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Ultrasound distinguishes early, late-stage endometriosis
VANCOUVER – and that can help ensure that a patient gets to the right surgeon.
Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.
The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”
He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”
The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.
“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.
It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.
The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.
Dr. Leonardi reported no relevant financial disclosures
VANCOUVER – and that can help ensure that a patient gets to the right surgeon.
Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.
The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”
He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”
The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.
“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.
It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.
The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.
Dr. Leonardi reported no relevant financial disclosures
VANCOUVER – and that can help ensure that a patient gets to the right surgeon.
Researchers retrospectively collected data from ultrasounds, using it to create an ASRM stage, and compared the results with the stage seen at surgery. “We’re very good at telling people what they should expect at surgery,” said Mathew Leonardi, MD, who is a gynecologist at the University of Sydney’s Nepean Hospital.
The researchers conducted the study because of perceived mistrust among surgeons when it comes to presurgical imaging. “There is still a lot of cynicism and a lot of hesitancy to adopt this,” Dr. Leonardi said at the meeting sponsored by AAGL. He was unapologetic about the activist nature of the research. “We thought, what better way [to convince surgeons] than to produce an ultrasound-based ASRM scoring system to then match to the surgical findings, because if we can predict the ASRM score preoperatively, there may be more buy-in by the surgeons for the value of imaging.”
He noted that surgeons differ in their training, so getting the patient to the right surgeon is critical. “If you go to a gynecologist who is not minimally invasive trained, you may [end up with] an abandoned surgery, or an incomplete surgical excision leading to residual disease. So being able to predict the severity of the disease preoperatively, you can allow the patient to get to the right surgeon with the right team members.”
The analysis included 204 procedures performed between January 2016 and April 2018. Participants underwent deep endometriosis transvaginal ultrasound at one of two tertiary referral service centers, and laparoscopy by surgeons in the Sydney metropolitan area. Each case was received as a ASRM score of 0-4 at both ultrasound and surgery, and scores of 0-2 and 3-4 were grouped together for analysis.
“We grouped patients that have ASRM 3-4 into one group and those who have less than that [into another group], because clinically that seems to be where the most practical divide is,” said Dr. Leonardi.
It was difficult to differentiate individual ASRM stages from one another using ultrasound, but the technique performed much better in the combined analysis. In assigning a patient to the ASRM stage 0-2 endometriosis group, it had 94.9% sensitivity and 93.8% specificity, and for assigning to ASRM stage 3-4, it had values of 93.8% and 94.9%, respectively.
The success is encouraging, but there is more work to be done. “We are going to have to differentiate those with early-stage endometriosis or stage 1-2, and those that are negative. We are working on being able to identify superficial endometriosis noninvasively, but for now, as a triaging tool ultrasound can get the patient to the right surgeon,” Dr. Leonardi said.
Dr. Leonardi reported no relevant financial disclosures
REPORTING FROM THE AAGL GLOBAL CONGRESS
Depression linked to persistent opioid use after hysterectomy
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
REPORTING FROM THE AAGL GLOBAL CONGRESS
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
Plug-unplug catheters: A good option, study suggests
Patients discharged with plug-unplug catheters after pelvic reconstructive surgery did not have adverse effects and reported less difficulty with catheter management and activities of daily living than women who were discharged with a continuous drainage catheter, a study has found.
“Plug-unplug catheter management technique is an acceptable method that does not appear to cause adverse events and may be considered for short-term catheterization after pelvic reconstructive surgery,” said Sarah Boyd, MD,* of the division of urogynecology at Hartford (Conn.) Hospital, and coinvestigators wrote in Obstetrics & Gynecology.
A total of 63 women who had a failed postoperative voiding trial after surgery for prolapse, with or without a concomitant incontinence procedure, were randomized to receive a 16-French transurethral catheter that was either attached to a leg bag (31 patients) or capped with a plastic plug (32 patients). Women in the second group – the plug-unplug group – were instructed to intermittently drain the bladder by uncapping the catheter when they felt the urge to void, or in the absence of urge, every 4 hours. All were scheduled for an outpatient voiding trial 5-7 days after discharge.
The first 30 study participants who did not require postoperative catheterization were assigned to a “reference,” or control, arm.
All patients in the study completed an activity assessment scale that covers both sedentary and ambulatory activities and is validated in women undergoing pelvic reconstructive surgery (Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18[4]:205-10); scores on the activity assessment scale (0-100) served as the primary outcome. Patients also answered questionnaires about their satisfaction and postoperative pain – and in the catheter arms, their experiences with the catheter.
The investigators found no difference in postoperative activity assessment scale scores (plug-unplug, 70; continuous drainage, 68; and reference arm, 79), However, patients with a continuous catheter indicated in the other evaluations that they had more difficulty managing the catheter and felt it impeded activities and the wearing of clothing they would otherwise use.
The activity scale, the investigators noted, may not have captured differences in activity during the first week postoperatively because patients are commonly instructed to restrict some of the activities assessed in the scale.
Regarding infection, there was no difference in the rate of positive urine cultures or treatment for urinary tract infection between the catheter arms during a 3-month follow-up period, “despite the theoretical concern that plugging and unplugging a catheter disrupts the closed catheter system, thus increasing the risk of infection,” the investigators wrote. However, the study was not powered to detect a difference in the risk of infection as it was for the primary outcome.
There was no difference between the catheter arms in the percentage of women who used narcotic or nonnarcotic pain medication, and overall patient satisfaction was similar.
The majority of patients passed their outpatient voiding trials at the initial postoperative visit (72% plug-unplug and 58% continuous). “Interestingly, patients in the plug-unplug arm had significantly higher voided volumes and almost half of the [postvoid residual volume] at the [5-7 day postoperative voiding trial] compared with the continuous drainage arm.” This suggests, Dr. Boyd and colleagues wrote, that patients using the plug-unplug catheter “could have undergone a voiding trial sooner.”
Offering patients options for catheter management is “valuable,” and providing them with a technique that is “easier to manage may decrease the catheter burden and improve patient experience,” the investigators added.
Luis E. Sanz, MD, director of urogynecology and pelvic reconstructive surgery at Virginia Hospital Center, Arlington, said, “I think that the plug and unplug drainage bladder catheter after reconstructive surgery is much more physiologic and ‘user friendly’ than continuous drainage. And [there is] no need for a leg bag, which is very inconvenient to the patient.”
Dr. Sanz, an Ob.Gyn. News Editorial Advisory Board member who was not involved in the study, was asked to provide a comment.
The authors did not report any potential conflicts of interest.
SOURCE: Boyd SS et al. Obstet Gynecol. 2019;134:1037-45.
* Correction, 10/24/2019: an earlier version misstated the chief investigator's name, which is Sarah Boyd, MD.
Patients discharged with plug-unplug catheters after pelvic reconstructive surgery did not have adverse effects and reported less difficulty with catheter management and activities of daily living than women who were discharged with a continuous drainage catheter, a study has found.
“Plug-unplug catheter management technique is an acceptable method that does not appear to cause adverse events and may be considered for short-term catheterization after pelvic reconstructive surgery,” said Sarah Boyd, MD,* of the division of urogynecology at Hartford (Conn.) Hospital, and coinvestigators wrote in Obstetrics & Gynecology.
A total of 63 women who had a failed postoperative voiding trial after surgery for prolapse, with or without a concomitant incontinence procedure, were randomized to receive a 16-French transurethral catheter that was either attached to a leg bag (31 patients) or capped with a plastic plug (32 patients). Women in the second group – the plug-unplug group – were instructed to intermittently drain the bladder by uncapping the catheter when they felt the urge to void, or in the absence of urge, every 4 hours. All were scheduled for an outpatient voiding trial 5-7 days after discharge.
The first 30 study participants who did not require postoperative catheterization were assigned to a “reference,” or control, arm.
All patients in the study completed an activity assessment scale that covers both sedentary and ambulatory activities and is validated in women undergoing pelvic reconstructive surgery (Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18[4]:205-10); scores on the activity assessment scale (0-100) served as the primary outcome. Patients also answered questionnaires about their satisfaction and postoperative pain – and in the catheter arms, their experiences with the catheter.
The investigators found no difference in postoperative activity assessment scale scores (plug-unplug, 70; continuous drainage, 68; and reference arm, 79), However, patients with a continuous catheter indicated in the other evaluations that they had more difficulty managing the catheter and felt it impeded activities and the wearing of clothing they would otherwise use.
The activity scale, the investigators noted, may not have captured differences in activity during the first week postoperatively because patients are commonly instructed to restrict some of the activities assessed in the scale.
Regarding infection, there was no difference in the rate of positive urine cultures or treatment for urinary tract infection between the catheter arms during a 3-month follow-up period, “despite the theoretical concern that plugging and unplugging a catheter disrupts the closed catheter system, thus increasing the risk of infection,” the investigators wrote. However, the study was not powered to detect a difference in the risk of infection as it was for the primary outcome.
There was no difference between the catheter arms in the percentage of women who used narcotic or nonnarcotic pain medication, and overall patient satisfaction was similar.
The majority of patients passed their outpatient voiding trials at the initial postoperative visit (72% plug-unplug and 58% continuous). “Interestingly, patients in the plug-unplug arm had significantly higher voided volumes and almost half of the [postvoid residual volume] at the [5-7 day postoperative voiding trial] compared with the continuous drainage arm.” This suggests, Dr. Boyd and colleagues wrote, that patients using the plug-unplug catheter “could have undergone a voiding trial sooner.”
Offering patients options for catheter management is “valuable,” and providing them with a technique that is “easier to manage may decrease the catheter burden and improve patient experience,” the investigators added.
Luis E. Sanz, MD, director of urogynecology and pelvic reconstructive surgery at Virginia Hospital Center, Arlington, said, “I think that the plug and unplug drainage bladder catheter after reconstructive surgery is much more physiologic and ‘user friendly’ than continuous drainage. And [there is] no need for a leg bag, which is very inconvenient to the patient.”
Dr. Sanz, an Ob.Gyn. News Editorial Advisory Board member who was not involved in the study, was asked to provide a comment.
The authors did not report any potential conflicts of interest.
SOURCE: Boyd SS et al. Obstet Gynecol. 2019;134:1037-45.
* Correction, 10/24/2019: an earlier version misstated the chief investigator's name, which is Sarah Boyd, MD.
Patients discharged with plug-unplug catheters after pelvic reconstructive surgery did not have adverse effects and reported less difficulty with catheter management and activities of daily living than women who were discharged with a continuous drainage catheter, a study has found.
“Plug-unplug catheter management technique is an acceptable method that does not appear to cause adverse events and may be considered for short-term catheterization after pelvic reconstructive surgery,” said Sarah Boyd, MD,* of the division of urogynecology at Hartford (Conn.) Hospital, and coinvestigators wrote in Obstetrics & Gynecology.
A total of 63 women who had a failed postoperative voiding trial after surgery for prolapse, with or without a concomitant incontinence procedure, were randomized to receive a 16-French transurethral catheter that was either attached to a leg bag (31 patients) or capped with a plastic plug (32 patients). Women in the second group – the plug-unplug group – were instructed to intermittently drain the bladder by uncapping the catheter when they felt the urge to void, or in the absence of urge, every 4 hours. All were scheduled for an outpatient voiding trial 5-7 days after discharge.
The first 30 study participants who did not require postoperative catheterization were assigned to a “reference,” or control, arm.
All patients in the study completed an activity assessment scale that covers both sedentary and ambulatory activities and is validated in women undergoing pelvic reconstructive surgery (Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18[4]:205-10); scores on the activity assessment scale (0-100) served as the primary outcome. Patients also answered questionnaires about their satisfaction and postoperative pain – and in the catheter arms, their experiences with the catheter.
The investigators found no difference in postoperative activity assessment scale scores (plug-unplug, 70; continuous drainage, 68; and reference arm, 79), However, patients with a continuous catheter indicated in the other evaluations that they had more difficulty managing the catheter and felt it impeded activities and the wearing of clothing they would otherwise use.
The activity scale, the investigators noted, may not have captured differences in activity during the first week postoperatively because patients are commonly instructed to restrict some of the activities assessed in the scale.
Regarding infection, there was no difference in the rate of positive urine cultures or treatment for urinary tract infection between the catheter arms during a 3-month follow-up period, “despite the theoretical concern that plugging and unplugging a catheter disrupts the closed catheter system, thus increasing the risk of infection,” the investigators wrote. However, the study was not powered to detect a difference in the risk of infection as it was for the primary outcome.
There was no difference between the catheter arms in the percentage of women who used narcotic or nonnarcotic pain medication, and overall patient satisfaction was similar.
The majority of patients passed their outpatient voiding trials at the initial postoperative visit (72% plug-unplug and 58% continuous). “Interestingly, patients in the plug-unplug arm had significantly higher voided volumes and almost half of the [postvoid residual volume] at the [5-7 day postoperative voiding trial] compared with the continuous drainage arm.” This suggests, Dr. Boyd and colleagues wrote, that patients using the plug-unplug catheter “could have undergone a voiding trial sooner.”
Offering patients options for catheter management is “valuable,” and providing them with a technique that is “easier to manage may decrease the catheter burden and improve patient experience,” the investigators added.
Luis E. Sanz, MD, director of urogynecology and pelvic reconstructive surgery at Virginia Hospital Center, Arlington, said, “I think that the plug and unplug drainage bladder catheter after reconstructive surgery is much more physiologic and ‘user friendly’ than continuous drainage. And [there is] no need for a leg bag, which is very inconvenient to the patient.”
Dr. Sanz, an Ob.Gyn. News Editorial Advisory Board member who was not involved in the study, was asked to provide a comment.
The authors did not report any potential conflicts of interest.
SOURCE: Boyd SS et al. Obstet Gynecol. 2019;134:1037-45.
* Correction, 10/24/2019: an earlier version misstated the chief investigator's name, which is Sarah Boyd, MD.
FROM OBSTETRICS & GYNECOLOGY
Consider treating ovarian torsion with conservative surgery in young women
PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.
The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.
“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.
The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).
Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).
Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).
Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.
(odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.
Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.
The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.
Dr. Mandelbaum reported no relevant conflicts of interest.
SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.
PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.
The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.
“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.
The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).
Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).
Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).
Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.
(odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.
Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.
The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.
Dr. Mandelbaum reported no relevant conflicts of interest.
SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.
PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.
The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.
“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.
The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).
Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).
Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).
Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.
(odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.
Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.
The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.
Dr. Mandelbaum reported no relevant conflicts of interest.
SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.
REPORTING FROM ASRM 2019
Trial of mesh vs. hysterectomy for prolapse yields inconclusive results
Transvaginal mesh hysteropexy for symptomatic uterovaginal prolapse may not significantly reduce treatment failure after 3 years, compared with vaginal hysterectomy with uterosacral ligament suspension, according to randomized trial results.
Nevertheless, “the point estimate favored hysteropexy,” the study authors wrote in JAMA. The 36-month cumulative treatment failure outcomes – defined as retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms – were 33% for patients who underwent hysteropexy, compared with 42% for patients who underwent hysterectomy. In addition, mean operative time was 45 minutes less for patients who underwent hysteropexy.
The publication follows the Food and Drug Administration’s ruling in April 2019 that manufacturers must cease marketing transvaginal mesh kits for repair of anterior or apical compartment prolapse. The investigators plan to continue evaluating patient outcomes to 5 years, and they noted that longer follow-up may lead to different conclusions.
From a class II device to class III
Surgical repair of uterovaginal prolapse is common. Although vaginal hysterectomy is the procedure of choice for many surgeons, “uterine-sparing suspension techniques ... are increasing in usage,” wrote Charles W. Nager, MD, chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, and coauthors. However, few high-quality, long-term studies have compared apical transvaginal mesh with native tissue procedures.
The FDA first approved a mesh device for transvaginal repair of prolapse in 2002. In 2008, the agency notified clinicians and patients about an increase in adverse event reports related to vaginal mesh. It later advised that mesh for the treatment of pelvic organ prolapse does not conclusively improve clinical outcomes and that serious adverse events are not rare.
In 2016, the FDA reclassified surgical mesh to repair pelvic organ prolapse transvaginally as high risk, citing safety concerns such as severe pelvic pain and organ perforation. And in April 2019, the FDA ordered companies to stop selling transvaginal mesh intended for pelvic organ prolapse repair. “Even though these products can no longer be used in patients moving forward, [manufacturers] are required to continue follow-up” of patients in post–market surveillance studies, the FDA said in a statement.
An FDA panel had concluded that 3-year outcomes for prolapse repair with mesh should be better than the outcomes for repair with native tissue, and that the procedures should have comparable safety profiles.
The SUPeR trial
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy, Dr. Nager and colleagues conducted the Study of Uterine Prolapse Procedures Randomized (SUPeR) trial.
Researchers enrolled 183 postmenopausal women with symptomatic uterovaginal prolapse undergoing surgical intervention at nine sites between April 2013 and February 2015. Investigators randomized 93 women to undergo vaginal mesh hysteropexy and 90 to undergo vaginal hysterectomy with uterosacral ligament suspension. Hysteropexy used the UpholdLITE transvaginal mesh support system (Boston Scientific). Uterosacral ligament suspension required one permanent and one delayed absorbable suture on each side. The primary analysis included data from 175 patients.
Compared with hysterectomy, hysteropexy resulted in an adjusted hazard ratio of treatment failure of 0.62 after 3 years, which was not statistically significant (P = .06). The 95% confidence interval of 0.38-1.02 “was wide and only slightly crossed the null value,” the researchers said. “The remaining uncertainty is too great” to establish or rule out the benefit of vaginal mesh hysteropexy.
Mean operative time was about 45 minutes shorter in the hysteropexy group versus the hysterectomy group (111.5 minutes vs. 156.7 minutes). Adverse events in the hysteropexy versus hysterectomy groups included mesh exposure (8% vs. 0%), ureteral kinking managed intraoperatively (0% vs. 7%), excessive granulation tissue after 12 weeks (1% vs. 11%), and suture exposure after 12 weeks (3% vs. 21%).
“Both groups reported improvements in sexual function, and dyspareunia and pain and de novo dyspareunia rates were low,” Dr. Nager and colleagues wrote. “All other complications with long-term sequelae were not different between groups.”
“Patients in the current study are being followed up for 60 months and the results and conclusions at 36 months could change with extended follow-up,” they added.
A role for mesh?
“The report ... by Nager and colleagues is particularly timely and important,” Cynthia A. Brincat, MD, PhD, wrote in an accompanying editorial. Dr. Brincat is affiliated with the division of female pelvic medicine and reconstructive surgery at Rush Medical College, Chicago.
Although the mesh exposures, granulation tissue, or suture exposures during the trial did not require reoperation, “management of these adverse events was not described,” the editorialist noted. “Clinically important differences could exist between the management of these reported adverse events.”
Based on the findings, gynecologic surgeons “will need to reconsider several important questions regarding the repair of pelvic organ prolapse. For instance, is hysterectomy a necessary component for the repair? What is the role of mesh, and can its use reduce the use of otherwise unnecessary procedures (i.e., hysterectomy) without increasing risk to patients?” she wrote. Other questions center on what constitutes operative failure and how surgeons should augment prolapse repair.
“This study also provides a potential new and well-defined role for the use of mesh in pelvic prolapse surgery, with no significant difference, and perhaps some benefit (i.e., no hysterectomy), compared with a native tissue repair,” Dr. Brincat wrote. “The study also provides useful information for shared decision-making discussions between patients and gynecologic surgeons with respect to selection of procedures and use of mesh for treatment of women with symptomatic uterovaginal prolapse undergoing vaginal surgery.”
The trial was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Boston Scientific provided support through an unrestricted grant. One author reported stock ownership in a medical device company, and others reported grants from medical device companies outside the submitted work. Dr. Brincat reported no conflicts of interest.
SOURCES: Nager CW et al. JAMA. 2019 Sep 17;322(11):1054-65; Brincat CA. JAMA. 2019 Sep 17;322(11):1047-8.
Transvaginal mesh hysteropexy for symptomatic uterovaginal prolapse may not significantly reduce treatment failure after 3 years, compared with vaginal hysterectomy with uterosacral ligament suspension, according to randomized trial results.
Nevertheless, “the point estimate favored hysteropexy,” the study authors wrote in JAMA. The 36-month cumulative treatment failure outcomes – defined as retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms – were 33% for patients who underwent hysteropexy, compared with 42% for patients who underwent hysterectomy. In addition, mean operative time was 45 minutes less for patients who underwent hysteropexy.
The publication follows the Food and Drug Administration’s ruling in April 2019 that manufacturers must cease marketing transvaginal mesh kits for repair of anterior or apical compartment prolapse. The investigators plan to continue evaluating patient outcomes to 5 years, and they noted that longer follow-up may lead to different conclusions.
From a class II device to class III
Surgical repair of uterovaginal prolapse is common. Although vaginal hysterectomy is the procedure of choice for many surgeons, “uterine-sparing suspension techniques ... are increasing in usage,” wrote Charles W. Nager, MD, chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, and coauthors. However, few high-quality, long-term studies have compared apical transvaginal mesh with native tissue procedures.
The FDA first approved a mesh device for transvaginal repair of prolapse in 2002. In 2008, the agency notified clinicians and patients about an increase in adverse event reports related to vaginal mesh. It later advised that mesh for the treatment of pelvic organ prolapse does not conclusively improve clinical outcomes and that serious adverse events are not rare.
In 2016, the FDA reclassified surgical mesh to repair pelvic organ prolapse transvaginally as high risk, citing safety concerns such as severe pelvic pain and organ perforation. And in April 2019, the FDA ordered companies to stop selling transvaginal mesh intended for pelvic organ prolapse repair. “Even though these products can no longer be used in patients moving forward, [manufacturers] are required to continue follow-up” of patients in post–market surveillance studies, the FDA said in a statement.
An FDA panel had concluded that 3-year outcomes for prolapse repair with mesh should be better than the outcomes for repair with native tissue, and that the procedures should have comparable safety profiles.
The SUPeR trial
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy, Dr. Nager and colleagues conducted the Study of Uterine Prolapse Procedures Randomized (SUPeR) trial.
Researchers enrolled 183 postmenopausal women with symptomatic uterovaginal prolapse undergoing surgical intervention at nine sites between April 2013 and February 2015. Investigators randomized 93 women to undergo vaginal mesh hysteropexy and 90 to undergo vaginal hysterectomy with uterosacral ligament suspension. Hysteropexy used the UpholdLITE transvaginal mesh support system (Boston Scientific). Uterosacral ligament suspension required one permanent and one delayed absorbable suture on each side. The primary analysis included data from 175 patients.
Compared with hysterectomy, hysteropexy resulted in an adjusted hazard ratio of treatment failure of 0.62 after 3 years, which was not statistically significant (P = .06). The 95% confidence interval of 0.38-1.02 “was wide and only slightly crossed the null value,” the researchers said. “The remaining uncertainty is too great” to establish or rule out the benefit of vaginal mesh hysteropexy.
Mean operative time was about 45 minutes shorter in the hysteropexy group versus the hysterectomy group (111.5 minutes vs. 156.7 minutes). Adverse events in the hysteropexy versus hysterectomy groups included mesh exposure (8% vs. 0%), ureteral kinking managed intraoperatively (0% vs. 7%), excessive granulation tissue after 12 weeks (1% vs. 11%), and suture exposure after 12 weeks (3% vs. 21%).
“Both groups reported improvements in sexual function, and dyspareunia and pain and de novo dyspareunia rates were low,” Dr. Nager and colleagues wrote. “All other complications with long-term sequelae were not different between groups.”
“Patients in the current study are being followed up for 60 months and the results and conclusions at 36 months could change with extended follow-up,” they added.
A role for mesh?
“The report ... by Nager and colleagues is particularly timely and important,” Cynthia A. Brincat, MD, PhD, wrote in an accompanying editorial. Dr. Brincat is affiliated with the division of female pelvic medicine and reconstructive surgery at Rush Medical College, Chicago.
Although the mesh exposures, granulation tissue, or suture exposures during the trial did not require reoperation, “management of these adverse events was not described,” the editorialist noted. “Clinically important differences could exist between the management of these reported adverse events.”
Based on the findings, gynecologic surgeons “will need to reconsider several important questions regarding the repair of pelvic organ prolapse. For instance, is hysterectomy a necessary component for the repair? What is the role of mesh, and can its use reduce the use of otherwise unnecessary procedures (i.e., hysterectomy) without increasing risk to patients?” she wrote. Other questions center on what constitutes operative failure and how surgeons should augment prolapse repair.
“This study also provides a potential new and well-defined role for the use of mesh in pelvic prolapse surgery, with no significant difference, and perhaps some benefit (i.e., no hysterectomy), compared with a native tissue repair,” Dr. Brincat wrote. “The study also provides useful information for shared decision-making discussions between patients and gynecologic surgeons with respect to selection of procedures and use of mesh for treatment of women with symptomatic uterovaginal prolapse undergoing vaginal surgery.”
The trial was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Boston Scientific provided support through an unrestricted grant. One author reported stock ownership in a medical device company, and others reported grants from medical device companies outside the submitted work. Dr. Brincat reported no conflicts of interest.
SOURCES: Nager CW et al. JAMA. 2019 Sep 17;322(11):1054-65; Brincat CA. JAMA. 2019 Sep 17;322(11):1047-8.
Transvaginal mesh hysteropexy for symptomatic uterovaginal prolapse may not significantly reduce treatment failure after 3 years, compared with vaginal hysterectomy with uterosacral ligament suspension, according to randomized trial results.
Nevertheless, “the point estimate favored hysteropexy,” the study authors wrote in JAMA. The 36-month cumulative treatment failure outcomes – defined as retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms – were 33% for patients who underwent hysteropexy, compared with 42% for patients who underwent hysterectomy. In addition, mean operative time was 45 minutes less for patients who underwent hysteropexy.
The publication follows the Food and Drug Administration’s ruling in April 2019 that manufacturers must cease marketing transvaginal mesh kits for repair of anterior or apical compartment prolapse. The investigators plan to continue evaluating patient outcomes to 5 years, and they noted that longer follow-up may lead to different conclusions.
From a class II device to class III
Surgical repair of uterovaginal prolapse is common. Although vaginal hysterectomy is the procedure of choice for many surgeons, “uterine-sparing suspension techniques ... are increasing in usage,” wrote Charles W. Nager, MD, chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, and coauthors. However, few high-quality, long-term studies have compared apical transvaginal mesh with native tissue procedures.
The FDA first approved a mesh device for transvaginal repair of prolapse in 2002. In 2008, the agency notified clinicians and patients about an increase in adverse event reports related to vaginal mesh. It later advised that mesh for the treatment of pelvic organ prolapse does not conclusively improve clinical outcomes and that serious adverse events are not rare.
In 2016, the FDA reclassified surgical mesh to repair pelvic organ prolapse transvaginally as high risk, citing safety concerns such as severe pelvic pain and organ perforation. And in April 2019, the FDA ordered companies to stop selling transvaginal mesh intended for pelvic organ prolapse repair. “Even though these products can no longer be used in patients moving forward, [manufacturers] are required to continue follow-up” of patients in post–market surveillance studies, the FDA said in a statement.
An FDA panel had concluded that 3-year outcomes for prolapse repair with mesh should be better than the outcomes for repair with native tissue, and that the procedures should have comparable safety profiles.
The SUPeR trial
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy, Dr. Nager and colleagues conducted the Study of Uterine Prolapse Procedures Randomized (SUPeR) trial.
Researchers enrolled 183 postmenopausal women with symptomatic uterovaginal prolapse undergoing surgical intervention at nine sites between April 2013 and February 2015. Investigators randomized 93 women to undergo vaginal mesh hysteropexy and 90 to undergo vaginal hysterectomy with uterosacral ligament suspension. Hysteropexy used the UpholdLITE transvaginal mesh support system (Boston Scientific). Uterosacral ligament suspension required one permanent and one delayed absorbable suture on each side. The primary analysis included data from 175 patients.
Compared with hysterectomy, hysteropexy resulted in an adjusted hazard ratio of treatment failure of 0.62 after 3 years, which was not statistically significant (P = .06). The 95% confidence interval of 0.38-1.02 “was wide and only slightly crossed the null value,” the researchers said. “The remaining uncertainty is too great” to establish or rule out the benefit of vaginal mesh hysteropexy.
Mean operative time was about 45 minutes shorter in the hysteropexy group versus the hysterectomy group (111.5 minutes vs. 156.7 minutes). Adverse events in the hysteropexy versus hysterectomy groups included mesh exposure (8% vs. 0%), ureteral kinking managed intraoperatively (0% vs. 7%), excessive granulation tissue after 12 weeks (1% vs. 11%), and suture exposure after 12 weeks (3% vs. 21%).
“Both groups reported improvements in sexual function, and dyspareunia and pain and de novo dyspareunia rates were low,” Dr. Nager and colleagues wrote. “All other complications with long-term sequelae were not different between groups.”
“Patients in the current study are being followed up for 60 months and the results and conclusions at 36 months could change with extended follow-up,” they added.
A role for mesh?
“The report ... by Nager and colleagues is particularly timely and important,” Cynthia A. Brincat, MD, PhD, wrote in an accompanying editorial. Dr. Brincat is affiliated with the division of female pelvic medicine and reconstructive surgery at Rush Medical College, Chicago.
Although the mesh exposures, granulation tissue, or suture exposures during the trial did not require reoperation, “management of these adverse events was not described,” the editorialist noted. “Clinically important differences could exist between the management of these reported adverse events.”
Based on the findings, gynecologic surgeons “will need to reconsider several important questions regarding the repair of pelvic organ prolapse. For instance, is hysterectomy a necessary component for the repair? What is the role of mesh, and can its use reduce the use of otherwise unnecessary procedures (i.e., hysterectomy) without increasing risk to patients?” she wrote. Other questions center on what constitutes operative failure and how surgeons should augment prolapse repair.
“This study also provides a potential new and well-defined role for the use of mesh in pelvic prolapse surgery, with no significant difference, and perhaps some benefit (i.e., no hysterectomy), compared with a native tissue repair,” Dr. Brincat wrote. “The study also provides useful information for shared decision-making discussions between patients and gynecologic surgeons with respect to selection of procedures and use of mesh for treatment of women with symptomatic uterovaginal prolapse undergoing vaginal surgery.”
The trial was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Boston Scientific provided support through an unrestricted grant. One author reported stock ownership in a medical device company, and others reported grants from medical device companies outside the submitted work. Dr. Brincat reported no conflicts of interest.
SOURCES: Nager CW et al. JAMA. 2019 Sep 17;322(11):1054-65; Brincat CA. JAMA. 2019 Sep 17;322(11):1047-8.
FROM JAMA
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.
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
Preventing delayed genitourinary tract injury during benign hysterectomy
and the circumstances under which it should be performed. Procedures directed at prolapse and incontinence have rates of genitourinary injury as high as 11%-38%, and national guidelines affirm the importance of cystoscopy in these patients.1 However, for patients undergoing hysterectomy in the absence of these procedures, the optimal strategy is debated. One approach that has been advanced is a policy of universal cystoscopy at the time of hysterectomy. This policy, by which all women undergoing hysterectomy would undergo cystoscopy, aims to prevent the occurrence of an unrecognized genitourinary injury by diagnosing and treating the injury intraoperatively. However, cystoscopy is not the only method that can be used to evaluate the urinary tract. Retroperitoneal dissection also can be used to visually identify the pertinent structures and has been performed with high fidelity by generations of experienced and skilled pelvic surgeons.
Injuries that are not identified intraoperatively at the time of surgery, so-called delayed genitourinary tract injuries, are associated with serious postoperative consequences for patients and high costs for institutions. As surgeons strive to decrease complications and improve the quality of gynecologic surgery, the question of whether cystoscopy should routinely be performed at the time of hysterectomy for benign indications remains unanswered. Proponents argue that cystoscopy is a low-cost assessment and that 75% of genitourinary injuries occur in women without identifiable risk factors.2 Opponents point out that cystoscopy is not an entirely benign intervention; it is associated with increased rates of urinary tract infection, bladder and ureteral trauma, and additional operating room time. Furthermore, it is unclear that the use of cystoscopy will reduce the incidence of delayed genitourinary tract injury in clinical practice.
Ultimately, cystoscopy after hysterectomy is being used as a screening test for genitourinary injury, and this lens can be applied to provide more information about its usefulness. For screening tests, the sensitivity and false negative rate are of paramount importance. High sensitivity and resultant few false negatives are the characteristics of a robust screening test which has a low likelihood of missing a diagnosis. Unfortunately, the sensitivity of cystoscopy is not 100% for genitourinary tract injury; it ranges from 60% to 85% and can be as low as 43% for ureteral injury.3,4 This means that cystoscopy will falsely reassure the surgeon with normal results in greater than 50% of the cases in which the patient actually has a ureteral injury.
Some larger series call into question the usefulness of cystoscopy as a screening tool, finding that this evaluation is not associated with a decreased rate of delayed genitourinary injury. A recent publication by our group of a series of 39,529 women who underwent benign hysterectomy without procedures directed at incontinence and prolapse recorded in the National Surgical Quality Improvement Program (NSQIP) database between 2015 and 2017 found no difference in the rate of delayed genitourinary injury among women exposed to diagnostic cystoscopy and those who were not.5 These results are consistent with those of the largest systematic review and meta-analysis of 79 studies capturing 41,482 hysterectomies which found universal cystoscopy was not associated with a decreased rate of delayed genitourinary tract injury.6
Another consideration with the use of universal cystoscopy is cost. Although cystoscopy is typically a short procedure, the false positive rate is approximately 2%,2 often leading to additional interventions to evaluate the urinary tract which can be time consuming. In the limited available data regarding operative time, patients who underwent cystoscopy had a median operative time that was 17 minutes longer than it was among patients who did not.5 Moreover, there may be risks associated with this additional bladder instrumentation, evidenced by an increased incidence of urinary tract infection among women undergoing cystoscopy. In a recent cost-effectiveness analysis of cystoscopy at the time of benign hysterectomy, universal cystoscopy was found to add $51.39-$57.86 per case, and the risk of bladder injury would need to exceed 21%-47% and ureteral injury 27%-38% to be cost saving, compared with selective cystoscopy.7 A prior cost-effectiveness analysis concluded that universal cystoscopy is cost effective when the incidence of ureteral injury at the time of hysterectomy exceeds 1.5%-2.0%.8 Given these high thresholds, with a contemporary composite lower–genitourinary tract injury incidence of 0.24%-0.27%, it is unlikely that universal cystoscopy could be considered a cost-saving strategy in the majority of clinical settings.
Potential explanations for these results are many. Intraoperative cystoscopy is likely to be normal in the setting of nonobstructive and thermal injuries, which in the current era of minimally invasive surgery may be more prevalent mechanisms of injury. False positives can occur leading to unnecessary interventions, as well as overdiagnosis of asymptomatic urinary tract injuries that may have resolved spontaneously.9 It has been observed that cystoscopy is performed less frequently when hysterectomy is completed by a high-volume surgeon, which suggests that surgeon skill and experience play a significant role in the usefulness of this evaluation.9
Given these data, what is the best way forward regarding evaluation of the urinary tract at the time of benign hysterectomy? Ultimately, this is a clinical question that should be individualized, taking into account patient and surgical complexity, as well as surgeon training and individual rates of genitourinary injuries.9 Given its low sensitivity, caution should be exercised regarding the routine use of cystoscopy alone for evaluation of the urinary tract because false negatives occur with significant frequency. Benefits of cystoscopy in a given clinical scenario should be weighed against the risks of longer operative time, increased costs, and increased rate of urinary tract infection. In the absence of clinical scenarios with high rates of genitourinary injury (greater than 5%), selective rather than universal cystoscopy is the preferred strategy.7 Cystoscopy is fundamentally a form of secondary prevention that aims to mitigate damage that has already been done, and is no substitute for primary prevention of genitourinary tract injury itself through thorough knowledge of pelvic anatomy, comfort with retroperitoneal dissection, and awareness of the ureter and bladder at all times.
Dr. Polan is a resident in obstetrics and gynecology at Northwestern University, Chicago. Dr. Barber is an assistant professor of obstetrics and gynecology, specializing in gynecologic oncology, at the university. Neither of them have relevant financial disclosures. Email Dr. Polan and Dr. Barber at [email protected].
References
1. Am J Obstet Gynecol. 2018 Jul;219(1):75-7.
2. Obstet Gynecol. 2009 Jan;113(1):6-10.
3. Obstet Gynecol. 2016 Feb;127(2):369-75.
4. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1278-86.
5. Obstet Gynecol. 2019 May;133(5):888-95.
6. Obstet Gynecol. 2015 Dec;126(6):1161-9.
7. Am J Obstet Gynecol. 2019 Apr;220(4):369.e1-7.
8. Obstet Gynecol. 2001 May;97(5 Pt 1):685-92.
9. Obstet Gynecol. 2012 Dec;120(6):1363-70.
and the circumstances under which it should be performed. Procedures directed at prolapse and incontinence have rates of genitourinary injury as high as 11%-38%, and national guidelines affirm the importance of cystoscopy in these patients.1 However, for patients undergoing hysterectomy in the absence of these procedures, the optimal strategy is debated. One approach that has been advanced is a policy of universal cystoscopy at the time of hysterectomy. This policy, by which all women undergoing hysterectomy would undergo cystoscopy, aims to prevent the occurrence of an unrecognized genitourinary injury by diagnosing and treating the injury intraoperatively. However, cystoscopy is not the only method that can be used to evaluate the urinary tract. Retroperitoneal dissection also can be used to visually identify the pertinent structures and has been performed with high fidelity by generations of experienced and skilled pelvic surgeons.
Injuries that are not identified intraoperatively at the time of surgery, so-called delayed genitourinary tract injuries, are associated with serious postoperative consequences for patients and high costs for institutions. As surgeons strive to decrease complications and improve the quality of gynecologic surgery, the question of whether cystoscopy should routinely be performed at the time of hysterectomy for benign indications remains unanswered. Proponents argue that cystoscopy is a low-cost assessment and that 75% of genitourinary injuries occur in women without identifiable risk factors.2 Opponents point out that cystoscopy is not an entirely benign intervention; it is associated with increased rates of urinary tract infection, bladder and ureteral trauma, and additional operating room time. Furthermore, it is unclear that the use of cystoscopy will reduce the incidence of delayed genitourinary tract injury in clinical practice.
Ultimately, cystoscopy after hysterectomy is being used as a screening test for genitourinary injury, and this lens can be applied to provide more information about its usefulness. For screening tests, the sensitivity and false negative rate are of paramount importance. High sensitivity and resultant few false negatives are the characteristics of a robust screening test which has a low likelihood of missing a diagnosis. Unfortunately, the sensitivity of cystoscopy is not 100% for genitourinary tract injury; it ranges from 60% to 85% and can be as low as 43% for ureteral injury.3,4 This means that cystoscopy will falsely reassure the surgeon with normal results in greater than 50% of the cases in which the patient actually has a ureteral injury.
Some larger series call into question the usefulness of cystoscopy as a screening tool, finding that this evaluation is not associated with a decreased rate of delayed genitourinary injury. A recent publication by our group of a series of 39,529 women who underwent benign hysterectomy without procedures directed at incontinence and prolapse recorded in the National Surgical Quality Improvement Program (NSQIP) database between 2015 and 2017 found no difference in the rate of delayed genitourinary injury among women exposed to diagnostic cystoscopy and those who were not.5 These results are consistent with those of the largest systematic review and meta-analysis of 79 studies capturing 41,482 hysterectomies which found universal cystoscopy was not associated with a decreased rate of delayed genitourinary tract injury.6
Another consideration with the use of universal cystoscopy is cost. Although cystoscopy is typically a short procedure, the false positive rate is approximately 2%,2 often leading to additional interventions to evaluate the urinary tract which can be time consuming. In the limited available data regarding operative time, patients who underwent cystoscopy had a median operative time that was 17 minutes longer than it was among patients who did not.5 Moreover, there may be risks associated with this additional bladder instrumentation, evidenced by an increased incidence of urinary tract infection among women undergoing cystoscopy. In a recent cost-effectiveness analysis of cystoscopy at the time of benign hysterectomy, universal cystoscopy was found to add $51.39-$57.86 per case, and the risk of bladder injury would need to exceed 21%-47% and ureteral injury 27%-38% to be cost saving, compared with selective cystoscopy.7 A prior cost-effectiveness analysis concluded that universal cystoscopy is cost effective when the incidence of ureteral injury at the time of hysterectomy exceeds 1.5%-2.0%.8 Given these high thresholds, with a contemporary composite lower–genitourinary tract injury incidence of 0.24%-0.27%, it is unlikely that universal cystoscopy could be considered a cost-saving strategy in the majority of clinical settings.
Potential explanations for these results are many. Intraoperative cystoscopy is likely to be normal in the setting of nonobstructive and thermal injuries, which in the current era of minimally invasive surgery may be more prevalent mechanisms of injury. False positives can occur leading to unnecessary interventions, as well as overdiagnosis of asymptomatic urinary tract injuries that may have resolved spontaneously.9 It has been observed that cystoscopy is performed less frequently when hysterectomy is completed by a high-volume surgeon, which suggests that surgeon skill and experience play a significant role in the usefulness of this evaluation.9
Given these data, what is the best way forward regarding evaluation of the urinary tract at the time of benign hysterectomy? Ultimately, this is a clinical question that should be individualized, taking into account patient and surgical complexity, as well as surgeon training and individual rates of genitourinary injuries.9 Given its low sensitivity, caution should be exercised regarding the routine use of cystoscopy alone for evaluation of the urinary tract because false negatives occur with significant frequency. Benefits of cystoscopy in a given clinical scenario should be weighed against the risks of longer operative time, increased costs, and increased rate of urinary tract infection. In the absence of clinical scenarios with high rates of genitourinary injury (greater than 5%), selective rather than universal cystoscopy is the preferred strategy.7 Cystoscopy is fundamentally a form of secondary prevention that aims to mitigate damage that has already been done, and is no substitute for primary prevention of genitourinary tract injury itself through thorough knowledge of pelvic anatomy, comfort with retroperitoneal dissection, and awareness of the ureter and bladder at all times.
Dr. Polan is a resident in obstetrics and gynecology at Northwestern University, Chicago. Dr. Barber is an assistant professor of obstetrics and gynecology, specializing in gynecologic oncology, at the university. Neither of them have relevant financial disclosures. Email Dr. Polan and Dr. Barber at [email protected].
References
1. Am J Obstet Gynecol. 2018 Jul;219(1):75-7.
2. Obstet Gynecol. 2009 Jan;113(1):6-10.
3. Obstet Gynecol. 2016 Feb;127(2):369-75.
4. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1278-86.
5. Obstet Gynecol. 2019 May;133(5):888-95.
6. Obstet Gynecol. 2015 Dec;126(6):1161-9.
7. Am J Obstet Gynecol. 2019 Apr;220(4):369.e1-7.
8. Obstet Gynecol. 2001 May;97(5 Pt 1):685-92.
9. Obstet Gynecol. 2012 Dec;120(6):1363-70.
and the circumstances under which it should be performed. Procedures directed at prolapse and incontinence have rates of genitourinary injury as high as 11%-38%, and national guidelines affirm the importance of cystoscopy in these patients.1 However, for patients undergoing hysterectomy in the absence of these procedures, the optimal strategy is debated. One approach that has been advanced is a policy of universal cystoscopy at the time of hysterectomy. This policy, by which all women undergoing hysterectomy would undergo cystoscopy, aims to prevent the occurrence of an unrecognized genitourinary injury by diagnosing and treating the injury intraoperatively. However, cystoscopy is not the only method that can be used to evaluate the urinary tract. Retroperitoneal dissection also can be used to visually identify the pertinent structures and has been performed with high fidelity by generations of experienced and skilled pelvic surgeons.
Injuries that are not identified intraoperatively at the time of surgery, so-called delayed genitourinary tract injuries, are associated with serious postoperative consequences for patients and high costs for institutions. As surgeons strive to decrease complications and improve the quality of gynecologic surgery, the question of whether cystoscopy should routinely be performed at the time of hysterectomy for benign indications remains unanswered. Proponents argue that cystoscopy is a low-cost assessment and that 75% of genitourinary injuries occur in women without identifiable risk factors.2 Opponents point out that cystoscopy is not an entirely benign intervention; it is associated with increased rates of urinary tract infection, bladder and ureteral trauma, and additional operating room time. Furthermore, it is unclear that the use of cystoscopy will reduce the incidence of delayed genitourinary tract injury in clinical practice.
Ultimately, cystoscopy after hysterectomy is being used as a screening test for genitourinary injury, and this lens can be applied to provide more information about its usefulness. For screening tests, the sensitivity and false negative rate are of paramount importance. High sensitivity and resultant few false negatives are the characteristics of a robust screening test which has a low likelihood of missing a diagnosis. Unfortunately, the sensitivity of cystoscopy is not 100% for genitourinary tract injury; it ranges from 60% to 85% and can be as low as 43% for ureteral injury.3,4 This means that cystoscopy will falsely reassure the surgeon with normal results in greater than 50% of the cases in which the patient actually has a ureteral injury.
Some larger series call into question the usefulness of cystoscopy as a screening tool, finding that this evaluation is not associated with a decreased rate of delayed genitourinary injury. A recent publication by our group of a series of 39,529 women who underwent benign hysterectomy without procedures directed at incontinence and prolapse recorded in the National Surgical Quality Improvement Program (NSQIP) database between 2015 and 2017 found no difference in the rate of delayed genitourinary injury among women exposed to diagnostic cystoscopy and those who were not.5 These results are consistent with those of the largest systematic review and meta-analysis of 79 studies capturing 41,482 hysterectomies which found universal cystoscopy was not associated with a decreased rate of delayed genitourinary tract injury.6
Another consideration with the use of universal cystoscopy is cost. Although cystoscopy is typically a short procedure, the false positive rate is approximately 2%,2 often leading to additional interventions to evaluate the urinary tract which can be time consuming. In the limited available data regarding operative time, patients who underwent cystoscopy had a median operative time that was 17 minutes longer than it was among patients who did not.5 Moreover, there may be risks associated with this additional bladder instrumentation, evidenced by an increased incidence of urinary tract infection among women undergoing cystoscopy. In a recent cost-effectiveness analysis of cystoscopy at the time of benign hysterectomy, universal cystoscopy was found to add $51.39-$57.86 per case, and the risk of bladder injury would need to exceed 21%-47% and ureteral injury 27%-38% to be cost saving, compared with selective cystoscopy.7 A prior cost-effectiveness analysis concluded that universal cystoscopy is cost effective when the incidence of ureteral injury at the time of hysterectomy exceeds 1.5%-2.0%.8 Given these high thresholds, with a contemporary composite lower–genitourinary tract injury incidence of 0.24%-0.27%, it is unlikely that universal cystoscopy could be considered a cost-saving strategy in the majority of clinical settings.
Potential explanations for these results are many. Intraoperative cystoscopy is likely to be normal in the setting of nonobstructive and thermal injuries, which in the current era of minimally invasive surgery may be more prevalent mechanisms of injury. False positives can occur leading to unnecessary interventions, as well as overdiagnosis of asymptomatic urinary tract injuries that may have resolved spontaneously.9 It has been observed that cystoscopy is performed less frequently when hysterectomy is completed by a high-volume surgeon, which suggests that surgeon skill and experience play a significant role in the usefulness of this evaluation.9
Given these data, what is the best way forward regarding evaluation of the urinary tract at the time of benign hysterectomy? Ultimately, this is a clinical question that should be individualized, taking into account patient and surgical complexity, as well as surgeon training and individual rates of genitourinary injuries.9 Given its low sensitivity, caution should be exercised regarding the routine use of cystoscopy alone for evaluation of the urinary tract because false negatives occur with significant frequency. Benefits of cystoscopy in a given clinical scenario should be weighed against the risks of longer operative time, increased costs, and increased rate of urinary tract infection. In the absence of clinical scenarios with high rates of genitourinary injury (greater than 5%), selective rather than universal cystoscopy is the preferred strategy.7 Cystoscopy is fundamentally a form of secondary prevention that aims to mitigate damage that has already been done, and is no substitute for primary prevention of genitourinary tract injury itself through thorough knowledge of pelvic anatomy, comfort with retroperitoneal dissection, and awareness of the ureter and bladder at all times.
Dr. Polan is a resident in obstetrics and gynecology at Northwestern University, Chicago. Dr. Barber is an assistant professor of obstetrics and gynecology, specializing in gynecologic oncology, at the university. Neither of them have relevant financial disclosures. Email Dr. Polan and Dr. Barber at [email protected].
References
1. Am J Obstet Gynecol. 2018 Jul;219(1):75-7.
2. Obstet Gynecol. 2009 Jan;113(1):6-10.
3. Obstet Gynecol. 2016 Feb;127(2):369-75.
4. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1278-86.
5. Obstet Gynecol. 2019 May;133(5):888-95.
6. Obstet Gynecol. 2015 Dec;126(6):1161-9.
7. Am J Obstet Gynecol. 2019 Apr;220(4):369.e1-7.
8. Obstet Gynecol. 2001 May;97(5 Pt 1):685-92.
9. Obstet Gynecol. 2012 Dec;120(6):1363-70.
FDA orders companies to cease all sales of transvaginal mesh for POP repair
The mandate came after Boston Scientific and Coloplast failed to provide adequate safety and efficacy information to the federal regulatory body in the wake of a 2016 reclassification to Class III (high-risk) devices, according to an FDA press statement. Both companies were required to submit a premarket approval application to continue marketing the mesh in the United States. Boston Scientific did file two PMAs, one for each of its transvaginal mesh products, but the FDA said the applications did not contain the required efficacy and safety data.
Both companies will have 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
The deadline for submitting premarket approval applications for POP repair with transvaginal mesh was July 5, 2018. Manufacturers that did not file PMAs were required to pull their devices from the market. Those that did could keep selling the mesh while FDA reviewed their PMAs.
Boston Scientific submitted PMAs for its two devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. But in February, the FDA convened an advisory panel to discuss just how to evaluate the safety and efficacy of the products.
To prove efficacy, the panel concluded, transvaginal POP repair with mesh should be better than repair with native tissue at 36 months, and the safety should be superior to repair with native tissue repair. The FDA agreed. However, the submitted premarket approval application did not include these kinds of data. Therefore, the agency declined to approve the devices.
In addition to stopping U.S. sales, FDA has required Boston Scientific and Coloplast to continue safety and efficacy follow-up of all women included in their 522 studies.
Coloplast did not have a press or public statement on its website as of April 16. Boston Scientific did have one.
“Up to 50% of women in the U.S. will suffer from POP during their lives, and we believe these women should have access to safe and effective treatment options,” according to the statement. “As a global leader in the pelvic floor space, we remain steadfast in our commitment to helping women live better and healthier lives. We also remain confident in the benefits and safety of our treatments for POP, and we look forward to continuing to work with the FDA on our PMAs for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, which are currently under review.”
The FDA statement also included advice to women who have had the mesh procedure for POP, and for their physicians
“Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. Women who were planning to have mesh placed transvaginally for the repair of POP should discuss other treatment options with their doctors.”
The Food and Drug Administration’s decision ordering manufacturers to remove mesh for transvaginal repair of prolapse from the market was based on the products’ effectiveness and safety profile, compared with vaginal native tissue repairs. Previous studies have shown that polypropylene mesh for anterior repair had similar or slightly higher success, compared with native tissue repairs. This was not a sufficient benefit considering the potential adverse events that include mesh exposure, and the pelvic pain and dyspareunia associated with using these products. There is no additional benefit of using polypropylene mesh in the posterior compartment.
It would be interesting to review the information provided by manufacturers as part of the premarket approval. What were the primary endpoints for efficacy that were used? What were the rates of complications for mesh exposure, pelvic pain, and dyspareunia? How did the rates of pelvic pain and dyspareunia compare with native tissue repair.
Gynecologic surgeons still have a number of options for treating vaginal prolapse, which include vaginal native tissue repairs, and laparoscopic and abdominal surgeries that involve native tissue or polypropylene mesh. It will be interesting to see how the FDA’s Medical Device Safety action plan will affect future innovations for treating vaginal prolapse, while at the same time providing women and their physicians with products that are safe and effective.
Jose S. Maceda, MD, is a urogynecologist at Axia Women’s Health in King of Prussia, Penn. Dr. Maceda, who was asked to comment on the FDA decision, has no relevant financial disclosures.
The Food and Drug Administration’s decision ordering manufacturers to remove mesh for transvaginal repair of prolapse from the market was based on the products’ effectiveness and safety profile, compared with vaginal native tissue repairs. Previous studies have shown that polypropylene mesh for anterior repair had similar or slightly higher success, compared with native tissue repairs. This was not a sufficient benefit considering the potential adverse events that include mesh exposure, and the pelvic pain and dyspareunia associated with using these products. There is no additional benefit of using polypropylene mesh in the posterior compartment.
It would be interesting to review the information provided by manufacturers as part of the premarket approval. What were the primary endpoints for efficacy that were used? What were the rates of complications for mesh exposure, pelvic pain, and dyspareunia? How did the rates of pelvic pain and dyspareunia compare with native tissue repair.
Gynecologic surgeons still have a number of options for treating vaginal prolapse, which include vaginal native tissue repairs, and laparoscopic and abdominal surgeries that involve native tissue or polypropylene mesh. It will be interesting to see how the FDA’s Medical Device Safety action plan will affect future innovations for treating vaginal prolapse, while at the same time providing women and their physicians with products that are safe and effective.
Jose S. Maceda, MD, is a urogynecologist at Axia Women’s Health in King of Prussia, Penn. Dr. Maceda, who was asked to comment on the FDA decision, has no relevant financial disclosures.
The Food and Drug Administration’s decision ordering manufacturers to remove mesh for transvaginal repair of prolapse from the market was based on the products’ effectiveness and safety profile, compared with vaginal native tissue repairs. Previous studies have shown that polypropylene mesh for anterior repair had similar or slightly higher success, compared with native tissue repairs. This was not a sufficient benefit considering the potential adverse events that include mesh exposure, and the pelvic pain and dyspareunia associated with using these products. There is no additional benefit of using polypropylene mesh in the posterior compartment.
It would be interesting to review the information provided by manufacturers as part of the premarket approval. What were the primary endpoints for efficacy that were used? What were the rates of complications for mesh exposure, pelvic pain, and dyspareunia? How did the rates of pelvic pain and dyspareunia compare with native tissue repair.
Gynecologic surgeons still have a number of options for treating vaginal prolapse, which include vaginal native tissue repairs, and laparoscopic and abdominal surgeries that involve native tissue or polypropylene mesh. It will be interesting to see how the FDA’s Medical Device Safety action plan will affect future innovations for treating vaginal prolapse, while at the same time providing women and their physicians with products that are safe and effective.
Jose S. Maceda, MD, is a urogynecologist at Axia Women’s Health in King of Prussia, Penn. Dr. Maceda, who was asked to comment on the FDA decision, has no relevant financial disclosures.
The mandate came after Boston Scientific and Coloplast failed to provide adequate safety and efficacy information to the federal regulatory body in the wake of a 2016 reclassification to Class III (high-risk) devices, according to an FDA press statement. Both companies were required to submit a premarket approval application to continue marketing the mesh in the United States. Boston Scientific did file two PMAs, one for each of its transvaginal mesh products, but the FDA said the applications did not contain the required efficacy and safety data.
Both companies will have 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
The deadline for submitting premarket approval applications for POP repair with transvaginal mesh was July 5, 2018. Manufacturers that did not file PMAs were required to pull their devices from the market. Those that did could keep selling the mesh while FDA reviewed their PMAs.
Boston Scientific submitted PMAs for its two devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. But in February, the FDA convened an advisory panel to discuss just how to evaluate the safety and efficacy of the products.
To prove efficacy, the panel concluded, transvaginal POP repair with mesh should be better than repair with native tissue at 36 months, and the safety should be superior to repair with native tissue repair. The FDA agreed. However, the submitted premarket approval application did not include these kinds of data. Therefore, the agency declined to approve the devices.
In addition to stopping U.S. sales, FDA has required Boston Scientific and Coloplast to continue safety and efficacy follow-up of all women included in their 522 studies.
Coloplast did not have a press or public statement on its website as of April 16. Boston Scientific did have one.
“Up to 50% of women in the U.S. will suffer from POP during their lives, and we believe these women should have access to safe and effective treatment options,” according to the statement. “As a global leader in the pelvic floor space, we remain steadfast in our commitment to helping women live better and healthier lives. We also remain confident in the benefits and safety of our treatments for POP, and we look forward to continuing to work with the FDA on our PMAs for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, which are currently under review.”
The FDA statement also included advice to women who have had the mesh procedure for POP, and for their physicians
“Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. Women who were planning to have mesh placed transvaginally for the repair of POP should discuss other treatment options with their doctors.”
The mandate came after Boston Scientific and Coloplast failed to provide adequate safety and efficacy information to the federal regulatory body in the wake of a 2016 reclassification to Class III (high-risk) devices, according to an FDA press statement. Both companies were required to submit a premarket approval application to continue marketing the mesh in the United States. Boston Scientific did file two PMAs, one for each of its transvaginal mesh products, but the FDA said the applications did not contain the required efficacy and safety data.
Both companies will have 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
The deadline for submitting premarket approval applications for POP repair with transvaginal mesh was July 5, 2018. Manufacturers that did not file PMAs were required to pull their devices from the market. Those that did could keep selling the mesh while FDA reviewed their PMAs.
Boston Scientific submitted PMAs for its two devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. But in February, the FDA convened an advisory panel to discuss just how to evaluate the safety and efficacy of the products.
To prove efficacy, the panel concluded, transvaginal POP repair with mesh should be better than repair with native tissue at 36 months, and the safety should be superior to repair with native tissue repair. The FDA agreed. However, the submitted premarket approval application did not include these kinds of data. Therefore, the agency declined to approve the devices.
In addition to stopping U.S. sales, FDA has required Boston Scientific and Coloplast to continue safety and efficacy follow-up of all women included in their 522 studies.
Coloplast did not have a press or public statement on its website as of April 16. Boston Scientific did have one.
“Up to 50% of women in the U.S. will suffer from POP during their lives, and we believe these women should have access to safe and effective treatment options,” according to the statement. “As a global leader in the pelvic floor space, we remain steadfast in our commitment to helping women live better and healthier lives. We also remain confident in the benefits and safety of our treatments for POP, and we look forward to continuing to work with the FDA on our PMAs for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, which are currently under review.”
The FDA statement also included advice to women who have had the mesh procedure for POP, and for their physicians
“Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. Women who were planning to have mesh placed transvaginally for the repair of POP should discuss other treatment options with their doctors.”