Gynecologic Surgery

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.

[email protected]

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.

[email protected]

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.

[email protected]

SOURCE: Shah N et al. SGS 2018 Oral Poster 3.

NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

Dr. Manning-Geist had no disclosures.

[email protected]

SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.

NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

Dr. Manning-Geist had no disclosures.

[email protected]

SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.

NEW ORLEANS – When complete resection of advanced-stage, epithelial ovarian cancer is not possible, surgical resection that leaves a small volume of residual tumor at a single site produces significantly better outcomes than leaving minimal residual cancer at multiple sites, according to a review of 510 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

Dr. Manning-Geist had no disclosures.

[email protected]

SOURCE: Manning-Geist B et al. SGO 2018, Abstract 43.

NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

• Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
• Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
• Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
• Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.

Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.

[email protected]

SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.

NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

• Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
• Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
• Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
• Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.

Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.

[email protected]

SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.

NEW ORLEANS – U.S. clinicians prescribe opioid tablets to postsurgical patients too often and at too high a pill count, according to results from two independent studies that examined prescribing patterns and opioid use in patients following gynecologic surgery.

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

Mitchel L. Zoler/MDedge News

• Patients undergoing minimally invasive or outpatient surgery and with no history of chronic pain and low opioid need while hospitalized received the default dispense of 600 mg ibuprofen every 6 hours as needed for 7 days and 500 mg acetaminophen every 6 hours as needed for 7 days.
• Patients who underwent this surgery but required 5 or more opioid tablets while hospitalized or those with a history of chronic pain and opioid use received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply with 1 tablet taken every 6 hours as needed.
• Patients who underwent laparotomy and had no chronic pain and opioid history and low opioid use while hospitalized received the ibuprofen and acetaminophen regimen plus 12 opioid tablets, a 3-day supply.
• Patients who underwent laparotomy and showed a higher opioid need based on their use during the 24 hours before discharge received the ibuprofen and acetaminophen regimen plus 24 opioid tablets for 3 days so they could take 2 tablets every 6 hours as needed.

Dr. Mark and his associates collected data from 337 patients managed with these guidelines during June 2017–January 2018 and compared them with 626 patients who underwent gynecologic surgery at Roswell Park during July 2016–June 2017. The data showed the average number of opioid tablets dispensed per patient for all discharges fell from 31.7 before the new guideline to 3.5, an 89% reduction. For the subgroup of patients who had undergone a laparotomy, the average pill number fell from 43.6 to 11.6, a 72% drop. Among patients treated with minimally invasive or outpatient surgery, average tablets dispensed fell from 28.1 before to 0.9 after, a 97% reduction. The reduction among opioid-naive patients was 90%, and it was 83% among patients who used opioids prior to their surgery.

Dr. Mark, Dr. Weston, and Dr. Dowdy had no disclosures.

[email protected]

SOURCE: Mark J et al. SGO 2018, Abstract 7. Weston E et al. SGO 2018, Abstract 8.

NEW ORLEANS – Use of minimally invasive radical hysterectomy to treat early-stage cervical cancer has grown over the past decade, and in current U.S. practice, roughly half of these cases are done with a minimally-invasive approach, with the rest done by conventional laparotomy. But the first data ever reported from a large, prospective trial that compared the efficacy of both methods for cervical cancer had the unexpected finding that disease-free survival following minimally invasive procedures significantly lagged behind radical hysterectomies done by open laparotomy, Pedro T. Ramirez, MD, said at the annual meeting of the Society of Gynecologic Oncology.

Just after this report came results from a second study that used propensity score–adjusted observational data from the National Cancer Database and found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy, said J. Alejandro Rauh-Hain, MD, a gynecologic oncologist at the University of Texas MD Anderson Cancer Center in Houston.

Both findings were “very surprising,” said Dr. Rauh-Hain in a video interview. “I was pretty sure we’d see no difference” in outcomes between minimally invasive radical hysterectomies and the same surgery either done by laparoscope or robotically assisted.

Prior prospective comparisons of minimally invasive and open surgical methods for other cancer types, including endometrial, gastric, and ovarian, showed no differences in cancer recurrences and survival, which led to widening use of minimally invasive surgery (MIS) for cervical cancer despite no direct evidence supporting equivalence, Dr. Rauh-Hain noted. “We adopted it with no data. It made sense that cervical cancer would be the same as endometrial cancer,” he explained.

The Laparoscopic Approach to Cervical Cancer (LACC) trial ran at 33 centers in 12 countries, including six U.S. centers. The study randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. Each participating center had to submit to a trial review committee full case records for 10 patients and unedited surgical videos of two patients who had previously undergone a minimally invasive radical hysterectomy at the center to document local prowess with MIS.

Dr. Ramirez and his colleagues designed LACC to prove the noninferiority of MIS and calculated an expected enrollment of 740 patients based on statistical expectations, but the study stopped early after enrolling 631 patients because of the adverse outcomes identified in the MIS patients, with a median follow-up of 2.5 years instead of the planned follow-up of 4.5 years. The study reached the 4.5-year follow-up in about 39% of patients. Of the 312 patients randomized to undergo laparotomy, 88% actually underwent the surgery; of the 319 patients randomized to MIS, 91% received this surgery, with 16% of the MIS procedures done using robotic assistance.

The study’s primary endpoint was disease-free survival at 4.5 years, which occurred in 86% of the MIS patients and in 96.5% of the laparotomy patients, a difference that failed to meet the study’s prespecified definition of noninferiority for MIS, reported Dr. Ramirez, a professor of gynecologic oncology and director of Minimally Invasive Surgery Research and Education at the MD Anderson Cancer Center. In addition, several secondary analyses of the data all showed starkly superior outcomes in the laparotomy subgroup.

Disease-free survival among all patients regardless of follow-up duration occurred in 98% of laparotomy patients and 92% of MIS patients, which translated into a 3.74 hazard ratio (P = .002) for disease recurrence or death among the MIS patients when compared with laparotomy patients. The all-cause mortality rates were 1% in the laparotomy patients and 6% among the MIS patients, a hazard ratio of 6.00 (P = .004). The risk of local or regional recurrences was more than fourfold higher in the MIS patients. A blinded, central panel adjudicated all recurrences identified during the study.

The LACC results “should be discussed with patients scheduled to undergo radical hysterectomy” for cervical cancer, Dr. Ramirez concluded.

The observational data from the National Cancer Database used in the analysis led by Dr. Rauh-Hain came from 2,221 patients hospitalized and treated with radical hysterectomy and pelvic lymph node dissection at a U.S. center during 2010-2012 for either stage 1A2 or 1B1 cervical cancer. Among these patients, 47.5% underwent MIS, with 79% of those procedures done with robotic assistance, while the other 52.5% underwent open laparotomy, Dr. Rauh-Hain reported. Additional analysis of data from this database by the researchers showed that, although the first report of MIS for radical hysterectomy appeared in 1992, the approach remained largely unused in U.S. practice until 2007, when use of MIS began to sharply rise. By 2010, about a third of radical hysterectomies for cervical cancer involved MIS, and usage increased still further during 2011 and 2012 to produce a nearly 48% rate during the 3-year study period.

The primary endpoint of Dr. Rauh-Hain’s analysis was overall survival following propensity-score matching of the MIS and laparotomy patients using 13 demographic and clinical criteria. The analysis showed 4-year mortality rates of 5.8% among the laparotomy patients and 8.4% among the MIS patients, which calculated to a relatively increased mortality hazard from MIS of 48% (P = .02).

Dr. Rauh-Hain also reported results from an interrupted time series analysis using data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute. This analysis compared annual 4-year relative survival rates among women undergoing radical hysterectomy for cervical cancer and found that, after survival rates showed a gradual, steady rise during the years culminating in 2006, once MIS began being more widely used in 2007 survival rates began to drop, with a statistically significant annualized decline of 1% through 2010.

Based on the results from both studies, “at MD Anderson we discuss the results with patients,” with the consequence that the percentage of patients treated with laparotomy is now increasing, Dr. Rauh-Hain said. The results from both studies “are concerning,” he explained.

[email protected]

SOURCE: Ramirez PT and Rauh-Hain JA. SGO 2018, Late-Breaking Abstracts 1 and 2.

NEW ORLEANS – Use of minimally invasive radical hysterectomy to treat early-stage cervical cancer has grown over the past decade, and in current U.S. practice, roughly half of these cases are done with a minimally-invasive approach, with the rest done by conventional laparotomy. But the first data ever reported from a large, prospective trial that compared the efficacy of both methods for cervical cancer had the unexpected finding that disease-free survival following minimally invasive procedures significantly lagged behind radical hysterectomies done by open laparotomy, Pedro T. Ramirez, MD, said at the annual meeting of the Society of Gynecologic Oncology.

Just after this report came results from a second study that used propensity score–adjusted observational data from the National Cancer Database and found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy, said J. Alejandro Rauh-Hain, MD, a gynecologic oncologist at the University of Texas MD Anderson Cancer Center in Houston.

Both findings were “very surprising,” said Dr. Rauh-Hain in a video interview. “I was pretty sure we’d see no difference” in outcomes between minimally invasive radical hysterectomies and the same surgery either done by laparoscope or robotically assisted.

Prior prospective comparisons of minimally invasive and open surgical methods for other cancer types, including endometrial, gastric, and ovarian, showed no differences in cancer recurrences and survival, which led to widening use of minimally invasive surgery (MIS) for cervical cancer despite no direct evidence supporting equivalence, Dr. Rauh-Hain noted. “We adopted it with no data. It made sense that cervical cancer would be the same as endometrial cancer,” he explained.

The Laparoscopic Approach to Cervical Cancer (LACC) trial ran at 33 centers in 12 countries, including six U.S. centers. The study randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. Each participating center had to submit to a trial review committee full case records for 10 patients and unedited surgical videos of two patients who had previously undergone a minimally invasive radical hysterectomy at the center to document local prowess with MIS.

Dr. Ramirez and his colleagues designed LACC to prove the noninferiority of MIS and calculated an expected enrollment of 740 patients based on statistical expectations, but the study stopped early after enrolling 631 patients because of the adverse outcomes identified in the MIS patients, with a median follow-up of 2.5 years instead of the planned follow-up of 4.5 years. The study reached the 4.5-year follow-up in about 39% of patients. Of the 312 patients randomized to undergo laparotomy, 88% actually underwent the surgery; of the 319 patients randomized to MIS, 91% received this surgery, with 16% of the MIS procedures done using robotic assistance.

The study’s primary endpoint was disease-free survival at 4.5 years, which occurred in 86% of the MIS patients and in 96.5% of the laparotomy patients, a difference that failed to meet the study’s prespecified definition of noninferiority for MIS, reported Dr. Ramirez, a professor of gynecologic oncology and director of Minimally Invasive Surgery Research and Education at the MD Anderson Cancer Center. In addition, several secondary analyses of the data all showed starkly superior outcomes in the laparotomy subgroup.

Disease-free survival among all patients regardless of follow-up duration occurred in 98% of laparotomy patients and 92% of MIS patients, which translated into a 3.74 hazard ratio (P = .002) for disease recurrence or death among the MIS patients when compared with laparotomy patients. The all-cause mortality rates were 1% in the laparotomy patients and 6% among the MIS patients, a hazard ratio of 6.00 (P = .004). The risk of local or regional recurrences was more than fourfold higher in the MIS patients. A blinded, central panel adjudicated all recurrences identified during the study.

The LACC results “should be discussed with patients scheduled to undergo radical hysterectomy” for cervical cancer, Dr. Ramirez concluded.

The observational data from the National Cancer Database used in the analysis led by Dr. Rauh-Hain came from 2,221 patients hospitalized and treated with radical hysterectomy and pelvic lymph node dissection at a U.S. center during 2010-2012 for either stage 1A2 or 1B1 cervical cancer. Among these patients, 47.5% underwent MIS, with 79% of those procedures done with robotic assistance, while the other 52.5% underwent open laparotomy, Dr. Rauh-Hain reported. Additional analysis of data from this database by the researchers showed that, although the first report of MIS for radical hysterectomy appeared in 1992, the approach remained largely unused in U.S. practice until 2007, when use of MIS began to sharply rise. By 2010, about a third of radical hysterectomies for cervical cancer involved MIS, and usage increased still further during 2011 and 2012 to produce a nearly 48% rate during the 3-year study period.

The primary endpoint of Dr. Rauh-Hain’s analysis was overall survival following propensity-score matching of the MIS and laparotomy patients using 13 demographic and clinical criteria. The analysis showed 4-year mortality rates of 5.8% among the laparotomy patients and 8.4% among the MIS patients, which calculated to a relatively increased mortality hazard from MIS of 48% (P = .02).

Dr. Rauh-Hain also reported results from an interrupted time series analysis using data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute. This analysis compared annual 4-year relative survival rates among women undergoing radical hysterectomy for cervical cancer and found that, after survival rates showed a gradual, steady rise during the years culminating in 2006, once MIS began being more widely used in 2007 survival rates began to drop, with a statistically significant annualized decline of 1% through 2010.

Based on the results from both studies, “at MD Anderson we discuss the results with patients,” with the consequence that the percentage of patients treated with laparotomy is now increasing, Dr. Rauh-Hain said. The results from both studies “are concerning,” he explained.

[email protected]

SOURCE: Ramirez PT and Rauh-Hain JA. SGO 2018, Late-Breaking Abstracts 1 and 2.

NEW ORLEANS – Use of minimally invasive radical hysterectomy to treat early-stage cervical cancer has grown over the past decade, and in current U.S. practice, roughly half of these cases are done with a minimally-invasive approach, with the rest done by conventional laparotomy. But the first data ever reported from a large, prospective trial that compared the efficacy of both methods for cervical cancer had the unexpected finding that disease-free survival following minimally invasive procedures significantly lagged behind radical hysterectomies done by open laparotomy, Pedro T. Ramirez, MD, said at the annual meeting of the Society of Gynecologic Oncology.

Just after this report came results from a second study that used propensity score–adjusted observational data from the National Cancer Database and found significantly worse overall survival following minimally invasive radical hysterectomy for early-stage cervical cancer, compared with laparotomy, said J. Alejandro Rauh-Hain, MD, a gynecologic oncologist at the University of Texas MD Anderson Cancer Center in Houston.

Both findings were “very surprising,” said Dr. Rauh-Hain in a video interview. “I was pretty sure we’d see no difference” in outcomes between minimally invasive radical hysterectomies and the same surgery either done by laparoscope or robotically assisted.

Prior prospective comparisons of minimally invasive and open surgical methods for other cancer types, including endometrial, gastric, and ovarian, showed no differences in cancer recurrences and survival, which led to widening use of minimally invasive surgery (MIS) for cervical cancer despite no direct evidence supporting equivalence, Dr. Rauh-Hain noted. “We adopted it with no data. It made sense that cervical cancer would be the same as endometrial cancer,” he explained.

The Laparoscopic Approach to Cervical Cancer (LACC) trial ran at 33 centers in 12 countries, including six U.S. centers. The study randomized women during 2008-2017 who had stage 1A1, 1A2, or 1B1 cervical cancer to either MIS or open surgery for a radical hysterectomy. Each participating center had to submit to a trial review committee full case records for 10 patients and unedited surgical videos of two patients who had previously undergone a minimally invasive radical hysterectomy at the center to document local prowess with MIS.

Dr. Ramirez and his colleagues designed LACC to prove the noninferiority of MIS and calculated an expected enrollment of 740 patients based on statistical expectations, but the study stopped early after enrolling 631 patients because of the adverse outcomes identified in the MIS patients, with a median follow-up of 2.5 years instead of the planned follow-up of 4.5 years. The study reached the 4.5-year follow-up in about 39% of patients. Of the 312 patients randomized to undergo laparotomy, 88% actually underwent the surgery; of the 319 patients randomized to MIS, 91% received this surgery, with 16% of the MIS procedures done using robotic assistance.

The study’s primary endpoint was disease-free survival at 4.5 years, which occurred in 86% of the MIS patients and in 96.5% of the laparotomy patients, a difference that failed to meet the study’s prespecified definition of noninferiority for MIS, reported Dr. Ramirez, a professor of gynecologic oncology and director of Minimally Invasive Surgery Research and Education at the MD Anderson Cancer Center. In addition, several secondary analyses of the data all showed starkly superior outcomes in the laparotomy subgroup.

Disease-free survival among all patients regardless of follow-up duration occurred in 98% of laparotomy patients and 92% of MIS patients, which translated into a 3.74 hazard ratio (P = .002) for disease recurrence or death among the MIS patients when compared with laparotomy patients. The all-cause mortality rates were 1% in the laparotomy patients and 6% among the MIS patients, a hazard ratio of 6.00 (P = .004). The risk of local or regional recurrences was more than fourfold higher in the MIS patients. A blinded, central panel adjudicated all recurrences identified during the study.

The LACC results “should be discussed with patients scheduled to undergo radical hysterectomy” for cervical cancer, Dr. Ramirez concluded.

The observational data from the National Cancer Database used in the analysis led by Dr. Rauh-Hain came from 2,221 patients hospitalized and treated with radical hysterectomy and pelvic lymph node dissection at a U.S. center during 2010-2012 for either stage 1A2 or 1B1 cervical cancer. Among these patients, 47.5% underwent MIS, with 79% of those procedures done with robotic assistance, while the other 52.5% underwent open laparotomy, Dr. Rauh-Hain reported. Additional analysis of data from this database by the researchers showed that, although the first report of MIS for radical hysterectomy appeared in 1992, the approach remained largely unused in U.S. practice until 2007, when use of MIS began to sharply rise. By 2010, about a third of radical hysterectomies for cervical cancer involved MIS, and usage increased still further during 2011 and 2012 to produce a nearly 48% rate during the 3-year study period.

The primary endpoint of Dr. Rauh-Hain’s analysis was overall survival following propensity-score matching of the MIS and laparotomy patients using 13 demographic and clinical criteria. The analysis showed 4-year mortality rates of 5.8% among the laparotomy patients and 8.4% among the MIS patients, which calculated to a relatively increased mortality hazard from MIS of 48% (P = .02).

Dr. Rauh-Hain also reported results from an interrupted time series analysis using data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute. This analysis compared annual 4-year relative survival rates among women undergoing radical hysterectomy for cervical cancer and found that, after survival rates showed a gradual, steady rise during the years culminating in 2006, once MIS began being more widely used in 2007 survival rates began to drop, with a statistically significant annualized decline of 1% through 2010.

Based on the results from both studies, “at MD Anderson we discuss the results with patients,” with the consequence that the percentage of patients treated with laparotomy is now increasing, Dr. Rauh-Hain said. The results from both studies “are concerning,” he explained.

[email protected]

SOURCE: Ramirez PT and Rauh-Hain JA. SGO 2018, Late-Breaking Abstracts 1 and 2.

There is an increased focus on reducing the costs of health care delivery, and one major driver of surgical cost is length of hospitalization. A minimally invasive surgical approach to hysterectomy is a strategy that significantly enhances recovery and shortens hospital stay, although many patients who can safely be considered for same-day discharge (SDD), including many with cancer, are still admitted to the hospital overnight. Much has been published on the predictors and pathways for successful same-day discharge after minimally invasive hysterectomy, and in this column we will review how to best predict who is a good candidate for SDD and how to optimize the success of this approach with respect to safety and patient satisfaction.

What are the benefits to SDD?

Certainly, decreased hospitalization costs are an attractive feature of SDD following hysterectomy, although surgeons should also be mindful that patient-centered outcomes, such as pain control, managing nausea, and patient satisfaction, also are considered with equal emphasis. Several studies have shown that, in appropriate candidates and when proactive pathways are used, patient satisfaction is preserved with SDD following hysterectomy.¹

Choosing patient candidates

Same day discharge is most successfully accomplished in patients of good general baseline health.² Diabetic patients, particularly those on insulin, are generally not good candidates for SDD because it is important to monitor and intervene in blood glucose changes that are influenced by a nothing-by-mouth status and surgical stress. We recommend observing patients overnight with a history of pulmonary disease who may have transient increased postoperative O₂ needs. Similarly, patients with significant cardiac disease (including heart failure and coronary disease) may benefit from prolonged overnight observation.

Particular caution should be paid to patients with obstructive sleep apnea, which may be occult but anticipated in patients with very high body mass indexes (greater than 40 kg/m²). General anesthetic drugs, the trauma of intubation, and opioids all couple with the underlying airway compromise such that these patients are at risk for postoperative apnea, which, in severe cases, can result in anoxia and death. These patients should be considered for continuous pulse-ox monitoring for at least 12-24 hours postoperatively and are not good candidates for same-day discharge.

Patients who have baseline anticoagulation that has been stopped or bridged preoperatively should have prolonged observation with recheck of their postoperative hemoglobin prior to discharge.

Patients who live alone or are very elderly with baseline frailty are poor candidates for SDD and may benefit from nursing observation overnight while they metabolize their anesthesia. Patients who have chronic opioid dependency present a greater challenge to control postoperative pain; these patients are generally less good candidates for SDD.

Studies have shown that the indication for the procedure (for example, cancer with staging, fibroids, endometriosis) is less critical in determining who is a good candidate for SDD.³ However, successful SDD rates are highest in more straightforward cases with few or no prior surgeries, small uteri (less than 14 weeks), a surgical duration of less than 3 hours, and a surgical start time before 2 p.m. Longer, more complex cases are typically associated with more blood loss, higher risk for occult complications, and more time under anesthesia (and in Trendelenburg), which can exacerbate airway edema. In preparation for such cases, it might be wise to prepare patients for the possibility that they may not be good candidates for discharge on the same day. In general, most SDD pathways exclude patients with very high BMI (greater than 50 kg/m²) because of concern for airway patency and because these cases may be more complex with higher underlying risk. In addition, many of these patients have diabetes and require perioperative metabolic interventions.

Patient preparation

A key component to successful SDD is setting patient expectations. Patients should be informed at their preoperative visit that, unless there is an unexpected occurrence or response to the surgery, they will be discharged to home the same day. This allows them to prepare their home (including transportation needs) in advance. They should be provided with information about what to expect that first night after surgery (including potential residual drowsiness or nausea from anesthesia and immediate postoperative pain).

On the day of surgery, under the influence of anesthesia and pain medication, patients will have difficulty retaining complex discharge instructions. The preoperative visit is critically important because it’s the best time to provide them with this information, including postoperative activity limitations, wound and dressing care, and follow-up instructions. This is also the best time to provide prescriptions for postoperative pain, nausea, and constipation prophylaxis with detailed instructions about best use. Patients should be encouraged to fill these prescriptions preoperatively so that they have these medications on hand on the evening of their discharge.

Many programs utilize a combination of educational strategies (in person, written, video) to maximize the likelihood of retention.¹ It is also important to offer an opportunity for patients to ask questions about this information after they have received it (for example, by phoning the patients prior to their procedure).
 

Preoperative strategies

Intraoperative strategies

Consider in-and-out catheterization rather than placement of an indwelling catheter for anticipated short cases without complex bladder dissection.⁵ Minimize blood loss and maximally evacuate blood and clots with suction because hemoperitoneum can induce nausea and pain.

Pain from retained gas under the diaphragm can be reduced by bathing the diaphragms with 400 cc of dilute local anesthetic made by mixing 50 mL of 0.5% bupivacaine in 1000 mL normal saline prior to removal of pneumoperitoneum and while still in Trendelenburg. Ensure there is minimal retained intraperitoneal CO₂ at the completion of the surgery by asking the anesthesiologists to perform positive pressure ventilations prior to fascial closure. Consider injecting port sites (including the peritoneal and fascial layers) with a mixture of immediate and long-acting local anesthetics. Request that the anesthesia staff administer intraoperative doses of IV ketorolac, acetaminophen, and tramadol (in preference to opioids) and an aggressive perioperative cocktail of antiemetics.

Management in the recovery room

Surgeons should ensure that recovery room staff are well versed in the pathway for patients who are selected for SDD to ensure proactive implementation of analgesic and antiemetic regimens and to fast-track the various tasks and education required for discharge.⁵

Patients should be started on their home postoperative medication regimen in the recovery room, including an anti-inflammatory such as diclofenac, sublingual tramadol (in preference to an opioid, such as hydrocodone), docusate, and sennosides. IV opioids should be avoided because they can result in somnolence and nausea.

If placed intraoperatively, the Foley catheter should be removed early to allow adequate time to void. Backfilling the bladder prior to removal can hasten the urge to void and help objectively document completeness of evacuation. All patients should be seen by the anesthesiologist and/or surgeon prior to discharge.

For patients who are discharged same day, a follow-up phone call on postoperative day 1 is valuable to ensure that they have continued their successful postoperative transition to the home and to intervene early if there are concerns for patient satisfaction.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Fountain CR et al. Promoting same-day discharge for gynecologic oncology patients in minimally invasive hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-9.

2. Rivard C et al. Factors influencing same-day hospital discharge and risk factors for readmission after robotic surgery in the gynecologic oncology patient population. J Minim Invasive Gynecol. 2015 Feb;22(2):219-26.

3. Lee SJ et al. The feasibility and safety of same-day discharge after robotic-assisted hysterectomy alone or with other procedures for benign and malignant indications. Gynecol Oncol. 2014 Jun;133(3):552-5.

4. Elia N et al. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304.

5. Donnez O et al. Low pain score after total laparoscopic hysterectomy and same-day discharge within less than 5 hours: Results of a prospective observational study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9.

There is an increased focus on reducing the costs of health care delivery, and one major driver of surgical cost is length of hospitalization. A minimally invasive surgical approach to hysterectomy is a strategy that significantly enhances recovery and shortens hospital stay, although many patients who can safely be considered for same-day discharge (SDD), including many with cancer, are still admitted to the hospital overnight. Much has been published on the predictors and pathways for successful same-day discharge after minimally invasive hysterectomy, and in this column we will review how to best predict who is a good candidate for SDD and how to optimize the success of this approach with respect to safety and patient satisfaction.

What are the benefits to SDD?

Certainly, decreased hospitalization costs are an attractive feature of SDD following hysterectomy, although surgeons should also be mindful that patient-centered outcomes, such as pain control, managing nausea, and patient satisfaction, also are considered with equal emphasis. Several studies have shown that, in appropriate candidates and when proactive pathways are used, patient satisfaction is preserved with SDD following hysterectomy.¹

Choosing patient candidates

Same day discharge is most successfully accomplished in patients of good general baseline health.² Diabetic patients, particularly those on insulin, are generally not good candidates for SDD because it is important to monitor and intervene in blood glucose changes that are influenced by a nothing-by-mouth status and surgical stress. We recommend observing patients overnight with a history of pulmonary disease who may have transient increased postoperative O₂ needs. Similarly, patients with significant cardiac disease (including heart failure and coronary disease) may benefit from prolonged overnight observation.

Particular caution should be paid to patients with obstructive sleep apnea, which may be occult but anticipated in patients with very high body mass indexes (greater than 40 kg/m²). General anesthetic drugs, the trauma of intubation, and opioids all couple with the underlying airway compromise such that these patients are at risk for postoperative apnea, which, in severe cases, can result in anoxia and death. These patients should be considered for continuous pulse-ox monitoring for at least 12-24 hours postoperatively and are not good candidates for same-day discharge.

Patients who have baseline anticoagulation that has been stopped or bridged preoperatively should have prolonged observation with recheck of their postoperative hemoglobin prior to discharge.

Patients who live alone or are very elderly with baseline frailty are poor candidates for SDD and may benefit from nursing observation overnight while they metabolize their anesthesia. Patients who have chronic opioid dependency present a greater challenge to control postoperative pain; these patients are generally less good candidates for SDD.

Studies have shown that the indication for the procedure (for example, cancer with staging, fibroids, endometriosis) is less critical in determining who is a good candidate for SDD.³ However, successful SDD rates are highest in more straightforward cases with few or no prior surgeries, small uteri (less than 14 weeks), a surgical duration of less than 3 hours, and a surgical start time before 2 p.m. Longer, more complex cases are typically associated with more blood loss, higher risk for occult complications, and more time under anesthesia (and in Trendelenburg), which can exacerbate airway edema. In preparation for such cases, it might be wise to prepare patients for the possibility that they may not be good candidates for discharge on the same day. In general, most SDD pathways exclude patients with very high BMI (greater than 50 kg/m²) because of concern for airway patency and because these cases may be more complex with higher underlying risk. In addition, many of these patients have diabetes and require perioperative metabolic interventions.

Patient preparation

A key component to successful SDD is setting patient expectations. Patients should be informed at their preoperative visit that, unless there is an unexpected occurrence or response to the surgery, they will be discharged to home the same day. This allows them to prepare their home (including transportation needs) in advance. They should be provided with information about what to expect that first night after surgery (including potential residual drowsiness or nausea from anesthesia and immediate postoperative pain).

On the day of surgery, under the influence of anesthesia and pain medication, patients will have difficulty retaining complex discharge instructions. The preoperative visit is critically important because it’s the best time to provide them with this information, including postoperative activity limitations, wound and dressing care, and follow-up instructions. This is also the best time to provide prescriptions for postoperative pain, nausea, and constipation prophylaxis with detailed instructions about best use. Patients should be encouraged to fill these prescriptions preoperatively so that they have these medications on hand on the evening of their discharge.

Many programs utilize a combination of educational strategies (in person, written, video) to maximize the likelihood of retention.¹ It is also important to offer an opportunity for patients to ask questions about this information after they have received it (for example, by phoning the patients prior to their procedure).
 

Preoperative strategies

Intraoperative strategies

Consider in-and-out catheterization rather than placement of an indwelling catheter for anticipated short cases without complex bladder dissection.⁵ Minimize blood loss and maximally evacuate blood and clots with suction because hemoperitoneum can induce nausea and pain.

Pain from retained gas under the diaphragm can be reduced by bathing the diaphragms with 400 cc of dilute local anesthetic made by mixing 50 mL of 0.5% bupivacaine in 1000 mL normal saline prior to removal of pneumoperitoneum and while still in Trendelenburg. Ensure there is minimal retained intraperitoneal CO₂ at the completion of the surgery by asking the anesthesiologists to perform positive pressure ventilations prior to fascial closure. Consider injecting port sites (including the peritoneal and fascial layers) with a mixture of immediate and long-acting local anesthetics. Request that the anesthesia staff administer intraoperative doses of IV ketorolac, acetaminophen, and tramadol (in preference to opioids) and an aggressive perioperative cocktail of antiemetics.

Management in the recovery room

Surgeons should ensure that recovery room staff are well versed in the pathway for patients who are selected for SDD to ensure proactive implementation of analgesic and antiemetic regimens and to fast-track the various tasks and education required for discharge.⁵

Patients should be started on their home postoperative medication regimen in the recovery room, including an anti-inflammatory such as diclofenac, sublingual tramadol (in preference to an opioid, such as hydrocodone), docusate, and sennosides. IV opioids should be avoided because they can result in somnolence and nausea.

If placed intraoperatively, the Foley catheter should be removed early to allow adequate time to void. Backfilling the bladder prior to removal can hasten the urge to void and help objectively document completeness of evacuation. All patients should be seen by the anesthesiologist and/or surgeon prior to discharge.

For patients who are discharged same day, a follow-up phone call on postoperative day 1 is valuable to ensure that they have continued their successful postoperative transition to the home and to intervene early if there are concerns for patient satisfaction.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Fountain CR et al. Promoting same-day discharge for gynecologic oncology patients in minimally invasive hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-9.

2. Rivard C et al. Factors influencing same-day hospital discharge and risk factors for readmission after robotic surgery in the gynecologic oncology patient population. J Minim Invasive Gynecol. 2015 Feb;22(2):219-26.

3. Lee SJ et al. The feasibility and safety of same-day discharge after robotic-assisted hysterectomy alone or with other procedures for benign and malignant indications. Gynecol Oncol. 2014 Jun;133(3):552-5.

4. Elia N et al. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304.

5. Donnez O et al. Low pain score after total laparoscopic hysterectomy and same-day discharge within less than 5 hours: Results of a prospective observational study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9.

There is an increased focus on reducing the costs of health care delivery, and one major driver of surgical cost is length of hospitalization. A minimally invasive surgical approach to hysterectomy is a strategy that significantly enhances recovery and shortens hospital stay, although many patients who can safely be considered for same-day discharge (SDD), including many with cancer, are still admitted to the hospital overnight. Much has been published on the predictors and pathways for successful same-day discharge after minimally invasive hysterectomy, and in this column we will review how to best predict who is a good candidate for SDD and how to optimize the success of this approach with respect to safety and patient satisfaction.

What are the benefits to SDD?

Certainly, decreased hospitalization costs are an attractive feature of SDD following hysterectomy, although surgeons should also be mindful that patient-centered outcomes, such as pain control, managing nausea, and patient satisfaction, also are considered with equal emphasis. Several studies have shown that, in appropriate candidates and when proactive pathways are used, patient satisfaction is preserved with SDD following hysterectomy.¹

Choosing patient candidates

Same day discharge is most successfully accomplished in patients of good general baseline health.² Diabetic patients, particularly those on insulin, are generally not good candidates for SDD because it is important to monitor and intervene in blood glucose changes that are influenced by a nothing-by-mouth status and surgical stress. We recommend observing patients overnight with a history of pulmonary disease who may have transient increased postoperative O₂ needs. Similarly, patients with significant cardiac disease (including heart failure and coronary disease) may benefit from prolonged overnight observation.

Particular caution should be paid to patients with obstructive sleep apnea, which may be occult but anticipated in patients with very high body mass indexes (greater than 40 kg/m²). General anesthetic drugs, the trauma of intubation, and opioids all couple with the underlying airway compromise such that these patients are at risk for postoperative apnea, which, in severe cases, can result in anoxia and death. These patients should be considered for continuous pulse-ox monitoring for at least 12-24 hours postoperatively and are not good candidates for same-day discharge.

Patients who have baseline anticoagulation that has been stopped or bridged preoperatively should have prolonged observation with recheck of their postoperative hemoglobin prior to discharge.

Patients who live alone or are very elderly with baseline frailty are poor candidates for SDD and may benefit from nursing observation overnight while they metabolize their anesthesia. Patients who have chronic opioid dependency present a greater challenge to control postoperative pain; these patients are generally less good candidates for SDD.

Studies have shown that the indication for the procedure (for example, cancer with staging, fibroids, endometriosis) is less critical in determining who is a good candidate for SDD.³ However, successful SDD rates are highest in more straightforward cases with few or no prior surgeries, small uteri (less than 14 weeks), a surgical duration of less than 3 hours, and a surgical start time before 2 p.m. Longer, more complex cases are typically associated with more blood loss, higher risk for occult complications, and more time under anesthesia (and in Trendelenburg), which can exacerbate airway edema. In preparation for such cases, it might be wise to prepare patients for the possibility that they may not be good candidates for discharge on the same day. In general, most SDD pathways exclude patients with very high BMI (greater than 50 kg/m²) because of concern for airway patency and because these cases may be more complex with higher underlying risk. In addition, many of these patients have diabetes and require perioperative metabolic interventions.

Patient preparation

A key component to successful SDD is setting patient expectations. Patients should be informed at their preoperative visit that, unless there is an unexpected occurrence or response to the surgery, they will be discharged to home the same day. This allows them to prepare their home (including transportation needs) in advance. They should be provided with information about what to expect that first night after surgery (including potential residual drowsiness or nausea from anesthesia and immediate postoperative pain).

On the day of surgery, under the influence of anesthesia and pain medication, patients will have difficulty retaining complex discharge instructions. The preoperative visit is critically important because it’s the best time to provide them with this information, including postoperative activity limitations, wound and dressing care, and follow-up instructions. This is also the best time to provide prescriptions for postoperative pain, nausea, and constipation prophylaxis with detailed instructions about best use. Patients should be encouraged to fill these prescriptions preoperatively so that they have these medications on hand on the evening of their discharge.

Many programs utilize a combination of educational strategies (in person, written, video) to maximize the likelihood of retention.¹ It is also important to offer an opportunity for patients to ask questions about this information after they have received it (for example, by phoning the patients prior to their procedure).
 

Preoperative strategies

Intraoperative strategies

Consider in-and-out catheterization rather than placement of an indwelling catheter for anticipated short cases without complex bladder dissection.⁵ Minimize blood loss and maximally evacuate blood and clots with suction because hemoperitoneum can induce nausea and pain.

Pain from retained gas under the diaphragm can be reduced by bathing the diaphragms with 400 cc of dilute local anesthetic made by mixing 50 mL of 0.5% bupivacaine in 1000 mL normal saline prior to removal of pneumoperitoneum and while still in Trendelenburg. Ensure there is minimal retained intraperitoneal CO₂ at the completion of the surgery by asking the anesthesiologists to perform positive pressure ventilations prior to fascial closure. Consider injecting port sites (including the peritoneal and fascial layers) with a mixture of immediate and long-acting local anesthetics. Request that the anesthesia staff administer intraoperative doses of IV ketorolac, acetaminophen, and tramadol (in preference to opioids) and an aggressive perioperative cocktail of antiemetics.

Management in the recovery room

Surgeons should ensure that recovery room staff are well versed in the pathway for patients who are selected for SDD to ensure proactive implementation of analgesic and antiemetic regimens and to fast-track the various tasks and education required for discharge.⁵

Patients should be started on their home postoperative medication regimen in the recovery room, including an anti-inflammatory such as diclofenac, sublingual tramadol (in preference to an opioid, such as hydrocodone), docusate, and sennosides. IV opioids should be avoided because they can result in somnolence and nausea.

If placed intraoperatively, the Foley catheter should be removed early to allow adequate time to void. Backfilling the bladder prior to removal can hasten the urge to void and help objectively document completeness of evacuation. All patients should be seen by the anesthesiologist and/or surgeon prior to discharge.

For patients who are discharged same day, a follow-up phone call on postoperative day 1 is valuable to ensure that they have continued their successful postoperative transition to the home and to intervene early if there are concerns for patient satisfaction.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Fountain CR et al. Promoting same-day discharge for gynecologic oncology patients in minimally invasive hysterectomy. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):932-9.

2. Rivard C et al. Factors influencing same-day hospital discharge and risk factors for readmission after robotic surgery in the gynecologic oncology patient population. J Minim Invasive Gynecol. 2015 Feb;22(2):219-26.

3. Lee SJ et al. The feasibility and safety of same-day discharge after robotic-assisted hysterectomy alone or with other procedures for benign and malignant indications. Gynecol Oncol. 2014 Jun;133(3):552-5.

4. Elia N et al. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304.

5. Donnez O et al. Low pain score after total laparoscopic hysterectomy and same-day discharge within less than 5 hours: Results of a prospective observational study. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1293-9.

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.

[email protected]

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.

[email protected]

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.

[email protected]

SOURCE: Bretschneider C et al. SGS 2018, Oral Poster 12.

DALLAS – No clear winner emerged in a first-ever randomized controlled trial comparing Pfannenstiel with vertical incisions for women with obesity having cesarean delivery, though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.

At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.

[email protected]

SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
 

DALLAS – No clear winner emerged in a first-ever randomized controlled trial comparing Pfannenstiel with vertical incisions for women with obesity having cesarean delivery, though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.

At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.

[email protected]

SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
 

DALLAS – No clear winner emerged in a first-ever randomized controlled trial comparing Pfannenstiel with vertical incisions for women with obesity having cesarean delivery, though enrollment difficulties limited study numbers, with almost two-thirds of eligible women declining to participate in the surgical trial.

At 6 weeks postdelivery, 21.1% of women who had a vertical incision experienced wound complications, compared with 18.6% of those who had a Pfannenstiel incision, a nonsignificant difference. This was a smaller difference than was seen at 2 weeks postpartum, when 20% of the vertical incision group had wound complications, compared with 10.4% of those who had a Pfannenstiel, also a nonsignificant difference. Maternal and fetal outcomes didn’t differ significantly with the two surgical approaches.

[email protected]

SOURCE: Marrs CC et al. Am J Obstet Gynecol. 2018 Jan;218:S29.
 

Hysteroscopic sterilization is associated with a significantly greater risk of gynecological complications but not medical or surgical complications, compared with laparoscopic sterilization, according to data from a French nationwide cohort study.

In a report published Jan. 23 in JAMA, researchers conducted a study of 105,357 women – 71,303 (67.7%) of whom underwent hysteroscopic sterilization, and 34,054 (32.3%) of whom underwent laparoscopic sterilization – and who were followed for at least 1 year after the procedure.

Women who had the hysteroscopic procedure had a nearly threefold higher risk of tubal disorder or surgery, a sevenfold higher risk of sterilization failure, and a 25-fold higher risk of undergoing a second sterilization procedure at 1 year compared with those who had the laparoscopic procedure (P less than .001 for each). These risk increases persisted even at 3 years after the procedure (hazard ratios of 1.79, 4.66, and 16.63, respectively; 95% confidence interval for each).

“A second sterilization procedure following hysteroscopic sterilization is a well-identified risk already described in phase 2 and 3 studies, in which the risk varied between 4.0% and 4.5%,” wrote Kim Bouillon, MD, PhD, of the French National Agency for Medicines and Health Products Safety, and her coauthors.

“In the present study, this risk was 4.1% at the 1-year follow-up, comparable with that reported in previous studies conducted in real-life conditions in patients who received care in public or private hospitals, and much higher than after laparoscopic sterilization.”

However, hysteroscopic sterilization was associated with a significantly reduced risk of surgical complications, compared with laparoscopic sterilization (adjusted odds ratio, 0.18; 95% CI, 0.14-0.23). The overall rate of in-hospital surgical complications was 0.13% with the hysteroscopic procedure and 0.78% with the laparoscopic procedure. Medical complications occurred in 0.06% of hysteroscopic procedures and 0.11% of laparoscopic procedures.

Women who underwent hysteroscopic procedures also had a significantly lower risk of uterine disorders (adjusted HR, 0.85; 95% CI, 0.74-0.98), uterine bleeding, and hysterectomies at 1 year, after adjustment for known hysterectomy risk factors.

The researchers noted that in absolute terms, the differences in the risk of procedural complications were very small, compared with the differences in the risk of gynecological complications.

The risk of pregnancy was significantly lower in the hysteroscopic group, compared with the laparoscopic group at 1 year after the procedure, but by 3 years’ follow-up, the difference was no longer significant.

There were no significant differences seen in the risk of medical complications such as autoimmune disease and thyroid disorders, attempted suicide, or death between the two procedures. Women who underwent hysteroscopic sterilization had a slightly lower use of analgesics, antidepressants, and benzodiazepines at 1 year that was more pronounced by 3 years.

There was a significantly higher risk of allergic reaction seen with hysteroscopic sterilization among women with prior allergies, but the authors suggested that a null overall effect and large number of tested interactions made the finding “hypothesis-generating” only.

The study was prompted by safety concerns about hysteroscopic sterilization, with the Food and Drug Administration in 2015 receiving a large number of reports of adverse events including bleeding, pelvic pain, fallopian tube perforation, unwanted pregnancy, hysterectomies, depression, and allergic reactions.

The FDA has since ordered the device manufacturer to undertake an open-label, nonrandomized study comparing outcomes between hysteroscopic and laparoscopic sterilization, which is expected to deliver results in 2023.

“To our knowledge, this is the first study aiming at comparing medical outcomes in addition to gynecological outcomes between hysteroscopic and laparoscopic sterilization,” the authors wrote, referring to their own work. They concluded, “these findings do not support increased medical risks associated with hysteroscopic sterilization.”

One author declared personal fees from Boston Scientific but no other conflicts of interest were declared.

SOURCE: Bouillon K et al. JAMA. 2018 Jan 23;319:375-87.

Hysteroscopic sterilization is associated with a significantly greater risk of gynecological complications but not medical or surgical complications, compared with laparoscopic sterilization, according to data from a French nationwide cohort study.

In a report published Jan. 23 in JAMA, researchers conducted a study of 105,357 women – 71,303 (67.7%) of whom underwent hysteroscopic sterilization, and 34,054 (32.3%) of whom underwent laparoscopic sterilization – and who were followed for at least 1 year after the procedure.

Women who had the hysteroscopic procedure had a nearly threefold higher risk of tubal disorder or surgery, a sevenfold higher risk of sterilization failure, and a 25-fold higher risk of undergoing a second sterilization procedure at 1 year compared with those who had the laparoscopic procedure (P less than .001 for each). These risk increases persisted even at 3 years after the procedure (hazard ratios of 1.79, 4.66, and 16.63, respectively; 95% confidence interval for each).

“A second sterilization procedure following hysteroscopic sterilization is a well-identified risk already described in phase 2 and 3 studies, in which the risk varied between 4.0% and 4.5%,” wrote Kim Bouillon, MD, PhD, of the French National Agency for Medicines and Health Products Safety, and her coauthors.

“In the present study, this risk was 4.1% at the 1-year follow-up, comparable with that reported in previous studies conducted in real-life conditions in patients who received care in public or private hospitals, and much higher than after laparoscopic sterilization.”

However, hysteroscopic sterilization was associated with a significantly reduced risk of surgical complications, compared with laparoscopic sterilization (adjusted odds ratio, 0.18; 95% CI, 0.14-0.23). The overall rate of in-hospital surgical complications was 0.13% with the hysteroscopic procedure and 0.78% with the laparoscopic procedure. Medical complications occurred in 0.06% of hysteroscopic procedures and 0.11% of laparoscopic procedures.

Women who underwent hysteroscopic procedures also had a significantly lower risk of uterine disorders (adjusted HR, 0.85; 95% CI, 0.74-0.98), uterine bleeding, and hysterectomies at 1 year, after adjustment for known hysterectomy risk factors.

The researchers noted that in absolute terms, the differences in the risk of procedural complications were very small, compared with the differences in the risk of gynecological complications.

The risk of pregnancy was significantly lower in the hysteroscopic group, compared with the laparoscopic group at 1 year after the procedure, but by 3 years’ follow-up, the difference was no longer significant.

There were no significant differences seen in the risk of medical complications such as autoimmune disease and thyroid disorders, attempted suicide, or death between the two procedures. Women who underwent hysteroscopic sterilization had a slightly lower use of analgesics, antidepressants, and benzodiazepines at 1 year that was more pronounced by 3 years.

There was a significantly higher risk of allergic reaction seen with hysteroscopic sterilization among women with prior allergies, but the authors suggested that a null overall effect and large number of tested interactions made the finding “hypothesis-generating” only.

The study was prompted by safety concerns about hysteroscopic sterilization, with the Food and Drug Administration in 2015 receiving a large number of reports of adverse events including bleeding, pelvic pain, fallopian tube perforation, unwanted pregnancy, hysterectomies, depression, and allergic reactions.

The FDA has since ordered the device manufacturer to undertake an open-label, nonrandomized study comparing outcomes between hysteroscopic and laparoscopic sterilization, which is expected to deliver results in 2023.

“To our knowledge, this is the first study aiming at comparing medical outcomes in addition to gynecological outcomes between hysteroscopic and laparoscopic sterilization,” the authors wrote, referring to their own work. They concluded, “these findings do not support increased medical risks associated with hysteroscopic sterilization.”

One author declared personal fees from Boston Scientific but no other conflicts of interest were declared.

SOURCE: Bouillon K et al. JAMA. 2018 Jan 23;319:375-87.

Hysteroscopic sterilization is associated with a significantly greater risk of gynecological complications but not medical or surgical complications, compared with laparoscopic sterilization, according to data from a French nationwide cohort study.

In a report published Jan. 23 in JAMA, researchers conducted a study of 105,357 women – 71,303 (67.7%) of whom underwent hysteroscopic sterilization, and 34,054 (32.3%) of whom underwent laparoscopic sterilization – and who were followed for at least 1 year after the procedure.

Women who had the hysteroscopic procedure had a nearly threefold higher risk of tubal disorder or surgery, a sevenfold higher risk of sterilization failure, and a 25-fold higher risk of undergoing a second sterilization procedure at 1 year compared with those who had the laparoscopic procedure (P less than .001 for each). These risk increases persisted even at 3 years after the procedure (hazard ratios of 1.79, 4.66, and 16.63, respectively; 95% confidence interval for each).

“A second sterilization procedure following hysteroscopic sterilization is a well-identified risk already described in phase 2 and 3 studies, in which the risk varied between 4.0% and 4.5%,” wrote Kim Bouillon, MD, PhD, of the French National Agency for Medicines and Health Products Safety, and her coauthors.

“In the present study, this risk was 4.1% at the 1-year follow-up, comparable with that reported in previous studies conducted in real-life conditions in patients who received care in public or private hospitals, and much higher than after laparoscopic sterilization.”

However, hysteroscopic sterilization was associated with a significantly reduced risk of surgical complications, compared with laparoscopic sterilization (adjusted odds ratio, 0.18; 95% CI, 0.14-0.23). The overall rate of in-hospital surgical complications was 0.13% with the hysteroscopic procedure and 0.78% with the laparoscopic procedure. Medical complications occurred in 0.06% of hysteroscopic procedures and 0.11% of laparoscopic procedures.

Women who underwent hysteroscopic procedures also had a significantly lower risk of uterine disorders (adjusted HR, 0.85; 95% CI, 0.74-0.98), uterine bleeding, and hysterectomies at 1 year, after adjustment for known hysterectomy risk factors.

The researchers noted that in absolute terms, the differences in the risk of procedural complications were very small, compared with the differences in the risk of gynecological complications.

The risk of pregnancy was significantly lower in the hysteroscopic group, compared with the laparoscopic group at 1 year after the procedure, but by 3 years’ follow-up, the difference was no longer significant.

There were no significant differences seen in the risk of medical complications such as autoimmune disease and thyroid disorders, attempted suicide, or death between the two procedures. Women who underwent hysteroscopic sterilization had a slightly lower use of analgesics, antidepressants, and benzodiazepines at 1 year that was more pronounced by 3 years.

There was a significantly higher risk of allergic reaction seen with hysteroscopic sterilization among women with prior allergies, but the authors suggested that a null overall effect and large number of tested interactions made the finding “hypothesis-generating” only.

The study was prompted by safety concerns about hysteroscopic sterilization, with the Food and Drug Administration in 2015 receiving a large number of reports of adverse events including bleeding, pelvic pain, fallopian tube perforation, unwanted pregnancy, hysterectomies, depression, and allergic reactions.

The FDA has since ordered the device manufacturer to undertake an open-label, nonrandomized study comparing outcomes between hysteroscopic and laparoscopic sterilization, which is expected to deliver results in 2023.

“To our knowledge, this is the first study aiming at comparing medical outcomes in addition to gynecological outcomes between hysteroscopic and laparoscopic sterilization,” the authors wrote, referring to their own work. They concluded, “these findings do not support increased medical risks associated with hysteroscopic sterilization.”

One author declared personal fees from Boston Scientific but no other conflicts of interest were declared.

SOURCE: Bouillon K et al. JAMA. 2018 Jan 23;319:375-87.

“Enhanced Recovery After Surgery” (ERAS) practices and protocols have been increasingly refined and adopted for the field of gynecology, and there is hope among gynecologic surgeons – and some recent evidence – that, with the ERAS movement, we are improving patient recoveries and outcomes and minimizing the need for opioids.

This applies not only to open surgeries but also to the minimally invasive procedures that already are prized for significant reductions in morbidity and length of stay. The overarching and guiding principle of ERAS is that any surgery – whether open or minimally invasive, major or minor – places stress on the body and is associated with risks and morbidity.

Improved Outcomes

The ERAS mindset notably intersected gynecology with the publication in 2016 of a two-part series of guidelines for gynecology/oncology surgery from the ERAS Society. The 8-year-old society has its roots in a study group of European surgeons and others who decided to examine surgical practices and the concept of multimodal surgical care put forth in the 1990s by Henrik Kehlet, MD, PhD, then a professor at the University of Copenhagen.

The first set of recommendations addressed pre- and intraoperative care (Gynecol Oncol. 2016 Feb;140[2]:313-22), and the second set addressed postoperative care (Gynecol Oncol. 2016 Feb;140[2]:323-32). Similar evidence-based recommendations were previously written for colonic resections, rectal and pelvic surgery, and other surgical specialties.

Most of the published outcomes of enhanced recovery protocols come from colorectal surgery. As noted in the ERAS Society gynecology/oncology guidelines, the benefits include an average reduction in length of stay of 2.5 days and a decrease in complications by as much as 50%.

There is growing evidence, however, that ERAS programs are also beneficial for patients undergoing laparoscopic surgery, and outcomes from gynecology – including minimally invasive surgery – are also being reported.

For instance, a retrospective case-control study of 55 consecutive gynecologic oncology patients treated at the University of California, San Francisco, with laparoscopic or robotic surgery and an enhanced recovery pathway – and 110 historical control patients matched on the basis of age and surgery type – found significant improvements in recovery time, decreased pain despite reduced opioid use, and overall lower hospital costs (Obstet Gynecol. 2016 Jul;128[1]:138-44).

The enhanced recovery pathway included patient education, multimodal antiemetics, multimodal analgesia, and balanced fluid administration. Early catheter removal, ambulation, and feeding were also components. Analgesia included routine preoperative gabapentin, diclofenac, and acetaminophen; routine postoperative gabapentin, NSAIDs, and acetaminophen; and transversus abdominis plane blocks in 32 of the ERAS patients.

ERAS patients were significantly more likely to be discharged on day 1 (91%, compared with 60% in the control group). Opioid use decreased by 30%, and pain scores on postoperative day 1 were significantly lower.

Another study looking at the effect of enhanced recovery implementation in gynecologic surgeries at the University of Virginia, Charlottesville, (gynecologic oncology, urogynecology, and general gynecology) similarly reported benefits for vaginal and minimally invasive procedures, as well as for open procedures (Obstet Gynecol. 2016 Sep;128[3]:457-66).

In the minimally invasive group, investigators compared 324 patients before ERAS implementation with 249 patients afterward and found that the median length of stay was unchanged (1 day). However, intraoperative and postoperative opioid consumption decreased significantly and – even though actual pain scores improved only slightly – patient satisfaction scores improved markedly among post-ERAS patients. Patients gave higher marks, for instance, to questions regarding pain control (“how well your pain was controlled”) and teamwork (“staff worked together to care for you”).

Reducing Opioids

New opioid use that persists after a surgical procedure is a postsurgical complication that we all should be working to prevent. It has been estimated that 6% of surgical patients – even those who’ve had relatively minor surgical procedures – will become long-term opioid users, developing a dependence on the drugs prescribed to them for postsurgical pain.

This was shown last year in a national study of insurance claims data from between 2013 and 2014; investigators identified adults without opioid use in the year prior to surgery (including hysterectomy) and found that 5.9%-6.5% were filling opioid prescriptions 90-180 days after their surgical procedure. The incidence in a nonoperative control cohort was 0.4% (JAMA Surg. 2017 Jun 21;152[6]:e170504). Notably, this prolonged use was greatest in patients with prior pain conditions, substance abuse, and mental health disorders – a finding that may have implications for the counseling we provide prior to surgery.

It’s not clear what the optimal analgesic regimen is for minimally invasive or other gynecologic surgeries. What is clearly recommended, however, is that the approach be multifaceted. In our practice, we believe that the preoperative use of acetaminophen, pregabalin, and celecoxib plays an important role in reducing postoperative pain and opioid use. But we also have striven to create a practice-wide culture shift (throughout the operating and recovery rooms), for instance, that encourages using the least amounts of narcotics possible and using the shortest-acting formulations possible.

Transversus abdominis plane (TAP) blocks are also often part of ERAS protocols; they have been shown in at least two randomized controlled trials of abdominal hysterectomy to reduce intraoperative fentanyl requirements and to reduce immediate postoperative pain scores and postoperative morphine requirements (Anesth Analg. 2008 Dec;107[6]:2056-60; J Anaesthesiol Clin Pharmacol. 2014 Jul-Sep;30[3]:391-6).

More recently, liposomal bupivacaine, which is slowly released over several days, has gained traction as a substitute for standard bupivacaine and other agents in TAP blocks. In one recent retrospective study, abdominal incision infiltration with liposomal bupivacaine was associated with less opioid use (with no change in pain scores), compared with bupivacaine hydrochloride after laparotomy for gynecologic malignancies (Obstet Gynecol. 2016 Nov;128[5]:1009-17). It’s significantly more expensive, however, making it likely that the formulation is being used more judiciously in minimally invasive gynecologic surgery than in open surgeries.

Because of costs, we currently are restricted to using liposomal bupivacaine in our robotic surgeries only. In our practice, the single 20 mL vial (266 mg of liposomal bupivacaine) is diluted with 20 mL of normal saline, but it can be further diluted without loss of efficacy. With a 16-gauge needle, the liposomal bupivacaine is distributed across the incisions (usually 20 mL in the umbilicus with a larger incision and 10 mL in each of the two lateral incisions). Patients are counseled that they may have more discomfort after 3 days, but by this point most are mobile and feeling relatively well with a combination of NSAIDs and acetaminophen.

With growing visibility of the problem of narcotic dependence in the United States, patients seem increasingly receptive and even eager to limit or avoid the use of opioids. Patients should be counseled that minimizing or avoiding opioids may also speed recovery. Narcotics cause gut motility to slow down, which may hinder mobilization. Early mobilization (within 24 hours) is among the enhanced recovery elements that the ERAS Society guidelines say is “of particular value” for minimally invasive surgery, along with maintenance of normothermia and normovolemia with maintenance of adequate cardiac output.
 

Selecting Steps

Our practice is also trying to reduce preoperative bowel preparation and preoperative fasting, both of which have been found to be stressful for the body without evidence of benefit. These practices can lead to insulin resistance and hyperglycemia, which are associated with increased morbidity and length of stay.

It is now recommended that clear fluids be allowed up to 2 hours before surgery and solids up to 6 hours before. Some health systems and practices also recommend presurgical carbohydrate loading (for example, 10 ounces of apple juice 2 hours before surgery) – another small change on the ERAS menu – to further reduce postoperative insulin resistance and help the body cope with its stress response to surgery.

Along with nutritional changes are also various measures aimed at optimizing the body’s functionality before surgery (“prehabilitation”), from walking 30 minutes a day to abstaining from alcohol for patients who drink heavily.

Throughout the country, enhanced recovery protocols are taking shape in gynecologic surgery. ERAS was featured in an aptly titled panel session at the 2017 annual meeting of the American Association of Gynecologic Laparoscopists: “Outpatient Hysterectomy, ERAS, and Same-Day Discharge: The Next Big Thing in Gyn Surgery.” Others are applying ERAS to scheduled cesarean sections. And in our practice, I believe that if we continue making small changes, we will reach our goal of opioid-free recoveries and a better surgical experience for our patients.
 

Kirsten Sasaki, MD, is an associate of the Advanced Gynecologic Surgery Institute. She reported that she has no disclosures relevant to this Master Class.

“Enhanced Recovery After Surgery” (ERAS) practices and protocols have been increasingly refined and adopted for the field of gynecology, and there is hope among gynecologic surgeons – and some recent evidence – that, with the ERAS movement, we are improving patient recoveries and outcomes and minimizing the need for opioids.

This applies not only to open surgeries but also to the minimally invasive procedures that already are prized for significant reductions in morbidity and length of stay. The overarching and guiding principle of ERAS is that any surgery – whether open or minimally invasive, major or minor – places stress on the body and is associated with risks and morbidity.

Improved Outcomes

The ERAS mindset notably intersected gynecology with the publication in 2016 of a two-part series of guidelines for gynecology/oncology surgery from the ERAS Society. The 8-year-old society has its roots in a study group of European surgeons and others who decided to examine surgical practices and the concept of multimodal surgical care put forth in the 1990s by Henrik Kehlet, MD, PhD, then a professor at the University of Copenhagen.

The first set of recommendations addressed pre- and intraoperative care (Gynecol Oncol. 2016 Feb;140[2]:313-22), and the second set addressed postoperative care (Gynecol Oncol. 2016 Feb;140[2]:323-32). Similar evidence-based recommendations were previously written for colonic resections, rectal and pelvic surgery, and other surgical specialties.

Most of the published outcomes of enhanced recovery protocols come from colorectal surgery. As noted in the ERAS Society gynecology/oncology guidelines, the benefits include an average reduction in length of stay of 2.5 days and a decrease in complications by as much as 50%.

There is growing evidence, however, that ERAS programs are also beneficial for patients undergoing laparoscopic surgery, and outcomes from gynecology – including minimally invasive surgery – are also being reported.

For instance, a retrospective case-control study of 55 consecutive gynecologic oncology patients treated at the University of California, San Francisco, with laparoscopic or robotic surgery and an enhanced recovery pathway – and 110 historical control patients matched on the basis of age and surgery type – found significant improvements in recovery time, decreased pain despite reduced opioid use, and overall lower hospital costs (Obstet Gynecol. 2016 Jul;128[1]:138-44).

The enhanced recovery pathway included patient education, multimodal antiemetics, multimodal analgesia, and balanced fluid administration. Early catheter removal, ambulation, and feeding were also components. Analgesia included routine preoperative gabapentin, diclofenac, and acetaminophen; routine postoperative gabapentin, NSAIDs, and acetaminophen; and transversus abdominis plane blocks in 32 of the ERAS patients.

ERAS patients were significantly more likely to be discharged on day 1 (91%, compared with 60% in the control group). Opioid use decreased by 30%, and pain scores on postoperative day 1 were significantly lower.

Another study looking at the effect of enhanced recovery implementation in gynecologic surgeries at the University of Virginia, Charlottesville, (gynecologic oncology, urogynecology, and general gynecology) similarly reported benefits for vaginal and minimally invasive procedures, as well as for open procedures (Obstet Gynecol. 2016 Sep;128[3]:457-66).

In the minimally invasive group, investigators compared 324 patients before ERAS implementation with 249 patients afterward and found that the median length of stay was unchanged (1 day). However, intraoperative and postoperative opioid consumption decreased significantly and – even though actual pain scores improved only slightly – patient satisfaction scores improved markedly among post-ERAS patients. Patients gave higher marks, for instance, to questions regarding pain control (“how well your pain was controlled”) and teamwork (“staff worked together to care for you”).

Reducing Opioids

New opioid use that persists after a surgical procedure is a postsurgical complication that we all should be working to prevent. It has been estimated that 6% of surgical patients – even those who’ve had relatively minor surgical procedures – will become long-term opioid users, developing a dependence on the drugs prescribed to them for postsurgical pain.

This was shown last year in a national study of insurance claims data from between 2013 and 2014; investigators identified adults without opioid use in the year prior to surgery (including hysterectomy) and found that 5.9%-6.5% were filling opioid prescriptions 90-180 days after their surgical procedure. The incidence in a nonoperative control cohort was 0.4% (JAMA Surg. 2017 Jun 21;152[6]:e170504). Notably, this prolonged use was greatest in patients with prior pain conditions, substance abuse, and mental health disorders – a finding that may have implications for the counseling we provide prior to surgery.

It’s not clear what the optimal analgesic regimen is for minimally invasive or other gynecologic surgeries. What is clearly recommended, however, is that the approach be multifaceted. In our practice, we believe that the preoperative use of acetaminophen, pregabalin, and celecoxib plays an important role in reducing postoperative pain and opioid use. But we also have striven to create a practice-wide culture shift (throughout the operating and recovery rooms), for instance, that encourages using the least amounts of narcotics possible and using the shortest-acting formulations possible.

Transversus abdominis plane (TAP) blocks are also often part of ERAS protocols; they have been shown in at least two randomized controlled trials of abdominal hysterectomy to reduce intraoperative fentanyl requirements and to reduce immediate postoperative pain scores and postoperative morphine requirements (Anesth Analg. 2008 Dec;107[6]:2056-60; J Anaesthesiol Clin Pharmacol. 2014 Jul-Sep;30[3]:391-6).

More recently, liposomal bupivacaine, which is slowly released over several days, has gained traction as a substitute for standard bupivacaine and other agents in TAP blocks. In one recent retrospective study, abdominal incision infiltration with liposomal bupivacaine was associated with less opioid use (with no change in pain scores), compared with bupivacaine hydrochloride after laparotomy for gynecologic malignancies (Obstet Gynecol. 2016 Nov;128[5]:1009-17). It’s significantly more expensive, however, making it likely that the formulation is being used more judiciously in minimally invasive gynecologic surgery than in open surgeries.

Because of costs, we currently are restricted to using liposomal bupivacaine in our robotic surgeries only. In our practice, the single 20 mL vial (266 mg of liposomal bupivacaine) is diluted with 20 mL of normal saline, but it can be further diluted without loss of efficacy. With a 16-gauge needle, the liposomal bupivacaine is distributed across the incisions (usually 20 mL in the umbilicus with a larger incision and 10 mL in each of the two lateral incisions). Patients are counseled that they may have more discomfort after 3 days, but by this point most are mobile and feeling relatively well with a combination of NSAIDs and acetaminophen.

With growing visibility of the problem of narcotic dependence in the United States, patients seem increasingly receptive and even eager to limit or avoid the use of opioids. Patients should be counseled that minimizing or avoiding opioids may also speed recovery. Narcotics cause gut motility to slow down, which may hinder mobilization. Early mobilization (within 24 hours) is among the enhanced recovery elements that the ERAS Society guidelines say is “of particular value” for minimally invasive surgery, along with maintenance of normothermia and normovolemia with maintenance of adequate cardiac output.
 

Selecting Steps

Our practice is also trying to reduce preoperative bowel preparation and preoperative fasting, both of which have been found to be stressful for the body without evidence of benefit. These practices can lead to insulin resistance and hyperglycemia, which are associated with increased morbidity and length of stay.

It is now recommended that clear fluids be allowed up to 2 hours before surgery and solids up to 6 hours before. Some health systems and practices also recommend presurgical carbohydrate loading (for example, 10 ounces of apple juice 2 hours before surgery) – another small change on the ERAS menu – to further reduce postoperative insulin resistance and help the body cope with its stress response to surgery.

Along with nutritional changes are also various measures aimed at optimizing the body’s functionality before surgery (“prehabilitation”), from walking 30 minutes a day to abstaining from alcohol for patients who drink heavily.

Throughout the country, enhanced recovery protocols are taking shape in gynecologic surgery. ERAS was featured in an aptly titled panel session at the 2017 annual meeting of the American Association of Gynecologic Laparoscopists: “Outpatient Hysterectomy, ERAS, and Same-Day Discharge: The Next Big Thing in Gyn Surgery.” Others are applying ERAS to scheduled cesarean sections. And in our practice, I believe that if we continue making small changes, we will reach our goal of opioid-free recoveries and a better surgical experience for our patients.
 

Kirsten Sasaki, MD, is an associate of the Advanced Gynecologic Surgery Institute. She reported that she has no disclosures relevant to this Master Class.

“Enhanced Recovery After Surgery” (ERAS) practices and protocols have been increasingly refined and adopted for the field of gynecology, and there is hope among gynecologic surgeons – and some recent evidence – that, with the ERAS movement, we are improving patient recoveries and outcomes and minimizing the need for opioids.

This applies not only to open surgeries but also to the minimally invasive procedures that already are prized for significant reductions in morbidity and length of stay. The overarching and guiding principle of ERAS is that any surgery – whether open or minimally invasive, major or minor – places stress on the body and is associated with risks and morbidity.

Improved Outcomes

The ERAS mindset notably intersected gynecology with the publication in 2016 of a two-part series of guidelines for gynecology/oncology surgery from the ERAS Society. The 8-year-old society has its roots in a study group of European surgeons and others who decided to examine surgical practices and the concept of multimodal surgical care put forth in the 1990s by Henrik Kehlet, MD, PhD, then a professor at the University of Copenhagen.

The first set of recommendations addressed pre- and intraoperative care (Gynecol Oncol. 2016 Feb;140[2]:313-22), and the second set addressed postoperative care (Gynecol Oncol. 2016 Feb;140[2]:323-32). Similar evidence-based recommendations were previously written for colonic resections, rectal and pelvic surgery, and other surgical specialties.

Most of the published outcomes of enhanced recovery protocols come from colorectal surgery. As noted in the ERAS Society gynecology/oncology guidelines, the benefits include an average reduction in length of stay of 2.5 days and a decrease in complications by as much as 50%.

There is growing evidence, however, that ERAS programs are also beneficial for patients undergoing laparoscopic surgery, and outcomes from gynecology – including minimally invasive surgery – are also being reported.

For instance, a retrospective case-control study of 55 consecutive gynecologic oncology patients treated at the University of California, San Francisco, with laparoscopic or robotic surgery and an enhanced recovery pathway – and 110 historical control patients matched on the basis of age and surgery type – found significant improvements in recovery time, decreased pain despite reduced opioid use, and overall lower hospital costs (Obstet Gynecol. 2016 Jul;128[1]:138-44).

The enhanced recovery pathway included patient education, multimodal antiemetics, multimodal analgesia, and balanced fluid administration. Early catheter removal, ambulation, and feeding were also components. Analgesia included routine preoperative gabapentin, diclofenac, and acetaminophen; routine postoperative gabapentin, NSAIDs, and acetaminophen; and transversus abdominis plane blocks in 32 of the ERAS patients.

ERAS patients were significantly more likely to be discharged on day 1 (91%, compared with 60% in the control group). Opioid use decreased by 30%, and pain scores on postoperative day 1 were significantly lower.

Another study looking at the effect of enhanced recovery implementation in gynecologic surgeries at the University of Virginia, Charlottesville, (gynecologic oncology, urogynecology, and general gynecology) similarly reported benefits for vaginal and minimally invasive procedures, as well as for open procedures (Obstet Gynecol. 2016 Sep;128[3]:457-66).

In the minimally invasive group, investigators compared 324 patients before ERAS implementation with 249 patients afterward and found that the median length of stay was unchanged (1 day). However, intraoperative and postoperative opioid consumption decreased significantly and – even though actual pain scores improved only slightly – patient satisfaction scores improved markedly among post-ERAS patients. Patients gave higher marks, for instance, to questions regarding pain control (“how well your pain was controlled”) and teamwork (“staff worked together to care for you”).

Reducing Opioids

New opioid use that persists after a surgical procedure is a postsurgical complication that we all should be working to prevent. It has been estimated that 6% of surgical patients – even those who’ve had relatively minor surgical procedures – will become long-term opioid users, developing a dependence on the drugs prescribed to them for postsurgical pain.

This was shown last year in a national study of insurance claims data from between 2013 and 2014; investigators identified adults without opioid use in the year prior to surgery (including hysterectomy) and found that 5.9%-6.5% were filling opioid prescriptions 90-180 days after their surgical procedure. The incidence in a nonoperative control cohort was 0.4% (JAMA Surg. 2017 Jun 21;152[6]:e170504). Notably, this prolonged use was greatest in patients with prior pain conditions, substance abuse, and mental health disorders – a finding that may have implications for the counseling we provide prior to surgery.

It’s not clear what the optimal analgesic regimen is for minimally invasive or other gynecologic surgeries. What is clearly recommended, however, is that the approach be multifaceted. In our practice, we believe that the preoperative use of acetaminophen, pregabalin, and celecoxib plays an important role in reducing postoperative pain and opioid use. But we also have striven to create a practice-wide culture shift (throughout the operating and recovery rooms), for instance, that encourages using the least amounts of narcotics possible and using the shortest-acting formulations possible.

Transversus abdominis plane (TAP) blocks are also often part of ERAS protocols; they have been shown in at least two randomized controlled trials of abdominal hysterectomy to reduce intraoperative fentanyl requirements and to reduce immediate postoperative pain scores and postoperative morphine requirements (Anesth Analg. 2008 Dec;107[6]:2056-60; J Anaesthesiol Clin Pharmacol. 2014 Jul-Sep;30[3]:391-6).

More recently, liposomal bupivacaine, which is slowly released over several days, has gained traction as a substitute for standard bupivacaine and other agents in TAP blocks. In one recent retrospective study, abdominal incision infiltration with liposomal bupivacaine was associated with less opioid use (with no change in pain scores), compared with bupivacaine hydrochloride after laparotomy for gynecologic malignancies (Obstet Gynecol. 2016 Nov;128[5]:1009-17). It’s significantly more expensive, however, making it likely that the formulation is being used more judiciously in minimally invasive gynecologic surgery than in open surgeries.

Because of costs, we currently are restricted to using liposomal bupivacaine in our robotic surgeries only. In our practice, the single 20 mL vial (266 mg of liposomal bupivacaine) is diluted with 20 mL of normal saline, but it can be further diluted without loss of efficacy. With a 16-gauge needle, the liposomal bupivacaine is distributed across the incisions (usually 20 mL in the umbilicus with a larger incision and 10 mL in each of the two lateral incisions). Patients are counseled that they may have more discomfort after 3 days, but by this point most are mobile and feeling relatively well with a combination of NSAIDs and acetaminophen.

With growing visibility of the problem of narcotic dependence in the United States, patients seem increasingly receptive and even eager to limit or avoid the use of opioids. Patients should be counseled that minimizing or avoiding opioids may also speed recovery. Narcotics cause gut motility to slow down, which may hinder mobilization. Early mobilization (within 24 hours) is among the enhanced recovery elements that the ERAS Society guidelines say is “of particular value” for minimally invasive surgery, along with maintenance of normothermia and normovolemia with maintenance of adequate cardiac output.
 

Selecting Steps

Our practice is also trying to reduce preoperative bowel preparation and preoperative fasting, both of which have been found to be stressful for the body without evidence of benefit. These practices can lead to insulin resistance and hyperglycemia, which are associated with increased morbidity and length of stay.

It is now recommended that clear fluids be allowed up to 2 hours before surgery and solids up to 6 hours before. Some health systems and practices also recommend presurgical carbohydrate loading (for example, 10 ounces of apple juice 2 hours before surgery) – another small change on the ERAS menu – to further reduce postoperative insulin resistance and help the body cope with its stress response to surgery.

Along with nutritional changes are also various measures aimed at optimizing the body’s functionality before surgery (“prehabilitation”), from walking 30 minutes a day to abstaining from alcohol for patients who drink heavily.

Throughout the country, enhanced recovery protocols are taking shape in gynecologic surgery. ERAS was featured in an aptly titled panel session at the 2017 annual meeting of the American Association of Gynecologic Laparoscopists: “Outpatient Hysterectomy, ERAS, and Same-Day Discharge: The Next Big Thing in Gyn Surgery.” Others are applying ERAS to scheduled cesarean sections. And in our practice, I believe that if we continue making small changes, we will reach our goal of opioid-free recoveries and a better surgical experience for our patients.
 

Kirsten Sasaki, MD, is an associate of the Advanced Gynecologic Surgery Institute. She reported that she has no disclosures relevant to this Master Class.

Patients with newly diagnosed advanced-stage ovarian cancer who were referred to receive three cycles of neoadjuvant chemotherapy experienced statistically significant improved recurrence-free survival and overall survival from hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery, results of a phase 3 trial showed.

After 4.7 years’ median follow-up, 89% of patients who received surgery with no HIPEC had disease recurrence or death, compared with 81% of patients treated with HIPEC (hazard ratio, 0.66; P = .003). Patients in the HIPEC cohort experienced recurrence-free survival a median of 3.5 months longer than patients who received surgery alone (10.7 months vs. 14.2 months), Willemien J. van Driel, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and her colleagues reported in the New England Journal of Medicine.

Dr. van Driel and her coauthors also reported a median 11.8 months increased overall survival (33.9 months vs. 45.7 months) for HIPEC, compared with surgery alone.

Both recurrence-free survival and overall survival remained consistently beneficial for patients in the HIPEC group across prespecified stratification factors and subgroups, including age, histology type, regional involvement, and previous surgery, according to the researchers.

They also reported that no significant differences between the two groups were noted in the incidence of adverse events of any grade. In total, grade 3 or 4 adverse events were reported by 32 patients (27%) who received HIPEC and 30 patients (25%) who received surgery (P = .76); the most common were abdominal pain, infection, and ileus.

Combination treatment with intravenous and intraperitoneal chemotherapy has been shown to prolong overall survival after primary cytoreductive surgery, according to the authors.

“Catheter-related problems, increased demands on the patient, and gastrointestinal and renal side effects have hampered the adoption of this approach in most countries,” the researchers wrote. “Hyperthermia increases the penetration of chemotherapy at the peritoneal surface and increases the sensitivity of the cancer to chemotherapy by impairing DNA repair [and] … can circumvent most of these drawbacks while maintaining its advantages.”

This research was supported by the Dutch Cancer Society. Dr. van Driel reported no relevant financial disclosures. Two other researchers reported funding from various pharmaceutical companies as well as the KFW–Dutch Cancer Foundation.

[email protected]

SOURCE: van Driel WJ et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMoa1708618.
 

Patients with newly diagnosed advanced-stage ovarian cancer who were referred to receive three cycles of neoadjuvant chemotherapy experienced statistically significant improved recurrence-free survival and overall survival from hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery, results of a phase 3 trial showed.

After 4.7 years’ median follow-up, 89% of patients who received surgery with no HIPEC had disease recurrence or death, compared with 81% of patients treated with HIPEC (hazard ratio, 0.66; P = .003). Patients in the HIPEC cohort experienced recurrence-free survival a median of 3.5 months longer than patients who received surgery alone (10.7 months vs. 14.2 months), Willemien J. van Driel, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and her colleagues reported in the New England Journal of Medicine.

Dr. van Driel and her coauthors also reported a median 11.8 months increased overall survival (33.9 months vs. 45.7 months) for HIPEC, compared with surgery alone.

Both recurrence-free survival and overall survival remained consistently beneficial for patients in the HIPEC group across prespecified stratification factors and subgroups, including age, histology type, regional involvement, and previous surgery, according to the researchers.

They also reported that no significant differences between the two groups were noted in the incidence of adverse events of any grade. In total, grade 3 or 4 adverse events were reported by 32 patients (27%) who received HIPEC and 30 patients (25%) who received surgery (P = .76); the most common were abdominal pain, infection, and ileus.

Combination treatment with intravenous and intraperitoneal chemotherapy has been shown to prolong overall survival after primary cytoreductive surgery, according to the authors.

“Catheter-related problems, increased demands on the patient, and gastrointestinal and renal side effects have hampered the adoption of this approach in most countries,” the researchers wrote. “Hyperthermia increases the penetration of chemotherapy at the peritoneal surface and increases the sensitivity of the cancer to chemotherapy by impairing DNA repair [and] … can circumvent most of these drawbacks while maintaining its advantages.”

This research was supported by the Dutch Cancer Society. Dr. van Driel reported no relevant financial disclosures. Two other researchers reported funding from various pharmaceutical companies as well as the KFW–Dutch Cancer Foundation.

[email protected]

SOURCE: van Driel WJ et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMoa1708618.
 

Patients with newly diagnosed advanced-stage ovarian cancer who were referred to receive three cycles of neoadjuvant chemotherapy experienced statistically significant improved recurrence-free survival and overall survival from hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery, results of a phase 3 trial showed.

After 4.7 years’ median follow-up, 89% of patients who received surgery with no HIPEC had disease recurrence or death, compared with 81% of patients treated with HIPEC (hazard ratio, 0.66; P = .003). Patients in the HIPEC cohort experienced recurrence-free survival a median of 3.5 months longer than patients who received surgery alone (10.7 months vs. 14.2 months), Willemien J. van Driel, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and her colleagues reported in the New England Journal of Medicine.

Dr. van Driel and her coauthors also reported a median 11.8 months increased overall survival (33.9 months vs. 45.7 months) for HIPEC, compared with surgery alone.

Both recurrence-free survival and overall survival remained consistently beneficial for patients in the HIPEC group across prespecified stratification factors and subgroups, including age, histology type, regional involvement, and previous surgery, according to the researchers.

They also reported that no significant differences between the two groups were noted in the incidence of adverse events of any grade. In total, grade 3 or 4 adverse events were reported by 32 patients (27%) who received HIPEC and 30 patients (25%) who received surgery (P = .76); the most common were abdominal pain, infection, and ileus.

Combination treatment with intravenous and intraperitoneal chemotherapy has been shown to prolong overall survival after primary cytoreductive surgery, according to the authors.

“Catheter-related problems, increased demands on the patient, and gastrointestinal and renal side effects have hampered the adoption of this approach in most countries,” the researchers wrote. “Hyperthermia increases the penetration of chemotherapy at the peritoneal surface and increases the sensitivity of the cancer to chemotherapy by impairing DNA repair [and] … can circumvent most of these drawbacks while maintaining its advantages.”

This research was supported by the Dutch Cancer Society. Dr. van Driel reported no relevant financial disclosures. Two other researchers reported funding from various pharmaceutical companies as well as the KFW–Dutch Cancer Foundation.

[email protected]

SOURCE: van Driel WJ et al. N Engl J Med. 2018 Jan 18. doi: 10.1056/NEJMoa1708618.