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AAGL Global Congress of Minimally Invasive Gynecology 2016
Sonovaginography bests negative ‘sliding sign’ in predicting deep infiltrating endometriosis
ORLANDO – Direct visualization with sonovaginography had greater success in predicting rectal/rectosigmoid deep infiltrating endometriosis than did negative transvaginal ultrasound uterine “sliding sign,” according to the findings of a prospective study of 189 women.
“Both performed quite well,” but sonovaginography was superior for predicting rectal deep infiltrating endometriosis on all measures, including accuracy – 92% vs. 88%, said Bassem Gerges, MBBS, an ob.gyn. at the University of Sydney, Kingswood.
Dr. Gerges and his colleagues evaluated 189 women of reproductive age who were scheduled for operative laparoscopy at a tertiary referral center for women. The patients had a history of chronic pelvic pain and/or endometriosis and presented between 2009 and 2013.
The women first had transvaginal ultrasound to determine if their uterine sliding sign was positive or negative, followed by sonovaginography to assess the posterior pelvic compartment for rectal or rectosigmoid deep infiltrating endometriosis. All patients then underwent laparoscopic surgery for endometriosis.
Laparoscopy revealed pouch of Douglas obliteration in 47 of the 189 women and rectal and/or rectosigmoid deep infiltrating endometriosis in 43 women.
The sensitivity of sonovaginography to predict deep infiltrating endometriosis was 88%, compared with 74% for the sliding-sign approach. Specificity was the same with the two methods at 93%. The positive predictive value was 79% vs. 74%, respectively, and the negative predictive value was 97% vs. 93%.
“These findings can help clinicians with preoperative planning,” Dr. Gerges said at the meeting, which was sponsored by AAGL.
Dr. Gerges and his colleagues also identified 11 false-negative cases in which the sliding sign was positive but laparoscopy confirmed rectal deep infiltrating endometriosis.
Previous research suggests that, in women with suspected endometriosis, a negative transvaginal ultrasound uterine sliding sign can predict rectal or rectosigmoid deep infiltrating endometriosis (Ultrasound Obstet Gynecol. 2013;41[6]:692-5, J Ultrasound Med. 2014;33:315-21). A negative sliding sign indicates the presence of uterorectal adhesions and whether the pouch of Douglas might be obliterated. The current study, however, suggested that sonovaginography might be the better method.
Dr. Gerges reported having no relevant financial disclosures.
ORLANDO – Direct visualization with sonovaginography had greater success in predicting rectal/rectosigmoid deep infiltrating endometriosis than did negative transvaginal ultrasound uterine “sliding sign,” according to the findings of a prospective study of 189 women.
“Both performed quite well,” but sonovaginography was superior for predicting rectal deep infiltrating endometriosis on all measures, including accuracy – 92% vs. 88%, said Bassem Gerges, MBBS, an ob.gyn. at the University of Sydney, Kingswood.
Dr. Gerges and his colleagues evaluated 189 women of reproductive age who were scheduled for operative laparoscopy at a tertiary referral center for women. The patients had a history of chronic pelvic pain and/or endometriosis and presented between 2009 and 2013.
The women first had transvaginal ultrasound to determine if their uterine sliding sign was positive or negative, followed by sonovaginography to assess the posterior pelvic compartment for rectal or rectosigmoid deep infiltrating endometriosis. All patients then underwent laparoscopic surgery for endometriosis.
Laparoscopy revealed pouch of Douglas obliteration in 47 of the 189 women and rectal and/or rectosigmoid deep infiltrating endometriosis in 43 women.
The sensitivity of sonovaginography to predict deep infiltrating endometriosis was 88%, compared with 74% for the sliding-sign approach. Specificity was the same with the two methods at 93%. The positive predictive value was 79% vs. 74%, respectively, and the negative predictive value was 97% vs. 93%.
“These findings can help clinicians with preoperative planning,” Dr. Gerges said at the meeting, which was sponsored by AAGL.
Dr. Gerges and his colleagues also identified 11 false-negative cases in which the sliding sign was positive but laparoscopy confirmed rectal deep infiltrating endometriosis.
Previous research suggests that, in women with suspected endometriosis, a negative transvaginal ultrasound uterine sliding sign can predict rectal or rectosigmoid deep infiltrating endometriosis (Ultrasound Obstet Gynecol. 2013;41[6]:692-5, J Ultrasound Med. 2014;33:315-21). A negative sliding sign indicates the presence of uterorectal adhesions and whether the pouch of Douglas might be obliterated. The current study, however, suggested that sonovaginography might be the better method.
Dr. Gerges reported having no relevant financial disclosures.
ORLANDO – Direct visualization with sonovaginography had greater success in predicting rectal/rectosigmoid deep infiltrating endometriosis than did negative transvaginal ultrasound uterine “sliding sign,” according to the findings of a prospective study of 189 women.
“Both performed quite well,” but sonovaginography was superior for predicting rectal deep infiltrating endometriosis on all measures, including accuracy – 92% vs. 88%, said Bassem Gerges, MBBS, an ob.gyn. at the University of Sydney, Kingswood.
Dr. Gerges and his colleagues evaluated 189 women of reproductive age who were scheduled for operative laparoscopy at a tertiary referral center for women. The patients had a history of chronic pelvic pain and/or endometriosis and presented between 2009 and 2013.
The women first had transvaginal ultrasound to determine if their uterine sliding sign was positive or negative, followed by sonovaginography to assess the posterior pelvic compartment for rectal or rectosigmoid deep infiltrating endometriosis. All patients then underwent laparoscopic surgery for endometriosis.
Laparoscopy revealed pouch of Douglas obliteration in 47 of the 189 women and rectal and/or rectosigmoid deep infiltrating endometriosis in 43 women.
The sensitivity of sonovaginography to predict deep infiltrating endometriosis was 88%, compared with 74% for the sliding-sign approach. Specificity was the same with the two methods at 93%. The positive predictive value was 79% vs. 74%, respectively, and the negative predictive value was 97% vs. 93%.
“These findings can help clinicians with preoperative planning,” Dr. Gerges said at the meeting, which was sponsored by AAGL.
Dr. Gerges and his colleagues also identified 11 false-negative cases in which the sliding sign was positive but laparoscopy confirmed rectal deep infiltrating endometriosis.
Previous research suggests that, in women with suspected endometriosis, a negative transvaginal ultrasound uterine sliding sign can predict rectal or rectosigmoid deep infiltrating endometriosis (Ultrasound Obstet Gynecol. 2013;41[6]:692-5, J Ultrasound Med. 2014;33:315-21). A negative sliding sign indicates the presence of uterorectal adhesions and whether the pouch of Douglas might be obliterated. The current study, however, suggested that sonovaginography might be the better method.
Dr. Gerges reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Plasma energy ablation yields pregnancy rates similar to cystectomy
ORLANDO – The first study to directly compare plasma energy treatment of ovarian endometriomas to cystectomy demonstrates similar postintervention pregnancy rates, suggesting that plasma energy ablation may be a comparable treatment option.
Researchers evaluated 104 women seeking pregnancy after 1 year or more of infertility. Women presented with unilateral or bilateral ovarian endometriomas larger than 3 cm between January 2009 and June 2014. Clinicians treated 64 patients with plasma energy ablation and another 40 with cystectomy and followed them to compare pregnancy rates.
After at least 1 year of follow-up, pregnancy rates were 68% following plasma energy ablation, compared with 80% after cystectomy. Of the 76 pregnancies, 24 were due to spontaneous conception, including 40% of pregnancies in the plasma energy group and 18% in the cystectomy group. Even after adjustment for multiple factors, the type of intervention had no statistically significant impact on achieving a subsequent pregnancy.
“Ablation using plasma energy may be considered a valuable tool that allows a high pregnancy rate,” Basma Darwish, MD, an ob.gyn. at Rouen (France) University Hospital, said at the meeting, which was sponsored by AAGL.
These similar outcomes were observed despite a higher prevalence of risk predictors for infertility in the plasma energy group at baseline. For instance, women in this cohort were significantly older and had significantly higher revised American Fertility Society (rAFS) classification scores, as well as higher rates of pouch of Douglas obliteration, deep endometriosis, and colorectal localizations.
“Endometrial ablation using plasma energy allows good postoperative [pregnancy] rates, that is well known,” Dr. Darwish said, but the technique has not been directly compared with cystectomy outcomes.
Pregnancy rates remained similar in both groups at 24 and 36 months. The probability of pregnancy was 61% in the plasma energy group versus 69% in the cystectomy group at 24 months. At 36 months, these rates changed to 84% and 78%, respectively.
A unique property of plasma energy ablation is “very limited thermal spread, both in depth and laterally,” Dr. Darwish said.
A lack of randomization is a potential limitation of the study. “Each surgeon chose the technique he or she was best at, which may have explained our good outcomes.” Dr. Darwish said. Strengths of the study include a prospective design and follow-up to 5 years. In addition, the six centers involved in the study included both private and public hospitals, “so it’s a good reflection of what happens in real life.”
The investigators plan to conduct a randomized controlled trial to confirm these findings.
ORLANDO – The first study to directly compare plasma energy treatment of ovarian endometriomas to cystectomy demonstrates similar postintervention pregnancy rates, suggesting that plasma energy ablation may be a comparable treatment option.
Researchers evaluated 104 women seeking pregnancy after 1 year or more of infertility. Women presented with unilateral or bilateral ovarian endometriomas larger than 3 cm between January 2009 and June 2014. Clinicians treated 64 patients with plasma energy ablation and another 40 with cystectomy and followed them to compare pregnancy rates.
After at least 1 year of follow-up, pregnancy rates were 68% following plasma energy ablation, compared with 80% after cystectomy. Of the 76 pregnancies, 24 were due to spontaneous conception, including 40% of pregnancies in the plasma energy group and 18% in the cystectomy group. Even after adjustment for multiple factors, the type of intervention had no statistically significant impact on achieving a subsequent pregnancy.
“Ablation using plasma energy may be considered a valuable tool that allows a high pregnancy rate,” Basma Darwish, MD, an ob.gyn. at Rouen (France) University Hospital, said at the meeting, which was sponsored by AAGL.
These similar outcomes were observed despite a higher prevalence of risk predictors for infertility in the plasma energy group at baseline. For instance, women in this cohort were significantly older and had significantly higher revised American Fertility Society (rAFS) classification scores, as well as higher rates of pouch of Douglas obliteration, deep endometriosis, and colorectal localizations.
“Endometrial ablation using plasma energy allows good postoperative [pregnancy] rates, that is well known,” Dr. Darwish said, but the technique has not been directly compared with cystectomy outcomes.
Pregnancy rates remained similar in both groups at 24 and 36 months. The probability of pregnancy was 61% in the plasma energy group versus 69% in the cystectomy group at 24 months. At 36 months, these rates changed to 84% and 78%, respectively.
A unique property of plasma energy ablation is “very limited thermal spread, both in depth and laterally,” Dr. Darwish said.
A lack of randomization is a potential limitation of the study. “Each surgeon chose the technique he or she was best at, which may have explained our good outcomes.” Dr. Darwish said. Strengths of the study include a prospective design and follow-up to 5 years. In addition, the six centers involved in the study included both private and public hospitals, “so it’s a good reflection of what happens in real life.”
The investigators plan to conduct a randomized controlled trial to confirm these findings.
ORLANDO – The first study to directly compare plasma energy treatment of ovarian endometriomas to cystectomy demonstrates similar postintervention pregnancy rates, suggesting that plasma energy ablation may be a comparable treatment option.
Researchers evaluated 104 women seeking pregnancy after 1 year or more of infertility. Women presented with unilateral or bilateral ovarian endometriomas larger than 3 cm between January 2009 and June 2014. Clinicians treated 64 patients with plasma energy ablation and another 40 with cystectomy and followed them to compare pregnancy rates.
After at least 1 year of follow-up, pregnancy rates were 68% following plasma energy ablation, compared with 80% after cystectomy. Of the 76 pregnancies, 24 were due to spontaneous conception, including 40% of pregnancies in the plasma energy group and 18% in the cystectomy group. Even after adjustment for multiple factors, the type of intervention had no statistically significant impact on achieving a subsequent pregnancy.
“Ablation using plasma energy may be considered a valuable tool that allows a high pregnancy rate,” Basma Darwish, MD, an ob.gyn. at Rouen (France) University Hospital, said at the meeting, which was sponsored by AAGL.
These similar outcomes were observed despite a higher prevalence of risk predictors for infertility in the plasma energy group at baseline. For instance, women in this cohort were significantly older and had significantly higher revised American Fertility Society (rAFS) classification scores, as well as higher rates of pouch of Douglas obliteration, deep endometriosis, and colorectal localizations.
“Endometrial ablation using plasma energy allows good postoperative [pregnancy] rates, that is well known,” Dr. Darwish said, but the technique has not been directly compared with cystectomy outcomes.
Pregnancy rates remained similar in both groups at 24 and 36 months. The probability of pregnancy was 61% in the plasma energy group versus 69% in the cystectomy group at 24 months. At 36 months, these rates changed to 84% and 78%, respectively.
A unique property of plasma energy ablation is “very limited thermal spread, both in depth and laterally,” Dr. Darwish said.
A lack of randomization is a potential limitation of the study. “Each surgeon chose the technique he or she was best at, which may have explained our good outcomes.” Dr. Darwish said. Strengths of the study include a prospective design and follow-up to 5 years. In addition, the six centers involved in the study included both private and public hospitals, “so it’s a good reflection of what happens in real life.”
The investigators plan to conduct a randomized controlled trial to confirm these findings.
AT THE AAGL GLOBAL CONGRESS
Narrow band imaging could expand endometriosis detection
ORLANDO – Narrow band imaging detects neovascularization associated with endometriosis and can be a useful adjunct to laparoscopic white light evaluation, a prospective cohort trial of 53 women with pelvic pain suggested.
The women in the study had no deep infiltrating endometriosis on preoperative ultrasound. Investigators then conducted a standard laparoscopic survey of the pelvis with white light to identify areas of suspected superficial endometriosis, followed by secondary analysis with narrow band imaging.
In the group of 32 patients, follow-up biopsy results confirmed endometriosis in 24 women, including 7 who also had lesions detected by narrow band imaging. Six of these seven were positive for endometriosis on histology. The women were enrolled in the study from September 2014 to October 2015.
“We found that the [narrow band imaging] is useful in detecting additional areas in patients who had histopathology-proven endometriosis,” said Tony J. Ma, MBBS, a fellow at Mercy Hospital for Women in Melbourne.
In the group of 21 women with no white light lesions, narrow band imaging detected four suspicious lesions. However, these four were not positive for endometriosis.
Narrow band imaging is a mixture of blue and green light, opposite of red color. “It causes blood vessels to be more visually prominent,” Dr. Ma said at the meeting sponsored by AAGL. White light laparoscopy for detection of endometriosis “is the gold standard … but depends on experience of [the] surgeon and severity of the disease.”
These findings support those of a 2008 study that reported a high detection rate of lesions with narrow band imaging, Dr. Ma said. In this earlier prospective cohort study of 20 women, 7 patients with endometriosis who had been ruled out by white light evaluation had a positive histologic finding with narrow band imaging (J Minim Invasive Gynecol. 2008 Sep-Oct;15[5]:636-9).
“Narrow band imaging is a simple, noninvasive adjunct that can assist in the identification of additional sites of endometriosis at laparoscopy,” Dr. Ma said. “The shortened depth of field with narrow band imaging requires the operator to inspect the surface quite closely.”
The study topic is an important one because endometriosis is such a challenge to diagnose and treat, said study discussant Sawsan As-Sanie, MD, a minimally invasive gynecologic surgeon at the University of Michigan, Ann Arbor. She estimated that with the current approach – visualization by white light followed by histopathology – “about 50%-70% of patients we think have endometriosis ultimately do.”
But several unanswered questions remain, Dr. As-Sanie said, such as whether the narrow band imaging findings are clinically relevant and whether they will lead to improved patient outcomes.
“We don’t know the answer yet,” she said. “The end game is really only relevant if we improve patient outcomes.”
Dr. Ma reported having no relevant financial disclosures.
ORLANDO – Narrow band imaging detects neovascularization associated with endometriosis and can be a useful adjunct to laparoscopic white light evaluation, a prospective cohort trial of 53 women with pelvic pain suggested.
The women in the study had no deep infiltrating endometriosis on preoperative ultrasound. Investigators then conducted a standard laparoscopic survey of the pelvis with white light to identify areas of suspected superficial endometriosis, followed by secondary analysis with narrow band imaging.
In the group of 32 patients, follow-up biopsy results confirmed endometriosis in 24 women, including 7 who also had lesions detected by narrow band imaging. Six of these seven were positive for endometriosis on histology. The women were enrolled in the study from September 2014 to October 2015.
“We found that the [narrow band imaging] is useful in detecting additional areas in patients who had histopathology-proven endometriosis,” said Tony J. Ma, MBBS, a fellow at Mercy Hospital for Women in Melbourne.
In the group of 21 women with no white light lesions, narrow band imaging detected four suspicious lesions. However, these four were not positive for endometriosis.
Narrow band imaging is a mixture of blue and green light, opposite of red color. “It causes blood vessels to be more visually prominent,” Dr. Ma said at the meeting sponsored by AAGL. White light laparoscopy for detection of endometriosis “is the gold standard … but depends on experience of [the] surgeon and severity of the disease.”
These findings support those of a 2008 study that reported a high detection rate of lesions with narrow band imaging, Dr. Ma said. In this earlier prospective cohort study of 20 women, 7 patients with endometriosis who had been ruled out by white light evaluation had a positive histologic finding with narrow band imaging (J Minim Invasive Gynecol. 2008 Sep-Oct;15[5]:636-9).
“Narrow band imaging is a simple, noninvasive adjunct that can assist in the identification of additional sites of endometriosis at laparoscopy,” Dr. Ma said. “The shortened depth of field with narrow band imaging requires the operator to inspect the surface quite closely.”
The study topic is an important one because endometriosis is such a challenge to diagnose and treat, said study discussant Sawsan As-Sanie, MD, a minimally invasive gynecologic surgeon at the University of Michigan, Ann Arbor. She estimated that with the current approach – visualization by white light followed by histopathology – “about 50%-70% of patients we think have endometriosis ultimately do.”
But several unanswered questions remain, Dr. As-Sanie said, such as whether the narrow band imaging findings are clinically relevant and whether they will lead to improved patient outcomes.
“We don’t know the answer yet,” she said. “The end game is really only relevant if we improve patient outcomes.”
Dr. Ma reported having no relevant financial disclosures.
ORLANDO – Narrow band imaging detects neovascularization associated with endometriosis and can be a useful adjunct to laparoscopic white light evaluation, a prospective cohort trial of 53 women with pelvic pain suggested.
The women in the study had no deep infiltrating endometriosis on preoperative ultrasound. Investigators then conducted a standard laparoscopic survey of the pelvis with white light to identify areas of suspected superficial endometriosis, followed by secondary analysis with narrow band imaging.
In the group of 32 patients, follow-up biopsy results confirmed endometriosis in 24 women, including 7 who also had lesions detected by narrow band imaging. Six of these seven were positive for endometriosis on histology. The women were enrolled in the study from September 2014 to October 2015.
“We found that the [narrow band imaging] is useful in detecting additional areas in patients who had histopathology-proven endometriosis,” said Tony J. Ma, MBBS, a fellow at Mercy Hospital for Women in Melbourne.
In the group of 21 women with no white light lesions, narrow band imaging detected four suspicious lesions. However, these four were not positive for endometriosis.
Narrow band imaging is a mixture of blue and green light, opposite of red color. “It causes blood vessels to be more visually prominent,” Dr. Ma said at the meeting sponsored by AAGL. White light laparoscopy for detection of endometriosis “is the gold standard … but depends on experience of [the] surgeon and severity of the disease.”
These findings support those of a 2008 study that reported a high detection rate of lesions with narrow band imaging, Dr. Ma said. In this earlier prospective cohort study of 20 women, 7 patients with endometriosis who had been ruled out by white light evaluation had a positive histologic finding with narrow band imaging (J Minim Invasive Gynecol. 2008 Sep-Oct;15[5]:636-9).
“Narrow band imaging is a simple, noninvasive adjunct that can assist in the identification of additional sites of endometriosis at laparoscopy,” Dr. Ma said. “The shortened depth of field with narrow band imaging requires the operator to inspect the surface quite closely.”
The study topic is an important one because endometriosis is such a challenge to diagnose and treat, said study discussant Sawsan As-Sanie, MD, a minimally invasive gynecologic surgeon at the University of Michigan, Ann Arbor. She estimated that with the current approach – visualization by white light followed by histopathology – “about 50%-70% of patients we think have endometriosis ultimately do.”
But several unanswered questions remain, Dr. As-Sanie said, such as whether the narrow band imaging findings are clinically relevant and whether they will lead to improved patient outcomes.
“We don’t know the answer yet,” she said. “The end game is really only relevant if we improve patient outcomes.”
Dr. Ma reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
New-onset pain rare after Essure placement
ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.
Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.
In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.
Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.
Set realistic expectations, take a comprehensive pain history, and reassure women when they report post-Essure placement pain, James Robinson, MD, a minimally invasive gynecologic surgeon at Medstar Washington Hospital in Washington, D.C., advised at the meeting, which was sponsored by AAGL.
Dr. Robinson pointed out that there is no standardized approach to managing women with complaints of pain or guidelines on how best to remove the device. Imaging to confirm proper placement and to rule out other sources of pelvic pain, followed by medical or surgical management as warranted, can be effective strategies.
“There is less science here – it’s more the art of medicine, I think,” he said.
Dr. Robinson filled in as a presenter for one of the study coauthors, John A. Thiel, MD, of the University of Saskatchewan, Saskatoon, who was unable to attend the conference.
The study by Dr. Thiel and his colleagues suggests a thorough examination will typically reveal other reasons for pelvic pain and rules out the Essure device as the cause, Dr. Robinson said. The full findings of the study are published in the Journal of Minimally Invasive Gynecology (2016 Nov-Dec;23[7]:1158-1162).
Does removal help?
In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).
“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.
The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”
Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
The bigger picture
Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.
Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”
Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.
When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.
“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”
ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.
Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.
In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.
Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.
Set realistic expectations, take a comprehensive pain history, and reassure women when they report post-Essure placement pain, James Robinson, MD, a minimally invasive gynecologic surgeon at Medstar Washington Hospital in Washington, D.C., advised at the meeting, which was sponsored by AAGL.
Dr. Robinson pointed out that there is no standardized approach to managing women with complaints of pain or guidelines on how best to remove the device. Imaging to confirm proper placement and to rule out other sources of pelvic pain, followed by medical or surgical management as warranted, can be effective strategies.
“There is less science here – it’s more the art of medicine, I think,” he said.
Dr. Robinson filled in as a presenter for one of the study coauthors, John A. Thiel, MD, of the University of Saskatchewan, Saskatoon, who was unable to attend the conference.
The study by Dr. Thiel and his colleagues suggests a thorough examination will typically reveal other reasons for pelvic pain and rules out the Essure device as the cause, Dr. Robinson said. The full findings of the study are published in the Journal of Minimally Invasive Gynecology (2016 Nov-Dec;23[7]:1158-1162).
Does removal help?
In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).
“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.
The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”
Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
The bigger picture
Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.
Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”
Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.
When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.
“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”
ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.
Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.
In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.
Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.
Set realistic expectations, take a comprehensive pain history, and reassure women when they report post-Essure placement pain, James Robinson, MD, a minimally invasive gynecologic surgeon at Medstar Washington Hospital in Washington, D.C., advised at the meeting, which was sponsored by AAGL.
Dr. Robinson pointed out that there is no standardized approach to managing women with complaints of pain or guidelines on how best to remove the device. Imaging to confirm proper placement and to rule out other sources of pelvic pain, followed by medical or surgical management as warranted, can be effective strategies.
“There is less science here – it’s more the art of medicine, I think,” he said.
Dr. Robinson filled in as a presenter for one of the study coauthors, John A. Thiel, MD, of the University of Saskatchewan, Saskatoon, who was unable to attend the conference.
The study by Dr. Thiel and his colleagues suggests a thorough examination will typically reveal other reasons for pelvic pain and rules out the Essure device as the cause, Dr. Robinson said. The full findings of the study are published in the Journal of Minimally Invasive Gynecology (2016 Nov-Dec;23[7]:1158-1162).
Does removal help?
In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).
“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.
The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”
Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
The bigger picture
Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.
Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”
Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.
When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.
“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”
Key clinical point:
Major finding: Of 1,430 women who had the Essure inserts placed, just 12 had new-onset pain that was found to be related to the device.
Data source: Retrospective cohort study of 1,430 women treated at a tertiary care hospital in Canada.
Disclosures: Dr. Robinson reported having no financial disclosures.
Ultrasound effective in diagnosing occult hernia in women
ORLANDO – Ultrasound appears to be an effective tool in diagnosing occult hernia in women with unexplained chronic pelvic pain, according to a retrospective cohort study of 96 women.
“As gynecologists, we are likely to see those patients with chronic pelvic pain in our clinic before other specialists due to the location of their pain,” said Joelle Aoun, MD, an ob.gyn. in the division of minimally invasive gynecologic surgery at Henry Ford Health System in Detroit. “So it’s very important to recognize women with a high clinical suspicion for occult hernia and evaluate them in order to prevent a delayed diagnosis and prolonged suffering.”
Hernias can be more difficult to diagnose in women than in men, Dr. Aoun said at the meeting sponsored by AAGL, and the literature offers conflicting findings since most hernia studies are conducted in men or with mixed gender cohorts.
Dr. Aoun and her coinvestigators conducted a retrospective cohort study from January 2005 to July 2016, identifying 96 women with chronic pelvic pain and focal inguinal tenderness. Protruding fat or visceral tissue on physical exam or observed visually led clinicians to suspect a hernia. A single sonographer performed the musculoskeletal ultrasound.
Investigators diagnosed an occult hernia in more than half of the patients (51 women) based on the physical exam and ultrasound findings. Diagnoses included inguinal, femoral, Spigelian, and umbilical hernias.
All women with an ultrasound-diagnosed hernia were referred to general surgery. A majority – 69% of women – underwent surgical exploration. The remaining 31% of women who declined tended to have lower pain scores, Dr. Aoun said. Surgeons confirmed the hernia diagnosis in 97% of the women, or 34 out of the 35 women who had consented to surgery.
The group with a hernia was older and more likely to have arthritis, but otherwise did not differ significantly from the nonhernia cohort.
“We believe musculoskeletal ultrasound is valuable as an initial imaging modality due to its high predictive value, low cost, and noninvasiveness,” Dr. Aoun said.
Chronic pelvic pain is not uncommon, affecting approximately 15% of women during their reproductive years often with significant impacts on quality of life, workplace productivity, and health care utilization, Dr. Aoun said. This presentation also accounts for about 10% outpatient gynecology consultations and approximately 40% of laparoscopies in the United States, she added.
Dr. Aoun and her colleagues are planning a subsequent study of all the women who opted not to undergo surgery to determine their follow-up pain profiles based on chart review and phone interviews.
Dr. Aoun reported having no relevant financial disclosures.
ORLANDO – Ultrasound appears to be an effective tool in diagnosing occult hernia in women with unexplained chronic pelvic pain, according to a retrospective cohort study of 96 women.
“As gynecologists, we are likely to see those patients with chronic pelvic pain in our clinic before other specialists due to the location of their pain,” said Joelle Aoun, MD, an ob.gyn. in the division of minimally invasive gynecologic surgery at Henry Ford Health System in Detroit. “So it’s very important to recognize women with a high clinical suspicion for occult hernia and evaluate them in order to prevent a delayed diagnosis and prolonged suffering.”
Hernias can be more difficult to diagnose in women than in men, Dr. Aoun said at the meeting sponsored by AAGL, and the literature offers conflicting findings since most hernia studies are conducted in men or with mixed gender cohorts.
Dr. Aoun and her coinvestigators conducted a retrospective cohort study from January 2005 to July 2016, identifying 96 women with chronic pelvic pain and focal inguinal tenderness. Protruding fat or visceral tissue on physical exam or observed visually led clinicians to suspect a hernia. A single sonographer performed the musculoskeletal ultrasound.
Investigators diagnosed an occult hernia in more than half of the patients (51 women) based on the physical exam and ultrasound findings. Diagnoses included inguinal, femoral, Spigelian, and umbilical hernias.
All women with an ultrasound-diagnosed hernia were referred to general surgery. A majority – 69% of women – underwent surgical exploration. The remaining 31% of women who declined tended to have lower pain scores, Dr. Aoun said. Surgeons confirmed the hernia diagnosis in 97% of the women, or 34 out of the 35 women who had consented to surgery.
The group with a hernia was older and more likely to have arthritis, but otherwise did not differ significantly from the nonhernia cohort.
“We believe musculoskeletal ultrasound is valuable as an initial imaging modality due to its high predictive value, low cost, and noninvasiveness,” Dr. Aoun said.
Chronic pelvic pain is not uncommon, affecting approximately 15% of women during their reproductive years often with significant impacts on quality of life, workplace productivity, and health care utilization, Dr. Aoun said. This presentation also accounts for about 10% outpatient gynecology consultations and approximately 40% of laparoscopies in the United States, she added.
Dr. Aoun and her colleagues are planning a subsequent study of all the women who opted not to undergo surgery to determine their follow-up pain profiles based on chart review and phone interviews.
Dr. Aoun reported having no relevant financial disclosures.
ORLANDO – Ultrasound appears to be an effective tool in diagnosing occult hernia in women with unexplained chronic pelvic pain, according to a retrospective cohort study of 96 women.
“As gynecologists, we are likely to see those patients with chronic pelvic pain in our clinic before other specialists due to the location of their pain,” said Joelle Aoun, MD, an ob.gyn. in the division of minimally invasive gynecologic surgery at Henry Ford Health System in Detroit. “So it’s very important to recognize women with a high clinical suspicion for occult hernia and evaluate them in order to prevent a delayed diagnosis and prolonged suffering.”
Hernias can be more difficult to diagnose in women than in men, Dr. Aoun said at the meeting sponsored by AAGL, and the literature offers conflicting findings since most hernia studies are conducted in men or with mixed gender cohorts.
Dr. Aoun and her coinvestigators conducted a retrospective cohort study from January 2005 to July 2016, identifying 96 women with chronic pelvic pain and focal inguinal tenderness. Protruding fat or visceral tissue on physical exam or observed visually led clinicians to suspect a hernia. A single sonographer performed the musculoskeletal ultrasound.
Investigators diagnosed an occult hernia in more than half of the patients (51 women) based on the physical exam and ultrasound findings. Diagnoses included inguinal, femoral, Spigelian, and umbilical hernias.
All women with an ultrasound-diagnosed hernia were referred to general surgery. A majority – 69% of women – underwent surgical exploration. The remaining 31% of women who declined tended to have lower pain scores, Dr. Aoun said. Surgeons confirmed the hernia diagnosis in 97% of the women, or 34 out of the 35 women who had consented to surgery.
The group with a hernia was older and more likely to have arthritis, but otherwise did not differ significantly from the nonhernia cohort.
“We believe musculoskeletal ultrasound is valuable as an initial imaging modality due to its high predictive value, low cost, and noninvasiveness,” Dr. Aoun said.
Chronic pelvic pain is not uncommon, affecting approximately 15% of women during their reproductive years often with significant impacts on quality of life, workplace productivity, and health care utilization, Dr. Aoun said. This presentation also accounts for about 10% outpatient gynecology consultations and approximately 40% of laparoscopies in the United States, she added.
Dr. Aoun and her colleagues are planning a subsequent study of all the women who opted not to undergo surgery to determine their follow-up pain profiles based on chart review and phone interviews.
Dr. Aoun reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point:
Major finding: About 53% of women with chronic pelvic pain were diagnosed with an occult hernia following physical exam and ultrasound. Surgeons confirmed the hernia diagnosis in 34 out of 35 patients who consented to surgery.
Data source: A retrospective cohort study of 96 women with chronic pelvic pain and focal inguinal tenderness.
Disclosures: Dr. Aoun reported having no relevant financial disclosures.
Survey: More than half of gynecologic oncologists altered morcellation practices
ORLANDO – Following the Food and Drug Administration’s 2014 warning against use of laparoscopic uterine power morcellation, 13% of gynecologic oncologists decreased their use of the technique and another 39% discontinued it altogether, according to survey responses from 199 members of the Society of Gynecologic Oncology.
“This really gives a snapshot about how gynecologic oncologists feel about power morcellation in light of the FDA warning,” said Kerac N. Falk, MD, a resident at the Icahn School of Medicine at Mount Sinai, New York.
About 41% of gynecologic oncologists changed their surgical technique to minimally invasive without power morcellation. Another 20% of respondents who previously used power morcellation have switched to laparotomy.
A more rigorous informed consent process, better attention to patient selection, and enhanced protocols are positive effects emerging since the FDA Safety Communication was issued in April 2014, Dr. Falk said at the meeting sponsored by AAGL.
The 34-item survey included questions about demographics, institutional policies, and attitudes before and after the FDA warning. Among the respondents, 65% were men. Both “early” and “very seasoned” surgeons participated in the survey. The majority of the respondents were moderate- to high-volume surgeons.
Men were significantly more likely to decrease or discontinue use of power morcellation, compared with women (P = .0015). Region of practice, years in practice, or institution type did not significantly influence changes in practice. “Most said it was not a personal choice, but more about patient choice or an institutional policy change,” Dr. Falk said.
There is still a role for power morcellation in carefully selected patients, Dr. Falk added.
In July 2014, AAGL issued a statement in response to the FDA warning, stating that “we should improve but not abandon power morcellation, and that power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.” In addition, the American College of Obstetricians and Gynecologists stated, “Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.”
Dr. Falk is not a coauthor on the study. He presented the findings on behalf of a colleague unable to attend the meeting. Dr. Falk reported having no relevant financial disclosures.
ORLANDO – Following the Food and Drug Administration’s 2014 warning against use of laparoscopic uterine power morcellation, 13% of gynecologic oncologists decreased their use of the technique and another 39% discontinued it altogether, according to survey responses from 199 members of the Society of Gynecologic Oncology.
“This really gives a snapshot about how gynecologic oncologists feel about power morcellation in light of the FDA warning,” said Kerac N. Falk, MD, a resident at the Icahn School of Medicine at Mount Sinai, New York.
About 41% of gynecologic oncologists changed their surgical technique to minimally invasive without power morcellation. Another 20% of respondents who previously used power morcellation have switched to laparotomy.
A more rigorous informed consent process, better attention to patient selection, and enhanced protocols are positive effects emerging since the FDA Safety Communication was issued in April 2014, Dr. Falk said at the meeting sponsored by AAGL.
The 34-item survey included questions about demographics, institutional policies, and attitudes before and after the FDA warning. Among the respondents, 65% were men. Both “early” and “very seasoned” surgeons participated in the survey. The majority of the respondents were moderate- to high-volume surgeons.
Men were significantly more likely to decrease or discontinue use of power morcellation, compared with women (P = .0015). Region of practice, years in practice, or institution type did not significantly influence changes in practice. “Most said it was not a personal choice, but more about patient choice or an institutional policy change,” Dr. Falk said.
There is still a role for power morcellation in carefully selected patients, Dr. Falk added.
In July 2014, AAGL issued a statement in response to the FDA warning, stating that “we should improve but not abandon power morcellation, and that power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.” In addition, the American College of Obstetricians and Gynecologists stated, “Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.”
Dr. Falk is not a coauthor on the study. He presented the findings on behalf of a colleague unable to attend the meeting. Dr. Falk reported having no relevant financial disclosures.
ORLANDO – Following the Food and Drug Administration’s 2014 warning against use of laparoscopic uterine power morcellation, 13% of gynecologic oncologists decreased their use of the technique and another 39% discontinued it altogether, according to survey responses from 199 members of the Society of Gynecologic Oncology.
“This really gives a snapshot about how gynecologic oncologists feel about power morcellation in light of the FDA warning,” said Kerac N. Falk, MD, a resident at the Icahn School of Medicine at Mount Sinai, New York.
About 41% of gynecologic oncologists changed their surgical technique to minimally invasive without power morcellation. Another 20% of respondents who previously used power morcellation have switched to laparotomy.
A more rigorous informed consent process, better attention to patient selection, and enhanced protocols are positive effects emerging since the FDA Safety Communication was issued in April 2014, Dr. Falk said at the meeting sponsored by AAGL.
The 34-item survey included questions about demographics, institutional policies, and attitudes before and after the FDA warning. Among the respondents, 65% were men. Both “early” and “very seasoned” surgeons participated in the survey. The majority of the respondents were moderate- to high-volume surgeons.
Men were significantly more likely to decrease or discontinue use of power morcellation, compared with women (P = .0015). Region of practice, years in practice, or institution type did not significantly influence changes in practice. “Most said it was not a personal choice, but more about patient choice or an institutional policy change,” Dr. Falk said.
There is still a role for power morcellation in carefully selected patients, Dr. Falk added.
In July 2014, AAGL issued a statement in response to the FDA warning, stating that “we should improve but not abandon power morcellation, and that power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.” In addition, the American College of Obstetricians and Gynecologists stated, “Although the worsening of an occult malignancy as a result of power morcellation is, of course, tragic, we believe that an approach that combines deliberate patient selection criteria with robust informed consent will help protect women from a negative outcome, while maintaining access to morcellation for women who would benefit from it.”
Dr. Falk is not a coauthor on the study. He presented the findings on behalf of a colleague unable to attend the meeting. Dr. Falk reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point:
Major finding: Among 199 members of the Society of Gynecologic Oncology, 39% said they suspended use of power morcellation, and 13% decreased their use of the technique.
Data source: A survey sent to all members of the Society of Gynecologic Oncology with responses from 199 members.
Disclosures: Dr. Falk reported having no relevant financial disclosures.
Low rate of occult uterine malignancy with vaginal morcellation
ORLANDO – The Food and Drug Administration’s 2014 warning that laparoscopic power morcellation during hysterectomy or myomectomy could spread unsuspected cancerous tissue had a chilling effect across the specialty, but what about the risks associated with morcellation during vaginal hysterectomy?
“There is only one case of morcellation during vaginal hysterectomy with a leiomyosarcoma recorded in the literature,” Megan N. Wasson, DO, a fellow in minimally invasive gynecologic surgery at the Mayo Clinic in Phoenix said at the meeting sponsored by AAGL. “It is really unclear if vaginal and electromechanical morcellation carry the same inherent risk.”
To find out more, Dr. Wasson and her colleagues identified 2,296 patients who underwent total vaginal hysterectomy at one of three academic medical centers. A total of 611 of these women had uterine removal with uncontained morcellation via cold-knife wedge resection. The investigators assessed this group for incidence of occult malignancy, perioperative outcomes, and long-term survival in a retrospective cohort study.
Of the 611 women who underwent morcellation during the study, five patients had an occult malignancy, for a rate less than one percent, 0.82%. Three patients had a stage IA, grade I endometrial adenocarcinoma, and two patients had a low-grade stromal sarcoma. No patients had a leiomyosarcoma.
This group of five patients had a mean age of 49 years, a mean BMI of 32 kg/m2 and a median parity of two. Abnormal uterine bleeding was the indication for surgery for all five patients with a malignancy. The mean uterine weight was elevated at 231 g. One patient with endometrial adenocarcinoma later underwent pelvic lymphadenectomy and vaginal brachytherapy.
“So far, thankfully, all of these patients show no evidence of disease recurrence,” Dr. Wasson said. All five patients are alive, with a mean disease-free survival of 43 months among those with endometrial adenocarcinoma and 37 months for the low-grade stroma sarcoma patients.
“Overall, the incidence of occult uterine carcinoma at the time of vaginal hysterectomy is less than 1%,” Dr. Wasson said. “Thankfully, it does not appear to have a negative effect on patient outcomes when it occurs.”
More research is needed, however. “The risk is very limited in terms of what we know,” she said. “We investigated cancer in this study, but there is also a risk of dissemination of benign conditions.”
All patients underwent a preoperative evaluation that included sampling of the lining of the uterus and imaging. “Out of the five patients with carcinomas, two of the adenocarcinomas had completely benign preoperative sampling and one had hyperplasia, which unfortunately did develop into occult disease,” Dr. Wasson said. “We wouldn’t recommend morcellating any patient with hyperplasia. In the two patients with low-grade stromal sarcoma, neither had any hyperplasia on preoperative sampling.”
Following the 2014 FDA Safety Communication on power morcellation, the AAGL released its own guidance on morcellation during uterine tissue extraction. The AAGL recommended that clinicians avoid morcellation for any patient who had a premalignant or malignant condition or who was at risk for malignancy, and use caution when considering morcellation. “This was for all types of morcellation, including electromechanical and vaginal morcellation,” Dr. Wasson said.
“This was in response to studies and awareness of increased risk of disease with morcellation – specifically leiomyosarcomas – for dissemination of disease in the abdomen and pelvis, but also for an increased risk of recurrence,” she said. “This means, in turn, that patients can have decreased overall survival and disease-free survival, so this is very important when we are talking to our patients.”
Dr. Wasson reported having no relevant financial disclosures.
ORLANDO – The Food and Drug Administration’s 2014 warning that laparoscopic power morcellation during hysterectomy or myomectomy could spread unsuspected cancerous tissue had a chilling effect across the specialty, but what about the risks associated with morcellation during vaginal hysterectomy?
“There is only one case of morcellation during vaginal hysterectomy with a leiomyosarcoma recorded in the literature,” Megan N. Wasson, DO, a fellow in minimally invasive gynecologic surgery at the Mayo Clinic in Phoenix said at the meeting sponsored by AAGL. “It is really unclear if vaginal and electromechanical morcellation carry the same inherent risk.”
To find out more, Dr. Wasson and her colleagues identified 2,296 patients who underwent total vaginal hysterectomy at one of three academic medical centers. A total of 611 of these women had uterine removal with uncontained morcellation via cold-knife wedge resection. The investigators assessed this group for incidence of occult malignancy, perioperative outcomes, and long-term survival in a retrospective cohort study.
Of the 611 women who underwent morcellation during the study, five patients had an occult malignancy, for a rate less than one percent, 0.82%. Three patients had a stage IA, grade I endometrial adenocarcinoma, and two patients had a low-grade stromal sarcoma. No patients had a leiomyosarcoma.
This group of five patients had a mean age of 49 years, a mean BMI of 32 kg/m2 and a median parity of two. Abnormal uterine bleeding was the indication for surgery for all five patients with a malignancy. The mean uterine weight was elevated at 231 g. One patient with endometrial adenocarcinoma later underwent pelvic lymphadenectomy and vaginal brachytherapy.
“So far, thankfully, all of these patients show no evidence of disease recurrence,” Dr. Wasson said. All five patients are alive, with a mean disease-free survival of 43 months among those with endometrial adenocarcinoma and 37 months for the low-grade stroma sarcoma patients.
“Overall, the incidence of occult uterine carcinoma at the time of vaginal hysterectomy is less than 1%,” Dr. Wasson said. “Thankfully, it does not appear to have a negative effect on patient outcomes when it occurs.”
More research is needed, however. “The risk is very limited in terms of what we know,” she said. “We investigated cancer in this study, but there is also a risk of dissemination of benign conditions.”
All patients underwent a preoperative evaluation that included sampling of the lining of the uterus and imaging. “Out of the five patients with carcinomas, two of the adenocarcinomas had completely benign preoperative sampling and one had hyperplasia, which unfortunately did develop into occult disease,” Dr. Wasson said. “We wouldn’t recommend morcellating any patient with hyperplasia. In the two patients with low-grade stromal sarcoma, neither had any hyperplasia on preoperative sampling.”
Following the 2014 FDA Safety Communication on power morcellation, the AAGL released its own guidance on morcellation during uterine tissue extraction. The AAGL recommended that clinicians avoid morcellation for any patient who had a premalignant or malignant condition or who was at risk for malignancy, and use caution when considering morcellation. “This was for all types of morcellation, including electromechanical and vaginal morcellation,” Dr. Wasson said.
“This was in response to studies and awareness of increased risk of disease with morcellation – specifically leiomyosarcomas – for dissemination of disease in the abdomen and pelvis, but also for an increased risk of recurrence,” she said. “This means, in turn, that patients can have decreased overall survival and disease-free survival, so this is very important when we are talking to our patients.”
Dr. Wasson reported having no relevant financial disclosures.
ORLANDO – The Food and Drug Administration’s 2014 warning that laparoscopic power morcellation during hysterectomy or myomectomy could spread unsuspected cancerous tissue had a chilling effect across the specialty, but what about the risks associated with morcellation during vaginal hysterectomy?
“There is only one case of morcellation during vaginal hysterectomy with a leiomyosarcoma recorded in the literature,” Megan N. Wasson, DO, a fellow in minimally invasive gynecologic surgery at the Mayo Clinic in Phoenix said at the meeting sponsored by AAGL. “It is really unclear if vaginal and electromechanical morcellation carry the same inherent risk.”
To find out more, Dr. Wasson and her colleagues identified 2,296 patients who underwent total vaginal hysterectomy at one of three academic medical centers. A total of 611 of these women had uterine removal with uncontained morcellation via cold-knife wedge resection. The investigators assessed this group for incidence of occult malignancy, perioperative outcomes, and long-term survival in a retrospective cohort study.
Of the 611 women who underwent morcellation during the study, five patients had an occult malignancy, for a rate less than one percent, 0.82%. Three patients had a stage IA, grade I endometrial adenocarcinoma, and two patients had a low-grade stromal sarcoma. No patients had a leiomyosarcoma.
This group of five patients had a mean age of 49 years, a mean BMI of 32 kg/m2 and a median parity of two. Abnormal uterine bleeding was the indication for surgery for all five patients with a malignancy. The mean uterine weight was elevated at 231 g. One patient with endometrial adenocarcinoma later underwent pelvic lymphadenectomy and vaginal brachytherapy.
“So far, thankfully, all of these patients show no evidence of disease recurrence,” Dr. Wasson said. All five patients are alive, with a mean disease-free survival of 43 months among those with endometrial adenocarcinoma and 37 months for the low-grade stroma sarcoma patients.
“Overall, the incidence of occult uterine carcinoma at the time of vaginal hysterectomy is less than 1%,” Dr. Wasson said. “Thankfully, it does not appear to have a negative effect on patient outcomes when it occurs.”
More research is needed, however. “The risk is very limited in terms of what we know,” she said. “We investigated cancer in this study, but there is also a risk of dissemination of benign conditions.”
All patients underwent a preoperative evaluation that included sampling of the lining of the uterus and imaging. “Out of the five patients with carcinomas, two of the adenocarcinomas had completely benign preoperative sampling and one had hyperplasia, which unfortunately did develop into occult disease,” Dr. Wasson said. “We wouldn’t recommend morcellating any patient with hyperplasia. In the two patients with low-grade stromal sarcoma, neither had any hyperplasia on preoperative sampling.”
Following the 2014 FDA Safety Communication on power morcellation, the AAGL released its own guidance on morcellation during uterine tissue extraction. The AAGL recommended that clinicians avoid morcellation for any patient who had a premalignant or malignant condition or who was at risk for malignancy, and use caution when considering morcellation. “This was for all types of morcellation, including electromechanical and vaginal morcellation,” Dr. Wasson said.
“This was in response to studies and awareness of increased risk of disease with morcellation – specifically leiomyosarcomas – for dissemination of disease in the abdomen and pelvis, but also for an increased risk of recurrence,” she said. “This means, in turn, that patients can have decreased overall survival and disease-free survival, so this is very important when we are talking to our patients.”
Dr. Wasson reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point:
Major finding: Of 611 patients who underwent morcellation during total vaginal hysterectomy, five patients (0.82%) had occult uterine carcinoma.
Data source: A retrospective cohort study of 611 women who had uterine removal with uncontained morcellation.
Disclosures: Dr. Wasson reported having no relevant financial disclosures.
Long-acting bupivacaine offers limited benefit in hysterectomy pain
ORLANDO – Port site infiltration during laparoscopic or robot-assisted hysterectomy with extended-release liposomal bupivacaine did not significantly improve most postoperative pain scores, compared with plain 0.25% bupivacaine.
In a randomized trial, the liposomal formulation was associated with 30% less pain on postoperative day 3, a significant difference not seen on postoperative day 1, 2, or 14.
“Liposomal bupivacaine is expected to last about 72 hours but it also comes at a cost,” Kenneth I. Barron, MD, a fellow in advanced minimally invasive gynecologic surgery at Florida Hospital Orlando, said at the meeting sponsored by AAGL. Extended-release bupivacaine costs $280, compared with $1.83 for plain bupivacaine, according to Dr. Barron.
“Based on this study, the routine use of liposomal bupivacaine as a port site local anesthetic in laparoscopic hysterectomy has limited usefulness and is not justified,” he said.
In the blinded study, surgeons at a tertiary-care community hospital performed pre-incision infiltration with undiluted liposomal extended-release bupivacaine for 32 surgery patients and with the short-acting formulation for another 32 surgery patients. All patients underwent either laparoscopic or robot-assisted total hysterectomy for benign indications. They were recruited for the study between July 2015 and January 2016 and there were no significant demographic differences between groups preoperatively.
For the primary outcome measure, investigators called each participant and asked them to rate their average overall pain on postoperative days 1, 2, 3, and 14. They used the Brief Pain Inventory 0-10 scale. There were no significant differences between groups on a composite score of their average and worst pain on days 1, 2, or 14. However, on day 3, the composite score was 3.26 in the extended-release group, compared with 4.83 for those receiving short-acting bupivacaine (P = .009).
“What this shows, if anything, is one method of local anesthetic is probably not enough to make a significant impact,” Dr. Barron said. What is needed instead is “probably more of a global approach to enhance recovery.”
There were no significant differences between groups in the secondary study outcomes: pain scores during the first 24 hours in the hospital, function based on pain interference scores, opioid use, or adverse events.
Dr. Barron reported having no relevant financial disclosures.
ORLANDO – Port site infiltration during laparoscopic or robot-assisted hysterectomy with extended-release liposomal bupivacaine did not significantly improve most postoperative pain scores, compared with plain 0.25% bupivacaine.
In a randomized trial, the liposomal formulation was associated with 30% less pain on postoperative day 3, a significant difference not seen on postoperative day 1, 2, or 14.
“Liposomal bupivacaine is expected to last about 72 hours but it also comes at a cost,” Kenneth I. Barron, MD, a fellow in advanced minimally invasive gynecologic surgery at Florida Hospital Orlando, said at the meeting sponsored by AAGL. Extended-release bupivacaine costs $280, compared with $1.83 for plain bupivacaine, according to Dr. Barron.
“Based on this study, the routine use of liposomal bupivacaine as a port site local anesthetic in laparoscopic hysterectomy has limited usefulness and is not justified,” he said.
In the blinded study, surgeons at a tertiary-care community hospital performed pre-incision infiltration with undiluted liposomal extended-release bupivacaine for 32 surgery patients and with the short-acting formulation for another 32 surgery patients. All patients underwent either laparoscopic or robot-assisted total hysterectomy for benign indications. They were recruited for the study between July 2015 and January 2016 and there were no significant demographic differences between groups preoperatively.
For the primary outcome measure, investigators called each participant and asked them to rate their average overall pain on postoperative days 1, 2, 3, and 14. They used the Brief Pain Inventory 0-10 scale. There were no significant differences between groups on a composite score of their average and worst pain on days 1, 2, or 14. However, on day 3, the composite score was 3.26 in the extended-release group, compared with 4.83 for those receiving short-acting bupivacaine (P = .009).
“What this shows, if anything, is one method of local anesthetic is probably not enough to make a significant impact,” Dr. Barron said. What is needed instead is “probably more of a global approach to enhance recovery.”
There were no significant differences between groups in the secondary study outcomes: pain scores during the first 24 hours in the hospital, function based on pain interference scores, opioid use, or adverse events.
Dr. Barron reported having no relevant financial disclosures.
ORLANDO – Port site infiltration during laparoscopic or robot-assisted hysterectomy with extended-release liposomal bupivacaine did not significantly improve most postoperative pain scores, compared with plain 0.25% bupivacaine.
In a randomized trial, the liposomal formulation was associated with 30% less pain on postoperative day 3, a significant difference not seen on postoperative day 1, 2, or 14.
“Liposomal bupivacaine is expected to last about 72 hours but it also comes at a cost,” Kenneth I. Barron, MD, a fellow in advanced minimally invasive gynecologic surgery at Florida Hospital Orlando, said at the meeting sponsored by AAGL. Extended-release bupivacaine costs $280, compared with $1.83 for plain bupivacaine, according to Dr. Barron.
“Based on this study, the routine use of liposomal bupivacaine as a port site local anesthetic in laparoscopic hysterectomy has limited usefulness and is not justified,” he said.
In the blinded study, surgeons at a tertiary-care community hospital performed pre-incision infiltration with undiluted liposomal extended-release bupivacaine for 32 surgery patients and with the short-acting formulation for another 32 surgery patients. All patients underwent either laparoscopic or robot-assisted total hysterectomy for benign indications. They were recruited for the study between July 2015 and January 2016 and there were no significant demographic differences between groups preoperatively.
For the primary outcome measure, investigators called each participant and asked them to rate their average overall pain on postoperative days 1, 2, 3, and 14. They used the Brief Pain Inventory 0-10 scale. There were no significant differences between groups on a composite score of their average and worst pain on days 1, 2, or 14. However, on day 3, the composite score was 3.26 in the extended-release group, compared with 4.83 for those receiving short-acting bupivacaine (P = .009).
“What this shows, if anything, is one method of local anesthetic is probably not enough to make a significant impact,” Dr. Barron said. What is needed instead is “probably more of a global approach to enhance recovery.”
There were no significant differences between groups in the secondary study outcomes: pain scores during the first 24 hours in the hospital, function based on pain interference scores, opioid use, or adverse events.
Dr. Barron reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Should surgeons change gloves during total laparoscopic hysterectomy?
ORLANDO – Many gynecologic surgeons change gloves, gowns, and even surgical drapes during total laparoscopic hysterectomy to prevent bacterial infections, but little data support the practice.
In a small study of women undergoing total laparoscopic hysterectomy, investigators found that the overall risk of infection from contaminated gowns, gloves, and instruments was very low, with bacterial growth below the infection threshold in 98.9% of samples and no surgical site infections reported during 6 weeks of follow-up after surgery.
“Tradition dictates that even after both fields have been prepped, we refer to the perineum and vagina as ‘dirty,’ and the abdomen as ‘clean,’ ” Dr. Shockley said, “And surgeons habitually change their gown and gloves when inadvertent contact with the perineum or vagina occurs.”
To elucidate the true pathogen picture, Dr. Shockley and her colleagues assessed 31 women undergoing total laparoscopic hysterectomy for a benign indication during 2016. They evaluated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus.
All patients received perioperative antibiotic prophylaxis and standard, separate perineovaginal and abdominal prep with chlorhexidine. Investigators swabbed the vaginal fornices and abdomen at six sites, as well as the surgeon’s gloves following placement of the uterine manipulator, tips of instruments used to close the vaginal cuff, uterine fundus after extraction, and surgeon’s gloves following removal of the uterus.
They detected no anaerobic bacterial growth from samples taken from the abdomen, in the vagina, or on the tips of instruments used for cuff closure. Similarly, there was no aerobic growth observed in the vagina of any patient. However, they did detect aerobic bacterial growth in the abdomen, which in all cases was consistent with skin flora.
Three patients demonstrated some growth with the surgeon’s gloves following manipulator placement. Nearly one-third – 32% – of surgeon’s gloves cultured bacteria after removal of the uterus. One sample yielded cumulative growth for a bacterial count considered high enough to potentially cause infection, defined as more than 5,000 colony-forming units (CFU) per milliliter. This was the highest growth sample out of the 180 samples collected.
Additionally, 39% of samples from the uterine fundus were positive, a higher percentage than at any other site, Dr. Shockley reported. “And the one sample with growth exceeding 5,000 CFU/mL – you guessed it – was from the same patient.”
Bacterial growth was scant on the instrument tips used to close the vaginal cuffs.
Overall, bacterial growth in 98.9% of samples was below the infection threshold. “We did not identify any post–surgical site infections during 6 weeks of follow-up,” Dr. Shockley said at the meeting sponsored by AAGL.
“This study does provide a good description and count of the bacteria encountered during total laparoscopic hysterectomy. They are unlikely to cause surgical site infections … but based on concentration and frequency of bacterial growth on the surgeon’s gloves after specimen extraction, we would recommend if you are going to change gloves, do it after this step, before turning your attention back to the abdomen for vaginal cuff closure,” she said.
But changing gloves after placing the Foley and uterine manipulator “seems to be a wasted exercise,” Dr. Shockley said. “There was no growth on the vaginal fornices of any patient.”
The bacteria on the gloves in those three cases developed very low colony counts. “Yes, there was growth after the removal of the specimen, but with the exception of one patient, the colony counts were all below 5,000,” she said. “I think we need more data to reassure ourselves [attire changes are] unnecessary at every step of the [total laparoscopic hysterectomy].”
The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.
ORLANDO – Many gynecologic surgeons change gloves, gowns, and even surgical drapes during total laparoscopic hysterectomy to prevent bacterial infections, but little data support the practice.
In a small study of women undergoing total laparoscopic hysterectomy, investigators found that the overall risk of infection from contaminated gowns, gloves, and instruments was very low, with bacterial growth below the infection threshold in 98.9% of samples and no surgical site infections reported during 6 weeks of follow-up after surgery.
“Tradition dictates that even after both fields have been prepped, we refer to the perineum and vagina as ‘dirty,’ and the abdomen as ‘clean,’ ” Dr. Shockley said, “And surgeons habitually change their gown and gloves when inadvertent contact with the perineum or vagina occurs.”
To elucidate the true pathogen picture, Dr. Shockley and her colleagues assessed 31 women undergoing total laparoscopic hysterectomy for a benign indication during 2016. They evaluated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus.
All patients received perioperative antibiotic prophylaxis and standard, separate perineovaginal and abdominal prep with chlorhexidine. Investigators swabbed the vaginal fornices and abdomen at six sites, as well as the surgeon’s gloves following placement of the uterine manipulator, tips of instruments used to close the vaginal cuff, uterine fundus after extraction, and surgeon’s gloves following removal of the uterus.
They detected no anaerobic bacterial growth from samples taken from the abdomen, in the vagina, or on the tips of instruments used for cuff closure. Similarly, there was no aerobic growth observed in the vagina of any patient. However, they did detect aerobic bacterial growth in the abdomen, which in all cases was consistent with skin flora.
Three patients demonstrated some growth with the surgeon’s gloves following manipulator placement. Nearly one-third – 32% – of surgeon’s gloves cultured bacteria after removal of the uterus. One sample yielded cumulative growth for a bacterial count considered high enough to potentially cause infection, defined as more than 5,000 colony-forming units (CFU) per milliliter. This was the highest growth sample out of the 180 samples collected.
Additionally, 39% of samples from the uterine fundus were positive, a higher percentage than at any other site, Dr. Shockley reported. “And the one sample with growth exceeding 5,000 CFU/mL – you guessed it – was from the same patient.”
Bacterial growth was scant on the instrument tips used to close the vaginal cuffs.
Overall, bacterial growth in 98.9% of samples was below the infection threshold. “We did not identify any post–surgical site infections during 6 weeks of follow-up,” Dr. Shockley said at the meeting sponsored by AAGL.
“This study does provide a good description and count of the bacteria encountered during total laparoscopic hysterectomy. They are unlikely to cause surgical site infections … but based on concentration and frequency of bacterial growth on the surgeon’s gloves after specimen extraction, we would recommend if you are going to change gloves, do it after this step, before turning your attention back to the abdomen for vaginal cuff closure,” she said.
But changing gloves after placing the Foley and uterine manipulator “seems to be a wasted exercise,” Dr. Shockley said. “There was no growth on the vaginal fornices of any patient.”
The bacteria on the gloves in those three cases developed very low colony counts. “Yes, there was growth after the removal of the specimen, but with the exception of one patient, the colony counts were all below 5,000,” she said. “I think we need more data to reassure ourselves [attire changes are] unnecessary at every step of the [total laparoscopic hysterectomy].”
The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.
ORLANDO – Many gynecologic surgeons change gloves, gowns, and even surgical drapes during total laparoscopic hysterectomy to prevent bacterial infections, but little data support the practice.
In a small study of women undergoing total laparoscopic hysterectomy, investigators found that the overall risk of infection from contaminated gowns, gloves, and instruments was very low, with bacterial growth below the infection threshold in 98.9% of samples and no surgical site infections reported during 6 weeks of follow-up after surgery.
“Tradition dictates that even after both fields have been prepped, we refer to the perineum and vagina as ‘dirty,’ and the abdomen as ‘clean,’ ” Dr. Shockley said, “And surgeons habitually change their gown and gloves when inadvertent contact with the perineum or vagina occurs.”
To elucidate the true pathogen picture, Dr. Shockley and her colleagues assessed 31 women undergoing total laparoscopic hysterectomy for a benign indication during 2016. They evaluated the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus.
All patients received perioperative antibiotic prophylaxis and standard, separate perineovaginal and abdominal prep with chlorhexidine. Investigators swabbed the vaginal fornices and abdomen at six sites, as well as the surgeon’s gloves following placement of the uterine manipulator, tips of instruments used to close the vaginal cuff, uterine fundus after extraction, and surgeon’s gloves following removal of the uterus.
They detected no anaerobic bacterial growth from samples taken from the abdomen, in the vagina, or on the tips of instruments used for cuff closure. Similarly, there was no aerobic growth observed in the vagina of any patient. However, they did detect aerobic bacterial growth in the abdomen, which in all cases was consistent with skin flora.
Three patients demonstrated some growth with the surgeon’s gloves following manipulator placement. Nearly one-third – 32% – of surgeon’s gloves cultured bacteria after removal of the uterus. One sample yielded cumulative growth for a bacterial count considered high enough to potentially cause infection, defined as more than 5,000 colony-forming units (CFU) per milliliter. This was the highest growth sample out of the 180 samples collected.
Additionally, 39% of samples from the uterine fundus were positive, a higher percentage than at any other site, Dr. Shockley reported. “And the one sample with growth exceeding 5,000 CFU/mL – you guessed it – was from the same patient.”
Bacterial growth was scant on the instrument tips used to close the vaginal cuffs.
Overall, bacterial growth in 98.9% of samples was below the infection threshold. “We did not identify any post–surgical site infections during 6 weeks of follow-up,” Dr. Shockley said at the meeting sponsored by AAGL.
“This study does provide a good description and count of the bacteria encountered during total laparoscopic hysterectomy. They are unlikely to cause surgical site infections … but based on concentration and frequency of bacterial growth on the surgeon’s gloves after specimen extraction, we would recommend if you are going to change gloves, do it after this step, before turning your attention back to the abdomen for vaginal cuff closure,” she said.
But changing gloves after placing the Foley and uterine manipulator “seems to be a wasted exercise,” Dr. Shockley said. “There was no growth on the vaginal fornices of any patient.”
The bacteria on the gloves in those three cases developed very low colony counts. “Yes, there was growth after the removal of the specimen, but with the exception of one patient, the colony counts were all below 5,000,” she said. “I think we need more data to reassure ourselves [attire changes are] unnecessary at every step of the [total laparoscopic hysterectomy].”
The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.
AT THE AAGL GLOBAL CONGRESS
Key clinical point:
Major finding: Bacterial concentrations did not exceed thresholds required to trigger potential infection in almost 99% of cultures.
Data source: A study of 31 women undergoing total laparoscopic hysterectomy for benign indications in 2016.
Disclosures: The study was supported by an educational grant from the Foundation of the AAGL Jerome J. Hoffman Endowment. Dr. Shockley reported having no relevant financial disclosures.