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In abdominal myomectomy, cell salvage may reduce transfusions
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
ORLANDO – Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy, according to findings from a retrospective cohort study.
Of 138 women who underwent abdominal myomectomy, 52 had no cell salvage and 86 had cell salvage ordered. Of those who had cell salvage ordered, 60 had salvage fully set up and 26 had salvage on standby; 46 of the 60 with full set-up had autologous blood returned, and of those, 14 required subsequent allogeneic transfusion of more than 20 U of blood, Julian A. Gingold, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Notable differences between those who did and those who did not have cell salvage ordered included the number of patients with fibroids weighing more than 250 g (52% vs. 13%) and with five or more total fibroids (83% vs. 56%), he said.
“And interestingly, reproductive surgeons were less likely (than general surgeons) to order cell salvage,” he said.
Surgery was performed by a reproductive surgeon in 25% of cases in the cell salvage group vs. in 67% of cases in the non–cell salvage group.
The finding of comparable allogeneic transfusion requirement between the two groups despite differences in blood loss and “arguably less complex surgeries [in those] without cell salvage” was striking, Dr. Gingold said.
“If you take these 86 patients who had cell salvage intraoperatively, 14 of them ultimately required donor blood, and that amounted to 23 units, giving kind of a lower limit for the potential benefit of cell salvage in this patient cohort,” he said.
Abdominal myomectomy often has a high rate of blood loss, with about a 10%-20% rate of transfusion. While the technique of cell salvage is widely used in other fields, it hasn’t been fully investigated in the context of gynecologic surgery, he said, explaining the rationale for the study.
Subjects included were women aged 18-60 years who underwent abdominal myomectomy for benign indications at the Cleveland Clinic during 2011-2016. Those with current malignancy or with surgery performed by a gynecologic oncologist were excluded.
The non–cell salvage and cell salvage groups were comparable with respect to age, body mass index, ethnicity, and preoperative and postoperative hemoglobin.
Dr. Gingold noted that “prospective study with randomization will be required to better define the role of cell salvage in abdominal myomectomies.”
During a question and answer session following his presentation, Charles Ascher-Walsh, MD, of Mount Sinai Health System, N.Y. noted that the transfusion rates and blood loss were high in the study, and that solid data support the use of tourniquets for patients undergoing abdominal myomectomy, with studies showing only a 1%-2% transfusion rate with continuous tourniquet use. Dr. Gingold said the use of tourniquets in the study was low and was dictated by surgeon preference. He agreed that tourniquet use is “certainly an option that should be adjunctive,” and that it would be useful to look at the outcomes in the cases with and without tourniquet use.
Dr. Gingold reported having no disclosures.
SOURCE: Gingold J et al. SGS 2018 Oral Poster 18.
REPORTING FROM SGS 2018
Key clinical point: Cell salvage may help reduce the need for allogeneic blood transfusion in patients undergoing abdominal myomectomy.
Major finding: Transfusion rates were similar (23% and 17%) despite greater blood loss in the cell salvage group.
Study details: A retrospective review of 138 patients’ charts.
Disclosures: Dr. Gingold reported having no disclosures.
Source: Gingold J et al. SGS 2018 Oral poster 18.
ERAS reduced opioid use, improved same-day discharge after gyn surgery
ORLANDO – The implementation of enhanced recovery after surgery (ERAS) pathways increased same-day discharge rates, but also was associated with a slight increase in readmissions within 30 days, according to a retrospective review of urogynecology cases at a single institution.
ERAS implementation also decreased total opioid use and pain scores, increased preemptive antiemetic use, and reduced rescue antiemetic needs in the postanesthesia care unit, Charelle M. Carter-Brooks, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
In a separate study at an urban safety-net hospital, ERAS implementation was feasible and rapidly accomplished, and resulted in a number of improved outcomes among gynecologic surgery patients, including reduced intraoperative opioid and intravenous fluid use, reduced postoperative intravenous opioid use, and shorter Foley catheter duration – all without an increase in total adverse events.
In the first study, same-day discharge rates were 91.7% in 137 women who underwent urogynecologic surgery after ERAS implementation vs. 25.9% in 121 patients who underwent surgery before ERAS implementation, and average length of admission decreased by 17.4 hours (27.7 vs. 10.3 hours), Dr. Carter-Brooks of Magee-Womens Hospital, University of Pittsburgh Medical Center, reported in an oral paper presentation.
Operative time and postsurgical recovery room times were similar before and after ERAS implementation, but earlier discharge in the ERAS group was associated with about a 5% increase in readmission rates within 30 days (readmission rates of 1.5% and 6.7% before and after implementation), she noted.
Other outcomes, including postoperative complications, urinary tract infections, emergency room visits, unanticipated office visits, and returns to the operating room were similar in the two groups, she said.
After adjusting for age, body mass index, comorbidities, and operative time, length of stay decreased by 13.6 hours after ERAS implementation; after adjusting for age and operative time, same-day discharge was 32 times more likely after ERAS implementation; and after adjusting for age, operative time, and prolapse surgery type, readmission was 5.7 times more likely after ERAS implementation, she said.
In a survey of 77 post-ERAS implementation patients conducted during postoperative nursing calls, 86.7%, 89.6%, and 93.5% reported very good or excellent pain control, surgery preparedness, and overall surgical experience, respectively, and 90% said they did not recall experiencing postoperative nausea during recovery, she added.
In a poster presented at the meeting, Dr. Carter-Brooks further noted that there was a 69% reduction in overall opioid use in the patients who underwent surgery after ERAS implementation, as well as a doubling in the median number of preemptive antiemetic doses (4 vs. 2) and a significant reduction in the percentage of patients receiving a rescue antiemetic after implementation (21.6% vs. 13.6%).
Patients included in the study were women with a mean age of 65.5 years and mean body mass index of 28.2 kg/m2. The most common preoperative diagnosis (in 93.8% of patients) was prolapse. Apical suspension procedures performed were transvaginal in 58 cases, laparoscopic or robotic in 112, and obliterative in 61. Most patients had a hysterectomy, including 83 laparoscopic or robotic, 64 transvaginal, and 1 combined procedure. Demographic and surgical procedures did not differ significantly in the pre- and post-ERAS groups, Dr. Carter-Brooks noted.
Surgeries were performed by seven different surgeons either before ERAS implementation (Jan. 1 to June 30, 2016) or after implementation (Feb. 2 to July 31, 2017).
ERAS – a multidisciplinary approach to patient perioperative care – involves implementation of evidence-based interventions to improve early discharge and length of stay in patients undergoing major elective surgery.
ERAS pathways, which are commonly used in colorectal surgery, were developed to hasten postoperative recovery and are now being increasingly adopted for gynecologic procedures, but data focusing on outcomes with ERAS in the prolapse repair setting are limited, Dr. Carter-Brooks noted.
The ERAS pathway in her study involved a preoperative optimization phase that included counseling about tobacco and alcohol cessation, education about ERAS pathway expectations, and recommendations regarding diet and exercise 1-2 weeks prior to surgery. On the day of surgery, the pathway involved a multimodal pain regimen and postoperative nausea and vomiting prevention.
In response to discussion questions about which interventions contributed most to improvements in same-day discharge rates and patient satisfaction, which interventions were most difficult to implement, and whether additional interventions could prevent readmissions, Dr. Carter-Brooks said that, in her experience the multimodal focus on pain and nausea/vomiting prevention has been particularly helpful, as has the emphasis on educating patients about the interventions and expectations.
“For the preoperative appointment we really spend about 15-30 minutes on education and expectations and prepare the patient to go home. We also encourage them to be advocates and stakeholders in their own recovery, and ... we think that has significantly improved our patients wanting to go home the day of surgery,” she said.
The most difficult aspect of implementation was changing the culture in the hospital, she added.
Support of leadership team members who advocated for change was key to achieving that. Regular audits to review outcomes and make changes as needed to achieve the intended benefit were also important, she noted.
As for readmissions, the numbers overall were small, and their relation to ERAS is questionable and something that is still being tracked and assessed, she said.
In the second study, early outcomes after ERAS implementation were encouraging. Compared with 96 patients who underwent gynecologic surgery between June 1 and Aug. 31, 2015 (before ERAS implementation), 65 who underwent surgery afterward (between February and April 2017) had decreased intraoperative opioid use in open surgery (95 mg vs. 115 mg) and in minimally invasive surgery (75 mg vs. 95 mg), as well as decreased intravenous opioid use postoperatively for open surgery (44% vs. 71%), Mary Louise Fowler, a 4th-year medical student at Boston University, reported at the conference.
The ERAS patients also had shorter Foley catheter duration for minimally invasive surgery (16 vs. 2.3 hours), and they had a trend toward decreased intraoperative fluids for minimally invasive surgery (3.3 vs. 4.2 mL/kg per hour), Ms. Fowler said.
“We also found that there was no significant difference in the length of stay and postdischarge 3-day adverse outcomes,” she said.
The multidisciplinary consensus-based ERAS pathway developed at her institution was implemented beginning Feb. 1, 2017, in response to the national call to reduce opioid use, she explained, noting that a predetermined 4-month time line facilitated implementation by the target date.
Eligible patients included those undergoing benign or oncologic gynecologic surgery with a planned overnight stay.
“Preliminary positive outcomes have been found [with ERAS] at our urban safety-net hospital, specifically in looking at decreased opioid use without a resultant total adverse event increase. It is important for us to continue to monitor ERAS in terms of long-term care to ensure adherence, safety, and effectiveness,” she said, adding that tracking of outcomes will continue, and a future goal is to assess impacts on cost.
Dr. Carter-Brooks’s study was supported by a National Institutes of Health grant. She and Ms. Fowler each reported having no disclosures.
SOURCES: Carter-Brooks C et al.; Fowler M et al. SGS 2018, Oral presentation 2; Oral posters 1 and 16.
The ERAS pathway described by Dr. Carter-Brooks embraces the core tenets of enhanced recovery, including standardized patient education, multimodal analgesia, and predefined postoperative metrics, according to invited discussant Mark Walters, MD.
In fact, systematic culture change requires the involvement of surgeons, nurses, anesthesiologists, and administrative staff, Dr. Walters added.
“Additionally, such significant behavioral changes inevitably result in unintended consequences that must be carefully documented to learn how to mitigate harm in future patients,” he said.
Dr. Walters is professor and vice chair of gynecology in the Center of Urogynecology and Reconstructive Pelvic Surgery, department of obstetrics and gynecology at the Cleveland Clinic. He is a consultant and teacher for Coloplast.
The ERAS pathway described by Dr. Carter-Brooks embraces the core tenets of enhanced recovery, including standardized patient education, multimodal analgesia, and predefined postoperative metrics, according to invited discussant Mark Walters, MD.
In fact, systematic culture change requires the involvement of surgeons, nurses, anesthesiologists, and administrative staff, Dr. Walters added.
“Additionally, such significant behavioral changes inevitably result in unintended consequences that must be carefully documented to learn how to mitigate harm in future patients,” he said.
Dr. Walters is professor and vice chair of gynecology in the Center of Urogynecology and Reconstructive Pelvic Surgery, department of obstetrics and gynecology at the Cleveland Clinic. He is a consultant and teacher for Coloplast.
The ERAS pathway described by Dr. Carter-Brooks embraces the core tenets of enhanced recovery, including standardized patient education, multimodal analgesia, and predefined postoperative metrics, according to invited discussant Mark Walters, MD.
In fact, systematic culture change requires the involvement of surgeons, nurses, anesthesiologists, and administrative staff, Dr. Walters added.
“Additionally, such significant behavioral changes inevitably result in unintended consequences that must be carefully documented to learn how to mitigate harm in future patients,” he said.
Dr. Walters is professor and vice chair of gynecology in the Center of Urogynecology and Reconstructive Pelvic Surgery, department of obstetrics and gynecology at the Cleveland Clinic. He is a consultant and teacher for Coloplast.
ORLANDO – The implementation of enhanced recovery after surgery (ERAS) pathways increased same-day discharge rates, but also was associated with a slight increase in readmissions within 30 days, according to a retrospective review of urogynecology cases at a single institution.
ERAS implementation also decreased total opioid use and pain scores, increased preemptive antiemetic use, and reduced rescue antiemetic needs in the postanesthesia care unit, Charelle M. Carter-Brooks, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
In a separate study at an urban safety-net hospital, ERAS implementation was feasible and rapidly accomplished, and resulted in a number of improved outcomes among gynecologic surgery patients, including reduced intraoperative opioid and intravenous fluid use, reduced postoperative intravenous opioid use, and shorter Foley catheter duration – all without an increase in total adverse events.
In the first study, same-day discharge rates were 91.7% in 137 women who underwent urogynecologic surgery after ERAS implementation vs. 25.9% in 121 patients who underwent surgery before ERAS implementation, and average length of admission decreased by 17.4 hours (27.7 vs. 10.3 hours), Dr. Carter-Brooks of Magee-Womens Hospital, University of Pittsburgh Medical Center, reported in an oral paper presentation.
Operative time and postsurgical recovery room times were similar before and after ERAS implementation, but earlier discharge in the ERAS group was associated with about a 5% increase in readmission rates within 30 days (readmission rates of 1.5% and 6.7% before and after implementation), she noted.
Other outcomes, including postoperative complications, urinary tract infections, emergency room visits, unanticipated office visits, and returns to the operating room were similar in the two groups, she said.
After adjusting for age, body mass index, comorbidities, and operative time, length of stay decreased by 13.6 hours after ERAS implementation; after adjusting for age and operative time, same-day discharge was 32 times more likely after ERAS implementation; and after adjusting for age, operative time, and prolapse surgery type, readmission was 5.7 times more likely after ERAS implementation, she said.
In a survey of 77 post-ERAS implementation patients conducted during postoperative nursing calls, 86.7%, 89.6%, and 93.5% reported very good or excellent pain control, surgery preparedness, and overall surgical experience, respectively, and 90% said they did not recall experiencing postoperative nausea during recovery, she added.
In a poster presented at the meeting, Dr. Carter-Brooks further noted that there was a 69% reduction in overall opioid use in the patients who underwent surgery after ERAS implementation, as well as a doubling in the median number of preemptive antiemetic doses (4 vs. 2) and a significant reduction in the percentage of patients receiving a rescue antiemetic after implementation (21.6% vs. 13.6%).
Patients included in the study were women with a mean age of 65.5 years and mean body mass index of 28.2 kg/m2. The most common preoperative diagnosis (in 93.8% of patients) was prolapse. Apical suspension procedures performed were transvaginal in 58 cases, laparoscopic or robotic in 112, and obliterative in 61. Most patients had a hysterectomy, including 83 laparoscopic or robotic, 64 transvaginal, and 1 combined procedure. Demographic and surgical procedures did not differ significantly in the pre- and post-ERAS groups, Dr. Carter-Brooks noted.
Surgeries were performed by seven different surgeons either before ERAS implementation (Jan. 1 to June 30, 2016) or after implementation (Feb. 2 to July 31, 2017).
ERAS – a multidisciplinary approach to patient perioperative care – involves implementation of evidence-based interventions to improve early discharge and length of stay in patients undergoing major elective surgery.
ERAS pathways, which are commonly used in colorectal surgery, were developed to hasten postoperative recovery and are now being increasingly adopted for gynecologic procedures, but data focusing on outcomes with ERAS in the prolapse repair setting are limited, Dr. Carter-Brooks noted.
The ERAS pathway in her study involved a preoperative optimization phase that included counseling about tobacco and alcohol cessation, education about ERAS pathway expectations, and recommendations regarding diet and exercise 1-2 weeks prior to surgery. On the day of surgery, the pathway involved a multimodal pain regimen and postoperative nausea and vomiting prevention.
In response to discussion questions about which interventions contributed most to improvements in same-day discharge rates and patient satisfaction, which interventions were most difficult to implement, and whether additional interventions could prevent readmissions, Dr. Carter-Brooks said that, in her experience the multimodal focus on pain and nausea/vomiting prevention has been particularly helpful, as has the emphasis on educating patients about the interventions and expectations.
“For the preoperative appointment we really spend about 15-30 minutes on education and expectations and prepare the patient to go home. We also encourage them to be advocates and stakeholders in their own recovery, and ... we think that has significantly improved our patients wanting to go home the day of surgery,” she said.
The most difficult aspect of implementation was changing the culture in the hospital, she added.
Support of leadership team members who advocated for change was key to achieving that. Regular audits to review outcomes and make changes as needed to achieve the intended benefit were also important, she noted.
As for readmissions, the numbers overall were small, and their relation to ERAS is questionable and something that is still being tracked and assessed, she said.
In the second study, early outcomes after ERAS implementation were encouraging. Compared with 96 patients who underwent gynecologic surgery between June 1 and Aug. 31, 2015 (before ERAS implementation), 65 who underwent surgery afterward (between February and April 2017) had decreased intraoperative opioid use in open surgery (95 mg vs. 115 mg) and in minimally invasive surgery (75 mg vs. 95 mg), as well as decreased intravenous opioid use postoperatively for open surgery (44% vs. 71%), Mary Louise Fowler, a 4th-year medical student at Boston University, reported at the conference.
The ERAS patients also had shorter Foley catheter duration for minimally invasive surgery (16 vs. 2.3 hours), and they had a trend toward decreased intraoperative fluids for minimally invasive surgery (3.3 vs. 4.2 mL/kg per hour), Ms. Fowler said.
“We also found that there was no significant difference in the length of stay and postdischarge 3-day adverse outcomes,” she said.
The multidisciplinary consensus-based ERAS pathway developed at her institution was implemented beginning Feb. 1, 2017, in response to the national call to reduce opioid use, she explained, noting that a predetermined 4-month time line facilitated implementation by the target date.
Eligible patients included those undergoing benign or oncologic gynecologic surgery with a planned overnight stay.
“Preliminary positive outcomes have been found [with ERAS] at our urban safety-net hospital, specifically in looking at decreased opioid use without a resultant total adverse event increase. It is important for us to continue to monitor ERAS in terms of long-term care to ensure adherence, safety, and effectiveness,” she said, adding that tracking of outcomes will continue, and a future goal is to assess impacts on cost.
Dr. Carter-Brooks’s study was supported by a National Institutes of Health grant. She and Ms. Fowler each reported having no disclosures.
SOURCES: Carter-Brooks C et al.; Fowler M et al. SGS 2018, Oral presentation 2; Oral posters 1 and 16.
ORLANDO – The implementation of enhanced recovery after surgery (ERAS) pathways increased same-day discharge rates, but also was associated with a slight increase in readmissions within 30 days, according to a retrospective review of urogynecology cases at a single institution.
ERAS implementation also decreased total opioid use and pain scores, increased preemptive antiemetic use, and reduced rescue antiemetic needs in the postanesthesia care unit, Charelle M. Carter-Brooks, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
In a separate study at an urban safety-net hospital, ERAS implementation was feasible and rapidly accomplished, and resulted in a number of improved outcomes among gynecologic surgery patients, including reduced intraoperative opioid and intravenous fluid use, reduced postoperative intravenous opioid use, and shorter Foley catheter duration – all without an increase in total adverse events.
In the first study, same-day discharge rates were 91.7% in 137 women who underwent urogynecologic surgery after ERAS implementation vs. 25.9% in 121 patients who underwent surgery before ERAS implementation, and average length of admission decreased by 17.4 hours (27.7 vs. 10.3 hours), Dr. Carter-Brooks of Magee-Womens Hospital, University of Pittsburgh Medical Center, reported in an oral paper presentation.
Operative time and postsurgical recovery room times were similar before and after ERAS implementation, but earlier discharge in the ERAS group was associated with about a 5% increase in readmission rates within 30 days (readmission rates of 1.5% and 6.7% before and after implementation), she noted.
Other outcomes, including postoperative complications, urinary tract infections, emergency room visits, unanticipated office visits, and returns to the operating room were similar in the two groups, she said.
After adjusting for age, body mass index, comorbidities, and operative time, length of stay decreased by 13.6 hours after ERAS implementation; after adjusting for age and operative time, same-day discharge was 32 times more likely after ERAS implementation; and after adjusting for age, operative time, and prolapse surgery type, readmission was 5.7 times more likely after ERAS implementation, she said.
In a survey of 77 post-ERAS implementation patients conducted during postoperative nursing calls, 86.7%, 89.6%, and 93.5% reported very good or excellent pain control, surgery preparedness, and overall surgical experience, respectively, and 90% said they did not recall experiencing postoperative nausea during recovery, she added.
In a poster presented at the meeting, Dr. Carter-Brooks further noted that there was a 69% reduction in overall opioid use in the patients who underwent surgery after ERAS implementation, as well as a doubling in the median number of preemptive antiemetic doses (4 vs. 2) and a significant reduction in the percentage of patients receiving a rescue antiemetic after implementation (21.6% vs. 13.6%).
Patients included in the study were women with a mean age of 65.5 years and mean body mass index of 28.2 kg/m2. The most common preoperative diagnosis (in 93.8% of patients) was prolapse. Apical suspension procedures performed were transvaginal in 58 cases, laparoscopic or robotic in 112, and obliterative in 61. Most patients had a hysterectomy, including 83 laparoscopic or robotic, 64 transvaginal, and 1 combined procedure. Demographic and surgical procedures did not differ significantly in the pre- and post-ERAS groups, Dr. Carter-Brooks noted.
Surgeries were performed by seven different surgeons either before ERAS implementation (Jan. 1 to June 30, 2016) or after implementation (Feb. 2 to July 31, 2017).
ERAS – a multidisciplinary approach to patient perioperative care – involves implementation of evidence-based interventions to improve early discharge and length of stay in patients undergoing major elective surgery.
ERAS pathways, which are commonly used in colorectal surgery, were developed to hasten postoperative recovery and are now being increasingly adopted for gynecologic procedures, but data focusing on outcomes with ERAS in the prolapse repair setting are limited, Dr. Carter-Brooks noted.
The ERAS pathway in her study involved a preoperative optimization phase that included counseling about tobacco and alcohol cessation, education about ERAS pathway expectations, and recommendations regarding diet and exercise 1-2 weeks prior to surgery. On the day of surgery, the pathway involved a multimodal pain regimen and postoperative nausea and vomiting prevention.
In response to discussion questions about which interventions contributed most to improvements in same-day discharge rates and patient satisfaction, which interventions were most difficult to implement, and whether additional interventions could prevent readmissions, Dr. Carter-Brooks said that, in her experience the multimodal focus on pain and nausea/vomiting prevention has been particularly helpful, as has the emphasis on educating patients about the interventions and expectations.
“For the preoperative appointment we really spend about 15-30 minutes on education and expectations and prepare the patient to go home. We also encourage them to be advocates and stakeholders in their own recovery, and ... we think that has significantly improved our patients wanting to go home the day of surgery,” she said.
The most difficult aspect of implementation was changing the culture in the hospital, she added.
Support of leadership team members who advocated for change was key to achieving that. Regular audits to review outcomes and make changes as needed to achieve the intended benefit were also important, she noted.
As for readmissions, the numbers overall were small, and their relation to ERAS is questionable and something that is still being tracked and assessed, she said.
In the second study, early outcomes after ERAS implementation were encouraging. Compared with 96 patients who underwent gynecologic surgery between June 1 and Aug. 31, 2015 (before ERAS implementation), 65 who underwent surgery afterward (between February and April 2017) had decreased intraoperative opioid use in open surgery (95 mg vs. 115 mg) and in minimally invasive surgery (75 mg vs. 95 mg), as well as decreased intravenous opioid use postoperatively for open surgery (44% vs. 71%), Mary Louise Fowler, a 4th-year medical student at Boston University, reported at the conference.
The ERAS patients also had shorter Foley catheter duration for minimally invasive surgery (16 vs. 2.3 hours), and they had a trend toward decreased intraoperative fluids for minimally invasive surgery (3.3 vs. 4.2 mL/kg per hour), Ms. Fowler said.
“We also found that there was no significant difference in the length of stay and postdischarge 3-day adverse outcomes,” she said.
The multidisciplinary consensus-based ERAS pathway developed at her institution was implemented beginning Feb. 1, 2017, in response to the national call to reduce opioid use, she explained, noting that a predetermined 4-month time line facilitated implementation by the target date.
Eligible patients included those undergoing benign or oncologic gynecologic surgery with a planned overnight stay.
“Preliminary positive outcomes have been found [with ERAS] at our urban safety-net hospital, specifically in looking at decreased opioid use without a resultant total adverse event increase. It is important for us to continue to monitor ERAS in terms of long-term care to ensure adherence, safety, and effectiveness,” she said, adding that tracking of outcomes will continue, and a future goal is to assess impacts on cost.
Dr. Carter-Brooks’s study was supported by a National Institutes of Health grant. She and Ms. Fowler each reported having no disclosures.
SOURCES: Carter-Brooks C et al.; Fowler M et al. SGS 2018, Oral presentation 2; Oral posters 1 and 16.
REPORTING FROM SGS 2018
Key clinical point: ERAS pathways improve same-day discharge rates and reduce opioid use in gynecologic surgery.
Major finding: Same-day discharge rates before and after ERAS were 25.9% and 91.7%, respectively.
Study details: A retrospective review of 258 patients; a study of 161 patients.
Disclosures: Dr. Carter-Brooks’s study was supported by a National Institutes of Health grant. She and Ms. Fowler each reported having no disclosures.
Sources: Carter-Brooks C et al.; Fowler M et al. SGS 2018, Oral presentation 2; Oral posters 1 and 16.
Study: Preop EKGs have little utility for benign hysterectomy
ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.
Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.
By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.
Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.
Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.
For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.
“Preoperative testing for benign hysterectomy is variable as there is no single standard of care,” she explained. “Though tests such as EKG are commonly ordered, there are no data linking study results to surgical outcomes.”
The current study was conducted to evaluate the rate of preoperative EKG performed in concordance with institutional and NICE guidelines, and to assess implications for management and perioperative complications.
Patients included in the review were adult women who underwent scheduled benign hysterectomy during 2016. Women who underwent emergency surgery or whose surgery was performed by gynecologic oncologists were excluded.
Subjects were primarily Hispanic, and had a mean age of 45 years, Dr. Shah noted.
Though limited by the single-center design and retrospective nature of the study, the findings suggest that preoperative EKG has little clinical utility.
“We found that practice patterns were highly concordant with institutional and NICE guidelines. However, EKG resulted in minimal impact on perioperative management, and no association between abnormal EKG and perioperative complications was found,” she said. “EKG may not accurately stratify perioperative cardiopulmonary risk, and alternative methods for preoperative evaluation should be considered.”
Dr. Shah reported having no disclosures.
SOURCE: Shah N et al. SGS 2018 Oral Poster 3.
ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.
Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.
By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.
Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.
Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.
For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.
“Preoperative testing for benign hysterectomy is variable as there is no single standard of care,” she explained. “Though tests such as EKG are commonly ordered, there are no data linking study results to surgical outcomes.”
The current study was conducted to evaluate the rate of preoperative EKG performed in concordance with institutional and NICE guidelines, and to assess implications for management and perioperative complications.
Patients included in the review were adult women who underwent scheduled benign hysterectomy during 2016. Women who underwent emergency surgery or whose surgery was performed by gynecologic oncologists were excluded.
Subjects were primarily Hispanic, and had a mean age of 45 years, Dr. Shah noted.
Though limited by the single-center design and retrospective nature of the study, the findings suggest that preoperative EKG has little clinical utility.
“We found that practice patterns were highly concordant with institutional and NICE guidelines. However, EKG resulted in minimal impact on perioperative management, and no association between abnormal EKG and perioperative complications was found,” she said. “EKG may not accurately stratify perioperative cardiopulmonary risk, and alternative methods for preoperative evaluation should be considered.”
Dr. Shah reported having no disclosures.
SOURCE: Shah N et al. SGS 2018 Oral Poster 3.
ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.
Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.
By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.
Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.
Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.
For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.
“Preoperative testing for benign hysterectomy is variable as there is no single standard of care,” she explained. “Though tests such as EKG are commonly ordered, there are no data linking study results to surgical outcomes.”
The current study was conducted to evaluate the rate of preoperative EKG performed in concordance with institutional and NICE guidelines, and to assess implications for management and perioperative complications.
Patients included in the review were adult women who underwent scheduled benign hysterectomy during 2016. Women who underwent emergency surgery or whose surgery was performed by gynecologic oncologists were excluded.
Subjects were primarily Hispanic, and had a mean age of 45 years, Dr. Shah noted.
Though limited by the single-center design and retrospective nature of the study, the findings suggest that preoperative EKG has little clinical utility.
“We found that practice patterns were highly concordant with institutional and NICE guidelines. However, EKG resulted in minimal impact on perioperative management, and no association between abnormal EKG and perioperative complications was found,” she said. “EKG may not accurately stratify perioperative cardiopulmonary risk, and alternative methods for preoperative evaluation should be considered.”
Dr. Shah reported having no disclosures.
SOURCE: Shah N et al. SGS 2018 Oral Poster 3.
REPORTING FROM SGS 2018
Key clinical point: Preoperative EKG appears to have little utility in patients undergoing benign hysterectomy.
Major finding: Only 16 of 89 patients with abnormal preoperative EKG underwent further workup, and surgery was delayed in only two cases.
Study details: A retrospective review of 587 cases.
Disclosures: Dr. Shah reported having no disclosures.
Source: Shah N et al. SGS 2018 Oral Poster 3.
Fast-track catheter management offers little benefit after benign hysterectomy
ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.
Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.
Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.
Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.
Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).
In women undergoing gynecologic surgery, indwelling urinary catheters often are used for an extended period as postoperative voiding dysfunction is presumed, Dr. Lang noted.
For the current single-center study, women undergoing any benign gynecologic surgery with an anticipated hospital stay of at least 1 night were enrolled and randomized to fast-track or conventional catheter management. All underwent hysterectomy, and the approaches, including robotic in 42%, traditional laparoscopic in 33%, vaginal in 14.3%, and abdominal in 10.3%, did not differ among the groups. Neither the rates of voiding trial success nor catheter dwell time differed, based on hysterectomy approach, he said.
“Catheter dwell time is reduced with a fast-track approach, but dwell time does not appear to influence patient satisfaction or urinary tract symptomatology, urinary tract infection, or antibiotic exposure in the 2-3 weeks following benign gynecologic surgery,” he concluded.
Dr. Lang reported having no disclosures.
SOURCE: Lang P et al. SGS 2018, Oral Poster 20.
ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.
Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.
Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.
Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.
Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).
In women undergoing gynecologic surgery, indwelling urinary catheters often are used for an extended period as postoperative voiding dysfunction is presumed, Dr. Lang noted.
For the current single-center study, women undergoing any benign gynecologic surgery with an anticipated hospital stay of at least 1 night were enrolled and randomized to fast-track or conventional catheter management. All underwent hysterectomy, and the approaches, including robotic in 42%, traditional laparoscopic in 33%, vaginal in 14.3%, and abdominal in 10.3%, did not differ among the groups. Neither the rates of voiding trial success nor catheter dwell time differed, based on hysterectomy approach, he said.
“Catheter dwell time is reduced with a fast-track approach, but dwell time does not appear to influence patient satisfaction or urinary tract symptomatology, urinary tract infection, or antibiotic exposure in the 2-3 weeks following benign gynecologic surgery,” he concluded.
Dr. Lang reported having no disclosures.
SOURCE: Lang P et al. SGS 2018, Oral Poster 20.
ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.
Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.
Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.
Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.
Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).
In women undergoing gynecologic surgery, indwelling urinary catheters often are used for an extended period as postoperative voiding dysfunction is presumed, Dr. Lang noted.
For the current single-center study, women undergoing any benign gynecologic surgery with an anticipated hospital stay of at least 1 night were enrolled and randomized to fast-track or conventional catheter management. All underwent hysterectomy, and the approaches, including robotic in 42%, traditional laparoscopic in 33%, vaginal in 14.3%, and abdominal in 10.3%, did not differ among the groups. Neither the rates of voiding trial success nor catheter dwell time differed, based on hysterectomy approach, he said.
“Catheter dwell time is reduced with a fast-track approach, but dwell time does not appear to influence patient satisfaction or urinary tract symptomatology, urinary tract infection, or antibiotic exposure in the 2-3 weeks following benign gynecologic surgery,” he concluded.
Dr. Lang reported having no disclosures.
SOURCE: Lang P et al. SGS 2018, Oral Poster 20.
REPORTING FROM SGS 2018
Key clinical point: Fast-track catheter management after surgery improves dwell time, but not other outcomes.
Major finding: Catheter dwell times were 650 versus 1,196 minutes with fast-track and conventional management, respectively.
Study details: A prospective, randomized study of 200 women.
Disclosures: Dr. Lang reported having no disclosures.
Source: Lang P et al. SGS 2018, Oral Poster 20.
Study: No increased risk of serious AEs with combined urogyn/gyn onc surgery
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
ORLANDO – Intraoperative and serious postoperative adverse events do not occur more frequently with concurrent urogynecologic and gynecologic oncology procedures versus the latter alone, but minor adverse events are more common, according to findings from a retrospective matched cohort study.
The study also showed that 10% of planned urogynecologic procedures are modified or abandoned at the time of gynecologic oncology surgery, Emily R. Davidson, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“Concurrent cases were longer by 76 minutes, which is not surprising given that additional procedures were performed, and on univariate analysis there were differences in the frequency of multiple postoperative adverse events between the cohorts, including estimated blood loss, discharge with a Foley catheter, perioperative transfusion, postoperative pulmonary complications, ileus, renal failure, and urinary tract infection,” she said.
However, on multivariate analysis controlling for preoperative cardiovascular and pulmonary comorbidities, only urinary tract infection and discharge with a Foley catheter related to postoperative voiding dysfunction, which were significantly more common in the combined surgery group (26% vs. 7% and 35% vs. 1%, respectively), remained significantly different between the groups, she noted.
No differences were seen between the groups in length of hospital stay, reoperation, readmission within 1 month, surgical site infection, or death within 1 year of surgery, but patients undergoing concurrent procedures had more Clavien-Dindo grade 2 complications (44% vs. 19%), and this was primarily related to the prescription of antibiotics for urinary tract infections, she said.
As for the 11 cases (10%) with planned urogynecologic surgeries that were significantly changed or aborted at the time of gynecologic oncology surgery, 5 were because of intraoperative complications, 3 because of technical limitations, and 3 because of a change in oncologic care plan, including the need for postoperative radiation, she noted.
Case patients were women who underwent planned concurrent procedures at a large tertiary care center from January 2004 to June 2017. Of these women, 77% had stress urinary incontinence, 74% had pelvic organ prolapse (with 55% having stage 3 or 4 prolapse), 71% had prolapse repair – most commonly a native-tissue transvaginal colpopexy – as part of their procedure, and 74% had an anti-incontinence procedure – most commonly a transobturator sling.
The most common final histologic diagnosis was benign disease (in 51% of patients), and uterine cancer was the most common malignancy encountered (36% of patients), Dr. Davidson said, noting that other diagnoses included ovarian and vulvar cancer, in 12% and 1% of cases, respectively.
Most surgeries were minimally invasive abdominal hysterectomies (56%), followed by laparotomies in 32%, minor vaginal surgeries in 6%, laparoscopy without hysterectomy in 5%, and vaginal hysterectomy in 1%.
Controls were matched 2:1 based on surgeon, surgery date and invasiveness (surgical route), and final pathological diagnosis.
The median age of all patients was 59 years. Case patients undergoing concurrent procedures were more likely to be older (median of 64 vs. 57 years) and postmenopausal.
“Other statistically significant differences were that women undergoing combined surgery had higher vaginal parity, and were more likely to have undergone preoperative chemotherapy. They were also more likely to have a prior diagnosis of cardiovascular or pulmonary disease,” Dr. Davidson said.
“Women undergoing treatment for suspected gynecologic malignancy have the same or higher prevalence of pelvic floor disorders, compared with the general population, and they may choose to have combined surgery if both subspecialists are available,” she continued. “However, there are limited data regarding the incidence of adverse events in these concurrent procedures, or how often the planned urogynecology portion of the procedure is modified intraoperatively.”
Though limited by factors inherent in retrospective chart review, such as information bias at the time of data collection (which was mitigated by cross-checking data and having only two data collectors), the findings of the current study suggest that “concurrent urogynecologic and gynecologic oncology surgery should be offered to appropriate patients, as adding urogynecology surgery does not increase the risk of serious adverse events,” she concluded, adding that the study “highlights the importance of preoperative counseling, including discussion of the increased risk of minor postoperative adverse events, such as postoperative voiding symptoms and urinary tract infection, as well as discussion of the 10% risk of a change in intraoperative plan in the urogynecologic procedure.”
“This study certainly helps us know that we’re doing no harm [in offering concurrent surgery],” he said.
Dr. Davidson and Dr. Noone each reported having no relevant disclosures.
SOURCE: Davidson ER et al. SGS 2018, Oral Presentation 13.
REPORTING FROM SGS 2018
Key clinical point: Concurrent urogynecologic/gynecologic oncology surgery does not increase the risk of serious adverse events.
Major finding: Concurrent surgery patients had more grade 2 complications (44% vs. 19%).
Study details: A retrospective study of 108 cases and 216 matched controls.
Disclosures: Dr. Davidson and Dr. Noone each reported having no disclosures.
Source: Davidson ER et al. SGS 2018, Oral Presentation 13.
Sling revisions: pain as indication linked with SUI recurrence
ORLANDO – Pain as an indication for midurethral sling revision is associated with an elevated risk of postoperative stress urinary incontinence recurrence, according to a review of 129 cases.
At a mean follow-up of 21 months, the overall rate of recurrent stress urinary incontinence (SUI) among study subjects was 39.5%, which is similar to what has been previously reported in the literature. However, women who underwent revision for the indication of pain, including dyspareunia, pelvic pain, or muscle spasms, had an SUI recurrence rate of 70%, Meagan S. Cramer, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Women older than 55 years at the time of revision were significantly less likely to recur (adjusted odds ratio, 0.34 vs. younger women), and those whose original slings were placed less than 1 year prior to revision had a significantly lower rate of SUI recurrence, compared with those whose slings were placed more than 1 year prior (23.1% vs. 46.7%), she noted.
“There was no difference in BMI [body mass index], race, or baseline comorbidities between the recurrence vs. no recurrence group. There was also no difference in estrogen use preoperatively, concurrent replacement with another sling, preoperative [pelvic organ prolapse quantification] exam, length of sling excised, or the original type of sling placed between the recurrence versus non recurrence groups,” she said. “On multivariable regression analysis controlling for age, BMI, race, tobacco use, time since original sling, erosion on exam, technique used for revision, and presenting indication, pain as an indication of revision was still associated with an increased risk for recurrent incontinence, with an adjusted odds ratio of 9.08.”
Study subjects were women aged 18 years and older who underwent mesh sling revision from January 2009 to July 2016 at a single center. Women were excluded if they underwent revision or excision of vaginal mesh, or if they underwent sling adjustment for persistent incontinence if the incontinence had never resolved after the original sling placement. Those without postoperative follow-up were also excluded.
“Approximately 2%-4% of women who undergo midurethral sling surgery for stress incontinence will later require revision or excision of the sling due to erosion, pain, and/or voiding dysfunction. Based on current literature, up to 56% of these women can experience postoperative recurrence of stress incontinence following their revision,” Dr. Cramer said, noting that there is no consensus on which women will require future surgeries for stress incontinence after revision.
In the current study, women with pain were significantly more likely to undergo a complete excision of their sling (45.0% vs. 17.9% with other indications).
“We also discovered that of all women who underwent complete excision of a prior sling, those with pain had a higher rate of recurrent SUI, compared with those without pain [66.7% vs. 31.6%], but the difference was not statistically significant,” Dr. Cramer said in an interview.
She noted, however, that partial sling excision has been shown in at least one prior study “to provide just as much benefit as complete sling excision for patients with pain without leading to an increased risk of SUI.”
Though limited by the retrospective study design, the current findings suggest that pain as an indication for sling revision is associated with a higher risk of postoperative recurrent SUI, regardless of the type of revision, she said.
“Future prospective studies investigating the relationship between the indication for revision and postoperative stress incontinence would help to further define the roles of pain in this process,” she said, adding that in the meantime, given the prior findings regarding the benefits of partial sling excision, it may be reasonable to advise patients with pain that undergoing a partial sling excision could reduce the risk of recurrent SUI.
Dr. Cramer reported having no disclosures.
SOURCE: Cramer MS et al. SGS 2018, Oral Presentation 04.
ORLANDO – Pain as an indication for midurethral sling revision is associated with an elevated risk of postoperative stress urinary incontinence recurrence, according to a review of 129 cases.
At a mean follow-up of 21 months, the overall rate of recurrent stress urinary incontinence (SUI) among study subjects was 39.5%, which is similar to what has been previously reported in the literature. However, women who underwent revision for the indication of pain, including dyspareunia, pelvic pain, or muscle spasms, had an SUI recurrence rate of 70%, Meagan S. Cramer, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Women older than 55 years at the time of revision were significantly less likely to recur (adjusted odds ratio, 0.34 vs. younger women), and those whose original slings were placed less than 1 year prior to revision had a significantly lower rate of SUI recurrence, compared with those whose slings were placed more than 1 year prior (23.1% vs. 46.7%), she noted.
“There was no difference in BMI [body mass index], race, or baseline comorbidities between the recurrence vs. no recurrence group. There was also no difference in estrogen use preoperatively, concurrent replacement with another sling, preoperative [pelvic organ prolapse quantification] exam, length of sling excised, or the original type of sling placed between the recurrence versus non recurrence groups,” she said. “On multivariable regression analysis controlling for age, BMI, race, tobacco use, time since original sling, erosion on exam, technique used for revision, and presenting indication, pain as an indication of revision was still associated with an increased risk for recurrent incontinence, with an adjusted odds ratio of 9.08.”
Study subjects were women aged 18 years and older who underwent mesh sling revision from January 2009 to July 2016 at a single center. Women were excluded if they underwent revision or excision of vaginal mesh, or if they underwent sling adjustment for persistent incontinence if the incontinence had never resolved after the original sling placement. Those without postoperative follow-up were also excluded.
“Approximately 2%-4% of women who undergo midurethral sling surgery for stress incontinence will later require revision or excision of the sling due to erosion, pain, and/or voiding dysfunction. Based on current literature, up to 56% of these women can experience postoperative recurrence of stress incontinence following their revision,” Dr. Cramer said, noting that there is no consensus on which women will require future surgeries for stress incontinence after revision.
In the current study, women with pain were significantly more likely to undergo a complete excision of their sling (45.0% vs. 17.9% with other indications).
“We also discovered that of all women who underwent complete excision of a prior sling, those with pain had a higher rate of recurrent SUI, compared with those without pain [66.7% vs. 31.6%], but the difference was not statistically significant,” Dr. Cramer said in an interview.
She noted, however, that partial sling excision has been shown in at least one prior study “to provide just as much benefit as complete sling excision for patients with pain without leading to an increased risk of SUI.”
Though limited by the retrospective study design, the current findings suggest that pain as an indication for sling revision is associated with a higher risk of postoperative recurrent SUI, regardless of the type of revision, she said.
“Future prospective studies investigating the relationship between the indication for revision and postoperative stress incontinence would help to further define the roles of pain in this process,” she said, adding that in the meantime, given the prior findings regarding the benefits of partial sling excision, it may be reasonable to advise patients with pain that undergoing a partial sling excision could reduce the risk of recurrent SUI.
Dr. Cramer reported having no disclosures.
SOURCE: Cramer MS et al. SGS 2018, Oral Presentation 04.
ORLANDO – Pain as an indication for midurethral sling revision is associated with an elevated risk of postoperative stress urinary incontinence recurrence, according to a review of 129 cases.
At a mean follow-up of 21 months, the overall rate of recurrent stress urinary incontinence (SUI) among study subjects was 39.5%, which is similar to what has been previously reported in the literature. However, women who underwent revision for the indication of pain, including dyspareunia, pelvic pain, or muscle spasms, had an SUI recurrence rate of 70%, Meagan S. Cramer, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Women older than 55 years at the time of revision were significantly less likely to recur (adjusted odds ratio, 0.34 vs. younger women), and those whose original slings were placed less than 1 year prior to revision had a significantly lower rate of SUI recurrence, compared with those whose slings were placed more than 1 year prior (23.1% vs. 46.7%), she noted.
“There was no difference in BMI [body mass index], race, or baseline comorbidities between the recurrence vs. no recurrence group. There was also no difference in estrogen use preoperatively, concurrent replacement with another sling, preoperative [pelvic organ prolapse quantification] exam, length of sling excised, or the original type of sling placed between the recurrence versus non recurrence groups,” she said. “On multivariable regression analysis controlling for age, BMI, race, tobacco use, time since original sling, erosion on exam, technique used for revision, and presenting indication, pain as an indication of revision was still associated with an increased risk for recurrent incontinence, with an adjusted odds ratio of 9.08.”
Study subjects were women aged 18 years and older who underwent mesh sling revision from January 2009 to July 2016 at a single center. Women were excluded if they underwent revision or excision of vaginal mesh, or if they underwent sling adjustment for persistent incontinence if the incontinence had never resolved after the original sling placement. Those without postoperative follow-up were also excluded.
“Approximately 2%-4% of women who undergo midurethral sling surgery for stress incontinence will later require revision or excision of the sling due to erosion, pain, and/or voiding dysfunction. Based on current literature, up to 56% of these women can experience postoperative recurrence of stress incontinence following their revision,” Dr. Cramer said, noting that there is no consensus on which women will require future surgeries for stress incontinence after revision.
In the current study, women with pain were significantly more likely to undergo a complete excision of their sling (45.0% vs. 17.9% with other indications).
“We also discovered that of all women who underwent complete excision of a prior sling, those with pain had a higher rate of recurrent SUI, compared with those without pain [66.7% vs. 31.6%], but the difference was not statistically significant,” Dr. Cramer said in an interview.
She noted, however, that partial sling excision has been shown in at least one prior study “to provide just as much benefit as complete sling excision for patients with pain without leading to an increased risk of SUI.”
Though limited by the retrospective study design, the current findings suggest that pain as an indication for sling revision is associated with a higher risk of postoperative recurrent SUI, regardless of the type of revision, she said.
“Future prospective studies investigating the relationship between the indication for revision and postoperative stress incontinence would help to further define the roles of pain in this process,” she said, adding that in the meantime, given the prior findings regarding the benefits of partial sling excision, it may be reasonable to advise patients with pain that undergoing a partial sling excision could reduce the risk of recurrent SUI.
Dr. Cramer reported having no disclosures.
SOURCE: Cramer MS et al. SGS 2018, Oral Presentation 04.
REPORTING FROM SGS 2018
Key clinical point: Sling revisions for pain may increase the risk of postoperative stress urinary incontinence recurrence.
Major finding: The recurrent SUI rate after revision was 39.5% overall vs. 70% among those with pain as an indication.
Study details: A retrospective cohort study of 129 women.
Disclosures: Dr. Cramer reported having no disclosures.
Source: Cramer MS et al. SGS 2018, Oral Presentation 04.
Survey: Litigation fears drive response to FDA power morcellator warnings
ORLANDO – A 2014 Food and Drug Administration Safety Communication warning about the risk of disseminating occult cancerous tissue when using power morcellation led to a sharp decline in its use among physicians in a large health care system, a survey and records review showed.
Of 126 ob.gyns. in the Charlotte, N.C., metro area who received the 24-question e-mail survey, 58% responded, and while 75% reported that they always or sometimes used power morcellation prior to receiving the FDA communication, more than 80% reported rarely or never using it after receiving the communication, Gerald Bernard Taylor, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Fear of litigation was cited as the reason for the change in practice by 45.7% of ob.gyns., followed by lack of access to power morcellators (34.7%), and concerns about undiagnosed malignancy (11.8%) and patient safety (5.7%), said Dr. Taylor of the Carolinas HealthCare System in Charlotte.
“We also heard from physicians about the guidelines,” he added, referring to informed consent protocols developed by a group of “key opinion leaders in gynecologic oncology and minimally invasive gynecology.” Many institutions developed moratoriums against the use of power morcellation in the wake of the FDA communication, but the Carolinas HealthCare System chose to commission these opinion leaders to address the issue, he explained.
“Interestingly enough, some [survey respondents] were not aware that the guidelines were available. Most (74.6%) thought that they were helpful when they actually reviewed them, and a few said that they were not helpful,” he said, noting that most of those who found the guidelines helpful said they felt that way because the guidelines “provide a standard of care and a possible defense against litigation.”
Analyses with respect to changes in practice after the FDA communication are ongoing but suggest that changes occurred mainly in the approach to myomectomies rather than in hysterectomy routes, Dr. Taylor said.
“We’re looking to see if there was increased use of minilaparotomy, and we are looking at the use of concealed morcellation bags right now,” he said.
The FDA Safety Communication was issued April 17, 2014 and stated that power morcellation used for hysterectomy or myomectomy in women with uterine fibroids “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
“Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the communication stated.
A Nov. 24, 2014 update stated that “laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal or are candidates for en bloc tissue removal, for example, through the vagina or minilaparotomy incision,” and “in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.”
The update also urged manufacturers of new and existing laparoscopic power morcellators to include the contraindications and a boxed warning in their product labeling and recommended that doctors share the information with their patients.
On Dec. 24, 2017, the FDA issued an updated assessment reinforcing their earlier communications. This latest update was based on a review of recent medical studies that, according to the FDA, suggested that “approximately 1 in 225 to 1 in 580 women who undergo surgery (hysterectomy or myomectomy) for presumed benign uterine growths (‘fibroids’) may have ‘occult’ or hidden uterine cancers known as sarcomas.” The FDA also said that “this is generally consistent with the 1 in 350 incidence estimated by the FDA in a 2014 review. The FDA also estimates the rate of occult leiomyosarcoma, a particularly aggressive type of sarcoma, to be approximately 1 in 495 to 1 in 1,100, again in general agreement with our previous assessment of 1 in 498.”
The FDA acknowledged that some health organizations have reported a lower estimate of risk but maintained its findings and recommendations, noting that it will continue to review new and relevant data.
Dr. Taylor reported having no disclosures.
SOURCE: Taylor GB et al. SGS 2018, Oral Poster 19.
ORLANDO – A 2014 Food and Drug Administration Safety Communication warning about the risk of disseminating occult cancerous tissue when using power morcellation led to a sharp decline in its use among physicians in a large health care system, a survey and records review showed.
Of 126 ob.gyns. in the Charlotte, N.C., metro area who received the 24-question e-mail survey, 58% responded, and while 75% reported that they always or sometimes used power morcellation prior to receiving the FDA communication, more than 80% reported rarely or never using it after receiving the communication, Gerald Bernard Taylor, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Fear of litigation was cited as the reason for the change in practice by 45.7% of ob.gyns., followed by lack of access to power morcellators (34.7%), and concerns about undiagnosed malignancy (11.8%) and patient safety (5.7%), said Dr. Taylor of the Carolinas HealthCare System in Charlotte.
“We also heard from physicians about the guidelines,” he added, referring to informed consent protocols developed by a group of “key opinion leaders in gynecologic oncology and minimally invasive gynecology.” Many institutions developed moratoriums against the use of power morcellation in the wake of the FDA communication, but the Carolinas HealthCare System chose to commission these opinion leaders to address the issue, he explained.
“Interestingly enough, some [survey respondents] were not aware that the guidelines were available. Most (74.6%) thought that they were helpful when they actually reviewed them, and a few said that they were not helpful,” he said, noting that most of those who found the guidelines helpful said they felt that way because the guidelines “provide a standard of care and a possible defense against litigation.”
Analyses with respect to changes in practice after the FDA communication are ongoing but suggest that changes occurred mainly in the approach to myomectomies rather than in hysterectomy routes, Dr. Taylor said.
“We’re looking to see if there was increased use of minilaparotomy, and we are looking at the use of concealed morcellation bags right now,” he said.
The FDA Safety Communication was issued April 17, 2014 and stated that power morcellation used for hysterectomy or myomectomy in women with uterine fibroids “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
“Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the communication stated.
A Nov. 24, 2014 update stated that “laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal or are candidates for en bloc tissue removal, for example, through the vagina or minilaparotomy incision,” and “in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.”
The update also urged manufacturers of new and existing laparoscopic power morcellators to include the contraindications and a boxed warning in their product labeling and recommended that doctors share the information with their patients.
On Dec. 24, 2017, the FDA issued an updated assessment reinforcing their earlier communications. This latest update was based on a review of recent medical studies that, according to the FDA, suggested that “approximately 1 in 225 to 1 in 580 women who undergo surgery (hysterectomy or myomectomy) for presumed benign uterine growths (‘fibroids’) may have ‘occult’ or hidden uterine cancers known as sarcomas.” The FDA also said that “this is generally consistent with the 1 in 350 incidence estimated by the FDA in a 2014 review. The FDA also estimates the rate of occult leiomyosarcoma, a particularly aggressive type of sarcoma, to be approximately 1 in 495 to 1 in 1,100, again in general agreement with our previous assessment of 1 in 498.”
The FDA acknowledged that some health organizations have reported a lower estimate of risk but maintained its findings and recommendations, noting that it will continue to review new and relevant data.
Dr. Taylor reported having no disclosures.
SOURCE: Taylor GB et al. SGS 2018, Oral Poster 19.
ORLANDO – A 2014 Food and Drug Administration Safety Communication warning about the risk of disseminating occult cancerous tissue when using power morcellation led to a sharp decline in its use among physicians in a large health care system, a survey and records review showed.
Of 126 ob.gyns. in the Charlotte, N.C., metro area who received the 24-question e-mail survey, 58% responded, and while 75% reported that they always or sometimes used power morcellation prior to receiving the FDA communication, more than 80% reported rarely or never using it after receiving the communication, Gerald Bernard Taylor, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
Fear of litigation was cited as the reason for the change in practice by 45.7% of ob.gyns., followed by lack of access to power morcellators (34.7%), and concerns about undiagnosed malignancy (11.8%) and patient safety (5.7%), said Dr. Taylor of the Carolinas HealthCare System in Charlotte.
“We also heard from physicians about the guidelines,” he added, referring to informed consent protocols developed by a group of “key opinion leaders in gynecologic oncology and minimally invasive gynecology.” Many institutions developed moratoriums against the use of power morcellation in the wake of the FDA communication, but the Carolinas HealthCare System chose to commission these opinion leaders to address the issue, he explained.
“Interestingly enough, some [survey respondents] were not aware that the guidelines were available. Most (74.6%) thought that they were helpful when they actually reviewed them, and a few said that they were not helpful,” he said, noting that most of those who found the guidelines helpful said they felt that way because the guidelines “provide a standard of care and a possible defense against litigation.”
Analyses with respect to changes in practice after the FDA communication are ongoing but suggest that changes occurred mainly in the approach to myomectomies rather than in hysterectomy routes, Dr. Taylor said.
“We’re looking to see if there was increased use of minilaparotomy, and we are looking at the use of concealed morcellation bags right now,” he said.
The FDA Safety Communication was issued April 17, 2014 and stated that power morcellation used for hysterectomy or myomectomy in women with uterine fibroids “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
“Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the communication stated.
A Nov. 24, 2014 update stated that “laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal or are candidates for en bloc tissue removal, for example, through the vagina or minilaparotomy incision,” and “in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.”
The update also urged manufacturers of new and existing laparoscopic power morcellators to include the contraindications and a boxed warning in their product labeling and recommended that doctors share the information with their patients.
On Dec. 24, 2017, the FDA issued an updated assessment reinforcing their earlier communications. This latest update was based on a review of recent medical studies that, according to the FDA, suggested that “approximately 1 in 225 to 1 in 580 women who undergo surgery (hysterectomy or myomectomy) for presumed benign uterine growths (‘fibroids’) may have ‘occult’ or hidden uterine cancers known as sarcomas.” The FDA also said that “this is generally consistent with the 1 in 350 incidence estimated by the FDA in a 2014 review. The FDA also estimates the rate of occult leiomyosarcoma, a particularly aggressive type of sarcoma, to be approximately 1 in 495 to 1 in 1,100, again in general agreement with our previous assessment of 1 in 498.”
The FDA acknowledged that some health organizations have reported a lower estimate of risk but maintained its findings and recommendations, noting that it will continue to review new and relevant data.
Dr. Taylor reported having no disclosures.
SOURCE: Taylor GB et al. SGS 2018, Oral Poster 19.
REPORTING FROM SGS 2018
Key clinical point: Litigation fears drove decline in power morcellation after FDA warning.
Study details: A survey of 126 physicians.
Disclosures: Dr. Taylor reported having no disclosures.
Source: Taylor GB et al. SGS 2018, Oral Poster 19.
High MIH case volume may up risk for adverse events in women with large uteri
ORLANDO – High case volume for surgeons performing minimally invasive hysterectomies in women with large uteri is associated with an increased rate of perioperative adverse events – but also with a decreased rate of conversion to laparotomy – according to a review of 763 procedures.
The minimally invasive hysterectomy (MIH) procedures in the study were performed by 66 surgeons and included 416 total laparoscopic hysterectomies, 196 robotic-assisted laparoscopic hysterectomies, 90 total vaginal hysterectomies, and 61 laparoscopic-assisted vaginal hysterectomies, Carol E. Bretschneider, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
The mean monthly case volume was 16.4 and mean MIH volume was 23, said Dr. Bretschneider, a fellow at the Cleveland Clinic.
“The rate of postoperative adverse events was 17.8%, the rate of intraoperative adverse events was 4.2%, and the rate of conversion from a minimally invasive approach to a laparotomy was 5.5%,” she said, explaining that adverse events were defined as those greater than grade 2 on the Clavien-Dindo classification scale. “No differences were appreciated across routes [of MIH] in terms of perioperative adverse events or conversion to laparotomy,” she noted.
Even after investigators controlled for age, body mass index, uterine weight, history of laparotomy, and parity, as well as surgeon volume and operative time, they found that higher monthly MIH volume, estimated blood loss, and operative time remained significantly associated with both intraoperative adverse events (adjusted odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (aOR, 1.3, 1.4, and 1.9, respectively), she said.
Higher BMI was associated with a lower incidence of intraoperative complications (aOR, 0.1).
“As for conversion to laparotomy, increasing surgeon volume was associated with a lower incidence of conversion (aOR, 0.4), but higher estimated blood loss and uterine weight were associated with a higher incidence of conversion (aOR, 2.6 and 7.1, respectively).”
Study subjects were women with a mean age of 47 years and mean BMI of 31 kg/m2 who underwent MIH during January 2014–June 2016 at a tertiary care referral center. Median uterine weight was 409 g, and indications for hysterectomy included fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Patients with malignancy were excluded.
“In the context of high-complexity cases, such as those for large uteri, many factors beyond surgical volume influence perioperative adverse events,” Dr. Bretschneider said, concluding that, to improve patient safety and outcomes, additional studies should be performed to explore the relationship between surgeon experience and patient factors on perioperative outcomes in the setting of common gynecologic procedures.
Dr. Bretschneider reported having no relevant disclosures.
SOURCE: Bretschneider C et al. SGS 2018, Oral Poster 12.
ORLANDO – High case volume for surgeons performing minimally invasive hysterectomies in women with large uteri is associated with an increased rate of perioperative adverse events – but also with a decreased rate of conversion to laparotomy – according to a review of 763 procedures.
The minimally invasive hysterectomy (MIH) procedures in the study were performed by 66 surgeons and included 416 total laparoscopic hysterectomies, 196 robotic-assisted laparoscopic hysterectomies, 90 total vaginal hysterectomies, and 61 laparoscopic-assisted vaginal hysterectomies, Carol E. Bretschneider, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
The mean monthly case volume was 16.4 and mean MIH volume was 23, said Dr. Bretschneider, a fellow at the Cleveland Clinic.
“The rate of postoperative adverse events was 17.8%, the rate of intraoperative adverse events was 4.2%, and the rate of conversion from a minimally invasive approach to a laparotomy was 5.5%,” she said, explaining that adverse events were defined as those greater than grade 2 on the Clavien-Dindo classification scale. “No differences were appreciated across routes [of MIH] in terms of perioperative adverse events or conversion to laparotomy,” she noted.
Even after investigators controlled for age, body mass index, uterine weight, history of laparotomy, and parity, as well as surgeon volume and operative time, they found that higher monthly MIH volume, estimated blood loss, and operative time remained significantly associated with both intraoperative adverse events (adjusted odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (aOR, 1.3, 1.4, and 1.9, respectively), she said.
Higher BMI was associated with a lower incidence of intraoperative complications (aOR, 0.1).
“As for conversion to laparotomy, increasing surgeon volume was associated with a lower incidence of conversion (aOR, 0.4), but higher estimated blood loss and uterine weight were associated with a higher incidence of conversion (aOR, 2.6 and 7.1, respectively).”
Study subjects were women with a mean age of 47 years and mean BMI of 31 kg/m2 who underwent MIH during January 2014–June 2016 at a tertiary care referral center. Median uterine weight was 409 g, and indications for hysterectomy included fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Patients with malignancy were excluded.
“In the context of high-complexity cases, such as those for large uteri, many factors beyond surgical volume influence perioperative adverse events,” Dr. Bretschneider said, concluding that, to improve patient safety and outcomes, additional studies should be performed to explore the relationship between surgeon experience and patient factors on perioperative outcomes in the setting of common gynecologic procedures.
Dr. Bretschneider reported having no relevant disclosures.
SOURCE: Bretschneider C et al. SGS 2018, Oral Poster 12.
ORLANDO – High case volume for surgeons performing minimally invasive hysterectomies in women with large uteri is associated with an increased rate of perioperative adverse events – but also with a decreased rate of conversion to laparotomy – according to a review of 763 procedures.
The minimally invasive hysterectomy (MIH) procedures in the study were performed by 66 surgeons and included 416 total laparoscopic hysterectomies, 196 robotic-assisted laparoscopic hysterectomies, 90 total vaginal hysterectomies, and 61 laparoscopic-assisted vaginal hysterectomies, Carol E. Bretschneider, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
The mean monthly case volume was 16.4 and mean MIH volume was 23, said Dr. Bretschneider, a fellow at the Cleveland Clinic.
“The rate of postoperative adverse events was 17.8%, the rate of intraoperative adverse events was 4.2%, and the rate of conversion from a minimally invasive approach to a laparotomy was 5.5%,” she said, explaining that adverse events were defined as those greater than grade 2 on the Clavien-Dindo classification scale. “No differences were appreciated across routes [of MIH] in terms of perioperative adverse events or conversion to laparotomy,” she noted.
Even after investigators controlled for age, body mass index, uterine weight, history of laparotomy, and parity, as well as surgeon volume and operative time, they found that higher monthly MIH volume, estimated blood loss, and operative time remained significantly associated with both intraoperative adverse events (adjusted odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (aOR, 1.3, 1.4, and 1.9, respectively), she said.
Higher BMI was associated with a lower incidence of intraoperative complications (aOR, 0.1).
“As for conversion to laparotomy, increasing surgeon volume was associated with a lower incidence of conversion (aOR, 0.4), but higher estimated blood loss and uterine weight were associated with a higher incidence of conversion (aOR, 2.6 and 7.1, respectively).”
Study subjects were women with a mean age of 47 years and mean BMI of 31 kg/m2 who underwent MIH during January 2014–June 2016 at a tertiary care referral center. Median uterine weight was 409 g, and indications for hysterectomy included fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Patients with malignancy were excluded.
“In the context of high-complexity cases, such as those for large uteri, many factors beyond surgical volume influence perioperative adverse events,” Dr. Bretschneider said, concluding that, to improve patient safety and outcomes, additional studies should be performed to explore the relationship between surgeon experience and patient factors on perioperative outcomes in the setting of common gynecologic procedures.
Dr. Bretschneider reported having no relevant disclosures.
SOURCE: Bretschneider C et al. SGS 2018, Oral Poster 12.
REPORTING FROM SGS 2018
Key clinical point: High case volume may increase risk for adverse events during minimally invasive hysterectomy with large uteri.
Major finding: MIH volume, estimated blood loss, and operative time were associated with intraoperative adverse events (odds ratios, 1.9, 2.0, and 22.1, respectively) and postoperative adverse events (ORs, 1.3, 1.4, and 1.9, respectively).
Study details: A retrospective cohort study of 763 women.
Disclosures: Dr. Bretschneider reported having no relevant disclosures.
Source: Bretschneider C et al. SGS 2018, Oral Poster 12.
Laparoscopic hysterectomy safest even for markedly enlarged uteri
ORLANDO – according to findings from a nationwide cohort of more than 27,000 women.
After adjusting for numerous potential confounding factors, including medical risk factors, procedure-related variables, and patient demographics, increasing uterine weight was significantly associated with increasing odds of complications – particularly after hysterectomy for uteri over 500 g, Michelle Louie, MD, reported during an oral poster session at the annual scientific meeting of the Society of Gynecologic Surgeons.
The same was true for uteri of 250-500 g (adjusted OR, 0.99, 1.73, and 1.06, respectively), she noted, adding that “abdominal hysterectomy always has the highest rate of a complication, except at above 850 g, when a vaginal hysterectomy is associated with a greater odds of complications.”
This secondary analysis was performed using prospectively collected quality improvement data abstracted from the American College of Surgeons National Surgical Quality Improvement Program database, which includes patient information and 30-day outcomes from more than 500 U.S. hospitals. Patients included in the analysis were 27,167 women who underwent a hysterectomy for benign conditions during 2014-2015 for whom uterine size was reported. Complications assessed included infection, vascular complications, reoperation, and readmission.
“Our study suggests that uterine weight is not an appropriate indication for abdominal hysterectomy – that we can, and should, offer a laparoscopic approach even for a markedly enlarged uterus,” she said. “We believe, therefore, that patients may benefit from referral to specialty surgeons who are able to offer a laparoscopic approach, even for a very large uterus.”
In response to a question from the audience about the role of physician experience in the findings, Dr. Louie said that it was not a covariate for which information was available, thus it was not included in the analysis.
“However, I think all of us realize that surgeon volume and surgeon experience is an important factor for patient safety,” she said.
Dr. Louie has received consulting fees from Teleflex.
SOURCE: Louie M et al. SGS 2018, Oral Poster 06.
ORLANDO – according to findings from a nationwide cohort of more than 27,000 women.
After adjusting for numerous potential confounding factors, including medical risk factors, procedure-related variables, and patient demographics, increasing uterine weight was significantly associated with increasing odds of complications – particularly after hysterectomy for uteri over 500 g, Michelle Louie, MD, reported during an oral poster session at the annual scientific meeting of the Society of Gynecologic Surgeons.
The same was true for uteri of 250-500 g (adjusted OR, 0.99, 1.73, and 1.06, respectively), she noted, adding that “abdominal hysterectomy always has the highest rate of a complication, except at above 850 g, when a vaginal hysterectomy is associated with a greater odds of complications.”
This secondary analysis was performed using prospectively collected quality improvement data abstracted from the American College of Surgeons National Surgical Quality Improvement Program database, which includes patient information and 30-day outcomes from more than 500 U.S. hospitals. Patients included in the analysis were 27,167 women who underwent a hysterectomy for benign conditions during 2014-2015 for whom uterine size was reported. Complications assessed included infection, vascular complications, reoperation, and readmission.
“Our study suggests that uterine weight is not an appropriate indication for abdominal hysterectomy – that we can, and should, offer a laparoscopic approach even for a markedly enlarged uterus,” she said. “We believe, therefore, that patients may benefit from referral to specialty surgeons who are able to offer a laparoscopic approach, even for a very large uterus.”
In response to a question from the audience about the role of physician experience in the findings, Dr. Louie said that it was not a covariate for which information was available, thus it was not included in the analysis.
“However, I think all of us realize that surgeon volume and surgeon experience is an important factor for patient safety,” she said.
Dr. Louie has received consulting fees from Teleflex.
SOURCE: Louie M et al. SGS 2018, Oral Poster 06.
ORLANDO – according to findings from a nationwide cohort of more than 27,000 women.
After adjusting for numerous potential confounding factors, including medical risk factors, procedure-related variables, and patient demographics, increasing uterine weight was significantly associated with increasing odds of complications – particularly after hysterectomy for uteri over 500 g, Michelle Louie, MD, reported during an oral poster session at the annual scientific meeting of the Society of Gynecologic Surgeons.
The same was true for uteri of 250-500 g (adjusted OR, 0.99, 1.73, and 1.06, respectively), she noted, adding that “abdominal hysterectomy always has the highest rate of a complication, except at above 850 g, when a vaginal hysterectomy is associated with a greater odds of complications.”
This secondary analysis was performed using prospectively collected quality improvement data abstracted from the American College of Surgeons National Surgical Quality Improvement Program database, which includes patient information and 30-day outcomes from more than 500 U.S. hospitals. Patients included in the analysis were 27,167 women who underwent a hysterectomy for benign conditions during 2014-2015 for whom uterine size was reported. Complications assessed included infection, vascular complications, reoperation, and readmission.
“Our study suggests that uterine weight is not an appropriate indication for abdominal hysterectomy – that we can, and should, offer a laparoscopic approach even for a markedly enlarged uterus,” she said. “We believe, therefore, that patients may benefit from referral to specialty surgeons who are able to offer a laparoscopic approach, even for a very large uterus.”
In response to a question from the audience about the role of physician experience in the findings, Dr. Louie said that it was not a covariate for which information was available, thus it was not included in the analysis.
“However, I think all of us realize that surgeon volume and surgeon experience is an important factor for patient safety,” she said.
Dr. Louie has received consulting fees from Teleflex.
SOURCE: Louie M et al. SGS 2018, Oral Poster 06.
REPORTING FROM SGS 2018
Key clinical point: Laparoscopic hysterectomy can and should be offered to women with uteri over 500 g.
Major finding: The odds ratios for complications after laparoscopic, abdominal, and vaginal hysterectomy for uteri over 500 g were 1.61, 2.16, and 2.57, respectively.
Study details: A secondary analysis of a nationwide cohort of 27,167 women.
Disclosures: Dr. Louie has received consulting fees from Teleflex.
Source: Louie M et al. SGS 2018, Oral Poster 06.