Gynecology

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Certain factors portend a rockier course for women who have serious obstetric anal sphincter injuries, a cohort study has found.

In the study, known as FORCAST (For Optimal Recovery, Care After Severe Tears), researchers prospectively followed 180 women who sustained a third- or fourth-degree injury during a term vaginal delivery between 2011 and 2013.

Overall, 18% developed a postpartum wound infection, 24% developed postpartum wound breakdown, and 9% developed postpartum depression, Dr. Kimberly Kenton reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

None of a variety of factors assessed independently predicted the development of wound infections. But women had a sharply elevated risk of wound breakdown if they had an operative vaginal delivery (relative risk, 3.07; P = .04), which was mainly via forceps in the cohort, and a sharply elevated risk of postpartum depression if they had a fourth-degree tear (relative risk, 4.59; P = .01).

"Obstetric anal sphincter injury is associated with high rates of wound complications and postpartum depression," she commented. The investigators hope that this new information can be applied to improve outcomes in this patient population, added Dr. Kenton, a urogynecologist and pelvic reconstructive surgeon at Northwestern Memorial Hospital in Chicago.

Session attendee Dr. Rebecca Rogers of the University of New Mexico in Albuquerque said, "I’m wondering how we can use these data to try to influence the pressure on training programs to support forceps delivery with their residencies, because I think we have a growing body of evidence that this can cause serious sequelae for our patients."

"The Accreditation Council for Graduate Medical Education still tracks forceps and vacuum deliveries, but then they collapse them into a combined category," Dr. Kenton replied. "So [a training program] won’t get a citation as long as you have the right number of operative vaginal deliveries, but it can be either forceps or vacuum."

Attendee Dr. Mikio Nihira of the University of Oklahoma in Oklahoma City noted that he and his colleagues are also studying severe perineal lacerations after obstetric delivery. "One finding that I found very interesting about your presentation was this association with depression, because we are getting this feeling when we work with these patients that it may actually interfere with their bonding with their children," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

"Anecdotally, based on my clinical experience, I think that makes a lot of sense," Dr. Kenton commented. "I have seen a lot of these women and had to take a lot of them back to the OR. When you finally see them back 3 or 4 months later when they are healed, one of the first things they tell you is how much better they are doing and how they can finally get on with their lives and enjoy their baby."

Attendee Dr. Carl Zimmerman, director of female pelvic medicine and reconstructive surgery at Vanderbilt University in Nashville, asked which service repaired the lacerations.

"We have actively reached out to the obstetrical service and invited them to consult us for severe lacerations – sulcus tears, fourth degrees, and so on. And we believe that it has resulted in a better initial repair," he commented.

Dr. Kenton said that the obstetric service performed the laceration repairs and noted that practice variation may have some role in outcomes. "One of the biggest things that we have found is, surprisingly, nobody gives antibiotics around the time of the third- or fourth-degree tear. So maybe there is room for obtaining some level 1 evidence about randomizing women to antibiotics or no antibiotics to see if that would improve healing rates," she commented.

"Right, there are multiple things that just haven’t been looked at here," Dr. Zimmerman agreed. "And this really seems like a window of opportunity to address some of these issues at the front end rather than waiting till 20 or 30 years down the road."

Providing some background to the research, Dr. Kenton noted that each year, about 37,500 women in the United States develop anal incontinence after experiencing sphincter injury during childbirth, underscoring the importance of this complication.

The women in FORCAST had clinical follow-up in the urogynecology clinic at 1, 2, 6, and 12 weeks post partum and annually thereafter, with perineal evaluation, completion of the Patient Health Questionnaire as a depression screen, and assessment of pain on a visual analog scale.

On average, they were 32 years old and had a body mass index of 29 kg/m², according to Dr. Kenton. The majority were primiparous (87%) and had an operative delivery (72%).

In addition to identifying operative delivery as a risk factor for wound breakdown and identifying fourth-degree tear as a risk factor for depression, analyses showed that the women experiencing wound infection or breakdown had significantly higher levels of pain than did peers with an intact perineum (mean, 35 vs. 23 points on a scale from 0 to 100; P = .03).

Dr. Kenton disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The number of apical pelvic organ prolapse repairs done each year in the United States has increased, but less invasive approaches have become the norm, a cross-sectional study spanning a 15-year period found.

Using data from the Medstat MarketScan database, which captures information on commercially insured individuals, researchers identified 53,980 women aged 18-65 years who underwent surgery for apical prolapse between 1996 and 2010.

The results showed that the number of procedures done each year rose steadily during the study period, first author Dr. Vani Dandolu reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

At the same time, there was a decrease in the proportion of procedures done abdominally, from 49% to 12%, and increases in the proportions done laparoscopically (including robotically), from 0% to 21%, and done vaginally, from 51% to 67%.

Among all vaginal procedures, the proportion in which mesh was used increased steadily after its approval in 2002, peaked in 2007, and fell thereafter with the first safety warning about this product by the Food and Drug Administration in 2008. As of 2010, about 18% of vaginal procedures were done with mesh.

"Surgical advances have brought new evolution in the repair of apical prolapse in the past decade," commented Dr. Dandolu, who is professor and chair of obstetrics and gynecology at the University of Nevada in Las Vegas. "Up until 2002, the data was fairly simple: About half the procedures performed were open sacrocolpopexies, and the other half were extraperitoneal vaginal suspensions, mainly sacrospinous fixations. Things changed in the second half of the study period – it became more complex, there was more variety of procedures.

"The proportion of abdominal sacrocolpopexies decreased sharply between 1996 and 2010. This corresponded to an increase in laparoscopic sacrocolpopexy and vaginal procedures, as well as the mesh repairs," she said.

A key advantage of the MarketScan database over other national databases is its high-quality coding, which permits precise categorization of the various types of prolapse repair, noted Dr. Dandolu.

"When you are looking at procedures, probably this is the most robust dataset because it gathers information both from the providers as well as the facilities. The providers typically record the procedures based on CPT [Current Procedural Terminology] procedure codes that are more precise than the facilities’ report based on ICD [International Classification of Diseases] procedure codes," she added.

Session attendee Dr. William Hurd of the Duke Fertility Center in Durham, N.C., asked, "Do you think the increased number of procedures is related to the aging population or to more people trained to do these procedures?"

"I think it’s a combination of several things – the two factors you mentioned, as well as more and more commercial insurers are reporting data into this dataset," Dr. Dandolu replied.

Attendee Dr. John Riggs of the University of Texas in Houston wondered if the CPT codes had changed in any way during the study period.

"The CPT codes for the laparoscopic sacrocolpopexies were introduced around 2003 and the mesh codes were introduced around 2005," Dr. Dandolu replied. "Otherwise, for the traditional procedures, the CPT procedural codes have not changed."

Finally, attendee Dr. Lisa Peacock of Louisiana State University Health Sciences Center in New Orleans asked, "Could you tell in your increase in laparoscopic procedures what proportion of that may be robotic?"

That information was not available as the database did not split out the robotic procedures until 2011, Dr. Dandolu said at the meeting, which was jointly sponsored by the American College of Surgeons.

Dr. Dandolu reported no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The number of apical pelvic organ prolapse repairs done each year in the United States has increased, but less invasive approaches have become the norm, a cross-sectional study spanning a 15-year period found.

Using data from the Medstat MarketScan database, which captures information on commercially insured individuals, researchers identified 53,980 women aged 18-65 years who underwent surgery for apical prolapse between 1996 and 2010.

The results showed that the number of procedures done each year rose steadily during the study period, first author Dr. Vani Dandolu reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

At the same time, there was a decrease in the proportion of procedures done abdominally, from 49% to 12%, and increases in the proportions done laparoscopically (including robotically), from 0% to 21%, and done vaginally, from 51% to 67%.

Among all vaginal procedures, the proportion in which mesh was used increased steadily after its approval in 2002, peaked in 2007, and fell thereafter with the first safety warning about this product by the Food and Drug Administration in 2008. As of 2010, about 18% of vaginal procedures were done with mesh.

"Surgical advances have brought new evolution in the repair of apical prolapse in the past decade," commented Dr. Dandolu, who is professor and chair of obstetrics and gynecology at the University of Nevada in Las Vegas. "Up until 2002, the data was fairly simple: About half the procedures performed were open sacrocolpopexies, and the other half were extraperitoneal vaginal suspensions, mainly sacrospinous fixations. Things changed in the second half of the study period – it became more complex, there was more variety of procedures.

"The proportion of abdominal sacrocolpopexies decreased sharply between 1996 and 2010. This corresponded to an increase in laparoscopic sacrocolpopexy and vaginal procedures, as well as the mesh repairs," she said.

A key advantage of the MarketScan database over other national databases is its high-quality coding, which permits precise categorization of the various types of prolapse repair, noted Dr. Dandolu.

"When you are looking at procedures, probably this is the most robust dataset because it gathers information both from the providers as well as the facilities. The providers typically record the procedures based on CPT [Current Procedural Terminology] procedure codes that are more precise than the facilities’ report based on ICD [International Classification of Diseases] procedure codes," she added.

Session attendee Dr. William Hurd of the Duke Fertility Center in Durham, N.C., asked, "Do you think the increased number of procedures is related to the aging population or to more people trained to do these procedures?"

"I think it’s a combination of several things – the two factors you mentioned, as well as more and more commercial insurers are reporting data into this dataset," Dr. Dandolu replied.

Attendee Dr. John Riggs of the University of Texas in Houston wondered if the CPT codes had changed in any way during the study period.

"The CPT codes for the laparoscopic sacrocolpopexies were introduced around 2003 and the mesh codes were introduced around 2005," Dr. Dandolu replied. "Otherwise, for the traditional procedures, the CPT procedural codes have not changed."

Finally, attendee Dr. Lisa Peacock of Louisiana State University Health Sciences Center in New Orleans asked, "Could you tell in your increase in laparoscopic procedures what proportion of that may be robotic?"

That information was not available as the database did not split out the robotic procedures until 2011, Dr. Dandolu said at the meeting, which was jointly sponsored by the American College of Surgeons.

Dr. Dandolu reported no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The number of apical pelvic organ prolapse repairs done each year in the United States has increased, but less invasive approaches have become the norm, a cross-sectional study spanning a 15-year period found.

Using data from the Medstat MarketScan database, which captures information on commercially insured individuals, researchers identified 53,980 women aged 18-65 years who underwent surgery for apical prolapse between 1996 and 2010.

The results showed that the number of procedures done each year rose steadily during the study period, first author Dr. Vani Dandolu reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

At the same time, there was a decrease in the proportion of procedures done abdominally, from 49% to 12%, and increases in the proportions done laparoscopically (including robotically), from 0% to 21%, and done vaginally, from 51% to 67%.

Among all vaginal procedures, the proportion in which mesh was used increased steadily after its approval in 2002, peaked in 2007, and fell thereafter with the first safety warning about this product by the Food and Drug Administration in 2008. As of 2010, about 18% of vaginal procedures were done with mesh.

"Surgical advances have brought new evolution in the repair of apical prolapse in the past decade," commented Dr. Dandolu, who is professor and chair of obstetrics and gynecology at the University of Nevada in Las Vegas. "Up until 2002, the data was fairly simple: About half the procedures performed were open sacrocolpopexies, and the other half were extraperitoneal vaginal suspensions, mainly sacrospinous fixations. Things changed in the second half of the study period – it became more complex, there was more variety of procedures.

"The proportion of abdominal sacrocolpopexies decreased sharply between 1996 and 2010. This corresponded to an increase in laparoscopic sacrocolpopexy and vaginal procedures, as well as the mesh repairs," she said.

A key advantage of the MarketScan database over other national databases is its high-quality coding, which permits precise categorization of the various types of prolapse repair, noted Dr. Dandolu.

"When you are looking at procedures, probably this is the most robust dataset because it gathers information both from the providers as well as the facilities. The providers typically record the procedures based on CPT [Current Procedural Terminology] procedure codes that are more precise than the facilities’ report based on ICD [International Classification of Diseases] procedure codes," she added.

Session attendee Dr. William Hurd of the Duke Fertility Center in Durham, N.C., asked, "Do you think the increased number of procedures is related to the aging population or to more people trained to do these procedures?"

"I think it’s a combination of several things – the two factors you mentioned, as well as more and more commercial insurers are reporting data into this dataset," Dr. Dandolu replied.

Attendee Dr. John Riggs of the University of Texas in Houston wondered if the CPT codes had changed in any way during the study period.

"The CPT codes for the laparoscopic sacrocolpopexies were introduced around 2003 and the mesh codes were introduced around 2005," Dr. Dandolu replied. "Otherwise, for the traditional procedures, the CPT procedural codes have not changed."

Finally, attendee Dr. Lisa Peacock of Louisiana State University Health Sciences Center in New Orleans asked, "Could you tell in your increase in laparoscopic procedures what proportion of that may be robotic?"

That information was not available as the database did not split out the robotic procedures until 2011, Dr. Dandolu said at the meeting, which was jointly sponsored by the American College of Surgeons.

Dr. Dandolu reported no relevant conflicts of interest.

The use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in the estimated 1 in 350 women with an unsuspected sarcoma, the Food and Drug Administration announced on April 17.

Based on an analysis of currently available data, the FDA has determined that the practice "poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcoma, beyond the uterus," Dr. William Maisel said during a press briefing. Physicians should discuss alternative treatment options with women who have symptomatic uterine fibroids, including the risks and benefits of those options, according to the FDA recommendations. The agency did not ban the use of the devices.

If, after "careful consideration of the benefits and risks," power morcellation is considered the best option, health care providers should inform the patient that "their fibroid may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis," said Dr. Maisel, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health.

The recommendationis based on the FDA’s analysis of currently available literature, conducted in response to approximately 12 reports to the FDA of women whose cancer had spread as a result of morcellation for fibroids, and a high profile case in the media. The analysis came up with the estimate that 1 in every 350 women who undergo a hysterectomy or myomectomy for uterine fibroids have a uterine sarcoma, which Dr. Maisel noted is higher than previous estimates in the medical literature and community, which have ranged from 1 in 500 to 1 in 10,000 cases.

While specimen bags may contain tissue during morcellation, Dr. Maisel said this approach is not "a panacea," and does not completely mitigate the risk. Bags can tear or obstruct the view of the operative field and have been associated with rare reports of uterine damage, he added.

The FDA is asking morcellator manufacturers to review the product labeling to ensure that these warnings are included and will hold a public meeting this summer of the agency’s Obstetrics and Gynecology Devices advisory committee to review the evidence on risks and whether it is possible to reduce those risks. The panel will not be asked to recommend whether the devices should be taken off the market, Dr. Maisel said.

The first power morcellator was cleared for marketing in 1995; approximately 24 devices are currently marketed for laparoscopic power morcellations for gynecologic indications, according to the FDA. They are considered class II "moderate risk" devices and were cleared for use based on older devices that were already on the market, such as electrosurgical cutting devices, Dr. Maisel said.

In an interview, Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said that prior to the focus on this risk, resulting from the media attention, a patient who was going to have a supracervical laparoscopic hysterectomy may not have been informed about the need to morcellate. But the increased focus on the issue and the FDA announcement has opened up the line of communication about morcellation between physicians and their patients "and enables physicians to enhance their discussions with their patients about risk," he said.

"Then it becomes a decision between the physician and patient about what risk is warranted, which is no different than any other surgical procedure." Another positive outcome of this announcement is that it may lead to more collaboration between leaders in the field of minimally invasive surgery and device manufacturers to developing innovations that improve the safety of minimally invasive procedures, he added.

Dr. Jaspan said he had no disclosures.

emechcatie@frontlinemedcom.com

The use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in the estimated 1 in 350 women with an unsuspected sarcoma, the Food and Drug Administration announced on April 17.

Based on an analysis of currently available data, the FDA has determined that the practice "poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcoma, beyond the uterus," Dr. William Maisel said during a press briefing. Physicians should discuss alternative treatment options with women who have symptomatic uterine fibroids, including the risks and benefits of those options, according to the FDA recommendations. The agency did not ban the use of the devices.

If, after "careful consideration of the benefits and risks," power morcellation is considered the best option, health care providers should inform the patient that "their fibroid may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis," said Dr. Maisel, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health.

The recommendationis based on the FDA’s analysis of currently available literature, conducted in response to approximately 12 reports to the FDA of women whose cancer had spread as a result of morcellation for fibroids, and a high profile case in the media. The analysis came up with the estimate that 1 in every 350 women who undergo a hysterectomy or myomectomy for uterine fibroids have a uterine sarcoma, which Dr. Maisel noted is higher than previous estimates in the medical literature and community, which have ranged from 1 in 500 to 1 in 10,000 cases.

While specimen bags may contain tissue during morcellation, Dr. Maisel said this approach is not "a panacea," and does not completely mitigate the risk. Bags can tear or obstruct the view of the operative field and have been associated with rare reports of uterine damage, he added.

The FDA is asking morcellator manufacturers to review the product labeling to ensure that these warnings are included and will hold a public meeting this summer of the agency’s Obstetrics and Gynecology Devices advisory committee to review the evidence on risks and whether it is possible to reduce those risks. The panel will not be asked to recommend whether the devices should be taken off the market, Dr. Maisel said.

The first power morcellator was cleared for marketing in 1995; approximately 24 devices are currently marketed for laparoscopic power morcellations for gynecologic indications, according to the FDA. They are considered class II "moderate risk" devices and were cleared for use based on older devices that were already on the market, such as electrosurgical cutting devices, Dr. Maisel said.

In an interview, Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said that prior to the focus on this risk, resulting from the media attention, a patient who was going to have a supracervical laparoscopic hysterectomy may not have been informed about the need to morcellate. But the increased focus on the issue and the FDA announcement has opened up the line of communication about morcellation between physicians and their patients "and enables physicians to enhance their discussions with their patients about risk," he said.

"Then it becomes a decision between the physician and patient about what risk is warranted, which is no different than any other surgical procedure." Another positive outcome of this announcement is that it may lead to more collaboration between leaders in the field of minimally invasive surgery and device manufacturers to developing innovations that improve the safety of minimally invasive procedures, he added.

Dr. Jaspan said he had no disclosures.

emechcatie@frontlinemedcom.com

The use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in the estimated 1 in 350 women with an unsuspected sarcoma, the Food and Drug Administration announced on April 17.

Based on an analysis of currently available data, the FDA has determined that the practice "poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcoma, beyond the uterus," Dr. William Maisel said during a press briefing. Physicians should discuss alternative treatment options with women who have symptomatic uterine fibroids, including the risks and benefits of those options, according to the FDA recommendations. The agency did not ban the use of the devices.

If, after "careful consideration of the benefits and risks," power morcellation is considered the best option, health care providers should inform the patient that "their fibroid may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis," said Dr. Maisel, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health.

The recommendationis based on the FDA’s analysis of currently available literature, conducted in response to approximately 12 reports to the FDA of women whose cancer had spread as a result of morcellation for fibroids, and a high profile case in the media. The analysis came up with the estimate that 1 in every 350 women who undergo a hysterectomy or myomectomy for uterine fibroids have a uterine sarcoma, which Dr. Maisel noted is higher than previous estimates in the medical literature and community, which have ranged from 1 in 500 to 1 in 10,000 cases.

While specimen bags may contain tissue during morcellation, Dr. Maisel said this approach is not "a panacea," and does not completely mitigate the risk. Bags can tear or obstruct the view of the operative field and have been associated with rare reports of uterine damage, he added.

The FDA is asking morcellator manufacturers to review the product labeling to ensure that these warnings are included and will hold a public meeting this summer of the agency’s Obstetrics and Gynecology Devices advisory committee to review the evidence on risks and whether it is possible to reduce those risks. The panel will not be asked to recommend whether the devices should be taken off the market, Dr. Maisel said.

The first power morcellator was cleared for marketing in 1995; approximately 24 devices are currently marketed for laparoscopic power morcellations for gynecologic indications, according to the FDA. They are considered class II "moderate risk" devices and were cleared for use based on older devices that were already on the market, such as electrosurgical cutting devices, Dr. Maisel said.

In an interview, Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said that prior to the focus on this risk, resulting from the media attention, a patient who was going to have a supracervical laparoscopic hysterectomy may not have been informed about the need to morcellate. But the increased focus on the issue and the FDA announcement has opened up the line of communication about morcellation between physicians and their patients "and enables physicians to enhance their discussions with their patients about risk," he said.

"Then it becomes a decision between the physician and patient about what risk is warranted, which is no different than any other surgical procedure." Another positive outcome of this announcement is that it may lead to more collaboration between leaders in the field of minimally invasive surgery and device manufacturers to developing innovations that improve the safety of minimally invasive procedures, he added.

Dr. Jaspan said he had no disclosures.

emechcatie@frontlinemedcom.com

Researchers have successfully engineered human tissue from autologous tissue for the reconstruction of nasal alar lobules in one first-in-human trial while investigators in separate study were able to engineer and implant vaginas in young women with congenital aplagia.

The results move human tissue engineering closer to one day becoming mainstream health care, according to an editorial accompanying the two studies published in the Lancet.

© Ivan Martin

"Progression from first-in-human experiences in only a few patients ... to a full integration into health systems involves many steps, and is often an uphill struggle," according to Dr. Martin A. Birchall, professor of laryngology at University College London, and Alexander M. Seifalian, Ph.D., professor of nanotechnology and regenerative medicine at the same institution, in an editorial on both studies (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60533-X]). However, because the human tissue engineering field is not unique in its need for larger trials and long-term follow-up to show efficacy in larger patient cohorts, further progress might be facilitated by the fact that "many countries now have large translational income streams, engaged biotech companies, and streamlined regulatory processes that might lower these barriers."

The two studies achieve three important milestones in the field of human tissue engineering, according to Dr. Birchall and Dr. Seifalian. They provide evidence that when biological scaffolds with or without cells are placed in the body, native tissue will grow in its place rather than scar tissue. And this can be achieved in pediatric populations.

The third – and possibly most important – milestone is that implanting large-scale engineered tissue is possible, since in situ angiogenesis was found to be adequate in the vaginal vaults constructed and implanted in the second study, wrote Dr. Birchall and Dr. Seifalian. The findings help to "edge tissue engineering towards the mainstream of organ and tissue replacement needs," they said.

For the nasal reconstruction study, researchers used nasal septum cartilage cells from each of the five study participants to grow and shape cartilage grafts, which were then implanted in the respective patients whose alar lobule had been badly damaged by treatment for nonmelanoma skin cancer, according to Dr. Ilario Fulco and his associates in the departments of surgery and regenerative medicine at the University of Basel in Switzerland (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60544-4]).

Growth factor was used to expand the cells over the course of 2 weeks before they were seeded onto collagen membranes and cultured for another 2 weeks, until they grew into cartilage that was 40 times larger than the original biopsy. The cartilage was then shaped to fit the defect and was implanted.

At 1-year follow-up, all five reconstruction recipients reported they were satisfied with their ability to breathe, were happy with the look of their nose, and had not experienced any relevant adverse events.

"The engineered cartilage had clinical results comparable to the gold standard cartilage graft surgery," said Dr. Fulco. "This new technique could help the body accept the new tissue more easily, and improve the stability and functionality of the nostril."

Wake Forest Institute for Regenerative Medicine

Currently, for this kind of reconstruction, grafts are made using cartilage excised from the nasal septum, ear, or rib, which is painful and requires additional surgery, often fraught with complications.

The second study dealt with four female patients, who had congenital vaginal aplagia. The investigators fashioned vaginal vaults from smooth muscle and vaginal epithelial cells taken from the patients’ own vulvar tissues and grown on vagina-shaped biodegradable scaffolds. The engineered vaults then were transplanted into each of the young women, who were aged 13-18 years at the time of surgery, according to Dr. Atlántida M. Raya-Rivera, a professor of bioengineering at the Metropolitan Autonomous University, Mexico City, and her associates.

At 8 years’ follow-up, all the vaginas were determined to be structurally and functionally normal. At that time, all four women reported that they were sexually active; were satisfied with their desire, arousal, lubrication, and orgasm; and did not experience pain during intercourse.

"Yearly tissue biopsy samples show that the reconstructed tissue is histologically and functionally similar to normal vaginal tissue," noted Dr. Raya-Rivera. The results mean that this method is a "viable" alternative to current vaginal reconstructive techniques because it requires only a small tissue sample and can help avoid the complications inherent when using nonvaginal tissue such as from the large intestine or skin; the complications include infections or grafts that shrink, she noted (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60542-0]).

Wake Forest Institute for Regenerative Medicine

"With the syndrome these women have, both the uterus and vagina can be missing or malformed. In this study, two of the patients were born with uteri, and there is potential for them to have children," Dr. Raya-Rivera said in an interview.

In both studies, the authors wrote respectively that further "fundamental studies" and "clinical experience" are warranted. Dr. Birchall and Dr. Seifalian concluded that the two studies show that "disruptive innovation might be nigh."

Funding for the study led by Dr. Fulco was provided by the department of surgery, University Hospital Basel, and Krebsliga bedier Basel; funding for the study led by Dr. Raya-Rivera was provided by Wake Forest University and Hospital Infantil de Mexico Federico Gomez. None of the researchers associated with the studies or the commentary reported having any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

Researchers have successfully engineered human tissue from autologous tissue for the reconstruction of nasal alar lobules in one first-in-human trial while investigators in separate study were able to engineer and implant vaginas in young women with congenital aplagia.

The results move human tissue engineering closer to one day becoming mainstream health care, according to an editorial accompanying the two studies published in the Lancet.

© Ivan Martin

"Progression from first-in-human experiences in only a few patients ... to a full integration into health systems involves many steps, and is often an uphill struggle," according to Dr. Martin A. Birchall, professor of laryngology at University College London, and Alexander M. Seifalian, Ph.D., professor of nanotechnology and regenerative medicine at the same institution, in an editorial on both studies (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60533-X]). However, because the human tissue engineering field is not unique in its need for larger trials and long-term follow-up to show efficacy in larger patient cohorts, further progress might be facilitated by the fact that "many countries now have large translational income streams, engaged biotech companies, and streamlined regulatory processes that might lower these barriers."

The two studies achieve three important milestones in the field of human tissue engineering, according to Dr. Birchall and Dr. Seifalian. They provide evidence that when biological scaffolds with or without cells are placed in the body, native tissue will grow in its place rather than scar tissue. And this can be achieved in pediatric populations.

The third – and possibly most important – milestone is that implanting large-scale engineered tissue is possible, since in situ angiogenesis was found to be adequate in the vaginal vaults constructed and implanted in the second study, wrote Dr. Birchall and Dr. Seifalian. The findings help to "edge tissue engineering towards the mainstream of organ and tissue replacement needs," they said.

For the nasal reconstruction study, researchers used nasal septum cartilage cells from each of the five study participants to grow and shape cartilage grafts, which were then implanted in the respective patients whose alar lobule had been badly damaged by treatment for nonmelanoma skin cancer, according to Dr. Ilario Fulco and his associates in the departments of surgery and regenerative medicine at the University of Basel in Switzerland (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60544-4]).

Growth factor was used to expand the cells over the course of 2 weeks before they were seeded onto collagen membranes and cultured for another 2 weeks, until they grew into cartilage that was 40 times larger than the original biopsy. The cartilage was then shaped to fit the defect and was implanted.

At 1-year follow-up, all five reconstruction recipients reported they were satisfied with their ability to breathe, were happy with the look of their nose, and had not experienced any relevant adverse events.

"The engineered cartilage had clinical results comparable to the gold standard cartilage graft surgery," said Dr. Fulco. "This new technique could help the body accept the new tissue more easily, and improve the stability and functionality of the nostril."

Wake Forest Institute for Regenerative Medicine

Currently, for this kind of reconstruction, grafts are made using cartilage excised from the nasal septum, ear, or rib, which is painful and requires additional surgery, often fraught with complications.

The second study dealt with four female patients, who had congenital vaginal aplagia. The investigators fashioned vaginal vaults from smooth muscle and vaginal epithelial cells taken from the patients’ own vulvar tissues and grown on vagina-shaped biodegradable scaffolds. The engineered vaults then were transplanted into each of the young women, who were aged 13-18 years at the time of surgery, according to Dr. Atlántida M. Raya-Rivera, a professor of bioengineering at the Metropolitan Autonomous University, Mexico City, and her associates.

At 8 years’ follow-up, all the vaginas were determined to be structurally and functionally normal. At that time, all four women reported that they were sexually active; were satisfied with their desire, arousal, lubrication, and orgasm; and did not experience pain during intercourse.

"Yearly tissue biopsy samples show that the reconstructed tissue is histologically and functionally similar to normal vaginal tissue," noted Dr. Raya-Rivera. The results mean that this method is a "viable" alternative to current vaginal reconstructive techniques because it requires only a small tissue sample and can help avoid the complications inherent when using nonvaginal tissue such as from the large intestine or skin; the complications include infections or grafts that shrink, she noted (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60542-0]).

Wake Forest Institute for Regenerative Medicine

"With the syndrome these women have, both the uterus and vagina can be missing or malformed. In this study, two of the patients were born with uteri, and there is potential for them to have children," Dr. Raya-Rivera said in an interview.

In both studies, the authors wrote respectively that further "fundamental studies" and "clinical experience" are warranted. Dr. Birchall and Dr. Seifalian concluded that the two studies show that "disruptive innovation might be nigh."

Funding for the study led by Dr. Fulco was provided by the department of surgery, University Hospital Basel, and Krebsliga bedier Basel; funding for the study led by Dr. Raya-Rivera was provided by Wake Forest University and Hospital Infantil de Mexico Federico Gomez. None of the researchers associated with the studies or the commentary reported having any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

Researchers have successfully engineered human tissue from autologous tissue for the reconstruction of nasal alar lobules in one first-in-human trial while investigators in separate study were able to engineer and implant vaginas in young women with congenital aplagia.

The results move human tissue engineering closer to one day becoming mainstream health care, according to an editorial accompanying the two studies published in the Lancet.

© Ivan Martin

"Progression from first-in-human experiences in only a few patients ... to a full integration into health systems involves many steps, and is often an uphill struggle," according to Dr. Martin A. Birchall, professor of laryngology at University College London, and Alexander M. Seifalian, Ph.D., professor of nanotechnology and regenerative medicine at the same institution, in an editorial on both studies (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60533-X]). However, because the human tissue engineering field is not unique in its need for larger trials and long-term follow-up to show efficacy in larger patient cohorts, further progress might be facilitated by the fact that "many countries now have large translational income streams, engaged biotech companies, and streamlined regulatory processes that might lower these barriers."

The two studies achieve three important milestones in the field of human tissue engineering, according to Dr. Birchall and Dr. Seifalian. They provide evidence that when biological scaffolds with or without cells are placed in the body, native tissue will grow in its place rather than scar tissue. And this can be achieved in pediatric populations.

The third – and possibly most important – milestone is that implanting large-scale engineered tissue is possible, since in situ angiogenesis was found to be adequate in the vaginal vaults constructed and implanted in the second study, wrote Dr. Birchall and Dr. Seifalian. The findings help to "edge tissue engineering towards the mainstream of organ and tissue replacement needs," they said.

For the nasal reconstruction study, researchers used nasal septum cartilage cells from each of the five study participants to grow and shape cartilage grafts, which were then implanted in the respective patients whose alar lobule had been badly damaged by treatment for nonmelanoma skin cancer, according to Dr. Ilario Fulco and his associates in the departments of surgery and regenerative medicine at the University of Basel in Switzerland (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60544-4]).

Growth factor was used to expand the cells over the course of 2 weeks before they were seeded onto collagen membranes and cultured for another 2 weeks, until they grew into cartilage that was 40 times larger than the original biopsy. The cartilage was then shaped to fit the defect and was implanted.

At 1-year follow-up, all five reconstruction recipients reported they were satisfied with their ability to breathe, were happy with the look of their nose, and had not experienced any relevant adverse events.

"The engineered cartilage had clinical results comparable to the gold standard cartilage graft surgery," said Dr. Fulco. "This new technique could help the body accept the new tissue more easily, and improve the stability and functionality of the nostril."

Wake Forest Institute for Regenerative Medicine

Currently, for this kind of reconstruction, grafts are made using cartilage excised from the nasal septum, ear, or rib, which is painful and requires additional surgery, often fraught with complications.

The second study dealt with four female patients, who had congenital vaginal aplagia. The investigators fashioned vaginal vaults from smooth muscle and vaginal epithelial cells taken from the patients’ own vulvar tissues and grown on vagina-shaped biodegradable scaffolds. The engineered vaults then were transplanted into each of the young women, who were aged 13-18 years at the time of surgery, according to Dr. Atlántida M. Raya-Rivera, a professor of bioengineering at the Metropolitan Autonomous University, Mexico City, and her associates.

At 8 years’ follow-up, all the vaginas were determined to be structurally and functionally normal. At that time, all four women reported that they were sexually active; were satisfied with their desire, arousal, lubrication, and orgasm; and did not experience pain during intercourse.

"Yearly tissue biopsy samples show that the reconstructed tissue is histologically and functionally similar to normal vaginal tissue," noted Dr. Raya-Rivera. The results mean that this method is a "viable" alternative to current vaginal reconstructive techniques because it requires only a small tissue sample and can help avoid the complications inherent when using nonvaginal tissue such as from the large intestine or skin; the complications include infections or grafts that shrink, she noted (Lancet 2014 April 11 [doi: 10.1016/S0140-6736(14)60542-0]).

Wake Forest Institute for Regenerative Medicine

"With the syndrome these women have, both the uterus and vagina can be missing or malformed. In this study, two of the patients were born with uteri, and there is potential for them to have children," Dr. Raya-Rivera said in an interview.

In both studies, the authors wrote respectively that further "fundamental studies" and "clinical experience" are warranted. Dr. Birchall and Dr. Seifalian concluded that the two studies show that "disruptive innovation might be nigh."

Funding for the study led by Dr. Fulco was provided by the department of surgery, University Hospital Basel, and Krebsliga bedier Basel; funding for the study led by Dr. Raya-Rivera was provided by Wake Forest University and Hospital Infantil de Mexico Federico Gomez. None of the researchers associated with the studies or the commentary reported having any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – Applying a paracervical block before laparoscopic supracervical hysterectomy improves some operative outcomes but not others, Dr. Rachel L. Barr said at the annual scientific meeting of the Society of Gynecologic Surgeons.

The 132 women undergoing scheduled ambulatory surgery for presumed benign indications were randomized evenly to receive paracervical injection of bupivacaine plus epinephrine or paracervical injection of normal saline as a placebo control, each in addition to standard anesthesia.

Overall, about one-third of women were admitted to the hospital after the surgery – the trial’s primary outcome – with no significant difference between groups, reported lead investigator Dr. Rachel L. Barr, an obstetrician-gynecologist at Mount Sinai Hospital in New York. The findings were similar when restricted to women admitted specifically for pain management.

The paracervical-block group consumed about one-tenth of a tablet less of narcotics per day after surgery. They also had significantly lower estimated blood loss, although the median value was identical at 100 mL.

"The paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy is recommended to decrease the number of postoperative narcotic tablets consumed. It has the additional benefit of decreased blood loss and was found to be safe," Dr. Barr commented. "However, it was not effective at decreasing admissions for pain control."

"My first question for the authors relates to the clinical vs. statistical significance of the estimated blood loss and its variability in measurement and whether the authors considered using hematocrit in the study design," said invited discussant Dr. Clifford Wai of the division of female pelvic medicine and reconstructive surgery, University of Texas Southwestern Medical Center, Dallas.

The attending surgeon who performed all of the hysterectomies was very experienced, which likely helped achieve fairly low estimated blood loss in general, according to Dr. Barr. "So within this population, maybe the 50-mL difference between the two groups [in interquartile ranges] may not be that clinically significant."

"However, if you were to generalize this to other surgeons who maybe don’t do quite as many laparoscopic supracervical hysterectomies or on average have a higher blood loss, there may be a role for the paracervical block in helping decrease their blood loss, and you may see a larger decrease in blood loss when using the block," she added. "In addition, I think the block can be used as a tool to reduce blood loss in cases where, based on uterine size or pathology, you might predict there would be a higher blood loss, or in patients who have a lower hematocrit to begin with and refuse transfusions; this might decrease their blood loss and improve their recovery."

The investigators did not use hematocrit because they expected many patients to go home after surgery, and they do not routinely obtain a complete blood cell count in the postanesthesia care unit unless there is a clinical indication, she said at the meeting jointly sponsored by the American College of Surgeons.

"My second question is, given the limitations of the study, do the authors feel the conclusions justify a change in clinical practice?" Dr. Wai asked.

"We do now use the paracervical block with bupivacaine and epinephrine for all of our patients prior to laparoscopic supracervical hysterectomy," Dr. Barr replied.

Session attendee Dr. William W. Hurd, professor of obstetrics and gynecology at Duke University, Durham, N.C., and director of the division of reproductive endocrinology and infertility at the Duke Fertility Center, wondered, "Do you think that tiny change in pain medication would be clinically significant?"

"I do," Dr. Barr answered. "Maybe it’s not clinically significant just looking at that one value. But when you are talking to your patients preoperatively and they are asking, ‘Doctor, am I going to be taking tons of narcotics after? Am I going to get addicted?’ I think you can reassure them that over their postoperative course they might only need to take one or two tablets instead of two or three over several days. This might not seem like a lot to us, but I think that difference is reassuring to our patients."

The investigators studied patients undergoing laparoscopic supracervical hysterectomy at Mount Sinai Hospital between 2011 and 2013.

"In designing our study, we had noted that many patients at our institution were staying overnight electively in the hospital for pain management despite otherwise being stable for discharge home following laparoscopic hysterectomy," noted Dr. Barr.

The paracervical injection was performed after intubation but before the uterine manipulator was inserted or the abdominal incision was made. Admission was defined as at least one overnight stay in the hospital.

Results showed that the paracervical block and control groups were statistically indistinguishable with respect to the overall admission rate (41% vs. 28%) and the unplanned admission rate (34% vs. 27%). In the subset with an unplanned admission, 21 women were admitted for pain management: 10 in the paracervical-block group and 11 in the control group.

Use of fentanyl and use of oxycodone while in the postanesthesia care unit did not differ significantly between groups. However, in the first 14 days after surgery, the paracervical block group consumed fewer tablets of narcotics per day (0.58 vs. 0.71) and more tablets of over-the-counter analgesics per day (1.02 vs. 0.77). Mean pain scores during the first 2 postoperative days were essentially the same.

"Maybe the patients who didn’t have the block were using narcotics more to achieve a lower pain score. That’s one way to think about it," Dr. Barr proposed.

The two groups had similar rates of perioperative outcomes such as operative time and complications. Estimated median blood loss was generally low, but significantly lower in the paracervical block group.

"Out of all 132 patients, we only had 7 patients who had a blood loss greater than or equal to 500 mL, and the largest blood loss was 900 mL. Also, there were no transfusions," she pointed out.

Three patients – two in the paracervical block group and one in the control group – developed a cervical infection after surgery. All were successfully treated with oral antibiotics.

"The hysterectomies were all supracervical so the results may not apply to total hysterectomies, and we did not control for additional procedures performed at the same time," Dr. Barr noted.

Dr. Barr disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Applying a paracervical block before laparoscopic supracervical hysterectomy improves some operative outcomes but not others, Dr. Rachel L. Barr said at the annual scientific meeting of the Society of Gynecologic Surgeons.

The 132 women undergoing scheduled ambulatory surgery for presumed benign indications were randomized evenly to receive paracervical injection of bupivacaine plus epinephrine or paracervical injection of normal saline as a placebo control, each in addition to standard anesthesia.

Overall, about one-third of women were admitted to the hospital after the surgery – the trial’s primary outcome – with no significant difference between groups, reported lead investigator Dr. Rachel L. Barr, an obstetrician-gynecologist at Mount Sinai Hospital in New York. The findings were similar when restricted to women admitted specifically for pain management.

The paracervical-block group consumed about one-tenth of a tablet less of narcotics per day after surgery. They also had significantly lower estimated blood loss, although the median value was identical at 100 mL.

"The paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy is recommended to decrease the number of postoperative narcotic tablets consumed. It has the additional benefit of decreased blood loss and was found to be safe," Dr. Barr commented. "However, it was not effective at decreasing admissions for pain control."

"My first question for the authors relates to the clinical vs. statistical significance of the estimated blood loss and its variability in measurement and whether the authors considered using hematocrit in the study design," said invited discussant Dr. Clifford Wai of the division of female pelvic medicine and reconstructive surgery, University of Texas Southwestern Medical Center, Dallas.

The attending surgeon who performed all of the hysterectomies was very experienced, which likely helped achieve fairly low estimated blood loss in general, according to Dr. Barr. "So within this population, maybe the 50-mL difference between the two groups [in interquartile ranges] may not be that clinically significant."

"However, if you were to generalize this to other surgeons who maybe don’t do quite as many laparoscopic supracervical hysterectomies or on average have a higher blood loss, there may be a role for the paracervical block in helping decrease their blood loss, and you may see a larger decrease in blood loss when using the block," she added. "In addition, I think the block can be used as a tool to reduce blood loss in cases where, based on uterine size or pathology, you might predict there would be a higher blood loss, or in patients who have a lower hematocrit to begin with and refuse transfusions; this might decrease their blood loss and improve their recovery."

The investigators did not use hematocrit because they expected many patients to go home after surgery, and they do not routinely obtain a complete blood cell count in the postanesthesia care unit unless there is a clinical indication, she said at the meeting jointly sponsored by the American College of Surgeons.

"My second question is, given the limitations of the study, do the authors feel the conclusions justify a change in clinical practice?" Dr. Wai asked.

"We do now use the paracervical block with bupivacaine and epinephrine for all of our patients prior to laparoscopic supracervical hysterectomy," Dr. Barr replied.

Session attendee Dr. William W. Hurd, professor of obstetrics and gynecology at Duke University, Durham, N.C., and director of the division of reproductive endocrinology and infertility at the Duke Fertility Center, wondered, "Do you think that tiny change in pain medication would be clinically significant?"

"I do," Dr. Barr answered. "Maybe it’s not clinically significant just looking at that one value. But when you are talking to your patients preoperatively and they are asking, ‘Doctor, am I going to be taking tons of narcotics after? Am I going to get addicted?’ I think you can reassure them that over their postoperative course they might only need to take one or two tablets instead of two or three over several days. This might not seem like a lot to us, but I think that difference is reassuring to our patients."

The investigators studied patients undergoing laparoscopic supracervical hysterectomy at Mount Sinai Hospital between 2011 and 2013.

"In designing our study, we had noted that many patients at our institution were staying overnight electively in the hospital for pain management despite otherwise being stable for discharge home following laparoscopic hysterectomy," noted Dr. Barr.

The paracervical injection was performed after intubation but before the uterine manipulator was inserted or the abdominal incision was made. Admission was defined as at least one overnight stay in the hospital.

Results showed that the paracervical block and control groups were statistically indistinguishable with respect to the overall admission rate (41% vs. 28%) and the unplanned admission rate (34% vs. 27%). In the subset with an unplanned admission, 21 women were admitted for pain management: 10 in the paracervical-block group and 11 in the control group.

Use of fentanyl and use of oxycodone while in the postanesthesia care unit did not differ significantly between groups. However, in the first 14 days after surgery, the paracervical block group consumed fewer tablets of narcotics per day (0.58 vs. 0.71) and more tablets of over-the-counter analgesics per day (1.02 vs. 0.77). Mean pain scores during the first 2 postoperative days were essentially the same.

"Maybe the patients who didn’t have the block were using narcotics more to achieve a lower pain score. That’s one way to think about it," Dr. Barr proposed.

The two groups had similar rates of perioperative outcomes such as operative time and complications. Estimated median blood loss was generally low, but significantly lower in the paracervical block group.

"Out of all 132 patients, we only had 7 patients who had a blood loss greater than or equal to 500 mL, and the largest blood loss was 900 mL. Also, there were no transfusions," she pointed out.

Three patients – two in the paracervical block group and one in the control group – developed a cervical infection after surgery. All were successfully treated with oral antibiotics.

"The hysterectomies were all supracervical so the results may not apply to total hysterectomies, and we did not control for additional procedures performed at the same time," Dr. Barr noted.

Dr. Barr disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Applying a paracervical block before laparoscopic supracervical hysterectomy improves some operative outcomes but not others, Dr. Rachel L. Barr said at the annual scientific meeting of the Society of Gynecologic Surgeons.

The 132 women undergoing scheduled ambulatory surgery for presumed benign indications were randomized evenly to receive paracervical injection of bupivacaine plus epinephrine or paracervical injection of normal saline as a placebo control, each in addition to standard anesthesia.

Overall, about one-third of women were admitted to the hospital after the surgery – the trial’s primary outcome – with no significant difference between groups, reported lead investigator Dr. Rachel L. Barr, an obstetrician-gynecologist at Mount Sinai Hospital in New York. The findings were similar when restricted to women admitted specifically for pain management.

The paracervical-block group consumed about one-tenth of a tablet less of narcotics per day after surgery. They also had significantly lower estimated blood loss, although the median value was identical at 100 mL.

"The paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy is recommended to decrease the number of postoperative narcotic tablets consumed. It has the additional benefit of decreased blood loss and was found to be safe," Dr. Barr commented. "However, it was not effective at decreasing admissions for pain control."

"My first question for the authors relates to the clinical vs. statistical significance of the estimated blood loss and its variability in measurement and whether the authors considered using hematocrit in the study design," said invited discussant Dr. Clifford Wai of the division of female pelvic medicine and reconstructive surgery, University of Texas Southwestern Medical Center, Dallas.

The attending surgeon who performed all of the hysterectomies was very experienced, which likely helped achieve fairly low estimated blood loss in general, according to Dr. Barr. "So within this population, maybe the 50-mL difference between the two groups [in interquartile ranges] may not be that clinically significant."

"However, if you were to generalize this to other surgeons who maybe don’t do quite as many laparoscopic supracervical hysterectomies or on average have a higher blood loss, there may be a role for the paracervical block in helping decrease their blood loss, and you may see a larger decrease in blood loss when using the block," she added. "In addition, I think the block can be used as a tool to reduce blood loss in cases where, based on uterine size or pathology, you might predict there would be a higher blood loss, or in patients who have a lower hematocrit to begin with and refuse transfusions; this might decrease their blood loss and improve their recovery."

The investigators did not use hematocrit because they expected many patients to go home after surgery, and they do not routinely obtain a complete blood cell count in the postanesthesia care unit unless there is a clinical indication, she said at the meeting jointly sponsored by the American College of Surgeons.

"My second question is, given the limitations of the study, do the authors feel the conclusions justify a change in clinical practice?" Dr. Wai asked.

"We do now use the paracervical block with bupivacaine and epinephrine for all of our patients prior to laparoscopic supracervical hysterectomy," Dr. Barr replied.

Session attendee Dr. William W. Hurd, professor of obstetrics and gynecology at Duke University, Durham, N.C., and director of the division of reproductive endocrinology and infertility at the Duke Fertility Center, wondered, "Do you think that tiny change in pain medication would be clinically significant?"

"I do," Dr. Barr answered. "Maybe it’s not clinically significant just looking at that one value. But when you are talking to your patients preoperatively and they are asking, ‘Doctor, am I going to be taking tons of narcotics after? Am I going to get addicted?’ I think you can reassure them that over their postoperative course they might only need to take one or two tablets instead of two or three over several days. This might not seem like a lot to us, but I think that difference is reassuring to our patients."

The investigators studied patients undergoing laparoscopic supracervical hysterectomy at Mount Sinai Hospital between 2011 and 2013.

"In designing our study, we had noted that many patients at our institution were staying overnight electively in the hospital for pain management despite otherwise being stable for discharge home following laparoscopic hysterectomy," noted Dr. Barr.

The paracervical injection was performed after intubation but before the uterine manipulator was inserted or the abdominal incision was made. Admission was defined as at least one overnight stay in the hospital.

Results showed that the paracervical block and control groups were statistically indistinguishable with respect to the overall admission rate (41% vs. 28%) and the unplanned admission rate (34% vs. 27%). In the subset with an unplanned admission, 21 women were admitted for pain management: 10 in the paracervical-block group and 11 in the control group.

Use of fentanyl and use of oxycodone while in the postanesthesia care unit did not differ significantly between groups. However, in the first 14 days after surgery, the paracervical block group consumed fewer tablets of narcotics per day (0.58 vs. 0.71) and more tablets of over-the-counter analgesics per day (1.02 vs. 0.77). Mean pain scores during the first 2 postoperative days were essentially the same.

"Maybe the patients who didn’t have the block were using narcotics more to achieve a lower pain score. That’s one way to think about it," Dr. Barr proposed.

The two groups had similar rates of perioperative outcomes such as operative time and complications. Estimated median blood loss was generally low, but significantly lower in the paracervical block group.

"Out of all 132 patients, we only had 7 patients who had a blood loss greater than or equal to 500 mL, and the largest blood loss was 900 mL. Also, there were no transfusions," she pointed out.

Three patients – two in the paracervical block group and one in the control group – developed a cervical infection after surgery. All were successfully treated with oral antibiotics.

"The hysterectomies were all supracervical so the results may not apply to total hysterectomies, and we did not control for additional procedures performed at the same time," Dr. Barr noted.

Dr. Barr disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Using a Foley catheter guide during midurethral sling surgery does not appear to reduce the risk of injury to the bladder and urethra, according to a retrospective study presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

Surgeons used the guide in 24.5% of the 310 women undergoing retropubic midurethral sling surgery, reported first author Dr. Jeannine M. Miranne, an ob.gyn. at Medstar Washington Hospital Center and Georgetown University, Washington.

The rate of cystotomy was 1.3% in the guide group and 5.6% in the no-guide group, a statistically indistinguishable difference and one that remained so even after adjustment for potential confounders. None of the patients studied experienced a urethrotomy.

"Foley catheter guide use does not decrease the risk of intraoperative lower urinary tract injury. However, larger prospective studies are needed to confirm this finding, given the possibility of a type 2 error," Dr. Miranne concluded.

Session attendee Dr. Eric Sokol, an assistant professor of obstetrics and gynecology, and of urology at Stanford (Calif.) University, wondered if injury rates were affected by the specific sling used.

"What I imagine has possibly influenced your results is the fact that you have changed also the sling that you use. As I understand it, you are using a lot of Advantage Fit slings," he said. In his experience in training residents, the bladder is often inadvertently punctured when this sling is used. "When I use other slings, with a rigid handle and a bigger curve, they don’t go in the bladder. So do you think there might be an influence of the exact sling that you are using?"

"There definitely may be an influence," Dr. Miranne replied. "Unfortunately, the majority of physicians in our group used the Advantage Fit sling for approximately 90% of their cases that were included. So it’s really hard to determine whether or not that played a role in the cystotomy rate in our study. But that’s definitely something to consider when you think about cystotomy – the type of retropubic sling."

Another attendee commented that using a Foley catheter guide adds an annoying, time-consuming step to the surgery. "It wasn’t our idea, but we have used the cystoscope shaft, and we will use that to manipulate the urethra. You have to put that in anyway to scope the patient, and it saves a lot of time putting things in and taking them out," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Giving some background to the study, Dr. Miranne said that "synthetic midurethral sling has become a gold-standard surgical procedure for stress urinary incontinence. Different techniques have been introduced to decrease the risk of intraoperative lower urinary tract injury during sling placement. One such technique involves use of a rigid Foley catheter guide during retropubic sling placement."

"Although the manufacturer of the original tension-free vaginal tape continues to recommend Foley catheter guide use in its instructions, it is unclear whether use of this device decreases the risk of intraoperative lower urinary tract injury," she noted.

For the study, the investigators included women undergoing retropubic midurethral sling surgery at a single academic center during 2011 and 2012. They excluded any who underwent autologous bladder neck, transobturator, or mini-/single-incision sling surgery.

On average, the patients were 57 years old and had a body mass index of 28 kg/m², according to Dr. Miranne. Overall, 17% had previously undergone anti-incontinence surgery and 20% had previously undergone prolapse surgery, with no significant difference between groups.

Patients in the no-guide group were more likely to have anterior prolapse (95% vs. 78%) and to have a concomitant prolapse repair (65% vs. 51%). They were less likely to have a resident or fellow as first assistant in the surgery (91% vs. 99%) and to have local retropubic anesthesia (71% vs. 96%). Similar proportions had a concomitant hysterectomy.

In addition to showing no significant difference in injury rates, analyses revealed that the groups were statistically the same with respect to mean intraoperative time; mean blood loss; and mean hospital stay, which was less than 1 day for the entire cohort.

Dr. Miranne disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Using a Foley catheter guide during midurethral sling surgery does not appear to reduce the risk of injury to the bladder and urethra, according to a retrospective study presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

Surgeons used the guide in 24.5% of the 310 women undergoing retropubic midurethral sling surgery, reported first author Dr. Jeannine M. Miranne, an ob.gyn. at Medstar Washington Hospital Center and Georgetown University, Washington.

The rate of cystotomy was 1.3% in the guide group and 5.6% in the no-guide group, a statistically indistinguishable difference and one that remained so even after adjustment for potential confounders. None of the patients studied experienced a urethrotomy.

"Foley catheter guide use does not decrease the risk of intraoperative lower urinary tract injury. However, larger prospective studies are needed to confirm this finding, given the possibility of a type 2 error," Dr. Miranne concluded.

Session attendee Dr. Eric Sokol, an assistant professor of obstetrics and gynecology, and of urology at Stanford (Calif.) University, wondered if injury rates were affected by the specific sling used.

"What I imagine has possibly influenced your results is the fact that you have changed also the sling that you use. As I understand it, you are using a lot of Advantage Fit slings," he said. In his experience in training residents, the bladder is often inadvertently punctured when this sling is used. "When I use other slings, with a rigid handle and a bigger curve, they don’t go in the bladder. So do you think there might be an influence of the exact sling that you are using?"

"There definitely may be an influence," Dr. Miranne replied. "Unfortunately, the majority of physicians in our group used the Advantage Fit sling for approximately 90% of their cases that were included. So it’s really hard to determine whether or not that played a role in the cystotomy rate in our study. But that’s definitely something to consider when you think about cystotomy – the type of retropubic sling."

Another attendee commented that using a Foley catheter guide adds an annoying, time-consuming step to the surgery. "It wasn’t our idea, but we have used the cystoscope shaft, and we will use that to manipulate the urethra. You have to put that in anyway to scope the patient, and it saves a lot of time putting things in and taking them out," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Giving some background to the study, Dr. Miranne said that "synthetic midurethral sling has become a gold-standard surgical procedure for stress urinary incontinence. Different techniques have been introduced to decrease the risk of intraoperative lower urinary tract injury during sling placement. One such technique involves use of a rigid Foley catheter guide during retropubic sling placement."

"Although the manufacturer of the original tension-free vaginal tape continues to recommend Foley catheter guide use in its instructions, it is unclear whether use of this device decreases the risk of intraoperative lower urinary tract injury," she noted.

For the study, the investigators included women undergoing retropubic midurethral sling surgery at a single academic center during 2011 and 2012. They excluded any who underwent autologous bladder neck, transobturator, or mini-/single-incision sling surgery.

On average, the patients were 57 years old and had a body mass index of 28 kg/m², according to Dr. Miranne. Overall, 17% had previously undergone anti-incontinence surgery and 20% had previously undergone prolapse surgery, with no significant difference between groups.

Patients in the no-guide group were more likely to have anterior prolapse (95% vs. 78%) and to have a concomitant prolapse repair (65% vs. 51%). They were less likely to have a resident or fellow as first assistant in the surgery (91% vs. 99%) and to have local retropubic anesthesia (71% vs. 96%). Similar proportions had a concomitant hysterectomy.

In addition to showing no significant difference in injury rates, analyses revealed that the groups were statistically the same with respect to mean intraoperative time; mean blood loss; and mean hospital stay, which was less than 1 day for the entire cohort.

Dr. Miranne disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Using a Foley catheter guide during midurethral sling surgery does not appear to reduce the risk of injury to the bladder and urethra, according to a retrospective study presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

Surgeons used the guide in 24.5% of the 310 women undergoing retropubic midurethral sling surgery, reported first author Dr. Jeannine M. Miranne, an ob.gyn. at Medstar Washington Hospital Center and Georgetown University, Washington.

The rate of cystotomy was 1.3% in the guide group and 5.6% in the no-guide group, a statistically indistinguishable difference and one that remained so even after adjustment for potential confounders. None of the patients studied experienced a urethrotomy.

"Foley catheter guide use does not decrease the risk of intraoperative lower urinary tract injury. However, larger prospective studies are needed to confirm this finding, given the possibility of a type 2 error," Dr. Miranne concluded.

Session attendee Dr. Eric Sokol, an assistant professor of obstetrics and gynecology, and of urology at Stanford (Calif.) University, wondered if injury rates were affected by the specific sling used.

"What I imagine has possibly influenced your results is the fact that you have changed also the sling that you use. As I understand it, you are using a lot of Advantage Fit slings," he said. In his experience in training residents, the bladder is often inadvertently punctured when this sling is used. "When I use other slings, with a rigid handle and a bigger curve, they don’t go in the bladder. So do you think there might be an influence of the exact sling that you are using?"

"There definitely may be an influence," Dr. Miranne replied. "Unfortunately, the majority of physicians in our group used the Advantage Fit sling for approximately 90% of their cases that were included. So it’s really hard to determine whether or not that played a role in the cystotomy rate in our study. But that’s definitely something to consider when you think about cystotomy – the type of retropubic sling."

Another attendee commented that using a Foley catheter guide adds an annoying, time-consuming step to the surgery. "It wasn’t our idea, but we have used the cystoscope shaft, and we will use that to manipulate the urethra. You have to put that in anyway to scope the patient, and it saves a lot of time putting things in and taking them out," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Giving some background to the study, Dr. Miranne said that "synthetic midurethral sling has become a gold-standard surgical procedure for stress urinary incontinence. Different techniques have been introduced to decrease the risk of intraoperative lower urinary tract injury during sling placement. One such technique involves use of a rigid Foley catheter guide during retropubic sling placement."

"Although the manufacturer of the original tension-free vaginal tape continues to recommend Foley catheter guide use in its instructions, it is unclear whether use of this device decreases the risk of intraoperative lower urinary tract injury," she noted.

For the study, the investigators included women undergoing retropubic midurethral sling surgery at a single academic center during 2011 and 2012. They excluded any who underwent autologous bladder neck, transobturator, or mini-/single-incision sling surgery.

On average, the patients were 57 years old and had a body mass index of 28 kg/m², according to Dr. Miranne. Overall, 17% had previously undergone anti-incontinence surgery and 20% had previously undergone prolapse surgery, with no significant difference between groups.

Patients in the no-guide group were more likely to have anterior prolapse (95% vs. 78%) and to have a concomitant prolapse repair (65% vs. 51%). They were less likely to have a resident or fellow as first assistant in the surgery (91% vs. 99%) and to have local retropubic anesthesia (71% vs. 96%). Similar proportions had a concomitant hysterectomy.

In addition to showing no significant difference in injury rates, analyses revealed that the groups were statistically the same with respect to mean intraoperative time; mean blood loss; and mean hospital stay, which was less than 1 day for the entire cohort.

Dr. Miranne disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Laparoscopic hysterectomy takes longer when residents participate, but is generally as safe as when an attending physician performs the surgery alone, a study showed.

A resident was involved in 46% of the 3,441 cases that were done for benign indications between 2008 and 2011 and identified in the National Surgical Quality Improvement Program (NSQIP) database.

Patients whose surgery involved a resident had higher levels of comorbidity and were higher-risk surgical candidates, according to data presented at the annual meeting of the Society of Gynecologic Surgeons.

Compared with patients whose surgery was performed by an attending physician alone, those whose surgery involved a resident took an average of 44 minutes, or about 25% longer.

However, rates of serious adverse outcomes and death were statistically indistinguishable. The group for whom a resident was involved did have higher rates of transfusion of more than 4 U of packed red blood cells and of readmission.

"Our study is the first of its kind to study this topic in the gynecologic field in such a large sample size," said lead author Dr. Elena Igwe, a third-year obstetrician-gynecologist resident at Temple University Hospital in Philadelphia.

The longer operative time for resident-involved cases "may be accounted for by the obvious training environment of gynecologic and anesthesia residents, medical students, as well as scrub nurse students. Also, more time may have been spent if there were greater intraoperative complications such as bleeding or organ injury that were not captured by the NSQIP database," she said at the meeting, jointly sponsored by the American College of Surgeons.

"Although there was a statistically significant increase in transfusion and readmissions in the resident-involved group, there was no overall effect on morbidity or mortality. Therefore, although laparoscopic hysterectomy may take longer to accomplish with a resident involved, the clinically significant safety profile is largely unchanged," Dr. Igwe said.

Invited discussant Dr. Marie Fidela Paraiso, head of female pelvic medicine and reconstructive surgery at the Cleveland Clinic, commented, "The findings of your investigation are not surprising in that training cases require significantly longer OR times – this is the story of an academician’s life – increased transfusions (cause uncertain) and increased 30-day admits. However, it is reassuring that morbidity and severe complications and 30-day mortality are not different despite greater patient acuity in the training cohort."

She added, "Due to a limit in training hours, alternatives to hysterectomy, and a variation of tools and routes for hysterectomy, resident experience in laparoscopic hysterectomy is likely to decrease. How do you apply your findings to guide future training?" she asked.

Considerable time is required to become skilled at this surgery, Dr. Igwe replied. "If the average resident is going to do less hysterectomies during their duration as a resident, then there are two potential ways to deal with this situation. One, you can increase the length of ob.gyn. training; of course, the lack of federal funding may not make this a very attractive option. Or two, split the specialty into a track system or alternative curriculum system, where a portion of residents go into a specialized gyn. track and receive the majority of hysterectomy and other major surgery trainings, and have the privilege to perform these procedures. A general ob.gyn. residency can therefore potentially be reduced to 3 years, and these practitioners would focus on more routine ob.gyn. and preventive gynecologic care," she suggested.

"We as a society can take the initiative to do this ourselves, or insurance companies, based on the Affordable Care Act initiative and driven by outcome-based research, will make us do this based on our performances, and this may not be a pretty thing," she added.

One session attendee expressed concern about potential selection bias in the study. "It’s possible that for the more complicated cases, the attendings asked the residents to assist them, and therefore we may be unduly giving the residents credit for the increased morbidity," he said.

"That is a concern, but that’s just one of the limitations of the NSQIP database that we were not able to adjust for," Dr. Igwe said.

Another attendee commented, "Your data is reassuring, but it begs the question, we don’t know the degree to which residents were actually involved, and it makes me think ... what would be a more meaningful way to measure this issue of the interaction between resident involvement and patient morbidity?"

"If there was a way to actually record or establish how much a resident is actually doing, that would be the best thing," Dr. Igwe said.

In the study, relative to the patients operated on by attending physicians only, patients whose surgery involved a resident were on average older, were more likely to be inpatients, had higher Charlson comorbidity scores, and had higher American Society of Anesthesiologists classes.

The mean operative time was 179 minutes when a resident was involved and 135 minutes when the attending physician operated alone, reported Dr. Igwe. There was no significant difference between junior residents (those in postgraduate year 1 or 2) and senior residents (all other years).

The group having a resident involved had significantly higher rates of transfusion with more than 4 U of packed red blood cells (2.0% vs. 0.4%) and readmission (5.5% vs. 2.9%). The difference in transfusion rates was greater for junior residents than for senior residents.

However, the groups were statistically indistinguishable with respect to the proportion of patients having at least one complication, experiencing severe morbidity, dying within 30 days, developing infections or sepsis, or having thromboembolic complications.

"The limitations of this study are largely those of the NSQIP database," Dr. Igwe noted. "We were unable to control for attending surgeon experience, presence of additional trainees in the operating room, or tallying up the intraoperative complications. Also, the degree of resident participation is not clearly defined, and there is no data about the conversion rate from laparoscopic to open cases."

Dr. Igwe disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Laparoscopic hysterectomy takes longer when residents participate, but is generally as safe as when an attending physician performs the surgery alone, a study showed.

A resident was involved in 46% of the 3,441 cases that were done for benign indications between 2008 and 2011 and identified in the National Surgical Quality Improvement Program (NSQIP) database.

Patients whose surgery involved a resident had higher levels of comorbidity and were higher-risk surgical candidates, according to data presented at the annual meeting of the Society of Gynecologic Surgeons.

Compared with patients whose surgery was performed by an attending physician alone, those whose surgery involved a resident took an average of 44 minutes, or about 25% longer.

However, rates of serious adverse outcomes and death were statistically indistinguishable. The group for whom a resident was involved did have higher rates of transfusion of more than 4 U of packed red blood cells and of readmission.

"Our study is the first of its kind to study this topic in the gynecologic field in such a large sample size," said lead author Dr. Elena Igwe, a third-year obstetrician-gynecologist resident at Temple University Hospital in Philadelphia.

The longer operative time for resident-involved cases "may be accounted for by the obvious training environment of gynecologic and anesthesia residents, medical students, as well as scrub nurse students. Also, more time may have been spent if there were greater intraoperative complications such as bleeding or organ injury that were not captured by the NSQIP database," she said at the meeting, jointly sponsored by the American College of Surgeons.

"Although there was a statistically significant increase in transfusion and readmissions in the resident-involved group, there was no overall effect on morbidity or mortality. Therefore, although laparoscopic hysterectomy may take longer to accomplish with a resident involved, the clinically significant safety profile is largely unchanged," Dr. Igwe said.

Invited discussant Dr. Marie Fidela Paraiso, head of female pelvic medicine and reconstructive surgery at the Cleveland Clinic, commented, "The findings of your investigation are not surprising in that training cases require significantly longer OR times – this is the story of an academician’s life – increased transfusions (cause uncertain) and increased 30-day admits. However, it is reassuring that morbidity and severe complications and 30-day mortality are not different despite greater patient acuity in the training cohort."

She added, "Due to a limit in training hours, alternatives to hysterectomy, and a variation of tools and routes for hysterectomy, resident experience in laparoscopic hysterectomy is likely to decrease. How do you apply your findings to guide future training?" she asked.

Considerable time is required to become skilled at this surgery, Dr. Igwe replied. "If the average resident is going to do less hysterectomies during their duration as a resident, then there are two potential ways to deal with this situation. One, you can increase the length of ob.gyn. training; of course, the lack of federal funding may not make this a very attractive option. Or two, split the specialty into a track system or alternative curriculum system, where a portion of residents go into a specialized gyn. track and receive the majority of hysterectomy and other major surgery trainings, and have the privilege to perform these procedures. A general ob.gyn. residency can therefore potentially be reduced to 3 years, and these practitioners would focus on more routine ob.gyn. and preventive gynecologic care," she suggested.

"We as a society can take the initiative to do this ourselves, or insurance companies, based on the Affordable Care Act initiative and driven by outcome-based research, will make us do this based on our performances, and this may not be a pretty thing," she added.

One session attendee expressed concern about potential selection bias in the study. "It’s possible that for the more complicated cases, the attendings asked the residents to assist them, and therefore we may be unduly giving the residents credit for the increased morbidity," he said.

"That is a concern, but that’s just one of the limitations of the NSQIP database that we were not able to adjust for," Dr. Igwe said.

Another attendee commented, "Your data is reassuring, but it begs the question, we don’t know the degree to which residents were actually involved, and it makes me think ... what would be a more meaningful way to measure this issue of the interaction between resident involvement and patient morbidity?"

"If there was a way to actually record or establish how much a resident is actually doing, that would be the best thing," Dr. Igwe said.

In the study, relative to the patients operated on by attending physicians only, patients whose surgery involved a resident were on average older, were more likely to be inpatients, had higher Charlson comorbidity scores, and had higher American Society of Anesthesiologists classes.

The mean operative time was 179 minutes when a resident was involved and 135 minutes when the attending physician operated alone, reported Dr. Igwe. There was no significant difference between junior residents (those in postgraduate year 1 or 2) and senior residents (all other years).

The group having a resident involved had significantly higher rates of transfusion with more than 4 U of packed red blood cells (2.0% vs. 0.4%) and readmission (5.5% vs. 2.9%). The difference in transfusion rates was greater for junior residents than for senior residents.

However, the groups were statistically indistinguishable with respect to the proportion of patients having at least one complication, experiencing severe morbidity, dying within 30 days, developing infections or sepsis, or having thromboembolic complications.

"The limitations of this study are largely those of the NSQIP database," Dr. Igwe noted. "We were unable to control for attending surgeon experience, presence of additional trainees in the operating room, or tallying up the intraoperative complications. Also, the degree of resident participation is not clearly defined, and there is no data about the conversion rate from laparoscopic to open cases."

Dr. Igwe disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Laparoscopic hysterectomy takes longer when residents participate, but is generally as safe as when an attending physician performs the surgery alone, a study showed.

A resident was involved in 46% of the 3,441 cases that were done for benign indications between 2008 and 2011 and identified in the National Surgical Quality Improvement Program (NSQIP) database.

Patients whose surgery involved a resident had higher levels of comorbidity and were higher-risk surgical candidates, according to data presented at the annual meeting of the Society of Gynecologic Surgeons.

Compared with patients whose surgery was performed by an attending physician alone, those whose surgery involved a resident took an average of 44 minutes, or about 25% longer.

However, rates of serious adverse outcomes and death were statistically indistinguishable. The group for whom a resident was involved did have higher rates of transfusion of more than 4 U of packed red blood cells and of readmission.

"Our study is the first of its kind to study this topic in the gynecologic field in such a large sample size," said lead author Dr. Elena Igwe, a third-year obstetrician-gynecologist resident at Temple University Hospital in Philadelphia.

The longer operative time for resident-involved cases "may be accounted for by the obvious training environment of gynecologic and anesthesia residents, medical students, as well as scrub nurse students. Also, more time may have been spent if there were greater intraoperative complications such as bleeding or organ injury that were not captured by the NSQIP database," she said at the meeting, jointly sponsored by the American College of Surgeons.

"Although there was a statistically significant increase in transfusion and readmissions in the resident-involved group, there was no overall effect on morbidity or mortality. Therefore, although laparoscopic hysterectomy may take longer to accomplish with a resident involved, the clinically significant safety profile is largely unchanged," Dr. Igwe said.

Invited discussant Dr. Marie Fidela Paraiso, head of female pelvic medicine and reconstructive surgery at the Cleveland Clinic, commented, "The findings of your investigation are not surprising in that training cases require significantly longer OR times – this is the story of an academician’s life – increased transfusions (cause uncertain) and increased 30-day admits. However, it is reassuring that morbidity and severe complications and 30-day mortality are not different despite greater patient acuity in the training cohort."

She added, "Due to a limit in training hours, alternatives to hysterectomy, and a variation of tools and routes for hysterectomy, resident experience in laparoscopic hysterectomy is likely to decrease. How do you apply your findings to guide future training?" she asked.

Considerable time is required to become skilled at this surgery, Dr. Igwe replied. "If the average resident is going to do less hysterectomies during their duration as a resident, then there are two potential ways to deal with this situation. One, you can increase the length of ob.gyn. training; of course, the lack of federal funding may not make this a very attractive option. Or two, split the specialty into a track system or alternative curriculum system, where a portion of residents go into a specialized gyn. track and receive the majority of hysterectomy and other major surgery trainings, and have the privilege to perform these procedures. A general ob.gyn. residency can therefore potentially be reduced to 3 years, and these practitioners would focus on more routine ob.gyn. and preventive gynecologic care," she suggested.

"We as a society can take the initiative to do this ourselves, or insurance companies, based on the Affordable Care Act initiative and driven by outcome-based research, will make us do this based on our performances, and this may not be a pretty thing," she added.

One session attendee expressed concern about potential selection bias in the study. "It’s possible that for the more complicated cases, the attendings asked the residents to assist them, and therefore we may be unduly giving the residents credit for the increased morbidity," he said.

"That is a concern, but that’s just one of the limitations of the NSQIP database that we were not able to adjust for," Dr. Igwe said.

Another attendee commented, "Your data is reassuring, but it begs the question, we don’t know the degree to which residents were actually involved, and it makes me think ... what would be a more meaningful way to measure this issue of the interaction between resident involvement and patient morbidity?"

"If there was a way to actually record or establish how much a resident is actually doing, that would be the best thing," Dr. Igwe said.

In the study, relative to the patients operated on by attending physicians only, patients whose surgery involved a resident were on average older, were more likely to be inpatients, had higher Charlson comorbidity scores, and had higher American Society of Anesthesiologists classes.

The mean operative time was 179 minutes when a resident was involved and 135 minutes when the attending physician operated alone, reported Dr. Igwe. There was no significant difference between junior residents (those in postgraduate year 1 or 2) and senior residents (all other years).

The group having a resident involved had significantly higher rates of transfusion with more than 4 U of packed red blood cells (2.0% vs. 0.4%) and readmission (5.5% vs. 2.9%). The difference in transfusion rates was greater for junior residents than for senior residents.

However, the groups were statistically indistinguishable with respect to the proportion of patients having at least one complication, experiencing severe morbidity, dying within 30 days, developing infections or sepsis, or having thromboembolic complications.

"The limitations of this study are largely those of the NSQIP database," Dr. Igwe noted. "We were unable to control for attending surgeon experience, presence of additional trainees in the operating room, or tallying up the intraoperative complications. Also, the degree of resident participation is not clearly defined, and there is no data about the conversion rate from laparoscopic to open cases."

Dr. Igwe disclosed no relevant financial conflicts of interest.

TAMPA – Vaginal cuff brachytherapy followed by paclitaxel and carboplatin chemotherapy was not superior to pelvic radiation therapy in randomized phase III Gynecologic Oncology Group trial 249 involving women with high-intermediate-risk, early stage endometrial cancer.

The 24-month recurrence-free survival was 82% and 84% in 301 women assigned to receive pelvic radiation therapy (PXRT) and 300 women assigned to receive vaginal cuff brachytherapy followed by paclitaxel and carboplatin chemotherapy (VCB/C) for a hazard ratio of 0.97. Survival at 24 months was 93% in the PXRT group and 92% in the VCB/C group (hazard ratio, 1.28), Dr. D. Scott McMeekin reported during a late-breaking abstract session at the annual meeting of the Society of Gynecologic Oncology.

"There was no statistically significant evidence of heterogeneity of treatment effects with respect to recurrence-free survival among stage, age, race, performance status, histology, or lymphadenectomy use in either of the groups," said Dr. McMeekin of the University of Oklahoma, Oklahoma City.

Study subjects were women with a median age of 63 years. All of the women underwent hysterectomy and had either stage I endometrioid disease with high risk based on GOG (Gynecologic Oncology Group) trial 99 study criteria, stage II disease, or stage I-II serous or clear cell tumors. Most (74%) had stage I disease, and 89% underwent lymphadenectomy. Histology was endometrioid type in 71% of patients, serous in 15%, and clear cell in 5%.

All patients participated in quality of life assessments at five time points, and tissue samples were collected for a translational research correlative, he said.

Treatment began within 12 weeks following surgery. Those in the PXRT group were treated using standard four-field or intensity-modulated radiation therapy techniques (with optional VCB for those with serous or clear cell tumors or with stage II disease), and patients in the VCB/C group received high-dose rate or low-dose rate brachytherapy followed by paclitaxel (175 mg/m² over 3 hours) and carboplatin (AUC 6) every 21 days for a total of three cycles.

Treatment was generally well tolerated, with 91% of PXRT patients and 87% of VCB/C patients completing therapy.

"That being said, acute adverse effects were more frequent and tended to be more severe in patients receiving VCB/C," Dr. McMeekin said, noting that the extent to which that affected quality of life is the subject of an analysis currently underway; those data are forthcoming.

Early-stage endometrial cancer poses a variety of clinical challenges, Dr. McMeekin said.

"Who is at risk? How is that risk defined? Which modalities reduce risk in which populations?" he said, noting that the information used on a day-to-day basis to help in decision making includes patient age and history, tumor grade, uterine characteristics, and nodal status.

Prior studies, including GOG 99 (Gyn. Oncol. 2004;92:744-51), have helped create risk models to identify patients at greater recurrence risk who might benefit most from adjuvant therapy such as pelvic radiation therapy. Risk criteria in GOG 99 were based on age and the number of risk factors, and while that study showed that pelvic radiation therapy reduced risk (and concluded that adjunctive radiation therapy in early-stage, intermediate-risk disease decreased the risk of recurrence, but should be limited to patients with high-intermediate risk), it also helped define patterns of failure, suggesting that distant sites of failure were "greater than we perhaps recognized," Dr. McMeekin said.

That, in turn, introduced the idea that a systemic therapy might improve outcomes, he added.

Chemotherapy moved to the forefront based on findings from GOG 122, which showed significant improvement in progression-free survival and overall survival with chemotherapy vs. whole abdomen radiation therapy in stage III and IV endometrial cancer, he said.

A number of uncontrolled studies have also suggested that chemotherapy may benefit other populations at increased risk, including patients with serous and clear cell stage I disease, who have a broad risk of recurrence ranging from 15% to 50% depending on disease and patient characteristics, and stage II patients, who have increased risk of loco-regional failure and progression-free survival rates comparable to those seen in high- intermediate-risk populations, he said.

The current study was initiated in light of these findings, but the investigators "could not identify subgroups for whom one therapy appeared to be more or less effective," Dr. McMeekin said.

He noted that the use of radiation therapy plus chemotherapy has been evaluated, including in two studies that demonstrated improved progression-free but not overall survival in patients with stage I-III disease.

"This is also the subject of the ongoing PORTEC-3 study, he said.

The current findings, which showed that "even in an enriched population, most patients did well," suggest that refinement is needed with respect to factors that define risk, he said, noting that selection based on clinical pathologic features and molecular profiling are underway both in the current study and another GOG study (GOG 210).

Dr. McMeekin reported having no disclosures.

TAMPA – Vaginal cuff brachytherapy followed by paclitaxel and carboplatin chemotherapy was not superior to pelvic radiation therapy in randomized phase III Gynecologic Oncology Group trial 249 involving women with high-intermediate-risk, early stage endometrial cancer.

The 24-month recurrence-free survival was 82% and 84% in 301 women assigned to receive pelvic radiation therapy (PXRT) and 300 women assigned to receive vaginal cuff brachytherapy followed by paclitaxel and carboplatin chemotherapy (VCB/C) for a hazard ratio of 0.97. Survival at 24 months was 93% in the PXRT group and 92% in the VCB/C group (hazard ratio, 1.28), Dr. D. Scott McMeekin reported during a late-breaking abstract session at the annual meeting of the Society of Gynecologic Oncology.

"There was no statistically significant evidence of heterogeneity of treatment effects with respect to recurrence-free survival among stage, age, race, performance status, histology, or lymphadenectomy use in either of the groups," said Dr. McMeekin of the University of Oklahoma, Oklahoma City.

Study subjects were women with a median age of 63 years. All of the women underwent hysterectomy and had either stage I endometrioid disease with high risk based on GOG (Gynecologic Oncology Group) trial 99 study criteria, stage II disease, or stage I-II serous or clear cell tumors. Most (74%) had stage I disease, and 89% underwent lymphadenectomy. Histology was endometrioid type in 71% of patients, serous in 15%, and clear cell in 5%.

All patients participated in quality of life assessments at five time points, and tissue samples were collected for a translational research correlative, he said.

Treatment began within 12 weeks following surgery. Those in the PXRT group were treated using standard four-field or intensity-modulated radiation therapy techniques (with optional VCB for those with serous or clear cell tumors or with stage II disease), and patients in the VCB/C group received high-dose rate or low-dose rate brachytherapy followed by paclitaxel (175 mg/m² over 3 hours) and carboplatin (AUC 6) every 21 days for a total of three cycles.

Treatment was generally well tolerated, with 91% of PXRT patients and 87% of VCB/C patients completing therapy.

"That being said, acute adverse effects were more frequent and tended to be more severe in patients receiving VCB/C," Dr. McMeekin said, noting that the extent to which that affected quality of life is the subject of an analysis currently underway; those data are forthcoming.

Early-stage endometrial cancer poses a variety of clinical challenges, Dr. McMeekin said.

"Who is at risk? How is that risk defined? Which modalities reduce risk in which populations?" he said, noting that the information used on a day-to-day basis to help in decision making includes patient age and history, tumor grade, uterine characteristics, and nodal status.

Prior studies, including GOG 99 (Gyn. Oncol. 2004;92:744-51), have helped create risk models to identify patients at greater recurrence risk who might benefit most from adjuvant therapy such as pelvic radiation therapy. Risk criteria in GOG 99 were based on age and the number of risk factors, and while that study showed that pelvic radiation therapy reduced risk (and concluded that adjunctive radiation therapy in early-stage, intermediate-risk disease decreased the risk of recurrence, but should be limited to patients with high-intermediate risk), it also helped define patterns of failure, suggesting that distant sites of failure were "greater than we perhaps recognized," Dr. McMeekin said.

That, in turn, introduced the idea that a systemic therapy might improve outcomes, he added.

Chemotherapy moved to the forefront based on findings from GOG 122, which showed significant improvement in progression-free survival and overall survival with chemotherapy vs. whole abdomen radiation therapy in stage III and IV endometrial cancer, he said.

A number of uncontrolled studies have also suggested that chemotherapy may benefit other populations at increased risk, including patients with serous and clear cell stage I disease, who have a broad risk of recurrence ranging from 15% to 50% depending on disease and patient characteristics, and stage II patients, who have increased risk of loco-regional failure and progression-free survival rates comparable to those seen in high- intermediate-risk populations, he said.

The current study was initiated in light of these findings, but the investigators "could not identify subgroups for whom one therapy appeared to be more or less effective," Dr. McMeekin said.

He noted that the use of radiation therapy plus chemotherapy has been evaluated, including in two studies that demonstrated improved progression-free but not overall survival in patients with stage I-III disease.

"This is also the subject of the ongoing PORTEC-3 study, he said.

The current findings, which showed that "even in an enriched population, most patients did well," suggest that refinement is needed with respect to factors that define risk, he said, noting that selection based on clinical pathologic features and molecular profiling are underway both in the current study and another GOG study (GOG 210).

Dr. McMeekin reported having no disclosures.

TAMPA – Vaginal cuff brachytherapy followed by paclitaxel and carboplatin chemotherapy was not superior to pelvic radiation therapy in randomized phase III Gynecologic Oncology Group trial 249 involving women with high-intermediate-risk, early stage endometrial cancer.

The 24-month recurrence-free survival was 82% and 84% in 301 women assigned to receive pelvic radiation therapy (PXRT) and 300 women assigned to receive vaginal cuff brachytherapy followed by paclitaxel and carboplatin chemotherapy (VCB/C) for a hazard ratio of 0.97. Survival at 24 months was 93% in the PXRT group and 92% in the VCB/C group (hazard ratio, 1.28), Dr. D. Scott McMeekin reported during a late-breaking abstract session at the annual meeting of the Society of Gynecologic Oncology.

"There was no statistically significant evidence of heterogeneity of treatment effects with respect to recurrence-free survival among stage, age, race, performance status, histology, or lymphadenectomy use in either of the groups," said Dr. McMeekin of the University of Oklahoma, Oklahoma City.

Study subjects were women with a median age of 63 years. All of the women underwent hysterectomy and had either stage I endometrioid disease with high risk based on GOG (Gynecologic Oncology Group) trial 99 study criteria, stage II disease, or stage I-II serous or clear cell tumors. Most (74%) had stage I disease, and 89% underwent lymphadenectomy. Histology was endometrioid type in 71% of patients, serous in 15%, and clear cell in 5%.

All patients participated in quality of life assessments at five time points, and tissue samples were collected for a translational research correlative, he said.

Treatment began within 12 weeks following surgery. Those in the PXRT group were treated using standard four-field or intensity-modulated radiation therapy techniques (with optional VCB for those with serous or clear cell tumors or with stage II disease), and patients in the VCB/C group received high-dose rate or low-dose rate brachytherapy followed by paclitaxel (175 mg/m² over 3 hours) and carboplatin (AUC 6) every 21 days for a total of three cycles.

Treatment was generally well tolerated, with 91% of PXRT patients and 87% of VCB/C patients completing therapy.

"That being said, acute adverse effects were more frequent and tended to be more severe in patients receiving VCB/C," Dr. McMeekin said, noting that the extent to which that affected quality of life is the subject of an analysis currently underway; those data are forthcoming.

Early-stage endometrial cancer poses a variety of clinical challenges, Dr. McMeekin said.

"Who is at risk? How is that risk defined? Which modalities reduce risk in which populations?" he said, noting that the information used on a day-to-day basis to help in decision making includes patient age and history, tumor grade, uterine characteristics, and nodal status.

Prior studies, including GOG 99 (Gyn. Oncol. 2004;92:744-51), have helped create risk models to identify patients at greater recurrence risk who might benefit most from adjuvant therapy such as pelvic radiation therapy. Risk criteria in GOG 99 were based on age and the number of risk factors, and while that study showed that pelvic radiation therapy reduced risk (and concluded that adjunctive radiation therapy in early-stage, intermediate-risk disease decreased the risk of recurrence, but should be limited to patients with high-intermediate risk), it also helped define patterns of failure, suggesting that distant sites of failure were "greater than we perhaps recognized," Dr. McMeekin said.

That, in turn, introduced the idea that a systemic therapy might improve outcomes, he added.

Chemotherapy moved to the forefront based on findings from GOG 122, which showed significant improvement in progression-free survival and overall survival with chemotherapy vs. whole abdomen radiation therapy in stage III and IV endometrial cancer, he said.

A number of uncontrolled studies have also suggested that chemotherapy may benefit other populations at increased risk, including patients with serous and clear cell stage I disease, who have a broad risk of recurrence ranging from 15% to 50% depending on disease and patient characteristics, and stage II patients, who have increased risk of loco-regional failure and progression-free survival rates comparable to those seen in high- intermediate-risk populations, he said.

The current study was initiated in light of these findings, but the investigators "could not identify subgroups for whom one therapy appeared to be more or less effective," Dr. McMeekin said.

He noted that the use of radiation therapy plus chemotherapy has been evaluated, including in two studies that demonstrated improved progression-free but not overall survival in patients with stage I-III disease.

"This is also the subject of the ongoing PORTEC-3 study, he said.

The current findings, which showed that "even in an enriched population, most patients did well," suggest that refinement is needed with respect to factors that define risk, he said, noting that selection based on clinical pathologic features and molecular profiling are underway both in the current study and another GOG study (GOG 210).

Dr. McMeekin reported having no disclosures.

TAMPA – High levels of FABP4 and ADH1B gene expression in patients with high-grade serous ovarian cancer are associated with significantly increased risk of residual disease after primary debulking surgery, according to an analysis of two large-scale, publicly available genomic data sets.

The findings could aid in the development of an algorithm for triaging patients to neoadjuvant approaches versus primary debulking, said Dr. Anil K. Sood at the annual meeting of the Society of Gynecologic Oncology.

In 491 patients from The Cancer Genome Atlas (TCGA) data set, and 189 from the Tothill data set, survival was significantly greater in patients with no residual disease than in those with any degree of residual disease. In both data sets, 47 prosets representing 38 different genes – significant in both data sets at a 10% false-discovery rate – were identified.

After several sets of validation, including qualitative validation in two additional data sets, and quantitative validation using primary ovarian cancer samples from 139 individuals, FABP4 and ADH1B were found to have the highest levels of expression, with substantial enrichment of FABP4 in those with residual disease in both the TCGA and Tothill data sets, Dr. Sood of the University of Texas M.D. Anderson Cancer Center, Houston, reported.

When FABP4 and ADH1B were plotted together, it was apparent that they were coordinated. That is, "when one is up, the other tends to be up," he said.

Furthermore, the changes weren’t subtle but were bimodal, he noted.

"If we consider those individuals who have the highest quartile of these genes – the top 25% – 88% of the individuals had residual disease when either FABP4 or ADH1B was elevated," he said, adding that looking at the second gene didn’t change things much because the two genes tend to be elevated jointly.

"To look at this in another way, the odds ratio was 5.5 for residual disease with high FABP4 levels, ... so if you look at those individuals with residual disease, 30 of 35 had high FABP4 levels, compared with those with low FABP4, where 54 out of 104 had residual disease," he said.

The findings are not surprising as FABP4 was shown in a prior study to play a prominent role in promoting omental metastasis and is considered a potential target for therapeutic approaches. However, the findings are important, because gross residual disease following primary cytoreduction is the best predictor of overall survival in patients with high-grade serous ovarian carcinoma, and the accurate identification of patients who will have residual disease has remained elusive.

"Outcome predictors could be very useful in predicting who would most likely benefit from surgical care up front versus potentially doing surgery in an interval setting following neoadjuvant chemotherapy," he said, noting that most prior attempts at identifying outcome predictors have focused on identifying patients most likely to undergo optimal debulking.

Furthermore, imaging parameters and circulating markers have not been particularly reliable predictors of residual disease following surgery.

"We have learned over the last several years that the greatest differences in outcomes really tend to be for those patients who have no gross residual, compared with those left with any degree of residual," he said, noting that this information prompted the current search for molecular predictors of residual disease, which is based on the premise that underlying biology could be different in tumors that are not fully resectable.

Though limited by the possibility that gene expression levels are different in primary versus metastatic disease sites, and by varying degrees of aggressiveness in debulking approaches at different cancer centers included in the data set, the findings nonetheless suggest that patients with high tumor expression of FABP4 may be candidates for neoadjuvant chemotherapy, Dr. Sood concluded.

Dr. Sood reported having no relevant disclosures.

TAMPA – High levels of FABP4 and ADH1B gene expression in patients with high-grade serous ovarian cancer are associated with significantly increased risk of residual disease after primary debulking surgery, according to an analysis of two large-scale, publicly available genomic data sets.

The findings could aid in the development of an algorithm for triaging patients to neoadjuvant approaches versus primary debulking, said Dr. Anil K. Sood at the annual meeting of the Society of Gynecologic Oncology.

In 491 patients from The Cancer Genome Atlas (TCGA) data set, and 189 from the Tothill data set, survival was significantly greater in patients with no residual disease than in those with any degree of residual disease. In both data sets, 47 prosets representing 38 different genes – significant in both data sets at a 10% false-discovery rate – were identified.

After several sets of validation, including qualitative validation in two additional data sets, and quantitative validation using primary ovarian cancer samples from 139 individuals, FABP4 and ADH1B were found to have the highest levels of expression, with substantial enrichment of FABP4 in those with residual disease in both the TCGA and Tothill data sets, Dr. Sood of the University of Texas M.D. Anderson Cancer Center, Houston, reported.

When FABP4 and ADH1B were plotted together, it was apparent that they were coordinated. That is, "when one is up, the other tends to be up," he said.

Furthermore, the changes weren’t subtle but were bimodal, he noted.

"If we consider those individuals who have the highest quartile of these genes – the top 25% – 88% of the individuals had residual disease when either FABP4 or ADH1B was elevated," he said, adding that looking at the second gene didn’t change things much because the two genes tend to be elevated jointly.

"To look at this in another way, the odds ratio was 5.5 for residual disease with high FABP4 levels, ... so if you look at those individuals with residual disease, 30 of 35 had high FABP4 levels, compared with those with low FABP4, where 54 out of 104 had residual disease," he said.

The findings are not surprising as FABP4 was shown in a prior study to play a prominent role in promoting omental metastasis and is considered a potential target for therapeutic approaches. However, the findings are important, because gross residual disease following primary cytoreduction is the best predictor of overall survival in patients with high-grade serous ovarian carcinoma, and the accurate identification of patients who will have residual disease has remained elusive.

"Outcome predictors could be very useful in predicting who would most likely benefit from surgical care up front versus potentially doing surgery in an interval setting following neoadjuvant chemotherapy," he said, noting that most prior attempts at identifying outcome predictors have focused on identifying patients most likely to undergo optimal debulking.

Furthermore, imaging parameters and circulating markers have not been particularly reliable predictors of residual disease following surgery.

"We have learned over the last several years that the greatest differences in outcomes really tend to be for those patients who have no gross residual, compared with those left with any degree of residual," he said, noting that this information prompted the current search for molecular predictors of residual disease, which is based on the premise that underlying biology could be different in tumors that are not fully resectable.

Though limited by the possibility that gene expression levels are different in primary versus metastatic disease sites, and by varying degrees of aggressiveness in debulking approaches at different cancer centers included in the data set, the findings nonetheless suggest that patients with high tumor expression of FABP4 may be candidates for neoadjuvant chemotherapy, Dr. Sood concluded.

Dr. Sood reported having no relevant disclosures.

TAMPA – High levels of FABP4 and ADH1B gene expression in patients with high-grade serous ovarian cancer are associated with significantly increased risk of residual disease after primary debulking surgery, according to an analysis of two large-scale, publicly available genomic data sets.

The findings could aid in the development of an algorithm for triaging patients to neoadjuvant approaches versus primary debulking, said Dr. Anil K. Sood at the annual meeting of the Society of Gynecologic Oncology.

In 491 patients from The Cancer Genome Atlas (TCGA) data set, and 189 from the Tothill data set, survival was significantly greater in patients with no residual disease than in those with any degree of residual disease. In both data sets, 47 prosets representing 38 different genes – significant in both data sets at a 10% false-discovery rate – were identified.

After several sets of validation, including qualitative validation in two additional data sets, and quantitative validation using primary ovarian cancer samples from 139 individuals, FABP4 and ADH1B were found to have the highest levels of expression, with substantial enrichment of FABP4 in those with residual disease in both the TCGA and Tothill data sets, Dr. Sood of the University of Texas M.D. Anderson Cancer Center, Houston, reported.

When FABP4 and ADH1B were plotted together, it was apparent that they were coordinated. That is, "when one is up, the other tends to be up," he said.

Furthermore, the changes weren’t subtle but were bimodal, he noted.

"If we consider those individuals who have the highest quartile of these genes – the top 25% – 88% of the individuals had residual disease when either FABP4 or ADH1B was elevated," he said, adding that looking at the second gene didn’t change things much because the two genes tend to be elevated jointly.

"To look at this in another way, the odds ratio was 5.5 for residual disease with high FABP4 levels, ... so if you look at those individuals with residual disease, 30 of 35 had high FABP4 levels, compared with those with low FABP4, where 54 out of 104 had residual disease," he said.

The findings are not surprising as FABP4 was shown in a prior study to play a prominent role in promoting omental metastasis and is considered a potential target for therapeutic approaches. However, the findings are important, because gross residual disease following primary cytoreduction is the best predictor of overall survival in patients with high-grade serous ovarian carcinoma, and the accurate identification of patients who will have residual disease has remained elusive.

"Outcome predictors could be very useful in predicting who would most likely benefit from surgical care up front versus potentially doing surgery in an interval setting following neoadjuvant chemotherapy," he said, noting that most prior attempts at identifying outcome predictors have focused on identifying patients most likely to undergo optimal debulking.

Furthermore, imaging parameters and circulating markers have not been particularly reliable predictors of residual disease following surgery.

"We have learned over the last several years that the greatest differences in outcomes really tend to be for those patients who have no gross residual, compared with those left with any degree of residual," he said, noting that this information prompted the current search for molecular predictors of residual disease, which is based on the premise that underlying biology could be different in tumors that are not fully resectable.

Though limited by the possibility that gene expression levels are different in primary versus metastatic disease sites, and by varying degrees of aggressiveness in debulking approaches at different cancer centers included in the data set, the findings nonetheless suggest that patients with high tumor expression of FABP4 may be candidates for neoadjuvant chemotherapy, Dr. Sood concluded.

Dr. Sood reported having no relevant disclosures.