Associations between race and ethnicity and perioperative outcomes among women undergoing hysterectomy for adenomyosis.

OBJECTIVE: To study racial and ethnic disparities among women undergoing hysterectomy performed for adenomyosis across the United States. DESIGN: A cohort study. SETTING: Data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) from 2012-2020. PATIENTS: Patients with an adenomyosis diagnosis. INTERVENTION: Hysterectomy for adenomyosis. MAIN OUTCOME MEASURES: Patients were identified using the International Classification of Diseases 9th and 10th editions codes 617.0 and N80.0 (endometriosis of the uterus). Hysterectomies were classified on the basis of the Current Procedural Terminology codes. We compared baseline and surgical characteristics and 30-day postoperative complications across the different racial and ethnic groups. Postoperative complications were classified into minor and major complications according to the Clavien-Dindo classification system. RESULTS: A total of 12,599 women underwent hysterectomy for adenomyosis during the study period: 8,822 (70.0%) non-Hispanic White, 1,597 (12.7%) Hispanic, 1,378 (10.9%) non-Hispanic Black or African American, 614 (4.9%) Asian, 97 (0.8%) Native Hawaiian or Pacific Islander, and 91 (0.7%) American Indian or Alaska Native. Postoperative complications occurred in 8.8% of cases (n = 1,104), including major complications in 3.1% (n = 385). After adjusting for confounders, non-Hispanic Black race and ethnicity were independently associated with an increased risk of major complications (adjusted odds ratio 1.54, 95% confidence interval [CI] {1.16-2.04}). Laparotomy was performed in 13.7% (n = 1,725) of cases. Compared with non-Hispanic White race and ethnicity, the adjusted odd ratios for undergoing laparoscopy were 0.58 (95% CI 0.50-0.67) for Hispanic, 0.56 (95% CI 0.48-0.65) for non-Hispanic Black or African American, 0.33 (95% CI 0.27-0.40) for Asian, and 0.26 (95% CI 0.17-0.41) for Native Hawaiian or Pacific Islander race and ethnicity. CONCLUSION: Among women undergoing hysterectomy for postoperatively diagnosed adenomyosis, non-Hispanic Black or African American race and ethnicity were associated with an increased risk of major postoperative complications. Compared with non-Hispanic White race and ethnicity, Hispanic ethnicity, non-Hispanic Black or African American, Asian, Native Hawaiian, or Pacific Islander race and ethnicity were less likely to undergo minimally invasive surgery.

Clinical Trial Racial and Ethnic Disparities in Minimally Invasive Gynecologic Surgery.

STUDY OBJECTIVE: To study racial and ethnic disparities in randomized controlled trials (RCTs) in minimally invasive gynecologic surgery (MIGS). DESIGN: Cross-sectional study. SETTING: Online review of all published MIGS RCTs in high-impact journals from 2012 to 2023. PATIENTS: Journals included all first quartile obstetrics and gynecology journals, as well as The New England Journal of Medicine, The Lancet, The British Medical Journal, and The Journal of the American Medical Association. The National Institutes of Health's PubMed and the ClinicalTrials.gov websites were queried using the following search terms from the American Board of Obstetrics and Gynecology's certifying examination bulletin 2022 to obtain relevant trials: adenomyosis, adnexal surgery, abnormal uterine bleeding, cystectomy, endometriosis, fibroids, gynecology, hysterectomy, hysteroscopy, laparoscopy, leiomyoma, minimally invasive gynecology, myomectomy, ovarian cyst, and robotic surgery. INTERVENTIONS: The US Census Bureau data were used to estimate the expected number of participants. We calculated the enrollment ratio (ER) of actual to expected participants for US trials with available race and ethnicity data. MEASUREMENTS AND MAIN RESULTS: A total of 352 RCTs were identified. Of these, race and/or ethnicity data were available in 65 studies (18.5%). We analyzed the 46 studies that originated in the United States, with a total of 4645 participants. Of these RCTs, only 8 (17.4%) reported ethnicity in addition to race. When comparing published RCT data with expected proportions of participants, White participants were overrepresented (70.8% vs. 59.6%; ER, 1.66; 95% confidence interval [CI], 1.52-1.81), as well as Black or African American participants (15.4% vs. 13.7%; ER, 1.15; 95% CI, 1.03-1.29). Hispanic (6.7% vs. 19.0%; ER, 0.31; 95% CI, 0.27-0.35), Asian (1.7% vs. 6.1%; ER, 0.26; 95% CI, 0.20-0.34), Native Hawaiian or other Pacific Islander (0.1% vs. 0.3%; ER, 0.21; 95% CI, 0.06-0.74), and Indian or Alaska Native participants (0.2% vs. 1.3%; ER, 0.16; 95% CI, 0.08-0.32) were underrepresented. When comparing race/ethnicity proportions in the 20 states where the RCTs were conducted, Black or African American participants were underrepresented. CONCLUSION: In MIGS RCTs conducted in the United States, White and Black or African American participants are overrepresented compared with other races, and ethnicity is characterized in fewer than one-fifth of trials. Efforts should be made to improve racial and ethnic recruitment equity and reporting in future MIGS RCTs.

Rates of Complications and Reoperation after Myomectomy-the Impact of Surgical Approach: A Statewide Population-based Cohort Study from 2005-2018.

STUDY OBJECTIVE: To assess rates of and factors associated with complications and reoperation after myomectomy. DESIGN: Population-based cohort study. SETTING: All non-Veterans Affairs facilities in the state of California from January 1, 2005, to December 31, 2018. PARTICIPANTS: Women undergoing abdominal or laparoscopic myomectomy for myoma disease were identified from the Office of Statewide Health Planning and Development datasets using appropriate International Classification of Diseases, Ninth and Tenth Revision and Current Procedural Terminology codes. INTERVENTIONS: Demographics, surgery facility type, facility surgical volume, and surgical approach were identified. Primary outcomes included complications occurring within 60 days of surgery and reoperations for myomas. Patients were followed up for over an average of 7.3 years. Univariate and multivariable associations were explored between the above factors and rates of complications and reoperation. All odds ratios (ORs) are adjusted ORs. MEASUREMENTS AND MAIN RESULTS: Of the 66 012 patients undergoing myomectomy, 5265 had at least one complication (8.0%). Advanced age, black, Asian race, MediCal and Medicare payor status, academic facility, and medical comorbidities were associated with increased odds of a complication. Minimally invasive myomectomy (MIM) was associated with decreased complications compared with abdominal myomectomy (AM) (OR, 0.29; 95% confidence interval [CI], 0.25-0.33; p <.001). Overall, 17 377 patients (26.3%) underwent reoperation. Medicare and MediCal payor status and medical comorbidities were associated with increased odds of a repeat surgery. Reoperation rates were higher in the MIM group over the entire study period (OR, 2.33; 95% CI, 1.95-2.79; p <.001). However, the odds of reoperation after MIM decreased each year (OR, 0.93; 95% CI 0.92-0.95; p <.001), with the odds of reoperation after AM surpassing MIM in 2015. CONCLUSION: This study identifies outcome disparities in the surgical management of myomas and describes important differences in the rates of complications and reoperations, which can be used to counsel patients on surgical approach. These findings suggest that MIM can be considered a lasting and safe approach in properly selected patients.

The case against endometrial ablation for treatment of heavy menstrual bleeding.

PURPOSE OF REVIEW: Endometrial ablation is a common treatment for heavy menstrual bleeding, but serious limitations and long-term complications exist. Our purpose is to summarize the use of endometrial ablation devices, potential short-term and long-term complications, cost effectiveness, and quality of life in relation to alternative treatments. RECENT FINDINGS: There is insufficient evidence to strongly recommend one endometrial ablation device over another. Providers should consider and discuss with their patients, complications including risk of future pregnancy, endometrial cancer, and hysterectomy for continued bleeding or pain. Patient selection is key to reducing postablation pain and failure; patients with a history of tubal ligation and dysmenorrhea should consider alternative treatments. All patients should also be counseled that the levonorgestrel intrauterine device is a cost-effective alternative with higher quality of life and fewer complications. Hysterectomy is definitive treatment with higher quality of life and fewer complications. SUMMARY: Although endometrial ablation can offer adequate symptom control for patients who have failed medical therapy, desire uterine preservation, or who are high-risk surgical candidates, patients should be appropriately selected and counseled regarding the potential for treatment failure and long-term complications.

Hysterectomy for the Transgendered Male: Review of Perioperative Considerations and Surgical Techniques with Description of a Novel 2-Port Laparoscopic Approach.

Transgendered individuals can suffer a significant amount of psychological distress that can be alleviated through hormonal treatments and/or gender-affirming surgery. The World Professional Association for Transgender Health considers a hysterectomy and bilateral salpingo-oophorectomy medically necessary gender-affirming procedures for the interested transgendered male. Several surgical approaches have been described in the literature, most of which endorse a laparoscopic approach. This review summarizes the available literature on surgical techniques in addition to reporting our institutional outcomes using a novel 2-port laparoscopic approach. Additional preoperative and perioperative considerations are needed when caring for this patient population and are reviewed.

Comparison of the levonorgestrel-releasing intrauterine system, hysterectomy, and endometrial ablation for heavy menstrual bleeding in a decision analysis model.

BACKGROUND: A better understanding of the relative risks and benefits of common treatment options for abnormal uterine bleeding (AUB) can help providers and patients to make balanced, evidence-based decisions. OBJECTIVES: To provide comparative estimates of clinical outcomes after placement of levonorgestrel-releasing intrauterine system (LNG-IUS), ablation, or hysterectomy for AUB. SEARCH STRATEGY: A PubMED search was done using combinations of search terms related to abnormal uterine bleeding, LNG-IUS, hysterectomy, endometrial ablation, cost-benefit analysis, cost-effectiveness, and quality-adjusted life years. SELECTION CRITERIA: Full articles published in 2006-2016 available in English comparing at least two treatment modalities of interest among women of reproductive age with AUB were included. DATA COLLECTION AND ANALYSIS: A decision tree was generated to compare clinical outcomes in a hypothetical cohort of 100 000 premenopausal women with nonmalignant AUB. We evaluated complications, mortality, and treatment outcomes over a 5-year period, calculated cumulative quality-adjusted life years (QALYs), and conducted probabilistic sensitivity analysis. MAIN RESULTS: Levonorgestrel-releasing intrauterine system had the highest number of QALYs (406 920), followed by hysterectomy (403 466), non-resectoscopic ablation (399 244), and resectoscopic ablation (395 827). Ablation had more treatment failures and complications than LNG-IUS and hysterectomy. Findings were robust in probabilistic sensitivity analysis. CONCLUSIONS: Levonorgestrel-releasing intrauterine system and hysterectomy outperformed endometrial ablation for treatment of AUB.

Cost-effectiveness of treatments for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding affects up to one third of women in the United States, resulting in a reduced quality of life and significant cost to the health care system. Multiple treatment options exist, offering different potential for symptom control at highly variable initial costs, but the relative value of these treatment options is unknown. OBJECTIVE: The objective of the study was to evaluate the relative cost-effectiveness of 4 treatment options for heavy menstrual bleeding: hysterectomy, resectoscopic endometrial ablation, nonresectoscopic endometrial ablation, and the levonorgestrel-releasing intrauterine system. STUDY DESIGN: We formulated a decision tree evaluating private payer costs and quality-adjusted life years over a 5 year time horizon for premenopausal women with heavy menstrual bleeding and no suspected malignancy. For each treatment option, we used probabilities derived from literature review to estimate frequencies of minor complications, major complications, and treatment failure resulting in the need for additional treatments. Treatments were compared in terms of total average costs, quality-adjusted life years, and incremental cost-effectiveness ratios. Probabilistic sensitivity analysis was conducted to understand the range of possible outcomes if model inputs were varied. RESULTS: The levonorgestrel-releasing intrauterine system had superior quality-of-life outcomes to hysterectomy with lower costs. In a probabilistic sensitivity analysis, levonorgestrel-releasing intrauterine system was cost-effective compared with hysterectomy in the majority of scenarios (90%). Both resectoscopic and nonresectoscopic endometrial ablation were associated with reduced costs compared with hysterectomy but resulted in a lower average quality of life. According to standard willingness-to-pay thresholds, resectoscopic endometrial ablation was considered cost effective compared with hysterectomy in 44% of scenarios, and nonresectoscopic endometrial ablation was considered cost effective compared with hysterectomy in 53% of scenarios. CONCLUSION: Comparing all trade-offs associated with 4 possible treatments of heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system was superior to both hysterectomy and endometrial ablation in terms of cost and quality of life. Hysterectomy is associated with a superior quality of life and fewer complications than either type of ablation but at a higher cost. For women who are unwilling or unable to choose the levonorgestrel-releasing intrauterine system as a first-course treatment for heavy menstrual bleeding, consideration of cost, procedure-specific complications, and patient preferences can guide the decision between hysterectomy and ablation.

Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroids: an updated decision analysis following the 2014 Food and Drug Administration safety communications.

Previous decision analyses demonstrate the safety of minimally invasive hysterectomy for presumed benign fibroids, accounting for the risk of occult leiomyosarcoma and the differential mortality risk associated with laparotomy. Studies published since the 2014 Food and Drug Administration safety communications offer updated leiomyosarcoma incidence estimates. Incorporating these studies suggests that mortality rates are low following hysterectomy for presumed benign fibroids overall, and a minimally invasive approach remains a safe option. Risk associated with morcellation, however, increases in women age >50 years due to increased leiomyosarcoma rates, an important finding for patient-centered discussions of treatment options for fibroids.

Updates in uterine fibroid tissue extraction.

PURPOSE OF REVIEW: Safety concerns regarding morcellation of presumed benign fibroid disease have led to an increase in recent research activity on this topic, as well as advances in surgical technique. RECENT FINDINGS: The prevalence of occult leiomyosarcoma is debated; however, estimates from a robust meta-analysis suggest it may be in the range of 1 case per 1960-8300 fibroid surgeries. Advancing age is an important clinical risk factor for occult malignancy. The impact of tumor morcellation may vary by mode of tissue removal, though tissue fragmentation is consistently associated with poorer outcomes. Decision and cost analyses continue to support laparoscopic hysterectomy as a low-morbidity and cost-effective approach. The increased scrutiny on fibroid procedures in the past few years may lead to changes in surgical approach; however, alternative tissue extraction options are evolving, including incorporation of contained morcellation. SUMMARY: Although the incidence of occult leiomyosarcoma is low, outcomes are poor and may be worsened by morcellation. By addressing risk factors for malignancy and incorporating evolving surgical techniques into practice, gynecologists can continue to offer patients a minimally invasive approach for fibroid management.

Cost-Effectiveness of Laparoscopic Hysterectomy With Morcellation Compared With Abdominal Hysterectomy for Presumed Myomas.

STUDY OBJECTIVE: Hysterectomy for presumed leiomyomata is 1 of the most common surgical procedures performed in nonpregnant women in the United States. Laparoscopic hysterectomy (LH) with morcellation is an appealing alternative to abdominal hysterectomy (AH) but may result in dissemination of malignant cells and worse outcomes in the setting of an occult leiomyosarcoma (LMS). We sought to evaluate the cost-effectiveness of LH versus AH. DESIGN: Decision-analytic model of 100 000 women in the United States assessing the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained (Canadian Task Force classification III). SETTING: U.S. hospitals. PATIENTS: Adult premenopausal women undergoing LH or AH for presumed benign leiomyomata. INTERVENTIONS: We developed a decision-analytic model from a provider perspective across 5 years, comparing the cost-effectiveness of LH to AH in terms of dollar (2014 US dollars) per QALY gained. The model included average total direct medical costs and utilities associated with the procedures, complications, and clinical outcomes. Baseline estimates and ranges for cost and probability data were drawn from the existing literature. MEASUREMENTS AND MAIN RESULTS: Estimated overall deaths were lower in LH versus AH (98 vs 103). Death due to LMS was more common in LH versus AH (86 vs 71). Base-case assumptions estimated that average per person costs were lower in LH versus AH, with a savings of $2193 ($24 181 vs $26 374). Over 5 years, women in the LH group experienced 4.99 QALY versus women in the AH group with 4.91 QALY (incremental gain of .085 QALYs). LH dominated AH in base-case estimates: LH was both less expensive and yielded greater QALY gains. The ICER was sensitive to operative costs for LH and AH. Varying operative costs of AH yielded an ICER of $87 651/QALY gained (minimum) to AH being dominated (maximum). Probabilistic sensitivity analyses, in which all input parameters and costs were varied simultaneously, demonstrated a relatively robust model. The AH approach was dominated 68.9% of the time; 17.4% of simulations fell above the willingness-to-pay threshold of $50 000/QALY gained. CONCLUSION: When considering total direct hospital costs, complications, and morbidity, LH was less costly and yielded more QALYs gained versus AH. Driven by the rarity of occult LMS and the reduced incidence of intra- and postoperative complications, LH with morcellation may be a more cost-effective and less invasive alternative to AH and should remain an option for women needing hysterectomy for leiomyomata.

Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis.

OBJECTIVE: The purpose of this study was to model outcomes in laparoscopic hysterectomy with morcellation compared with abdominal hysterectomy for the presumed fibroid uterus and to examine short- and long-term complications and death. STUDY DESIGN: A decision tree was constructed to compare outcomes for a hypothetical cohort of 100,000 premenopausal women who underwent hysterectomy for presumed fibroid tumors over a 5-year time horizon. Parameter and quality-of-life utility estimates were determined from published literature for postoperative complications, leiomyosarcoma incidence, death related to leiomyosarcoma, and procedure-related death. RESULTS: The decision-tree analysis predicted fewer overall deaths with laparoscopic hysterectomy compared with abdominal hysterectomy (98 vs 103 per 100,000). Although there were more deaths from leiomyosarcoma after laparoscopic hysterectomy (86 vs 71 per 100,000), there were more hysterectomy-related deaths with abdominal hysterectomy (32 vs 12 per 100,000). The laparoscopic group had lower rates of transfusion (2400 vs 4700 per 100,000), wound infection (1500 vs 6300 per 100,000), venous thromboembolism (690 vs 840 per 100,000) and incisional hernia (710 vs 8800 per 100,000), but a higher rate of vaginal cuff dehiscence (640 vs 290 per 100,000). Laparoscopic hysterectomy resulted in more quality-adjusted life years (499,171 vs 490,711 over 5 years). CONCLUSION: The risk of leiomyosarcoma morcellation is balanced by procedure-related complications that are associated with laparotomy, including death. This analysis provides patients and surgeons with estimates of risk and benefit on which patient-centered decisions can be made.