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Objective: To estimate the effectiveness of prophylactic negative pressure wound therapy in patients undergoing laparotomy for gynecologic surgery.Methods: We conducted a randomized controlled trial. Eligible, consenting patients, regardless of body mass index (BMI), who were undergoing laparotomy for presumed gynecologic malignancy were randomly allocated to standard gauze or negative pressure wound therapy. Patients with BMIs of 40 or greater and benign disease also were eligible. Randomization, stratified by BMI, occurred after skin closure. The primary outcome was wound complication within 30 (±5) days of surgery. A sample size of 343 per group (N=686) was planned.Results: From March 1, 2016, to August 20, 2019, we identified 663 potential patients; 289 were randomized to negative pressure wound therapy (254 evaluable participants) and 294 to standard gauze (251 evaluable participants), for a total of 505 evaluable patients. The median age of the entire cohort was 61 years (range 20-87). Four hundred ninety-five patients (98%) underwent laparotomy for malignancy. The trial was eventually stopped for futility after an interim analysis of 444 patients. The rate of wound complications was 17.3% in the negative pressure wound therapy (NPWT) group and 16.3% in the gauze group, absolute risk difference 1% (90% CI -4.5 to 6.5%; P=.77). Adjusted odds ratio controlling for estimated blood loss and diabetes was 0.99 (90% CI 0.62-1.60). Skin blistering occurred in 33 patients (13%) in the NPWT group and in three patients (1.2%) in the gauze group (P<.001).Conclusion: Negative pressure wound therapy after laparotomy for gynecologic surgery did not lower the wound complication rate but did increase skin blistering.Clinical Trial Registration: ClinicalTrials.gov, NCT02682316.Funding Source: The protocol was supported in part by KCI/Acelity. [ABSTRACT FROM AUTHOR]

Objective: To compare perioperative use and persistent postoperative opioid use among Medicaid-insured women and commercially insured women who underwent gynecologic surgery for benign indications.Methods: The Truven Health MarketScan database, a nationwide data source collecting commercial insurance claims across all states and Medicaid insurance claims from 12 states, was used to identify opioid-naïve women without cancer aged 18-64 years who underwent common gynecologic surgeries from 2012 to 2016 and filled a prescription for an opioid perioperatively. Persistent opioid use was defined as filling an opioid prescription 90-180 days after the surgery. Opioid use disorder (OUD) was defined as hospitalizations or emergency department visits for opioid dependence, misuse, or overdose. Multivariable models were developed to examine the insurance-associated disparity in persistent opioid use and OUD.Results: A total of 31,155 Medicaid-insured women and 270,716 commercially insured women were identified. Medicaid-insured women received greater quantities of opioids and for longer durations than did commercially insured women. Persistent postoperative opioid use was identified in 14.1% of Medicaid-insured women and 5.8% of commercially insured women (P<.001). More opioid prescriptions filled, longer days supplied, and higher total doses perioperatively contributed most to the prediction of persistent opioid use. Medicaid-insured patients who persistently used opioids were two times more likely to develop OUD than commercially insured patients (16.8% vs 5.1% adjusted relative risk 1.99; 99% CI 1.26-3.15).Conclusion: Medicaid-insured women received larger quantities of opioids perioperatively, were more likely to use them persistently, and were more likely to develop OUD than commercially insured women. [ABSTRACT FROM AUTHOR]

Objective: To compare long-term health-related quality of life (HRQOL) 1 year after hysterectomy or myomectomy for treatment of uterine fibroids (UFs) and to determine whether route of procedure, race, or age affected improvements in HRQOL.Design: Prospective cohort study.Setting: Eight clinical sites throughout the United States.Patient(s): A total of 1,113 premenopausal women with UFs who underwent hysterectomy or myomectomy as part of Comparing Options for Management: Patient-Centered Results for Uterine Fibroids.Intervention(s): None.Main Outcome Measure (s): Self-reported HRQOL measures including Uterine Fibroid Symptom Quality of Life, the European QOL 5 Dimension Health Questionnaire, and the visual analog scale at baseline and 1-year after hysterectomy or myomectomy.Result (s): Hysterectomy patients were older with a longer history of symptomatic UF compared with myomectomy patients. There were no differences in baseline HRQOL. After adjustment for baseline differences between groups, compared with myomectomy, patients' HRQOL (95% confidence interval [CI], 5.4, 17.2) and symptom severity (95% CI, -16.3, -8.8) were significantly improved with hysterectomy. When stratified across race/ethnicity and age, hysterectomy had higher HRQOL scores compared with myomectomy. There was little difference in HRQOL (95% CI, 0.1 [-9.5, 9.6]) or symptom severity (95% CI, -3.4 [-10, 3.2]) between abdominal hysterectomy and abdominal myomectomy.Conclusion (s): HRQOL improved in all women 1 year after hysterectomy or myomectomy. Hysterectomy patients reported higher HRQOL summary scores compared with myomectomy patients. When stratified by route, minimally invasive hysterectomy had better HRQOL scores than minimally invasive myomectomy. There was little difference in scores with abdominal approaches. [ABSTRACT FROM AUTHOR]

Background: Persistent rural-urban disparities for colorectal and cervical cancers raise concerns regarding access to treatment providers. To the authors knowledge, little is known regarding rural-urban differences in residential proximity to cancer specialists.Methods: Using the 2018 Physician Compare data concerning physician practice locations and the 2012 to 2016 American Community Survey, the current study estimated the driving distance from each residential zip code tabulation area (ZCTA) centroid to the nearest cancer provider of the following medical specialties involved in treating patients with colorectal and cervical cancer: medical oncology, radiation oncology, surgical oncology, general surgery, gynecological oncology, and colorectal surgery. Using population-weighted multivariable logistic regression, the authors analyzed the associations between ZCTA-level characteristics and driving distances >60 miles to each type of specialist. ZCTA-level residential rurality was defined using rural-urban commuting area codes.Results: Nearly 1 in 5 rural Americans lives >60 miles from a medical oncologist. Rural-urban differences in travel distances to the nearest cancer care provider(s) increased substantially for cancer surgeons; greater than one-half of rural residents were required to travel 60 miles to reach a gynecological oncologist, compared with 8 miles for their urban counterparts. Individuals residing within ZCTAs with a higher poverty rate, those of American Indian/Alaska Native ethnicity, and/or were located in the South and West regions were more likely than their counterparts to be >60 miles away from any of the aforementioned providers.Conclusions: The substantial travel distances required for rural, low-income residents to reach a cancer specialist should prompt a policy action to increase access to specialized cancer care for millions of rural residents. [ABSTRACT FROM AUTHOR]

Objective: To quantify the average and total hospital delivery costs associated with severe maternal morbidity in excess of nonsevere maternal morbidity deliveries over a 5-year period in New York City adjusting for other sociodemographic and clinical factors.Methods: We conducted a population-based cross-sectional study using linked birth certificates and hospital discharge data for New York City deliveries from 2008 to 2012. Severe maternal morbidity was defined using a published algorithm of International Classification of Diseases, 9 Revision, Clinical Modification disease and procedure codes. Hospital costs were estimated by converting hospital charges using factors specific to each year and hospital and to each diagnosis. These estimates approximate what it costs the hospital to provide services (excluding professional fees) and were used in all subsequent analyses. To estimate adjusted mean costs associated with severe maternal morbidity, we used multivariable regression models with a log link, gamma distribution, robust standard errors, and hospital fixed effects, controlling for age, race and ethnicity, neighborhood poverty, primary payer, number of deliveries, method of delivery, comorbidities, and year. We used the adjusted mean cost to determine the average and total hospital delivery costs associated with severe maternal morbidity in excess of nonsevere maternal morbidity deliveries from 2008 to 2012.Results: Approximately 2.3% (n=13,502) of all New York City delivery hospitalizations were complicated by severe maternal morbidity. Compared with nonsevere maternal morbidity deliveries, these hospitalizations were clinically complicated, required more and intensive clinical services, and had a longer stay in the hospital. The average cost of delivery with severe maternal morbidity was $14,442 (95% CI $14,128-14,756), compared with $7,289 (95% CI $7,276-7,302) among deliveries without severe maternal morbidity. After adjusting for other factors, the difference between deliveries with and without severe maternal morbidity remained high ($6,126). Over 5 years, this difference resulted in approximately $83 million in total excess costs (13,502×$6,126).Conclusion: Severe maternal morbidity nearly doubled the cost of delivery above and beyond other drivers of cost, resulting in tens of millions of excess dollars spent in the health care system in New York City. These findings can be used to demonstrate the burden of severe maternal morbidity and evaluate the cost-effectiveness of interventions to improve maternal health. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas.Methods: This is a cross-sectional study using data from 2013 to 2014 in the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgical Databases from Arizona, Florida, Kentucky, and New Jersey. Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis. Multivariable models were used to assess changes in the proportion of hysterectomies performed laparoscopically, vaginally, or by laparotomy in the 15 months before the FDA safety communication in April 2013 (January 2013 to March 2014) to the 9 months after the FDA communication (April to December 2014). Changes in the proportion of women who underwent myomectomy compared with hysterectomy were also evaluated during this time period.Results: There were 77,637 hysterectomy and myomectomy cases analyzed from states with both inpatient and ambulatory surgery data; 59% of patients were outpatients. Overall, there was a 4% (95% CI 3.2-4.8%) decrease in the use of laparoscopic hysterectomy for treatment of uterine leiomyomas from 62% of all hysterectomies before the FDA communication on morcellation to 58% afterward. Changes in surgical practice were more pronounced in the inpatient compared with outpatient setting; inpatient laparoscopic hysterectomy decreased by 7% (95% CI 6.1-7.9%) from 24% to 17% of all hysterectomies with an accompanying increase in abdominal hysterectomy of 8% (95% CI 6.7-8.6%) from 71% to 79%. There were no significant changes in the proportion of women with leiomyomas who underwent myomectomy compared with hysterectomy.Conclusion: The FDA communication discouraging the use of power morcellators was associated with a decline in laparoscopy to perform hysterectomy, particularly in the inpatient setting. There was no change in the selection of myomectomy compared with hysterectomy for leiomyoma treatment after the FDA communication. [ABSTRACT FROM AUTHOR]

Objective: To compare risk of reintervention, long-term clinical outcomes, and health care utilization among women who have bulk symptoms from leiomyoma and who underwent the following procedures: hysterectomy, myomectomy, uterine artery embolization, and magnetic resonance-guided, focused ultrasound surgery.Methods: This was a retrospective analysis of administrative claims from a large U.S. commercial insurance database. Women aged 18-54 years undergoing any of the previously mentioned leiomyoma procedures between 2000 and 2013 were included. We assessed the following outcome measures: risk of reintervention between uterine-sparing procedures, risk of other surgical procedures or complications of the index procedure, 5-year health care utilization, pregnancy rates, and reproductive outcomes. Propensity score matching along with Cox proportional hazard models were used to adjust for differences in baseline characteristics between study cohorts.Results: Among the 135,522 study-eligible women with mean follow-up of 3.4 years, hysterectomy was the most common first-line procedural therapy (111,324 [82.2%]) followed by myomectomy (19,965 [14.7%]), uterine artery embolization (4,186 [3.1%]) and magnetic resonance-guided focused ultrasound surgery (47 [0.0003%]). Small but statistically significant differences were noted for uterine artery embolization and myomectomy in reintervention rate (17.1% compared with 15.0%, P=.02), subsequent hysterectomy rates (13.2% compared with 11.1%, P<.01) and subsequent complications from index procedures (18.1% compared with 24.6%, P<.001). During follow-up, women undergoing myomectomy had lower leiomyoma-related health care utilization, but had higher all-cause outpatient services. Pregnancy rates were 7.5% and 2.2% among myomectomy and uterine artery embolization cohorts, respectively (P<.001) with both cohorts having similar rates of adverse reproductive outcome (69.4%).Conclusions: Although the overwhelming majority of women having leiomyoma with bulk symptoms underwent hysterectomy as their first treatment procedure, among those undergoing uterine-sparing index procedures, approximately one seventh had a reintervention, and one tenth ended up undergoing hysterectomy during follow-up. Compared with women undergoing myomectomy, women undergoing uterine artery embolization had a higher risk of reintervention, lower risk of subsequent complications, but similar rate of adverse reproductive outcomes. [ABSTRACT FROM AUTHOR]

Objective: To investigate the temporal trends in minimally invasive myomectomy at one reproductive medicine center before and after the US Food and Drug Administration (FDA) recommendation against electric morcellation.Methods: A retrospective chart review was undertaken of patients undergoing minimally invasive myomectomy between April 1, 2012, and April 30, 2016, at a center in New York. Temporal trends in laparoscopic myomectomy (LM), robot-assisted laparoscopic myomectomy (RAM), and laparoscopically assisted myomectomy (LAM), and intraoperative and postoperative outcomes before and after the April 2014 recommendation were compared.Results: Minimally invasive myomectomy was performed in 73 patients. No difference was noted in the rates of minimally invasive myomectomy 2 years before (35/74 [47.3%]) and after (38/79 [48.1%]) the FDA's recommendation. The ratio of abdominal to minimally invasive myomectomy remained relatively constant before (68/59=1.15) and during the study period (80/73=1.10). There was a significant decrease in LM and RAM and a corresponding rise in LAM immediately after the recommendation (P<0.001).Conclusion: The rates of minimally invasive myomectomy before and after the FDA's recommendation did not differ, indicating that technical modifications to laparoscopic technique can allow surgeons to offer minimally invasive myomectomy to patients with symptomatic leiomyomas. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate obstetrics and gynecology resident physicians' performance following a simulation curriculum on dilation and evacuation (D&E) procedures.Study Design: This study included two phases: simulation curriculum development and resident physician performance evaluation following training on a D&E simulator. Trainees participated in two evaluations. Simulation training evaluated participants performing six cases on a D&E simulator, measuring procedural time and a 26-step checklist of D&E steps. The operative training portion evaluated residents' performance after training on the simulator using mastery learning techniques. Intra-operative evaluation was based on a 21-step checklist score, Objective Structured Assessment of Technical Skills (OSATS), and percentage of cases completed.Results: Twenty-two residents participated in simulation training, demonstrating improved performance from cases one and two to cases five and six, as measured by checklist score and procedural time (p<.001 and p=.001, respectively). Of 10 participants in the operative training, all performed at least three D&Es, while seven performed at least six cases. While checklist scores did not change significantly from the first to sixth case (mean for first case: 18.3; for sixth case: 19.6; p=.593), OSATS ratings improved from case one (19.7) to case three (23.5; p=.001) and to case six (26.8; p=.005). Trainees completed approximately 71.6% of their first case (range: 21.4-100%). By case six, the six participants performed 81.2% of the case (range: 14.3-100%).Conclusions: D&E simulation using a newly-developed uterine model and simulation curriculum improves resident technical skills. Simulation training with mastery learning techniques transferred to high level of performance in OR using checklist. The OSATS measured skills and showed improvement in performance with subsequent cases.Implications: Implementation of a D&E simulation curriculum offers potential for improved surgical training and abortion provision. [ABSTRACT FROM AUTHOR]

Objective: To understand the effect of the Food and Drug Administration (FDA) public health notifications regarding transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) on surgeon practice patterns in tertiary care academic medical centers.Materials and Methods: Surgical volume for procedures performed primarily by fellowship trained Female Pelvic Medicine and Reconstructive Surgery at a sampling of 8 academic institutions across the US were collected using current procedural technology codes for POP repair and revision surgeries from 2007 to 2013. SAS statistical software was used to analyze data for trends and to assess differences in number of procedures across years by performing Spearman correlation analysis and Pearson's chi-squared test. Significance of trend was defined as P <.05 for both analysis methods.Results: There has been a substantial reduction in transvaginal mesh-augmented repair of POP since the FDA warning statements of 2008 and 2011. Mesh revision surgery has increased over this same period. However, the total number of interventions for POP has remained stable over the study period. Abdominal sacrocolpopexy has increased as a whole but represents only a small percentage of total cases.Conclusion: Surgical correction of POP comprises a large portion of Female Pelvic Medicine and Reconstructive Surgery practice that continues to evolve in the aftermath of the FDA public health notifications. The utilization of transvaginal placement of surgical mesh augmented POP repair has decreased among practicing urologists at a sampling of academic institutions across the United States. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study; however, such data may provide alternative insights into the reasons for the observed trends. [ABSTRACT FROM AUTHOR]

Background: Widespread disparities in care have been documented in women with gynecologic cancer in the United States. This study was designed to determine whether structural barriers to optimal care were present during the preoperative period for patients with gynecologic cancer.Methods: A retrospective review was conducted for patients undergoing surgery for a gynecologic malignancy at a public hospital or a private hospital staffed by the same team of gynecologic oncologists between July 1, 2013 and July 1, 2014.Results: Two hundred fifty-seven cases were included for analysis (public hospital, 69; private hospital, 188). Patients treated at the private hospital were older (58 vs 52 years; P = .004) and had similar medical comorbidities (median Charlson comorbidity index at both hospitals, 6) but required fewer hospital visits in preparation for surgery (2 vs 4; P < .001). Public hospital patients had a longer wait time from the diagnosis of disease to surgery (63 vs 34 days; P < .001). According to a multiple linear regression model, the public hospital setting was associated with a longer interval from diagnosis to surgery with adjustments for the insurance status, age at diagnosis, cancer stage, and number of preoperative hospital visits (P < .001).Conclusions: Patients at the public hospital were subject to a greater number of preoperative visits and had to wait longer for surgery than patients at the private hospital. Attempts to reduce health care disparities should focus on improving efficiency in health care delivery systems once contact has been established. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether there was a change in surgical practice immediately after the U.S. Food and Drug Administration (FDA) warning statement discouraging the use of power morcellation in the surgical treatment of uterine leiomyomas.Methods: We performed a time-series analysis. Surgical case logs from the Florida Hospital operating room documentation system were used to retrospectively identify patients who underwent a hysterectomy or myomectomy between August 1, 2013, and December 31, 2014. Cases performed during the 8 months before the FDA announcement on April 17, 2014, were compared with cases performed during the 8 months after the FDA announcement. Six hospitals and 98 surgeons were included. We compared the proportion of minimally invasive surgery cases (vaginal, laparoscopic, or robotic-assisted) for each study period.Results: There was a 5.8% decrease in minimally invasive hysterectomies after the FDA warning statement (85.7% [1,451/1,694] compared with 79.9% [1,350/1,690]; P<.001) and an 8.7% decrease when oncologist cases were excluded (90.2% [985/1,092] compared with 81.5% [834/1,023]; P<.001). There was a 19% decrease in minimally invasive myomectomies (62.7% [64/102] compared with 43.7% [38/87]; P=.009). Analysis by subspecialty showed a significant decrease in minimally invasive hysterectomies by obstetrician-gynecologists (ob-gyns) and minimally invasive gynecologic specialists but not urogynecologists or oncologists and a significant decrease in minimally invasive myomectomies by reproductive endocrinologists and minimally invasive gynecologic specialists but not ob-gyns.Conclusion: There was a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation.Level Of Evidence: II. [ABSTRACT FROM AUTHOR]

Objective: To investigate recent trends in mesh use for pelvic organ prolapse (POP)-related reconstruction procedures.Materials and Methods: Using the 2001-2011 5% Medicare claims database, we identified POP diagnoses and related procedures. Transvaginal mesh use and sacrocolpopexy were first reported in 2005 and 2004, respectively.Results: A total of 613,160 cases of vaginal and abdominal POP repair procedures were identified. The majority of procedures involved multiple compartments. The rate of mesh use increased dramatically from 2% of repairs in 2005 to 35% by 2008. After the Food and Drug Administration warning in 2008, mesh use plateaued and then decreased in 2011. Mesh was used more commonly in younger (odds ratio [OR] 0.722, P < .001), white (OR 0.712-0.791 for other races, P < .001) women in the South (OR 0.741-0.848 for non-South regions, P < .001). Starting in 2008, the rate of sacrocolpopexy procedures almost doubled yearly until 2011. Sacrocolpopexy was more common in younger patients (49% in women <70 years) and in white women (88%); the majority of sacrocolpopexies were performed in the South (60%) and laparoscopically (83%-98%).Conclusion: The treatment of POP has changed over time. The use of mesh increased significantly until 2008, after which it plateaued following the Food and Drug Administration warning regarding mesh-related complications. Concurrently, the number of sacrocolpopexy procedures increased significantly starting in 2008 as the use of laparoscopic and/or robotic technique and concern regarding transvaginal mesh increased. [ABSTRACT FROM AUTHOR]