To assess the effect of once-daily relugolix combination therapy (relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding. Two replicate, multinational, double-blind, 24-week, randomized, phase 3 studies (LIBERTY 1 and 2) were conducted in premenopausal women with uterine leiomyoma-associated heavy menstrual bleeding (80 mL or greater per cycle for two cycles or 160 mL or greater during one cycle). A predefined secondary objective was to determine the effect of relugolix-CT on moderate-to-severe uterine leiomyoma-associated pain in the pain subpopulation (women with maximum pain scores of 4 or higher on the 0-10 numerical rating scale at baseline, with pain score reporting compliance of 80% (ie, 28 days or more over the last 35 days of treatment). This key secondary endpoint was defined as the proportion of women achieving minimal-to-no uterine leiomyoma-associated pain (maximum numerical rating scale score 1 or lower) at week 24; menstrual and nonmenstrual pain were evaluated in prespecified secondary analyses. Treatment comparisons were performed in the pooled LIBERTY 1 and 2 pain subpopulation using the Cochran-Mantel-Haenszel test stratified by baseline menstrual blood loss volume. Across both trials, 509 women were randomized to relugolix-CT or placebo (April 2017-December 2018). Of these, 277 (54.4%) met pain subpopulation requirements. With relugolix-CT, 45.2% (95% CI 36.4-54.3) of women achieved minimal-to-no pain compared with 13.9% (95% CI 8.8-20.5) with placebo (nominal P<.001). The proportions of women with minimal-to-no pain during menstrual days and during nonmenstrual days were significantly higher with relugolix-CT (65.0% [95% CI 55.6-73.5] and 44.6% [95% CI 32.3-57.5], respectively) compared with placebo (19.3% [95% CI 13.2-26.7], nominal P<.001, and 21.6% [95% CI 12.9-32.7], nominal P=.004, respectively). Over 24 weeks, relugolix-CT significantly reduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain. These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma-associated pain. ClinicalTrials.gov: LIBERTY 1, NCT03049735; LIBERTY 2, NCT03103087. Myovant Sciences GmbH.

To evaluate the cost effectiveness of sequential medical and surgical therapy for the treatment of endometriosis-related dysmenorrhea. A cost-effectiveness model was created to compare three stepwise medical and surgical treatment strategies compared with immediate surgical management for dysmenorrhea using a health care payor perspective. A theoretical study cohort was derived from the estimated number of reproductive age (18-45) women in the United States with endometriosis-related dysmenorrhea. The treatment strategies modeled were: strategy 1) nonsteroidal antiinflammatory drugs (NSAIDs) followed by surgery; strategy 2) NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs) followed by surgery; strategy 3) NSAIDs, then a short-acting reversible contraceptive or LARC, then a LARC or gonadotropin-releasing hormone modulator followed by surgery; strategy 4) proceeding directly to surgery. Probabilities, utilities, and costs were derived from the literature. Outcomes included cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Univariate, bivariate, and multivariate sensitivity analyses were performed. In this theoretical cohort of 4,817,894 women with endometriosis-related dysmenorrhea, all medical and surgical treatment strategies were cost effective at a standard willingness-to-pay threshold of $100,000 per QALY gained when compared with surgery alone. Strategy 2 was associated with the lowest cost per QALY gained ($1,155). Requiring a trial of a third medication before surgery would cost an additional $257 million, compared with proceeding to surgery after failing two medical treatments. The probability of improvement with surgery would need to exceed 83% for this to be the preferred first-line approach. All sequential medical and surgical management strategies for endometriosis-related dysmenorrhea were cost effective when compared with surgery alone. A trial of hormonal management after NSAIDs, before proceeding to surgery, may provide cost savings. Delaying surgical management in an individual with pain refractory to more than three medications may decrease quality of life and increase cost.

To estimate the incidence and risk factors for bowel injury in women undergoing hysterectomy for benign indications. A retrospective cohort study was conducted among women undergoing hysterectomy for benign indications from 2012 to 2016 at institutes participating in the American College of Surgeons National Surgical Quality Improvement Program, including both inpatient and outpatient settings. Bowel injury was identified using Current Procedural Terminology codes as patients who underwent bowel repair at the time of hysterectomy or postoperatively within 30 days. Multivariate logistic regression models were used to control for patient clinical factors and perioperative factors. Bowel injury occurred in 610 of 155,557 (0.39%) included women. After bivariate analysis, factors associated with bowel injury included age, race, body mass index, American Society of Anesthesiologists classification, increased operative time, surgical approach, type of hysterectomy, lysis of adhesions, and operative indication. After adjusting for potential confounders, bowel injury was found associated with older age, surgical indication of endometriosis, and abdominal surgical approach. Compared with the surgical indication of endometriosis (n=63/10,625), the surgical indications of menstrual disorder (odds ratio [OR] 0.33, 95% CI 0.23-0.47; adjusted odds ratio [aOR] 0.33, 95% CI 0.23-0.48; n=67/34,168), uterine leiomyomas (OR 0.80, 95% CI 0.61-1.05; aOR 0.44, 95% CI 0.33-0.59; n=243/51,232), and genital prolapse (OR 0.30, 95% CI 0.20-0.45; aOR 0.41, 95% CI 0.25-0.67; n=36/20,384) were each associated with lower odds of bowel injury. Compared with the vaginal approach to hysterectomy (n=27/27,434), the abdominal approach was found to have significantly increased odds of bowel injury (OR 10.80, 95% CI 7.31-15.95; aOR 10.49 95% CI 6.42-17.12; n=401/38,106); the laparoscopic approach had smaller but significantly increased odds (OR 2.06, 95% CI 1.37-3.08; aOR 2.03 95% CI 1.24-3.34; n=182/90,017) as well. Increased risk of bowel injury is associated with endometriosis and the abdominal surgical approach to hysterectomy. These findings have implications for the surgical care of women with benign uterine disease.

To evaluate the effects of shared decision making using a simple decision aid for opioid prescribing after hysterectomy. We conducted a prospective quality initiative study including all patients undergoing hysterectomy for benign, nonobstetric indications between March 1, 2018, and July 31, 2018, at our academic institution. Using a visual decision aid, patients received uniform education regarding postoperative pain management. They were then educated on the department's guidelines regarding the maximum number of tablets recommended per prescription and the mean number of opioid tablets used by a similar cohort of patients in a previously published study at our institution. Patients were then asked to choose their desired number of tablets to receive on discharge. Structured telephone interviews were conducted 14 days after surgery. The primary outcome was total opioids prescribed before compared with after implementation of the decision aid. Secondary outcomes included opioid consumption, patient satisfaction, and refill requests after intervention implementation. Of 170 eligible patients, 159 (93.5%) used the decision aid (one patient who used the decision aid was subsequently excluded from the analysis owing to significant perioperative complications), including 110 (69.6%) laparoscopic, 40 (25.3%) vaginal, and eight (5.3%) abdominal hysterectomies. Telephone surveys were completed for 89.2% (n=141) of participants. Student's t-test showed that patients who participated in the decision aid (post-decision aid cohort) were discharged with significantly fewer oral morphine equivalents than patients who underwent hysterectomy before implementation of the decision aid (pre-decision aid cohort) (92±35 vs 160±81, P<.01), with no significant change in the number of requested refills (9.5% [n=15] vs 5.7% [n=14], P=.15). In the post-decision aid cohort, 76.6% of patients (n=121) chose fewer tablets than the guideline-allotted maximum. Approximately 76% of patients (n=102) reported having leftover tablets. This quality improvement initiative illustrates that a simple decision aid can result in a significant decrease in opioid prescribing without compromising patient satisfaction or postoperative pain management.

There are limited robotic dry lab training resources that include presacral dissection with vaginal and sacral mesh attachment for robotic sacrocolpopexy. Our objective was to create a simulation model to resemble the anatomy encountered during robotic sacrocolpopexy. Additionally, we sought to outline the steps required to complete a robotic sacrocolpopexy by performing a hierarchical task analysis. With the results of the hierarchical task analysis, we assessed the model's ability to provide an adequate platform for completion of robotic sacrocolpopexy procedural steps. This observational simulation study was divided into two phases. Phase 1 included model development. Phase 2 involved development of the hierarchical task analysis and assessment of the model. After model creation, six experts each performed a robotic sacrocolpopexy using the model. Overall, experts agreed that the model replicated opening the peritoneum, presacral dissection, suturing on the anterior and posterior vagina, and presacral mesh attachment. We demonstrate construction and use of a robotic sacrocolpopexy simulation model to aid surgeons in training. Further, the hierarchical task analysis provides a method to assess the model's ability to replicate each step of robotic sacrocolpopexy.

To determine whether backfilling the bladder postoperatively will reduce time to discharge in patients undergoing outpatient laparoscopic hysterectomy. In a single-blind, randomized, controlled trial among women undergoing outpatient laparoscopic hysterectomy, patients were randomly assigned to a backfill-assisted void trial or a trial of spontaneous voiding. The primary outcome was time to discharge assessed by length of time spent in the postanesthesia care unit. Secondary outcomes included time to first spontaneous void, urinary retention rates, and postoperative complications within 8 weeks. We estimated that 152 patients (76/group) would provide greater than 80% power to identify a 30-minute difference in the primary outcome with a SD of 56 minutes and a two-sided α of 0.05. Between June 2017 to May 2018, 202 women were screened, 162 women were randomized, and results were analyzed for 153 women. Seventy-five patients (group A) who had a backfill-assisted voiding trial and 78 patients (group B) who had a spontaneous voiding trial were included in the analysis. The mean time to discharge was 273.4 minutes for group A vs 283.2 minutes for group B, which was not found to be significant (P=.45). The mean time to first spontaneous void was 181.1 minutes in group A vs 206.0 minutes in group B. There was a statistically significant reduction of 24.9 minutes in time to first spontaneous void with patients randomized to the backfill group (P=.04). Five of 75 patients (6.7%) in group A and 10 of 78 patients (12.8%) in group B developed urinary retention postoperatively and required recatheterization before discharge, which was also not significant (P=.20). Bladder filling before removing the Foley catheter is a simple procedure shown to reduce time to first spontaneous void, but not time to discharge in patients undergoing outpatient laparoscopic hysterectomy. ClinicalTrials.gov, NCT03126162.

To report the frequency of perioperative antibiotic use at time of myomectomy and associated risk of infectious outcomes. We conducted a retrospective cohort study including all women who underwent any route of myomectomy from 2009 to 2016 at two academic hospitals in Boston, Massachusetts. Cases involving chromopertubation or conversion to hysterectomy were excluded from further analysis. Medical records were queried for the use or nonuse of perioperative antibiotics, as well as baseline patient factors and perioperative outcomes. Statistical analyses included univariate comparisons between treatment groups, as well as multivariable logistic regression analyses of infectious morbidity controlling for patient age, route of surgery, presence of high-risk factors, any intraoperative complication, myoma weight, and entrance into the endometrial cavity. Matched cohort analysis also was performed to confirm findings in the setting of underlying differences between groups. A total of 1,211 patients were included in the myomectomy cohort, 92.7% of whom received perioperative antibiotics at the time of surgery. Demographic characteristics were similar between the group that received and the group that did not receive antibiotics. The cases with antibiotic use were associated with longer operative times, higher estimated blood loss, and greater myoma burden. No difference was noted with regard to intraoperative or postoperative complications. Surgical site infection occurred more commonly in the group that did not receive antibiotics (2.9% vs 6.8% in the antibiotic and no-antibiotic groups, respectively; effect size 0.43, 95% CI 0.18-0.97 P=.04), representing a nearly fourfold increase in odds of any surgical site infection in the absence of perioperative antibiotic use (adjusted odds ratio 3.77, 95% CI 1.30-10.97, P=.015). A high frequency of antibiotic use was noted at time of myomectomy, despite lack of clear evidence supporting the practice. Patients who received perioperative antibiotics had fewer postoperative infectious outcomes and, in particular, experienced a lower incidence of surgical site infection.

To evaluate the incidence of postoperative venous thromboembolism after gynecologic surgery by mode of incision. We conducted a retrospective cohort study of all patients who underwent gynecologic surgery from May 2006 to June 2015 at two tertiary care academic hospitals in Massachusetts. Billing and diagnosis codes were used to identify surgeries and cases of venous thromboembolism. A total of 43,751 surgical encounters among 37,485 individual patients were noted during the study. The overall incidence of venous thromboembolism is 0.2% for all gynecologic surgeries, 0.7% for hysterectomy, and 0.2% for myomectomy. Compared with patients undergoing laparotomy, patients who underwent minimally invasive gynecologic surgery were less likely to develop venous thromboembolism (laparoscopy risk ratio 0.22, 95% CI 0.13-0.37; vaginal surgery risk ratio 0.07, 95% CI 0.04-0.12). This effect persisted when data were adjusted for other known venous thromboembolism risk factors such as age, race, cancer, medical comorbidities, use of pharmacologic thromboprophylaxis, admission status, and surgical time. Minimally invasive surgery is associated with a decreased risk of venous thromboembolism in patients undergoing gynecologic surgery, including hysterectomy and myomectomy. Although society guidelines and risk assessment tools do not currently account for mode of surgery when assessing venous thromboembolism risk and recommendations for prevention, there is a small but growing body of evidence in both general and gynecologic surgery literature that surgical approach affects a patient's risk of postoperative venous thromboembolism. Mode of surgery should be considered when assessing venous thromboembolism risk and planning venous thromboembolism prophylaxis for patients undergoing gynecologic surgery.