Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

The impact of ankle haemarthropathy in patients with moderate haemophilia.

INTRODUCTION: Moderate haemophilia has traditionally been associated with less complications than severe haemophilia. Changes in treatment recommendations have highlighted the burden of moderate haemophilia with a subset of patients with a severe bleeding phenotype. The ankle joint is disproportionally affected by ankle haemarthropathy however the impact has not been evaluated in moderate haemophilia, nor the effect on health related quality of life (HRQoL) or foot and ankle outcomes. AIMS: To establish the impact of ankle haemarthropathy in patients with moderate haemophilia. METHODS: A multicentre questionnaire study recruited patients from 11 haemophilia centres in England, Scotland and Wales. The HAEMO-QoL-A and Manchester-Oxford foot and ankle questionnaire (MOXFQ) with total and domain scores measured impact. Measures of pain and ankle haemophilia joint health (HJHS) scores were also collected. RESULTS: Twenty-nine participants were recruited. HAEMO-QoL A mean (SD) total scores of 10.8 (5.2) of 100 (best health) and foot and ankle specific MOXFQ total scores of 45.5 (24.7) above zero (best outcome) indicate poor HRQoL and foot and ankle outcomes. Average ankle pain over past 6 months of (0-10) 5.5 (SD2.5) was reported and median (IQR) ankle HJHS of 3.0 (1;12.5) to 4.5 (0;9.5) for the left and right ankles. CONCLUSION: HRQoL and foot and ankle specific outcomes are poor in patients with moderate haemophilia and ankle haemarthropathy, driven by chronic levels of ankle joint pain. Despite moderate haemophilia being considered less affected by haemarthrosis and haemarthropathy, patients with a bleeding or haemarthropathy phenotype are clinically similar to patients with severe haemophilia A.

Gynecologic cancer care in the first year of the COVID-19 pandemic.

OBJECTIVE: To analyze the impact of the early COVID-19 pandemic on the diagnosis and initiation of treatment for patients with gynecologic cancer. METHODS: Patients diagnosed with gynecologic cancer in the National Cancer Database during 2017-2020 were included. For the first aim, incidence rate ratios were calculated to compare gynecologic cancer diagnosis in the first year of the COVID-19 pandemic to the three years prior, and factors associated with a reduction in diagnosis were identified. For the second aim, patients who experienced an 8-week delay in cancer treatment were compared to those who did not. Multivariate logistic regression was used to identify factors associated with treatment delay. Propensity score analysis was utilized to compare the rate of cancer treatment delay in patients who were diagnosed with COVID-19 to those who were not. RESULTS: The incidence rate ratio of being diagnosed with gynecologic cancer in 2020 versus 2017-2019 was 0.90 (95%CI 0.90-0.91). Factors associated with increased risk of missed or delayed diagnosis in 2020 included cervical cancer, earlier cancer stage, younger age, lower levels of medical comorbidity, and lack of health insurance. In 2020, factors associated with treatment delay included COVID-19 diagnosis (aOR 1.50, 95%CI 1.35-1.67), in addition to race and ethnicity, insurance type, comorbidity, cancer stage, and primary site. The risk of treatment delay remained significantly elevated in patients diagnosed with COVID-19 after propensity-score matching. CONCLUSIONS: Gynecologic cancer diagnosis and timely provision of care were negatively impacted during the first year of the COVID-19 pandemic, with certain subgroups at elevated risk.

A systematic review and narrative synthesis of footwear and orthotic devices used in the management of ankle haemarthrosis and haemarthropathy in haemophilia.

INTRODUCTION: Haemarthrosis is a clinical feature of haemophilia leading to haemarthropathy. The ankle joint is most commonly affected, resulting in significant pain, disability and a reduction in health-related quality of life. Footwear and orthotic devices are effective in other diseases that affect the foot and ankle, such as rheumatoid arthritis, but little is known about their effect in haemophilia. AIMS: To review the efficacy and effectiveness of footwear and orthotic devices in the management of ankle joint haemarthrosis and haemarthropathy in haemophilia. METHODS: A systematic literature review was conducted. Two review authors independently screened studies for inclusion and appraised methodological quality using Joanna Briggs Institute Critical Appraisal checklists. A narrative analysis was undertaken. RESULTS: Ten studies involving 271 male participants were eligible for inclusion. All studies were quasi-experimental; three employed a within-subject design. Two studies included an independent comparison or control group. A range of footwear and orthotic devices were investigated. Limited evidence from non-randomised studies suggested that footwear and orthotic devices improve the number of ankle joint bleeding episodes, gait parameters and patient-reported pain. CONCLUSION: This review demonstrates a lack of robust evidence regarding the efficacy and effectiveness of footwear and orthotic devices in the management of ankle joint haemarthrosis and haemarthropathy in haemophilia. Methodological heterogeneities and limitations with the study designs, small sample sizes and limited follow-up of participants exist. Future studies utilising randomised designs, larger sample sizes, long-term follow-up and validated patient-reported outcome measures are needed to inform the clinical management of ankle joint haemarthrosis and haemarthropathy.

Racial and ethnic disparities in surgical care for endometriosis across the United States.

BACKGROUND: Despite an estimated 10% prevalence of endometriosis among reproductive-age women, surgical population-based data are limited. OBJECTIVE: We sought to investigate racial and ethnic disparities in surgical interventions and complications among patients undergoing endometriosis surgery across the United States. STUDY DESIGN: We performed a retrospective cohort study of American College of Surgeons National Surgical Quality Improvement Program data from 2010 to 2018 identifying International Classification of Diseases, Ninth/Tenth Revision codes for endometriosis We compared procedures, surgical routes (laparoscopy vs laparotomy), and 30-day postoperative complications by race and ethnicity. RESULTS: We identified 11,936 patients who underwent surgery for endometriosis (65% White, 8.2% Hispanic, 7.3% Black or African American, 6.2% Asian, 1.0% Native Hawaiian or Pacific Islander, 0.6% American Indian or Alaska Native, and 11.5% of unknown race). Perioperative complications occurred in 9.6% of cases. After adjusting for confounders, being Hispanic (adjusted odds ratio, 1.31; 95% confidence interval, 1.06-1.64), Black or African American (adjusted odds ratio, 1.71; confidence interval, 1.39-2.10), Native Hawaiian or Pacific Islander (adjusted odds ratio, 2.08; confidence interval, 1.28-3.37), or American Indian or Alaska Native (adjusted odds ratio, 2.34; confidence interval, 1.32-4.17) was associated with surgical complications. Hysterectomies among Hispanic (adjusted odds ratio, 1.68; confidence interval, 1.38-2.06), Black or African American (adjusted odds ratio, 1.77; confidence interval, 1.43-2.18), Asian (adjusted odds ratio, 1.87; confidence interval, 1.43-2.46), Native Hawaiian or Pacific Islander (adjusted odds ratio, 4.16; confidence interval, 2.14-8.10), and patients of unknown race or ethnicity (adjusted odds ratio, 2.07; confidence interval, 1.75-2.47) were more likely to be open. Being Hispanic (adjusted odds ratio, 1.64; confidence interval, 1.16-2.30) or Black or African American (adjusted odds ratio, 2.64; confidence interval, 1.95-3.58) was also associated with receipt of laparotomy for nonhysterectomy procedures. The likelihood of undergoing oophorectomy was increased for Hispanic and Black women (adjusted odds ratio, 2.57; confidence interval, 1.96-3.37 and adjusted odds ratio, 2.06; confidence interval, 1.51-2.80, respectively), especially at younger ages. CONCLUSION: Race and ethnicity were independently associated with surgical care for endometriosis, with elevated complication rates experienced by Hispanic, Black or African American, Native Hawaiian or Pacific Islander, and American Indian or Alaska Native patients.

Predictors of prolonged admission after outpatient female pelvic reconstructive surgery.

OBJECTIVES: This study aimed to determine factors associated with prolonged hospital admission following outpatient female pelvic reconstructive surgery (FPRS) and associated adverse clinical outcomes. METHODS: Using the National Surgical Quality Improvement Program database, we identified outpatient FPRS performed 2011-2016. Isolated hysterectomy without concurrent prolapse repair was excluded. Surgeries were classified as major or minor for analysis. The primary outcome was prolonged length of stay (LOS), defined as admission of ≥2 days. Secondary outcomes included complications, readmission and reoperation associated with prolonged LOS. We abstracted data on covariates, and following univariable analysis, performed backward stepwise regression analysis. RESULTS: A total of 29645 women were included: 12311 (41.5%) major and 17334 (58.5%) minor procedures. A total of 6.9% (2033) had a prolonged LOS. On full cohort multivariable regression analysis, patient characteristics associated with prolonged LOS were older age (odds ratio [OR]: 1.1 per 10 years, confidence interval [CI]: 1.06-1.1, p < 0.001), frailty (OR: 1.8, 95% CI: 1.3-2.6, p = 0.001), and Caucasian race (OR: 1.2, CI: 1.02-1.3, p = 0.024). Associated surgical factors included having a major surgical procedure (OR: 1.3, CI: 1.2-1.4, p < 0.001), use of general anesthesia (OR: 2.0, CI: 1.5-2.6, p < 0.001) and longer operative time (OR: 2.0, CI: 1.8-2.2, p < 0.001). The occurrence of any complication (10.3% vs. 4.7%, p < 0.001), hospital readmission (4.3% vs. 1.7%, p < 0.001), and reoperation (2.7% vs. 1.0%, p < 0.001) were more likely with prolonged LOS. CONCLUSIONS: After outpatient FPRS, 6.9% of patients experience an admission of ≥2 days. Prolonged LOS is more common in patients who are older, frail and Caucasian, and in those who have major surgery with long operative time and general anesthesia.

Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial.

BACKGROUND: Postoperative urinary retention is common after female pelvic reconstructive surgery. Alpha receptor antagonists can improve dysfunctional voiding by relaxing the bladder outlet and may be effective in reducing the risk of postoperative urinary retention. OBJECTIVE: This study aimed to determine whether tamsulosin is effective in preventing postoperative urinary retention in women undergoing surgery for pelvic organ prolapse. STUDY DESIGN: This was a multicenter, double-blind, randomized controlled trial between August 2018 and June 2020, including women undergoing surgery for pelvic organ prolapse. Patients were excluded from recruitment if they had elevated preoperative postvoid residual volume, history of postoperative urinary retention, or a contraindication to tamsulosin. Those who experienced cystotomy were excluded from analysis. Participants were randomized to a 10-day perioperative course of tamsulosin 0.4 mg vs placebo, beginning 3 days before surgery. A standardized voiding trial was performed on postoperative day 1. The primary outcome was the development of postoperative urinary retention, as defined by the failure of the voiding trial or subsequent need for catheterization to empty the bladder. Secondary outcomes included the rate of urinary tract infection and the impact on lower urinary tract symptoms as measured by the American Urological Association Symptom Index. RESULTS: Of 119 patients, 57 received tamsulosin and 62 received placebo. Groups were similar in regard to demographics, preoperative prolapse and voiding characteristics, and surgical details. Tamsulosin was associated with a lower rate of postoperative urinary retention than placebo (5 patients [8.8%] vs 16 patients [25.8%]; odds ratio, 0.28; 95% confidence interval, 0.09-81; P=.02). The number needed to treat to prevent 1 case of postoperative urinary retention was 5.9 patients. The rate of urinary tract infection did not differ between groups. American Urological Association Symptom Index scores significantly improved after surgery in both groups (median total score, 14 vs 7; P<.01). Scores related to urinary stream improved more in the tamsulosin group than in placebo (P=.03). CONCLUSION: In this placebo-controlled trial, tamsulosin use was associated with a reduced risk of postoperative urinary retention in women undergoing surgery for pelvic organ prolapse.

Evaluation of 30-day complication rates following vaginal anterior compartment repair with and without graft augmentation in a propensity score matched cohort.

OBJECTIVE: To determine if graft augmentation with anterior colporrhaphy (AC+G) is associated with higher complication rates compared to native tissue repair (AC). MATERIALS AND METHODS: Retrospective cohort study using data from the ACS-NSQIP database between 2010 and 2017. CPT codes were used to identify women undergoing AC+G and AC. Propensity scores for the likelihood of undergoing AC+G were calculated and were used to match to women undergoing native tissue repair at a ratio of 1:2. The primary outcome was the composite complication rate. Descriptive statistics are reported as means with standard deviations for parametric data and as medians and interquartile ranges for non-parametric data. Pairwise comparisons were performed using Fisher's exact test, Wilcoxon rank-sum and Student's t test as appropriate. Multivariable logistic regression was then used to adjust for confounders to identify statistically significant factors associated with the likelihood of experiencing a complication after prolapse repair. RESULTS: 582 women met inclusion criteria for AC+G and were matched with 1164 women undergoing AC. There were no differences in preoperative characteristics between groups. There was no difference in the composite complication rate, (10.8% vs. 8.5%, p = 0.13) between groups. Dependent functional status (aOR 4.31, 95% CI 1.96-13.58) was the strongest predictor of the likelihood of a complication: other significant predictors were operating time greater than 20 min (aOR 1.68, 95% CI 1.19-2.38) and ASA class greater than 2 (aOR 1.44, 95% CI 1.01-2.05). CONCLUSION: There is no increase in 30-day complication rates in women undergoing AC+G compared to a matched cohort of those undergoing AC alone.

Perioperative outcomes of reconstructive surgery for apical prolapse in the very elderly: a national contemporary analysis.

INTRODUCTION AND HYPOTHESIS: It is predicted that the number of women aged 80 years or older will more than triple by 2050. In the US, women have a 13% lifetime risk of undergoing pelvic organ prolapse surgery. Our aim was to compare the perioperative outcomes following various reconstructive approaches for apical prolapse surgery in the very elderly. METHODS: The National Surgical Quality Improvement Program database was used to identify women age ≥ 80 years of age who underwent reconstructive apical prolapse surgery from 2010 to 2017. Perioperative morbidity of vaginal colpopexy, minimally invasive sacrocolpopexy (MISC) and abdominal sacrocolpopexy (ASC) were compared. The primary outcome was the rate of composite serious complications. Univariate and multivariate logistic regression was used to identify independent predictors of serious complications. RESULTS: A total of 1012 patients were identified: vaginal (n = 792), MISC (n = 151) and ASC (n = 69). The composite serious complication rate was higher in the ASC group compared to vaginal/MISC groups (18.8% vs. 9.3% and 9.3%, p < 0.05). ASC had higher rates of blood transfusion, thromboembolism and reintubation. Life-threatening complications, readmission, pneumonia, stroke and 30-day mortality were lowest in the vaginal group. ASC (aOR 2.27), age > 85 years (aOR 1.98), operative time > 3 h (aOR 2.02), baseline dyspnea (aOR 2.17), "other race" (aOR 2.04), preoperative coagulopathy (aOR 2.92) and ASA (aOR 1.47) were associated with composite serious complications. CONCLUSION: ASC is associated with higher perioperative morbidity in the very elderly population. MISC and vaginal colpopexy have similar rates of composite serious complications; however, vaginal colpopexy is overall the safest approach in this population.

Apical suspension is underutilized for repair of stage IV pelvic organ prolapse: an analysis of national practice patterns in the United States.

INTRODUCTION AND HYPOTHESIS: Support of the vaginal apex is paramount for a durable repair of pelvic organ prolapse (POP). Our aim is to assess national utilization of apical suspension procedures for the surgical treatment of complete POP. We hypothesize that there might be a high rate of apical suspension with advanced prolapse. METHODS: The 2006-2016 National Surgical Quality Improvement Program database was queried for a primary postoperative diagnosis of complete POP. The primary outcome was type of repair. Secondary outcomes included patient characteristics associated with apical suspension or colpocleisis. Procedures were delineated using CPT codes. Chi-squared and multivariate logistic regression analyses were used to evaluate factors associated with repair type. RESULTS: A total of 2,784 women underwent surgery for complete POP with a mean age of 64.6 ± 11.0 years. Overall, 1,300 (46.7%) patients underwent apical suspension: 487 sacrocolpopexies (17.5%), 428 extraperitoneal suspensions (15.4%), and 391 uterosacral suspensions (14.0%). 5.2% (144) underwent colpocleisis, and 47.5% (1,332) of women had a concurrent hysterectomy (CH). With CH, 38.6% (502) had apical suspension or colpocleisis versus 69.5% (940) of post-hysterectomy cases. On logistic regression, CH was inversely associated with apical suspension (adjusted odds ratio [aOR] 0.37, CI 0.32-0.44, p < 0.001). Colpocleisis was associated with older age (aOR 4.9 per 10 years, CI 3.8-6.3, p < 0.001), post-hysterectomy surgery (aOR 0.23, CI 0.1-0.4, p < 0.001 for CH), and higher comorbidity index (OR 1.7, CI 1.1-2.6, p = 0.009). Complication rates are similar with and without apical suspension (8.2% versus 7.0%, p = 0.269). CONCLUSIONS: During surgery for complete POP, an apical suspension procedure is performed in 46.7% of patients and is more common post-hysterectomy.

Preoperative Pain Symptoms and the Incidence of Endometriosis in Transgender Men Undergoing Hysterectomy for Gender Affirmation.

STUDY OBJECTIVE: To describe the incidence of pelvic pain in transgender men undergoing hysterectomy for gender affirmation and to describe the incidence of endometriosis found at the time of surgery. DESIGN: Retrospective chart review of transgender men presenting for gender-affirming hysterectomy between 2010 and 2019. Patients were identified by Current Procedural Terminology codes and documented male gender in the medical record, which was queried for perioperative data. SETTING: All patients underwent minimally invasive hysterectomy under general anesthesia by 2 surgeons at 2 institutions. PATIENTS: Patients were individuals assigned female at birth identifying as male who met the criteria for gender-affirming hysterectomy. INTERVENTIONS: Hysterectomy performed using preferred techniques by the surgeons in this study. MEASUREMENTS AND MAIN RESULTS: Sixty-seven (N = 67) patients underwent hysterectomy: 98.5% (66) total laparoscopic with salpingo-oophorectomy and 1.5% (1) total laparoscopic with ovarian preservation. Mean age and body mass index were 29(±8) years and 28.6(±6.7) kg/m2, respectively. Of the patients, 89.5% (60) were on testosterone for a median of 36 (12-300) months: 59.7% (40) were amenorrheic, 43.2% (29) had dysmenorrhea, 17.9% (12) reported heavy menses, and 14.9% had irregular menses. Furthermore, 50.7% (34) complained of pelvic pain (35.3% constant, 64.7% cyclic). Intraoperative endometriosis was diagnosed in 26.9% (18) of the patients: in 32.3% of the patients who reported pelvic pain and in 21.9% of the patients without pain. There were no differences between patients with endometriosis compared with those without endometriosis except for those with endometriosis were more likely to report irregular bleeding (27.8% vs 8.3%, p = .04) and were also more likely to complain of heavy menses (66.7% vs 35.4%, p = .03). CONCLUSION: Of the transgender men who presented for hysterectomy, 50% reported pelvic pain, but only 1 in 3 with pain had findings of endometriosis. Patients found to have endometriosis were more likely to report irregular bleeding and/or heavy menses.

Perioperative Complications of Laparoscopic versus Open Surgery for Pelvic Inflammatory Disease.

STUDY OBJECTIVE: To compare complications in patients undergoing laparoscopic vs open surgery for acute pelvic inflammatory disease (PID). DESIGN: We performed a retrospective cohort study of patients who underwent surgery for PID, using the American College of Surgeons National Surgical Quality Improvement Program database from 2010 to 2015. Propensity score matching was used to balance baseline characteristics and compare complications in patients who underwent laparoscopic vs open surgery. SETTING: Surgical management of acute PID. PATIENTS: Patients with a preoperative diagnosis of PID were identified using International Classification of Diseases, Ninth Revision, codes. We excluded patients with chronic PID, gynecologic malignancy, and those for whom the surgical route was unknown. INTERVENTIONS: Surgery for acute PID. MEASUREMENTS AND MAIN RESULTS: The study included 367 patients. The mean age was 43.0 ± 11.1 years, body mass index was 30.9 ± 11.2 kg/m2, and American Society of Anesthesiology class was 2 (interquartile range 2-3). Preoperative signs of sepsis were noted in 33.8% of the patients, and septic shock was present in 1.4%. Hysterectomy was performed in 67.6%, oophorectomy in 12.0%, and salpingectomy in 4.6%. Complications were experienced by 114 patients (31.1%), 11 (3.0%) of which were potentially life-threatening. Multivariate logistic regression identified the following to be independently associated with complications: laparoscopy (adjusted odds ratio [aOR] 0.48; 95% confidence interval [CI], 0.3-0.8; p <.01), operative time (aOR 1.01; 95% CI, 1.00-1.01; p <.01), appendectomy (aOR 2.36; 95% CI, 1.0-5.4; p = .04), elevated international normalized ratio (aOR 2.30; 95% CI, 1.3-4.2; p <.01), and low hematocrit level (aOR 2.53; 95% CI, 1.4-4.5; p <.01). Propensity scores were calculated and used to generate a matched cohort of patients who underwent laparoscopic vs open surgery; the groups were similar, with p <.05 for all covariates. After balancing confounding variables, a laparoscopic approach to surgery remained significantly associated with a lower risk of complications (coefficient -0.07; 95% CI, -0.11 to -0.02; p = .008). CONCLUSION: Laparoscopy was associated with lower complication rates than open surgery in this well-matched cohort of patients who underwent surgery for acute PID.

National Analysis of Perioperative Morbidity of Vaginal Versus Laparoscopic Hysterectomy at the Time of Uterosacral Ligament Suspension.

STUDY OBJECTIVE: The objective of this study was to compare the morbidity of vaginal versus laparoscopic hysterectomy when performed with uterosacral ligament suspension. DESIGN: Retrospective propensity-score matched cohort study. SETTING: American College of Surgeons National Surgical Quality Improvement Program database. PATIENTS: We included all patients who had undergone uterosacral ligament suspension and concurrent total vaginal hysterectomy (TVH-USLS) or total laparoscopic hysterectomy (TLH-USLS) from 2010 to 2015. We excluded those who underwent laparoscopic-assisted vaginal hysterectomy, abdominal hysterectomy, other surgical procedures for apical pelvic organ prolapse, or had gynecologic malignancy. INTERVENTIONS: We compared 30-day complication rates in patients who underwent TVH-USLS versus TLH-USLS in both the total study population and a propensity score matched cohort. MEASUREMENTS AND MAIN RESULTS: The study population consisted of 3,349 patients who underwent TVH-USLS and 484 who underwent TLH-USLS. Patients who underwent TVH-USLS had a significantly higher composite complication rate (11.4% vs 6.4%, odds ratio [OR] 1.9, 1.3-2.8; p <.01) and a higher serious complication rate (5.6% vs 3.1%, OR 1.8, 1.1-3.1; p = .02), which excluded urinary tract infection and superficial surgical site infection. The propensity score analysis was performed, and patients were matched in a 1:1 ratio between the TVH-USLS group and the TLH-USLS group. In the matched cohort, patients who underwent TVH-USLS had a higher composite complication rate than those who underwent TLH-USLS (10.3% vs 6.4%, OR 1.7, 95% confidence interval [CI], 1.1-2.7; p = .04), whereas the rate of serious complications did not differ between the groups (4.3% vs 3.1%, OR 1.4, 95% CI, 0.7-2.8; p = .4). On multivariate logistic regression, TVH-USLS remained an independent predictor of composite complications (adjusted OR 1.6, 95% CI, 1.0-2.6; p = .04) but not serious complications (adjusted OR 1.4, 95% CI, 0.7-2.8; p = .3). CONCLUSION: In this large national cohort, TVH-USLS was associated with a higher composite complication rate than TLH-USLS, largely secondary to an increased rate of urinary tract infection. After matching, the groups had similar rates of serious complications. These data suggest that TLH-USLS should be viewed as a safe alternative to TVH-USLS.

Ovarian Histopathology in Transmasculine Persons on Testosterone: A Multicenter Case Series.

BACKGROUND: As transmasculine persons utilize androgen gender affirming hormone therapy as a part of transition, guidance has been lacking on the effects of the therapy on the ovaries, especially for those who may desire retention. AIM: To describe the ovarian histopathology of transmasculine persons on testosterone therapy following oophorectomy at the time of hysterectomy performed for gender affirmation. METHODS: This was a multicenter case series study of transmasculine patients on testosterone therapy who underwent hysterectomy with oophorectomy for gender affirmation between January 2015 and December 2017 at 5 tertiary care referral centers. Patients were identified by their current procedural and International Classification of Diseases codes. OUTCOMES: Pre-, perioperative, and pathologic data were obtained from the electronic medical records and ovarian tissue descriptions from pathology reports were grouped into the following classifications: (i) simple/follicular cysts; (ii) polycystic ovaries; (iii) complex cysts; (iv) endometriomas; (v) other masses; (vi) atrophy; and (vii) normal. RESULTS: 85 patients were included in the study. At the time of oophorectomy, the mean age and body mass index of the cohort were 30.4 ± 8.4 years and 30.2 ± 7.3 kg/m2, respectively, and the average interval from the initiation of testosterone to oophorectomy was 36 0.3 ± 37.9 months. On examination of ovarian histopathology, 49.4% (42) of specimens were found to have follicular/simple cysts, 5.9% (5) were polycystic, and 38.8% (33) had normal pathology. For those specimens with volume documented (n = 41), the median volume was 9.6 (range 1.5-82.5) cm3. There was no association between the duration of testosterone therapy or body mass index and the presence of cysts in the ovaries. CLINICAL IMPLICATIONS: The results of this study reported benign histopathology in ovaries of a large cohort of transmasculine persons on testosterone which should be included when counseling patients on ovarian retention, as transmasculine patients may choose to retain their ovaries while on testosterone for a variety of reasons (including no desire to undergo surgery, desire for backup sex steroids, and potential use for future fertility). STRENGTHS & LIMITATIONS: This is a large multicenter study seeking to address the uncertainty in present counseling surrounding ovarian conservation in transmasculine persons on testosterone therapy. Its limitations included its retrospective nature and inability to address ovarian function after testosterone discontinuance. CONCLUSION: In this cohort of transmasculine patients on testosterone therapy undergoing hysterectomy with oophorectomy for gender affirmation, ovarian histopathology was benign in all the specimens. Grimstad FW, Fowler KG, New EP, et al. Ovarian Histopathology in Transmasculine Persons on Testosterone: A Multicenter Case Series. J Sex Med 2020;17:1807-1818.

Cystoscopy with antibiotic irrigation during pelvic reconstruction and minimally invasive gynecologic surgery: A double-blind randomized controlled trial.

AIMS: After pelvic reconstructive surgery, the risk of postoperative urinary tract infection (UTI) is significant; intraoperative cystoscopy may contribute to this risk. Intravesical antibiotics are used in the ambulatory setting and may be applied to the surgical arena. Our objective was to evaluate the efficacy of antibiotic irrigation during intraoperative cystoscopy to prevent postoperative UTI. METHODS: This double-blind randomized controlled trial enrolled 216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019. Participants were randomized to cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B + 40 mg neomycin solution in normal saline (antibiotic). Patients and providers who treated UTIs were blinded. The primary outcome was treatment of UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI. χ2 and multivariable logistic regression analyses were performed. RESULTS: We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6%). Mean age was 51.6 years. Groups were well matched in medical comorbidities and surgery type. Primary vaginal surgery was most common (n = 127, 58.8%). Overall, 10.7% of patients developed a postoperative UTI with no difference in incidence between groups: 9.9% of control (n = 11, 95% confidence interval [CI]: 4.0%-16.0%) versus 11.4% of antibiotic subjects (n = 12, 95% CI: 5.0%-18.0%), on χ2 (p = .718) and logistic regression analysis (adjusted odds ratio, 1.3; CI: 0.53-3.16; p = .569). CONCLUSION: When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.

Evaluation of the ACS NSQIP surgical risk calculator in patients undergoing pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to evaluate the accuracy of the American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP) surgical risk calculator in predicting postoperative complications in patients undergoing pelvic organ prolapse surgery. METHODS: We performed a retrospective review of 354 patients who underwent surgery for pelvic organ prolapse from 2013 to 2017 at a single academic institution. Patient medical information and surgical procedure were entered into the calculator to obtain predicted complication rates, which were compared with observed complications. Logistic regression, C-statistic, and Brier score were used to assess the accuracy of the calculator. RESULTS: Of 354 patients included in the analysis, 79.7% were under the age of 75, and 41.5% were classified as American Society of Anesthesiologists class ≥3. The majority of patients underwent robotic sacrocolpopexy (40.7%) or uterosacral ligament suspension (36.4%), followed by colpocleisis, abdominal sacrocolpopexy, and extraperitoneal suspension. Complications were experienced by 100 patients (28.3%). Most common complications were urinary tract infection (n = 57), surgical site infection (n = 42), and readmission (n = 16); other complications were rare. The surgical risk calculator displayed poor predictive ability for experiencing a complication (C-statistic = 0.547, Brier score = 0.25). CONCLUSIONS: The NSQIP surgical risk calculator displayed poor predictive ability in our cohort of patients undergoing surgery for pelvic organ prolapse, suggesting that this tool might have limited clinical applicability to individual patients in this population.

Adnexectomy at the time of vaginal hysterectomy for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Preoperative counseling about salpingectomy with pelvic surgery is recommended by the American College of Obstetrics and Gynecology for ovarian cancer risk reduction. Our objective was to determine recent practice patterns and patient factors associated with salpingectomy with vaginal hysterectomy (VH) for pelvic organ prolapse (POP) in the USA. We hypothesize that salpingectomy might have become more common in recent years. METHODS: We queried the 2014-2016 National Surgical Quality Improvement Program database for women with a postoperative diagnosis of POP who underwent VH with any combination of pelvic reconstructive procedures. CPT codes do not differentiate salpingectomy from salpingo-oophorectomy, so subjects were stratified by whether concurrent adnexectomy was performed. Chi-squared and multivariate logistic regression analyses were used to evaluate characteristics associated with adnexectomy. Propensity score matching was utilized when evaluating postoperative complication rates. RESULTS: Of 5,344 women who underwent VH, 2019 (37.8%) had adnexectomy. Adnexectomy rate increased from 34.4% in 2014 to 46.8% in 2016 (p < 0.001). Adnexectomy rates of fellowship-trained urogynecologists and general gynecologists were similar (36.0% vs 38.8%, p = 0.197). On logistic regression analysis, patients more likely to undergo adnexectomy were < 65 years old (OR 0.844, CI 0.75-0.95, p = 0.004), had BMI <30 (OR 0.76, CI 0.68-0.86, p < 0.001), and were non-smokers (OR 0.78, CI 0.64-0.95, p = 0.016). Mean operative time was 17 min longer with adnexectomy (145 vs 128 min, p < 0.001). There were no differences in postoperative complications or reoperation rates between groups. CONCLUSIONS: Adnexectomy during VH for POP is safe and increasingly utilized by gynecology surgeons in the USA.

Current Preclinical Testing of New Hip Arthroplasty Technologies Does Not Reflect Real-World Loadings: Capturing Patient-Specific and Activity-Related Variation in Hip Contact Forces.

BACKGROUND: Total hip arthroplasty (THA) implants are routinely tested for their tribological performance through regulatory preclinical wear testing (eg, ISO-14242). The standardized loading conditions defined in these tests consist of simplified waveforms, which do not specifically represent in vivo loads in different groups of patients. The aim of this study is to investigate, through musculoskeletal modeling, patient-specific and activity-related variation in hip contact forces (HCFs) in a large cohort of THA patients during common activities of daily living (ADLs). METHODS: A total of 132 THA patients participated in a motion-capture analysis while performing different ADLs, including walk, fast walk, stair ascent, and descent (locomotor); sit to stand, stand to sit, squat, and lunge (nonlocomotor). HCFs were then calculated using the AnyBody Modeling System and qualitatively compared across all activities. The influence of gender on HCFs was analyzed through statistical parametric mapping analysis. RESULTS: Systematic differences were found in HCF magnitudes and individual components in both locomotor and nonlocomotor ADLs. The qualitative analysis of the ADLs revealed a large range and a large variability in forces experienced at the hip during different activities. Significant differences in the 3-dimensional loading patterns were observed between males and females across most activities. CONCLUSION: THA patients present a large variability in the forces experienced at the hip joint during their daily life. The interpatient variation might partially explain the heterogeneity observed in implant survival rates. A more extensive preclinical implant testing standard under clinically relevant loading conditions has been advocated to better predict and avoid clinical wear problems.

Uterine pathology in transmasculine persons on testosterone: a retrospective multicenter case series.

BACKGROUND: As part of transition, transmasculine persons often use testosterone gender-affirming hormone therapy; however, there is limited data on its long-term effects. The impact of exogenous testosterone on uterine pathology remains unclear. While testosterone achieves amenorrhea in the majority of this population, persistence of abnormal uterine bleeding can be difficult to manage. Excess androgens in cisgender females are associated with pathologic uterine processes such as polycystic ovary syndrome, endometrial hyperplasia, or cancer. There are no guidelines for management of abnormal uterine bleeding or endometrial surveillance in this population. OBJECTIVE: The aim of this study was to describe the characteristics of uterine pathology after the initiation of testosterone in transmasculine persons. MATERIALS AND METHODS: A retrospective, multicenter case series was performed. Uterine pathology reports of transmasculine persons who received testosterone and subsequently underwent hysterectomy were reviewed. The endometrial phase and endometrial thickness were recorded. RESULTS: A total of 94 subjects met search criteria. The mean age of participants was 30 ± 8.6 years, and the mean interval from initiation of testosterone to hysterectomy was 36.7 ± 36.6 months. Active endometrium was found in the majority of patients (n = 65; 69.1%). One patient had complex hyperplasia without atypia. There were no cases of endometrial cancer. CONCLUSION: Despite amenorrhea in the majority of transmasculine persons on testosterone, endometrial activity persists with predominantly proliferative endometrium on histopathology. Individualized counseling for abnormal uterine bleeding is encouraged in this patient population.

Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial.

BACKGROUND: Postoperative pain control after urogynecological surgery has traditionally been opioid centered with frequent narcotic administration. Few studies have addressed optimal pain control strategies for vaginal pelvic reconstructive surgery that limit opioid use. OBJECTIVE: The objective of the study was to determine whether, ice packs, Tylenol, and Toradol, a novel opioid-sparing multimodal postoperative pain regimen has improved pain control compared with the standard postoperative pain regimen in patients undergoing inpatient vaginal pelvic reconstructive surgery. STUDY DESIGN: This was a multicenter randomized controlled trial of women undergoing vaginal pelvic reconstructive surgery. Patients were randomized to the ice packs, Tylenol, and Toradol postoperative pain regimen or the standard regimen. The ice packs, Tylenol, and Toradol regimen consists of around-the-clock ice packs, around-the-clock oral acetaminophen, around-the-clock intravenous ketorolac, and intravenous hydromorphone for breakthrough pain. The standard regimen consists of as-needed ibuprofen, as-needed acetaminophen/oxycodone, and intravenous hydromorphone for breakthrough pain. The primary outcome was postoperative day 1 pain evaluated the morning after surgery using a visual analog scale. Secondary outcomes included the validated Quality of Recovery Questionnaire, satisfaction scores, inpatient narcotic consumption, outpatient pain medication consumption, and visual analog scale scores at other time intervals. In all, 27 patients in each arm were required to detect a mean difference of 25 mm on a 100 mm visual analog scale (90% power). RESULTS: Thirty patients were randomized to ice packs, Tylenol, and Toradol and 33 to the standard therapy. Patient and surgical demographics were similar. The median morning visual analog scale pain score was lower in the ice packs, Tylenol, and Toradol group (20 mm vs 40 mm, P = .03). Numerical median pain scores were lower at the 96 hour phone call in the ice packs, Tylenol, and Toradol group (2 vs 3, P = .04). Patients randomized to the ICE-T regimen received fewer narcotics (expressed in oral morphine equivalents) from the postanesthesia care unit exit to discharge (2.9 vs 20.4, P < .001) and received fewer narcotics during the entire hospitalization (55.7 vs 91.2, P < .001). At 96 hour follow up, patients in the ice packs, Tylenol, and Toradol group used 4.9 ketorolac tablets compared with 4.6 oxycodone/acetaminophen tablets in the standard group (P = .81); however, ice packs, Tylenol, and Toradol patients required more acetaminophen than ibuprofen by patients in the standard arm (10.7 vs 6.2 tablets, P = .012). There were no differences in Quality of Recovery Questionnaire or satisfaction scores either in the morning after surgery or at 96 hour follow up. CONCLUSION: The ice packs, Tylenol, and Toradol multimodal pain regimen offers improved pain control the morning after surgery and 96 hours postoperatively compared with the standard regimen with no differences in patient satisfaction and quality of recovery. Ice packs, Tylenol, and Toradol can significantly limit postoperative inpatient narcotic use and eliminate outpatient narcotic use in patients undergoing vaginal pelvic reconstructive surgery.