy backlash, particularly from those who had legitimate concerns regarding study design and conclusions that reach beyond the scope of this column, ultimately their findings (that there is no therapeutic benefit to surgically removing clinically normal lymph nodes) has become largely accepted. The subsequent findings of the Laparoscopic Approach to Cancer of the Endometrium (LACE) trial further support this, as there was no difference in survival found between patients who were randomly assigned to laparoscopic versus open staging for endometrial cancer, even despite a significantly lower rate of lymphadenectomy among the laparoscopic arm.7
SLN biopsy, in which the specific nodes which drain the uterus are selectively removed, represents the most recent development in lymph node assessment for endometrial cancer. On average, only three lymph nodes are removed per patient, and para-aortic nodes infrequently are removed, because it is rare that lymphatic pathways drain directly into the aortic basins after cervical injection. Yet despite this more limited dissection of lymph nodes, especially para-aortic, with SLN biopsy, surgeons still observe similar rates of IIIC disease, compared with full lymphadenectomy, suggesting that the presence or absence of lymphatic metastases still is able to be adequately determined. SLN biopsy misses only 3% of lymphatic disease.8 What is of particular interest to practitioners of the SLN approach is that “atypical” pathways are discovered approximately 20% of the time, and nodes are harvested from locations such as the presacral space or medial to the internal iliac vessels. These nodes are in locations previously overlooked by even the most comprehensive pelvic and para-aortic lymphadenectomy. Therefore, while the para-aortic nodes may not be systematically removed with SLN biopsy, new and arguably more relevant regions are interrogated, which might explain its equivalent diagnostic virtue.
With this evolution in surgical-staging practice, what we have come to recognize is that the role of lymph node assessment is predominantly, if not exclusively, diagnostic. It can help us determine which patients are at risk for distant relapse and therefore candidates for systemic therapy (chemotherapy), versus those whose risk is predominantly of local relapse and can be adequately treated with local therapies alone, such as vaginal radiation. This brings us to the results of GOG 258. If defining the specific and complete extent of lymph node metastases (as if that was ever truly what surgeons were doing) is no longer necessary to guide the prescription and extent of external beam radiation, then lymph node dissection need only inform us of whether or not there are nodal metastases, not specifically the location of those nodal metastases. The prescription of chemotherapy is the same whether the disease is limited to the pelvic nodes or also includes the para-aortic nodes. While GOG 258 discovered more para-aortic failures among the chemotherapy-alone group, suggesting there may be some therapeutic role of radiation in preventing this, it should be noted that these para-aortic relapses did not negatively impact relapse-free survival, and these patients still can presumably be salvaged with external beam radiation to the site of para-aortic relapse.
It would seem logical that the results of GOG 258 further limit the potential role of para-aortic lymphadenectomy in women with clinical stage I disease. Perhaps para-aortic dissection can be limited to women who are at highest risk for isolated para-aortic disease, such as those with deeply invasive high-grade tumors not successfully mapped with the highly targeted sentinel node biopsy technique? Most clinicians look forward to an era in which we no longer rely on crude dissections of disease-free tissue just to prove they are disease free, but instead can utilize more sophisticated diagnostic methods to recognize disseminated disease.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Email her at [email protected].
References
1. N Engl J Med. 2019 Jun 13;380(24):2317-26.
2. Cancer. 1987 Oct 15;60(8 Suppl):2035-41.
3. Gynecol Oncol. 2008;109(1):11-8.
4. Int J Gynecol Cancer. 2019 Mar;29(3):613-21.
5. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16.
6. Lancet. 2009 Jan 10;373(9658):125-36.
7. JAMA. 2017 Mar 28;317(12):1224-33.
8. Lancet Oncol. 2017 Mar;18(3):384-92.
A landmark study of advanced endometrial cancer, GOG 258, was published in the New England Journal of Medicine this summer.1 This clinical trial compared the use of carboplatin and paclitaxel chemotherapy with a combination of chemotherapy with external beam radiation, exploring the notion of “more is better.” The results of the trial revealed that the “more” (chemotherapy with external beam radiation) was no better than chemotherapy alone with respect to overall survival. These results have challenged a creeping dogma in gynecologic oncology, which has seen many providers embrace combination therapy, particularly for patients with stage III (node-positive) endometrial cancer, a group of patients who made up approximately three-quarters of GOG 258’s study population. Many have been left searching for justification of their early adoption of combination therapy before the results of a trial such as this were available. For me it also raised a slightly different question: In the light of these results, what IS the role of para-aortic lymphadenectomy in the staging of endometrial cancers? If radiation to the nodal basins is no longer part of adjuvant therapy, then
It was in the 1980s that the removal of clinically normal para-aortic lymph nodes (those residing between the renal and proximal common iliac vessels) became a part of surgical staging. This practice was endorsed by the International Federation of Gynecology and Obstetrics (FIGO) and the Gynecologic Oncology Group (GOG) surgical committee in response to findings that 11% of women with clinical stage I endometrial cancer had microscopic lymph node metastases which were discovered only with routine pathologic evaluation of these tissues. Among those with pelvic lymph node metastases (stage IIIC disease), approximately one-third also harbored disease in para-aortic nodal regions.2 Among all patients with endometrial cancer, including those with low-grade disease, only a small fraction (approximately 2%) have isolated para-aortic lymph nodes (positive para-aortic nodes, but negative pelvic nodes). However, among patients with deeply invasive higher-grade tumors, the likelihood of discovering isolated para-aortic metastases is higher at approximately 16%.3 Therefore, the dominant pattern of lymph node metastases and lymphatic dissemination of endometrial cancer appears to be via the parametrial channels laterally towards the pelvic basins, and then sequentially to the para-aortic regions. The direct lymphatic pathway to the para-aortic basins from the uterine fundus through the adnexal lymphatics misses the pelvic regions altogether and may seen logical, but actually is observed fairly infrequently.4
Over the subsequent decades, there have been debates and schools of thought regarding what is the optimal degree of lymphatic dissection for endometrial cancer staging. Some advocated for full pelvic and infrarenal para-aortic nodal dissections in all patients, including even those in the lowest risk for metastases. Others advocated for a more limited, inframesenteric para-aortic nodal dissection, although the origins of such a distinction appear to be largely arbitrary. The inferior mesenteric artery is not a physiologic landmark for lymphatic pathways, and approximately half of para-aortic metastases are located above the level of the inferior mesenteric artery. This limited sampling may have been preferred because of relative ease of dissection rather than diagnostic or therapeutic efficacy.
As the population became more obese, making para-aortic nodal dissections less feasible, and laparoscopic staging became accepted as the standard of care in endometrial cancer staging, there was a further push towards limiting the scope of lymphadenectomy. Selective algorithms, such as the so-called “Mayo clinic criteria,” were widely adopted. In this approach, gynecologic oncologists perform full pelvic and infrarenal para-aortic lymphadenectomies but only in the presence of a high-risk uterine feature such as tumor size greater than 2 cm, deep myometrial invasion, or grade 3 histology.3 While this reduced the number of para-aortic dissections being performed, it did not eliminate them, as approximately 40% of patients with endometrial cancer meet at least one of those criteria.
At this same time, we learned something else critical about the benefits, or lack thereof, of lymphadenectomy. Two landmark surgical-staging trials were published in 2009 which randomly assigned women to hysterectomy with lymphadenectomy or hysterectomy alone, and found no survival benefit for lymphadenectomy.5,6 While these trial results initially were met with noisy backlash, particularly from those who had legitimate concerns regarding study design and conclusions that reach beyond the scope of this column, ultimately their findings (that there is no therapeutic benefit to surgically removing clinically normal lymph nodes) has become largely accepted. The subsequent findings of the Laparoscopic Approach to Cancer of the Endometrium (LACE) trial further support this, as there was no difference in survival found between patients who were randomly assigned to laparoscopic versus open staging for endometrial cancer, even despite a significantly lower rate of lymphadenectomy among the laparoscopic arm.7
SLN biopsy, in which the specific nodes which drain the uterus are selectively removed, represents the most recent development in lymph node assessment for endometrial cancer. On average, only three lymph nodes are removed per patient, and para-aortic nodes infrequently are removed, because it is rare that lymphatic pathways drain directly into the aortic basins after cervical injection. Yet despite this more limited dissection of lymph nodes, especially para-aortic, with SLN biopsy, surgeons still observe similar rates of IIIC disease, compared with full lymphadenectomy, suggesting that the presence or absence of lymphatic metastases still is able to be adequately determined. SLN biopsy misses only 3% of lymphatic disease.8 What is of particular interest to practitioners of the SLN approach is that “atypical” pathways are discovered approximately 20% of the time, and nodes are harvested from locations such as the presacral space or medial to the internal iliac vessels. These nodes are in locations previously overlooked by even the most comprehensive pelvic and para-aortic lymphadenectomy. Therefore, while the para-aortic nodes may not be systematically removed with SLN biopsy, new and arguably more relevant regions are interrogated, which might explain its equivalent diagnostic virtue.
With this evolution in surgical-staging practice, what we have come to recognize is that the role of lymph node assessment is predominantly, if not exclusively, diagnostic. It can help us determine which patients are at risk for distant relapse and therefore candidates for systemic therapy (chemotherapy), versus those whose risk is predominantly of local relapse and can be adequately treated with local therapies alone, such as vaginal radiation. This brings us to the results of GOG 258. If defining the specific and complete extent of lymph node metastases (as if that was ever truly what surgeons were doing) is no longer necessary to guide the prescription and extent of external beam radiation, then lymph node dissection need only inform us of whether or not there are nodal metastases, not specifically the location of those nodal metastases. The prescription of chemotherapy is the same whether the disease is limited to the pelvic nodes or also includes the para-aortic nodes. While GOG 258 discovered more para-aortic failures among the chemotherapy-alone group, suggesting there may be some therapeutic role of radiation in preventing this, it should be noted that these para-aortic relapses did not negatively impact relapse-free survival, and these patients still can presumably be salvaged with external beam radiation to the site of para-aortic relapse.
It would seem logical that the results of GOG 258 further limit the potential role of para-aortic lymphadenectomy in women with clinical stage I disease. Perhaps para-aortic dissection can be limited to women who are at highest risk for isolated para-aortic disease, such as those with deeply invasive high-grade tumors not successfully mapped with the highly targeted sentinel node biopsy technique? Most clinicians look forward to an era in which we no longer rely on crude dissections of disease-free tissue just to prove they are disease free, but instead can utilize more sophisticated diagnostic methods to recognize disseminated disease.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Email her at [email protected].
References
1. N Engl J Med. 2019 Jun 13;380(24):2317-26.
2. Cancer. 1987 Oct 15;60(8 Suppl):2035-41.
3. Gynecol Oncol. 2008;109(1):11-8.
4. Int J Gynecol Cancer. 2019 Mar;29(3):613-21.
5. J Natl Cancer Inst. 2008 Dec 3;100(23):1707-16.
6. Lancet. 2009 Jan 10;373(9658):125-36.
7. JAMA. 2017 Mar 28;317(12):1224-33.
8. Lancet Oncol. 2017 Mar;18(3):384-92.
Gynecologic surgeries linked with persistent opioid use
– showing that persistent opioid use can follow such surgeries.
For a study published in Obstetrics & Gynecology, Jason D. Wright, MD, of Columbia University, New York, and colleagues looked at insurance claims data from 729,625 opioid-naive women, median age 44 years, who had undergone a myomectomy; a minimally invasive, vaginal, or abdominal hysterectomy; an open or laparoscopic oophorectomy; endometrial ablation; tubal ligation; or dilation and curettage. The vast majority of subjects, 93%, had commercial health insurance, with the rest enrolled in Medicaid. Women undergoing multiple surgical procedures, with serious comorbidities, or who underwent another surgery within 6 months of the initial one, were excluded from the analysis.
Dr. Wright and colleagues found that 60% of patients in the cohort received an initial opioid prescription in the perioperative period. Additional opioids were then prescribed to 6.8% (P less than .001) of those women between 90 and 180 days after surgery. The rate of additional prescriptions varied by year across the study period, from 2009 to 2016, and declined to 6% by the final year of the study. The rate of further opioid prescriptions varied according to procedure: 4.8% for myomectomy, 6.6% for minimally invasive hysterectomy, 6.7% for abdominal hysterectomy, 6.3% for endometrial ablation, 7% for tubal ligation, and 7.2% for dilation and curettage (P less than .001).
Factors significantly increasing likelihood of a new prescription included younger age and a history of depression, anxiety, or a substance abuse disorder. Also, a higher total dose of opioids initially prescribed, and a greater number of days supplied, were associated with increased risk for an additional prescription.
“These data demonstrate that the rate of new persistent opioid use after common gynecologic procedures is substantial,” Dr. Wright and colleagues wrote in their analysis, noting that prior studies across a wide range of surgeries have shown rates of new persistent opioid use to be between 3% and 8%. “Careful risk assessment of patients preoperatively may be useful to mitigate opioid misuse in high risk populations,” the investigators wrote. “Women with underlying psychosocial disorders, medical comorbidities, or a history of substance use disorder are at particular risk for persistent opioid use and should be prescribed opioids with extra caution.”
Dr. Wright and colleagues’ study “provides powerful data that should cause gynecological surgeons to pause when writing an opioid prescription,” David M. Jaspan, DO, chairman of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Is an opioid the best first line medication for this patient? Would an NSAID work better? Is multimodal medication an option? What are the patient characteristics that may be associated with persistent use?”
Dr. Wright and colleagues noted among the study’s limitations the fact that actual opioid use could not be measured, nor could use of nonopioid painkillers.
Dr. Wright has served as a consultant for Tesaro and Clovis Oncology. Dr. Alfred I. Neugut disclosed relationships with various pharmaceutical firms. Dr. Dawn L. Hershman received a grant from the Breast Cancer Research Foundation/Conquer Cancer Foundation. The remaining coauthors had no relevant financial disclosures.
SOURCE: Wright JD et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003358.
– showing that persistent opioid use can follow such surgeries.
For a study published in Obstetrics & Gynecology, Jason D. Wright, MD, of Columbia University, New York, and colleagues looked at insurance claims data from 729,625 opioid-naive women, median age 44 years, who had undergone a myomectomy; a minimally invasive, vaginal, or abdominal hysterectomy; an open or laparoscopic oophorectomy; endometrial ablation; tubal ligation; or dilation and curettage. The vast majority of subjects, 93%, had commercial health insurance, with the rest enrolled in Medicaid. Women undergoing multiple surgical procedures, with serious comorbidities, or who underwent another surgery within 6 months of the initial one, were excluded from the analysis.
Dr. Wright and colleagues found that 60% of patients in the cohort received an initial opioid prescription in the perioperative period. Additional opioids were then prescribed to 6.8% (P less than .001) of those women between 90 and 180 days after surgery. The rate of additional prescriptions varied by year across the study period, from 2009 to 2016, and declined to 6% by the final year of the study. The rate of further opioid prescriptions varied according to procedure: 4.8% for myomectomy, 6.6% for minimally invasive hysterectomy, 6.7% for abdominal hysterectomy, 6.3% for endometrial ablation, 7% for tubal ligation, and 7.2% for dilation and curettage (P less than .001).
Factors significantly increasing likelihood of a new prescription included younger age and a history of depression, anxiety, or a substance abuse disorder. Also, a higher total dose of opioids initially prescribed, and a greater number of days supplied, were associated with increased risk for an additional prescription.
“These data demonstrate that the rate of new persistent opioid use after common gynecologic procedures is substantial,” Dr. Wright and colleagues wrote in their analysis, noting that prior studies across a wide range of surgeries have shown rates of new persistent opioid use to be between 3% and 8%. “Careful risk assessment of patients preoperatively may be useful to mitigate opioid misuse in high risk populations,” the investigators wrote. “Women with underlying psychosocial disorders, medical comorbidities, or a history of substance use disorder are at particular risk for persistent opioid use and should be prescribed opioids with extra caution.”
Dr. Wright and colleagues’ study “provides powerful data that should cause gynecological surgeons to pause when writing an opioid prescription,” David M. Jaspan, DO, chairman of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Is an opioid the best first line medication for this patient? Would an NSAID work better? Is multimodal medication an option? What are the patient characteristics that may be associated with persistent use?”
Dr. Wright and colleagues noted among the study’s limitations the fact that actual opioid use could not be measured, nor could use of nonopioid painkillers.
Dr. Wright has served as a consultant for Tesaro and Clovis Oncology. Dr. Alfred I. Neugut disclosed relationships with various pharmaceutical firms. Dr. Dawn L. Hershman received a grant from the Breast Cancer Research Foundation/Conquer Cancer Foundation. The remaining coauthors had no relevant financial disclosures.
SOURCE: Wright JD et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003358.
– showing that persistent opioid use can follow such surgeries.
For a study published in Obstetrics & Gynecology, Jason D. Wright, MD, of Columbia University, New York, and colleagues looked at insurance claims data from 729,625 opioid-naive women, median age 44 years, who had undergone a myomectomy; a minimally invasive, vaginal, or abdominal hysterectomy; an open or laparoscopic oophorectomy; endometrial ablation; tubal ligation; or dilation and curettage. The vast majority of subjects, 93%, had commercial health insurance, with the rest enrolled in Medicaid. Women undergoing multiple surgical procedures, with serious comorbidities, or who underwent another surgery within 6 months of the initial one, were excluded from the analysis.
Dr. Wright and colleagues found that 60% of patients in the cohort received an initial opioid prescription in the perioperative period. Additional opioids were then prescribed to 6.8% (P less than .001) of those women between 90 and 180 days after surgery. The rate of additional prescriptions varied by year across the study period, from 2009 to 2016, and declined to 6% by the final year of the study. The rate of further opioid prescriptions varied according to procedure: 4.8% for myomectomy, 6.6% for minimally invasive hysterectomy, 6.7% for abdominal hysterectomy, 6.3% for endometrial ablation, 7% for tubal ligation, and 7.2% for dilation and curettage (P less than .001).
Factors significantly increasing likelihood of a new prescription included younger age and a history of depression, anxiety, or a substance abuse disorder. Also, a higher total dose of opioids initially prescribed, and a greater number of days supplied, were associated with increased risk for an additional prescription.
“These data demonstrate that the rate of new persistent opioid use after common gynecologic procedures is substantial,” Dr. Wright and colleagues wrote in their analysis, noting that prior studies across a wide range of surgeries have shown rates of new persistent opioid use to be between 3% and 8%. “Careful risk assessment of patients preoperatively may be useful to mitigate opioid misuse in high risk populations,” the investigators wrote. “Women with underlying psychosocial disorders, medical comorbidities, or a history of substance use disorder are at particular risk for persistent opioid use and should be prescribed opioids with extra caution.”
Dr. Wright and colleagues’ study “provides powerful data that should cause gynecological surgeons to pause when writing an opioid prescription,” David M. Jaspan, DO, chairman of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Is an opioid the best first line medication for this patient? Would an NSAID work better? Is multimodal medication an option? What are the patient characteristics that may be associated with persistent use?”
Dr. Wright and colleagues noted among the study’s limitations the fact that actual opioid use could not be measured, nor could use of nonopioid painkillers.
Dr. Wright has served as a consultant for Tesaro and Clovis Oncology. Dr. Alfred I. Neugut disclosed relationships with various pharmaceutical firms. Dr. Dawn L. Hershman received a grant from the Breast Cancer Research Foundation/Conquer Cancer Foundation. The remaining coauthors had no relevant financial disclosures.
SOURCE: Wright JD et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003358.
FROM OBSTETRICS & GYNECOLOGY
Cellulitis ranks as top reason for skin-related pediatric inpatient admissions
AUSTIN, TEX. – showed.
“Skin conditions significantly affect pediatric inpatients, and dermatologists ought be accessible for consultation to enhance care and costs,” the study’s first author, Marcus L. Elias, said in an interview prior to the annual meeting of the Society for Pediatric Dermatology.
According to Mr. Elias, who is a 4th-year medical student at Rutgers New Jersey Medical School–Newark, few national studies on skin diseases for pediatric inpatients have been published in the medical literature. Earlier this year, researchers examined inpatient dermatologic conditions in patients aged 18 years and older (J Am Acad Dermatol 2019;80[2]:425-32), but Mr. Elias and associates set out to analyze the burden of inpatient pediatric dermatologic conditions on a national basis. “We wanted to see if the same conditions that were hospitalizing adults were also hospitalizing kids,” he said. “We found that this was indeed the case.”
The researchers queried the National Inpatient Sample database for all cases involving patients aged 18 years and younger during 2001-2013. The search yielded a sample of 16,837,857 patients. From this, the researchers analyzed diagnosis-related groups for dermatologic conditions denoting the principal diagnosis at discharge, which left a final sample of 84,090 patients. Frequency and chi-squared tests were used to analyze categorical variables.
More than half of patients (54%) were male, 36% were white, 48% had Medicaid insurance, and 43% had private insurance. Mr. Elias reported that the median length of stay for patients was 2 days and the median cost of care was $6,289.50 for each case. More than three-quarters of pediatric inpatients with dermatologic diagnoses were treated for “cellulitis” (66,147 cases, or 79%), with most cases involving the legs (16,875 cases, or 20%). Other pediatric inpatients were admitted for “minor skin disorder without complications” (5,458 cases, or 7%), and “minor skin disorder with complications” (2,822 cases, or 3%). A total of 64 patients died during the study period. Of these, 31 cases (50%) involved “skin graft and/or debridement of skin ulcer or cellulitis without complications,” the study found.
“We were surprised that the major cause of mortality for our patients was classified as ‘skin graft and/or debridement of skin ulcer or cellulitis without complications,’ as a similar diagnosis-related groupings exist denoting that complications did arise,” Mr. Elias said. “Still, it is not possible for us to determine if the mortality was from the skin graft/debridement or another cause entirely. It is possible that the procedure was without complications, only to have the patient succumb to an ancillary process.”
He acknowledged certain limitations of the study, including the fact that the function of dermatologic consults for hospitalized patients was not examined. “We also cannot draw conclusions as to whether improved outpatient therapy reduces the need for hospitalization,” he said. Mr. Elias reported having no financial disclosures.
AUSTIN, TEX. – showed.
“Skin conditions significantly affect pediatric inpatients, and dermatologists ought be accessible for consultation to enhance care and costs,” the study’s first author, Marcus L. Elias, said in an interview prior to the annual meeting of the Society for Pediatric Dermatology.
According to Mr. Elias, who is a 4th-year medical student at Rutgers New Jersey Medical School–Newark, few national studies on skin diseases for pediatric inpatients have been published in the medical literature. Earlier this year, researchers examined inpatient dermatologic conditions in patients aged 18 years and older (J Am Acad Dermatol 2019;80[2]:425-32), but Mr. Elias and associates set out to analyze the burden of inpatient pediatric dermatologic conditions on a national basis. “We wanted to see if the same conditions that were hospitalizing adults were also hospitalizing kids,” he said. “We found that this was indeed the case.”
The researchers queried the National Inpatient Sample database for all cases involving patients aged 18 years and younger during 2001-2013. The search yielded a sample of 16,837,857 patients. From this, the researchers analyzed diagnosis-related groups for dermatologic conditions denoting the principal diagnosis at discharge, which left a final sample of 84,090 patients. Frequency and chi-squared tests were used to analyze categorical variables.
More than half of patients (54%) were male, 36% were white, 48% had Medicaid insurance, and 43% had private insurance. Mr. Elias reported that the median length of stay for patients was 2 days and the median cost of care was $6,289.50 for each case. More than three-quarters of pediatric inpatients with dermatologic diagnoses were treated for “cellulitis” (66,147 cases, or 79%), with most cases involving the legs (16,875 cases, or 20%). Other pediatric inpatients were admitted for “minor skin disorder without complications” (5,458 cases, or 7%), and “minor skin disorder with complications” (2,822 cases, or 3%). A total of 64 patients died during the study period. Of these, 31 cases (50%) involved “skin graft and/or debridement of skin ulcer or cellulitis without complications,” the study found.
“We were surprised that the major cause of mortality for our patients was classified as ‘skin graft and/or debridement of skin ulcer or cellulitis without complications,’ as a similar diagnosis-related groupings exist denoting that complications did arise,” Mr. Elias said. “Still, it is not possible for us to determine if the mortality was from the skin graft/debridement or another cause entirely. It is possible that the procedure was without complications, only to have the patient succumb to an ancillary process.”
He acknowledged certain limitations of the study, including the fact that the function of dermatologic consults for hospitalized patients was not examined. “We also cannot draw conclusions as to whether improved outpatient therapy reduces the need for hospitalization,” he said. Mr. Elias reported having no financial disclosures.
AUSTIN, TEX. – showed.
“Skin conditions significantly affect pediatric inpatients, and dermatologists ought be accessible for consultation to enhance care and costs,” the study’s first author, Marcus L. Elias, said in an interview prior to the annual meeting of the Society for Pediatric Dermatology.
According to Mr. Elias, who is a 4th-year medical student at Rutgers New Jersey Medical School–Newark, few national studies on skin diseases for pediatric inpatients have been published in the medical literature. Earlier this year, researchers examined inpatient dermatologic conditions in patients aged 18 years and older (J Am Acad Dermatol 2019;80[2]:425-32), but Mr. Elias and associates set out to analyze the burden of inpatient pediatric dermatologic conditions on a national basis. “We wanted to see if the same conditions that were hospitalizing adults were also hospitalizing kids,” he said. “We found that this was indeed the case.”
The researchers queried the National Inpatient Sample database for all cases involving patients aged 18 years and younger during 2001-2013. The search yielded a sample of 16,837,857 patients. From this, the researchers analyzed diagnosis-related groups for dermatologic conditions denoting the principal diagnosis at discharge, which left a final sample of 84,090 patients. Frequency and chi-squared tests were used to analyze categorical variables.
More than half of patients (54%) were male, 36% were white, 48% had Medicaid insurance, and 43% had private insurance. Mr. Elias reported that the median length of stay for patients was 2 days and the median cost of care was $6,289.50 for each case. More than three-quarters of pediatric inpatients with dermatologic diagnoses were treated for “cellulitis” (66,147 cases, or 79%), with most cases involving the legs (16,875 cases, or 20%). Other pediatric inpatients were admitted for “minor skin disorder without complications” (5,458 cases, or 7%), and “minor skin disorder with complications” (2,822 cases, or 3%). A total of 64 patients died during the study period. Of these, 31 cases (50%) involved “skin graft and/or debridement of skin ulcer or cellulitis without complications,” the study found.
“We were surprised that the major cause of mortality for our patients was classified as ‘skin graft and/or debridement of skin ulcer or cellulitis without complications,’ as a similar diagnosis-related groupings exist denoting that complications did arise,” Mr. Elias said. “Still, it is not possible for us to determine if the mortality was from the skin graft/debridement or another cause entirely. It is possible that the procedure was without complications, only to have the patient succumb to an ancillary process.”
He acknowledged certain limitations of the study, including the fact that the function of dermatologic consults for hospitalized patients was not examined. “We also cannot draw conclusions as to whether improved outpatient therapy reduces the need for hospitalization,” he said. Mr. Elias reported having no financial disclosures.
REPORTING FROM SPD 2019
Key clinical point: Cellulitis is the cause of the majority of skin-related pediatric inpatient admissions in the United States.
Major finding: In all, 79% of pediatric inpatients with dermatologic diagnoses were treated for cellulitis.
Study details: An analysis of data from 84,090 patients younger than age 18 in the National Inpatient Sample.
Disclosures: The researchers reported having no financial disclosures.
Bilateral salpingectomy gains favor for sterilization
NASHVILLE, TENN. –
“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.
For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.
“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.
ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”
“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).
Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”
Dr. Espey reported having no relevant financial disclosures.
NASHVILLE, TENN. –
“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.
For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.
“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.
ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”
“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).
Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”
Dr. Espey reported having no relevant financial disclosures.
NASHVILLE, TENN. –
“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.
For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.
“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.
ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”
“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).
Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”
Dr. Espey reported having no relevant financial disclosures.
EXPERT COMMENTARY FROM ACOG 2019
Single-center study outlines stroke risk, DOAC type in nonvalvular AFib patients
PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.
The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.
A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.
Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.
While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.
Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.
To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.
Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.
Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.
One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.
Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.
SOURCE: Chan F et al. AAN 2019. P1.3-001.
PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.
The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.
A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.
Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.
While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.
Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.
To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.
Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.
Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.
One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.
Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.
SOURCE: Chan F et al. AAN 2019. P1.3-001.
PHILADELPHIA – A disproportionate number of breakthrough strokes were observed among patients receiving rivaroxaban for nonvalvular atrial fibrillation in a stroke unit, according to a small, single-center, retrospective study presented at the annual meeting of the American Academy of Neurology.
The researchers reviewed all patients presenting to a tertiary care stroke unit in Australia from January 2015 to June 2018.
A total of 56 patients (median age was 74 years; 61% were male) had received direct oral anticoagulant (DOAC) therapy and then had an ischemic stroke. Of those patients, 37 (66%) had strokes while receiving the treatment; 14 patients (25%) had a stroke after recently stopping a DOAC, often prior to a medical procedure; and 5 patients (9%) were not adherent to their DOAC regimen.
Of the 37 patients who had strokes during DOAC treatment, 48% were on rivaroxaban, 9% were on dabigatran, and 9% were on apixaban, Fiona Chan, MD, of The Princess Alexandra Hospital, Brisbane, Australia, and coinvestigators reported in a poster presentation.
While these findings need to be replicated in a larger study, they do “raise concern for inadequate stroke prevention within this cohort,” they said.
Moreover, the findings illustrate the importance of bridging anticoagulation prior to procedures, when appropriate, to minimize stroke risk, they added, as 25% of the strokes had occurred in patients who recently stopped the DOACs due to procedures.
To determine which DOAC was most often associated with breakthrough ischemic strokes in patients with nonvalvular atrial fibrillation, the investigators compared the proportion of DOACs prescribed in Australia to the proportion of observed strokes in their cohort.
Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving the treatment (P = .001), the investigators reported.
Conversely, apixaban accounted for about 35% of prescriptions but 14% of the breakthrough strokes (P = .0007), while dabigatran accounted for 14% of prescriptions and 14% of the strokes (P = 0.99), the investigators said in their poster.
One limitation of this retrospective study is that the patient cohort came from a single specialized center, and may not reflect the true incidence of nonvalvular atrial fibrillation across Australia, the researchers noted.
Dr. Chan and coinvestigators reported that they had no relevant financial disclosures.
SOURCE: Chan F et al. AAN 2019. P1.3-001.
REPORTING FROM AAN 2019
Key clinical point: Rivaroxaban was associated with a disproportionate number of breakthrough strokes among patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants at one stroke unit in Australia.
Major finding: Despite accounting for about 51% of Australian DOAC prescriptions, rivaroxaban represented nearly 73% of breakthrough strokes among the patients who had strokes while receiving treatment (P = .001).
Study details: Retrospective study of 56 patients with nonvalvular atrial fibrillation reporting to a tertiary care stroke unit in Australia.
Disclosures: The authors reported no financial disclosures.
Source: Chan F et al. AAN 019. Poster P1.3-001.
Laparoscopic magnetic sphincter augmentation may accrue savings over time
BALTIMORE – because the former procedure is associated with lower medical therapy costs after the procedure.
The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.
“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”
Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.
Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.
In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.
In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.
He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.
During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”
Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.
Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”
Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.
SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
BALTIMORE – because the former procedure is associated with lower medical therapy costs after the procedure.
The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.
“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”
Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.
Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.
In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.
In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.
He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.
During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”
Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.
Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”
Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.
SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
BALTIMORE – because the former procedure is associated with lower medical therapy costs after the procedure.
The finding comes from to a prospective observational study from the Allegheny Health Network in Pittsburgh, reported by Shahin Ayazi, MD, at the annual meeting of the American Society of Gastrointestinal Endoscopic Surgeons.
“Magnetic sphincter augmentation (MSA) results in comparable symptom control, proton-pump inhibitor (PPI) elimination rate, and GERD health-related quality of life and Reflux Symptom Index measures compared to values reported for laparoscopic Nissen fundoplication (LNF) in the literature,” said Dr. Ayazi of the University of Rochester (N.Y.). “Unlike reported values for LNF, the majority of patients after MSA were discharged on the same day of surgery.”
Dr. Ayazi reported on 180 patients who had MSA and 1,131 who had LNF over a 2-year period beginning in September 2015 at Allegheny Health, a network of eight hospitals and related facilities in western Pennsylvania and western New York State. The study analyzed Highmark claims data to calculate costs for 12 months before and after surgery in four categories: total procedure payer cost, payer costs of PPI, disease-related costs, and all medical costs.
Dr. Ayazi noted that many payers have been reluctant to cover the costs of MSA because the device costs around $5,000 on average. “There’s also a paucity of data in the literature in regard to the cost analysis of MSA in the management of reflux disease,” he said, adding that this is the first study that uses payer data to analyze the cost of antireflux surgery.
In this study, MSA costs slightly more up front than LNF ($13,522 vs. $13,388, respectively; P = .02). Per-member/per-month (PMPM) costs in the 12 months before their procedures were higher in the MSA group ($305 vs. $233). After surgery, these costs were significantly lower at $104 for MSA patients versus $126 for LNF patients, Dr. Ayazi said.
In the MSA group, 89% of patients were discharged on the same day as surgery, 90.7% said they were satisfied with the outcome, and 91.8% discontinued PPI therapy, Dr. Ayazi said.
He noted the claims data did not provide access to clinical data, Highmark did not provide information on the etiology of the costs differences, and the follow-up for cost analysis is relatively short-term.
During the discussion, Michel Gagner, MD, of Westmount, Quebec, warned against reading too much into the study because of its short duration and gave the example of experience with the laparoscopic adjustable gastric band. “The 10 years after, when you look at the reoperation, the removal, the conversions, some of the disasters in this area – all this needs to be added to the cost, and then when you looked at this, it was no longer cost effective. So I’m wondering if the same story could happen in the next 10 years. You may find that your conclusions are totally reversed.”
Peter Crookes, MD, of the University of Southern California, Los Angeles, challenged the study’s comparison of procedure cost, noting that the trend is toward same-day discharge after LNF, whereas study patients were hospitalized after LNF. Dr. Ayazi noted that the data presented reported procedure cost, not the hospital stay costs, because Highmark did not provide that data.
Lead researcher Blair Jobe, MD, director of the Esophageal and Lung Institute at Allegheny Health Network, added, “The higher initial cost of a LINX (Ethicon) procedure compared to a Nissen fundoplication is perceived as a drawback by insurers, which can make getting insurance approvals challenging. This study suggests that perception may be short sighted in that insurance plans can provide better care for their GERD patients at a similar cost to laparoscopic Nissen fundoplication when you factor in the greater reductions in medical costs after the procedure.”
Dr. Ayazi has no relevant financial relationships to disclose. Dr. Jobe reported he is a consultant for Ethicon.
SOURCE: Ayazi S et al. SAGES 2019, Session SS04.
REPORTING FROM SAGES 2019
Alternative regimen reduces narcotic use after pelvic reconstructive surgery
TUCSON, ARIZ. – compared with a standard regimen, with no difference in patient satisfaction scores.
The new study extends findings from other surgical procedures to pelvic reconstructive surgery.
“This can limit both inpatient and outpatient narcotic use. It uses oral Toradol on an outpatient basis. It’s totally underutilized. People are afraid of it, people think it causes more bleeding, and maybe there’s a cost issue,” Andrey Petrikovets, MD, a urogynecologist in Los Angeles, said in an interview.
The regimen, which he calls ICE-T, relies in part on 16 tablets of Toradol sent home with the patient – 4 days’ worth. “It’s just 16 tablets, so it’s cheap, and patients do great with it. If you really use Toradol appropriately, especially on an outpatient basis, you can pretty much eliminate outpatient narcotic use,” said Dr. Petrikovets, who presented the work at the annual scientific meeting of the Society of Gynecologic Surgeons.
He believes that ICE-T is a good option for vaginal surgery. It’s a possibility for benign laparoscopic and perhaps robotic surgery, although those applications need to be studied. ICE-T should be avoided in patients with chronic pain, as well as patients with contraindications to any of the regimen’s medications, Dr. Petrikovets said.
According to the protocol, until hospital discharge, patients receive 20 minutes of ice to the perineum every 2 hours, 30 mg IV Toradol every 6 hours, 1,000 mg oral Tylenol every 6 hours, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. The constant pain management is important, said Dr. Petrikovets. “Patients don’t have an opportunity for the pain to get really high,” he said. At-home management includes 1,000 mg oral Tylenol every 6 hours, as needed (pain level 1-5, 60 tablets), and 10 mg Toradol every 6 hours as needed (pain level 6-10, 16 tablets).
The trial was conducted at two centers, where 63 patients were randomized to ICE-T or a standard regimen, which at the hospital included 600 mg ibuprofen every 6 hours as needed for pain levels 1-3, one tablet of Percocet (5/325 mg) every 4-6 hours as needed for pain levels 4-6, two tablets of Percocet for pain levels 7-10, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. At-home management consisted of 600 mg ibuprofen every 6 hours for pain levels 1-5 (60 tablets), and Percocet 5/325 mg every 6 hours for pain levels 6-10 (16 tablets).
Using the visual analog scale, researchers found that the 30 patients in the ICE-T arm of the study had less morning pain (VAS score, 20 mm vs. 40 mm; P = .03), and lower numerical pain score at 96 hours (2 vs. 3; P = .04). During the mornings and at 96 hours, the two groups had similar quality of recovery and satisfaction scores.
Narcotic use, measured as oral morphine equivalents, was significantly lower in the ICE-T arm between exit from the postanesthesia care unit (PACU) and hospital discharge (3 vs. 20; P less than .001) and through PACU all the way to discharge (17 vs. 38; P less than .001); 70% of patients in the ICE-T arm required no narcotics after PACU discharge, compared with 12% in the standard care arm (P less than .001).
At 96 hours, there was no significant difference between the two groups in the number of emergency department visits, percentage who had a bowel movement since surgery, or the number of Percocet/Toradol tablets taken. The ICE-T group took more Tylenol tablets than did the standard group took ibuprofen (11 vs. 6; P = .012).
SOURCE: Petrikovets A et al. SGS 2019, Abstract 07.
TUCSON, ARIZ. – compared with a standard regimen, with no difference in patient satisfaction scores.
The new study extends findings from other surgical procedures to pelvic reconstructive surgery.
“This can limit both inpatient and outpatient narcotic use. It uses oral Toradol on an outpatient basis. It’s totally underutilized. People are afraid of it, people think it causes more bleeding, and maybe there’s a cost issue,” Andrey Petrikovets, MD, a urogynecologist in Los Angeles, said in an interview.
The regimen, which he calls ICE-T, relies in part on 16 tablets of Toradol sent home with the patient – 4 days’ worth. “It’s just 16 tablets, so it’s cheap, and patients do great with it. If you really use Toradol appropriately, especially on an outpatient basis, you can pretty much eliminate outpatient narcotic use,” said Dr. Petrikovets, who presented the work at the annual scientific meeting of the Society of Gynecologic Surgeons.
He believes that ICE-T is a good option for vaginal surgery. It’s a possibility for benign laparoscopic and perhaps robotic surgery, although those applications need to be studied. ICE-T should be avoided in patients with chronic pain, as well as patients with contraindications to any of the regimen’s medications, Dr. Petrikovets said.
According to the protocol, until hospital discharge, patients receive 20 minutes of ice to the perineum every 2 hours, 30 mg IV Toradol every 6 hours, 1,000 mg oral Tylenol every 6 hours, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. The constant pain management is important, said Dr. Petrikovets. “Patients don’t have an opportunity for the pain to get really high,” he said. At-home management includes 1,000 mg oral Tylenol every 6 hours, as needed (pain level 1-5, 60 tablets), and 10 mg Toradol every 6 hours as needed (pain level 6-10, 16 tablets).
The trial was conducted at two centers, where 63 patients were randomized to ICE-T or a standard regimen, which at the hospital included 600 mg ibuprofen every 6 hours as needed for pain levels 1-3, one tablet of Percocet (5/325 mg) every 4-6 hours as needed for pain levels 4-6, two tablets of Percocet for pain levels 7-10, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. At-home management consisted of 600 mg ibuprofen every 6 hours for pain levels 1-5 (60 tablets), and Percocet 5/325 mg every 6 hours for pain levels 6-10 (16 tablets).
Using the visual analog scale, researchers found that the 30 patients in the ICE-T arm of the study had less morning pain (VAS score, 20 mm vs. 40 mm; P = .03), and lower numerical pain score at 96 hours (2 vs. 3; P = .04). During the mornings and at 96 hours, the two groups had similar quality of recovery and satisfaction scores.
Narcotic use, measured as oral morphine equivalents, was significantly lower in the ICE-T arm between exit from the postanesthesia care unit (PACU) and hospital discharge (3 vs. 20; P less than .001) and through PACU all the way to discharge (17 vs. 38; P less than .001); 70% of patients in the ICE-T arm required no narcotics after PACU discharge, compared with 12% in the standard care arm (P less than .001).
At 96 hours, there was no significant difference between the two groups in the number of emergency department visits, percentage who had a bowel movement since surgery, or the number of Percocet/Toradol tablets taken. The ICE-T group took more Tylenol tablets than did the standard group took ibuprofen (11 vs. 6; P = .012).
SOURCE: Petrikovets A et al. SGS 2019, Abstract 07.
TUCSON, ARIZ. – compared with a standard regimen, with no difference in patient satisfaction scores.
The new study extends findings from other surgical procedures to pelvic reconstructive surgery.
“This can limit both inpatient and outpatient narcotic use. It uses oral Toradol on an outpatient basis. It’s totally underutilized. People are afraid of it, people think it causes more bleeding, and maybe there’s a cost issue,” Andrey Petrikovets, MD, a urogynecologist in Los Angeles, said in an interview.
The regimen, which he calls ICE-T, relies in part on 16 tablets of Toradol sent home with the patient – 4 days’ worth. “It’s just 16 tablets, so it’s cheap, and patients do great with it. If you really use Toradol appropriately, especially on an outpatient basis, you can pretty much eliminate outpatient narcotic use,” said Dr. Petrikovets, who presented the work at the annual scientific meeting of the Society of Gynecologic Surgeons.
He believes that ICE-T is a good option for vaginal surgery. It’s a possibility for benign laparoscopic and perhaps robotic surgery, although those applications need to be studied. ICE-T should be avoided in patients with chronic pain, as well as patients with contraindications to any of the regimen’s medications, Dr. Petrikovets said.
According to the protocol, until hospital discharge, patients receive 20 minutes of ice to the perineum every 2 hours, 30 mg IV Toradol every 6 hours, 1,000 mg oral Tylenol every 6 hours, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. The constant pain management is important, said Dr. Petrikovets. “Patients don’t have an opportunity for the pain to get really high,” he said. At-home management includes 1,000 mg oral Tylenol every 6 hours, as needed (pain level 1-5, 60 tablets), and 10 mg Toradol every 6 hours as needed (pain level 6-10, 16 tablets).
The trial was conducted at two centers, where 63 patients were randomized to ICE-T or a standard regimen, which at the hospital included 600 mg ibuprofen every 6 hours as needed for pain levels 1-3, one tablet of Percocet (5/325 mg) every 4-6 hours as needed for pain levels 4-6, two tablets of Percocet for pain levels 7-10, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. At-home management consisted of 600 mg ibuprofen every 6 hours for pain levels 1-5 (60 tablets), and Percocet 5/325 mg every 6 hours for pain levels 6-10 (16 tablets).
Using the visual analog scale, researchers found that the 30 patients in the ICE-T arm of the study had less morning pain (VAS score, 20 mm vs. 40 mm; P = .03), and lower numerical pain score at 96 hours (2 vs. 3; P = .04). During the mornings and at 96 hours, the two groups had similar quality of recovery and satisfaction scores.
Narcotic use, measured as oral morphine equivalents, was significantly lower in the ICE-T arm between exit from the postanesthesia care unit (PACU) and hospital discharge (3 vs. 20; P less than .001) and through PACU all the way to discharge (17 vs. 38; P less than .001); 70% of patients in the ICE-T arm required no narcotics after PACU discharge, compared with 12% in the standard care arm (P less than .001).
At 96 hours, there was no significant difference between the two groups in the number of emergency department visits, percentage who had a bowel movement since surgery, or the number of Percocet/Toradol tablets taken. The ICE-T group took more Tylenol tablets than did the standard group took ibuprofen (11 vs. 6; P = .012).
SOURCE: Petrikovets A et al. SGS 2019, Abstract 07.
REPORTING FROM SGS 2019
