Approach to radical hysterectomy for cervical cancer after the LACC trial and associated complications: a NSQIP study.

BACKGROUND: The Laparoscopic Approach to Cervical Cancer (LACC) study results revolutionized our understanding of the best surgical management for this disease. Following its publication, guidelines state that the standard and recommended approach for radical hysterectomy is with an open abdominal approach. Nevertheless, the impact of the LACC trial on real-world changes in the surgical approach to radical hysterectomy remains elusive. OBJECTIVE: We aimed to study the trends and routes of radical hysterectomies and to evaluate post-operative complication rates before and after the LACC trial (2018). STUDY DESIGN: The National Surgical Quality Improvement Program registry was used to examine radical hysterectomies performed for cervical cancer between 2012-2022. We excluded vaginal radical hysterectomies and simple hysterectomies. The primary outcome measures were the trends in route of surgery [minimally invasive surgery (MIS) vs. laparotomy] and surgical complications rate, stratified by periods before and after the publication of the LACC trial in 2018 (2012-2017 vs. 2019-2022). The secondary outcome measure was major complications associated specifically with the different routes of surgery. RESULTS: Of the 3,611 patients included, 2,080 (57.6%) underwent laparotomy and 1,531 (42.4%) underwent MIS radical hysterectomy. There was a significant increase in the MIS approach from 2012 to 2017 (45.6% MIS in 2012 to 75.3% MIS in 2017, p<.001), and a significant decrease in MIS from 2018 to 2022 (50.4% MIS in 2018 to 11.4% MIS in 2022, p<.001). The rate of minor complications was lower in the period before the LACC trial [317 (16.9%) vs. 288 (21.3%), p=.002]. Major complications rate was similar before and after the LACC trial [139 (7.4%) vs. 78 (5.8%), p=.26]. The rates of blood transfusions and superficial surgical site infections were lower in the period before the LACC trial [137 (7.3%) vs. 133 (9.8%), p=.012 and 20 (1.1%) vs. 53 (3.9%), p<.001, respectively]. In a comparison of MIS vs. laparotomy radical hysterectomy during the entire study period, patients in the MIS group had lower rates of minor complications [190 (12.4%) vs. 472 (22.7%), p<.001] and the rate of major complications was similar in both groups [100 (6.5%) in the MIS group vs. 139 (6.7%) in the laparotomy group, p=.89]. In a specific complications analysis, the rates of blood transfusion and superficial surgical site infections were lower in the MIS groups (2.4% vs. 12.7%, and 0.6% vs. 3.4%, p<.001 for both comparisons) and the rate of deep incisional surgical site infections was lower in the MIS group (0.2% vs. 0.7%, p=.048). In a multiple logistic regression analysis, the route of radical hysterectomy was not independently associated with occurrence of major complications [aOR 95% CI 1.02 (0.63-1.65)]. CONCLUSION: While the proportion of MIS radical hysterectomy decreased abruptly following the LACC trial, there was no change in the rate of major post-operative complications. In addition, hysterectomy route was not associated with major post-operative complications.

Race, Ethnicity, and Sex Representation Trends Among Minimally Invasive Gynecologic Surgery Fellowship Trainees and Graduates.

STUDY OBJECTIVE: To study the race, ethnicity, and sex representation and annual trends of AAGL FMIGS fellows and graduates. DESIGN: A retrospective cross-sectional study. SETTING: AAMC databases were queried for demographic information between 2011 and 2023. PATIENTS/SUBJECTS: AAGL FMIGS fellows and graduates. INTERVENTIONS: N/A MEASUREMENTS AND MAIN RESULTS: Descriptive statistical analysis and the actual-to-expected (AE) ratio of each race, ethnicity, and sex were performed. AE ratio was calculated by dividing the 13-year average actual percentage of FMIGS trainees and graduates by the expected percentage based demographics of OBGYN residents and the US general population. 477 fellows graduated or were in training between 2011 and 2023; race and ethnicity information was obtained for 347 (72.7%) individuals, and sex information was available for 409 (85.7%). Representation of females ranged from 66.7% in 2017 to 93.3% in 2022. There was a significantly increasing slope for the representation of females (+1.3% per year; 95% CI 0.00-0.03; p = .027). Compared to their distribution among US OBGYN residents, White fellows' representation was lower [AE ratio, 95% CI 0.60 (0.44-0.81)] and of Asian fellows was higher [AE ratio, 95% CI 2.17 (1.47-3.21)]. Female fellows' representation was lower than expected [AE ratio, 95% CI 0.68 (0.48-0.96)] compared to their distribution among US OBGYN residents. Compared to the general US population, White fellows [AE ratio, 95% CI 0.65 (0.48-0.87)] and Hispanic fellows [AE ratio, 95% CI 0.53 (0.34-0.83)] representation was lower. Asian fellows' representation was higher compared to the general US population [AE ratio, 95% CI 5.87 (3.48-9.88)]. CONCLUSION: White and Hispanic fellows' representation was lower than expected, while Asian fellows' representation was higher in AAGL-accredited FMIGS programs. Female representation increased throughout the years, but overall, female fellows' representation was lower than expected compared to their distribution among OBGYN residents. These findings may help develop equitable recruitment strategies for FMIGS programs and reduce health disparities within complex gynecology.

Surgical Field Separation in Total Laparoscopic Hysterectomy.

We aimed to study whether separating the vaginal and abdominal surgical fields during total laparoscopic hysterectomy (TLH) is associated with surgical site infection rates. This was a retrospective cohort study of all patients who underwent TLH and any concomitant procedures with two minimally invasive gynecologic surgery subspecialists between January 2016 and May 2023. Among 680 included patients, the rate of infection was 0.8% with surgical field separation and 1.3% without (3/377 vs 4/303; odds ratio 0.60, 95% CI, 0.13-2.70). There was no statistical difference between groups; however, the difference in infection rates between groups was extremely small, which led to inadequate power. Our findings suggest that rates of infection after TLH are low, with or without surgical field separation. Treating the vagina, perineum, and abdomen as a single, continuous operative field during TLH may be an acceptable practice.

Validation of a Simulation Model for Robotic Myomectomy.

STUDY OBJECTIVE: Several simulation models have been evaluated for gynecologic procedures such as hysterectomy, but there are limited published data for myomectomy. This study aimed to assess the validity of a low-cost robotic myomectomy model for surgical simulation training. DESIGN: Prospective cohort simulation study. SETTING: Surgical simulation laboratory. PARTICIPANTS: Twelve obstetrics and gynecology residents and 4 fellowship-trained minimally invasive gynecologic surgeons were recruited for a 3:1 novice-to-expert ratio. INTERVENTIONS: A robotic myomectomy simulation model was constructed using <$5 worth of materials: a foam cylinder, felt, a stress ball, bandage wrap, and multipurpose sealing wrap. Participants performed a simulation task involving 2 steps: fibroid enucleation and hysterotomy repair. Video-recorded performances were timed and scored by 2 blinded reviewers using the validated Global Evaluative Assessment of Robotic Skills (GEARS) scale (5-25 points) and a modified GEARS scale (5-40 points), which adds 3 novel domains specific to robotic myomectomy. Performance was also scored using predefined task errors. Participants completed a post-task questionnaire assessing the model's realism and utility. MEASUREMENTS AND MAIN RESULTS: Median task completion time was shorter for experts than novices (9.7 vs 24.6 min, p = .001). Experts scored higher than novices on both the GEARS scale (median 23 vs 12, p = .004) and modified GEARS scale (36 vs 20, p = .004). Experts made fewer task errors than novices (median 15.5 vs 37.5, p = .034). For interrater reliability of scoring, the intraclass correlation coefficient was calculated to be 0.91 for the GEARS assessment, 0.93 for the modified GEARS assessment, and 0.60 for task errors. Using the contrasting groups method, the passing mark for the simulation task was set to a minimum modified GEARS score of 28 and a maximum of 28 errors. Most participants agreed that the model was realistic (62.5%) and useful for training (93.8%). CONCLUSION: We have demonstrated evidence supporting the validity of a low-cost robotic myomectomy model. This simulation model and the performance assessments developed in this study provide further educational tools for robotic myomectomy training.

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.

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.

Characteristics associated with blood transfusion among women undergoing laparoscopic myomectomy: a National Surgical Quality Improvement Program study.

BACKGROUND: Uterine fibroids are the most common benign tumors that affect females. A laparoscopic myomectomy is the standard surgical treatment for most women who wish to retain their uterus. The most common complication of a myomectomy is excessive bleeding. However, risk factors for hemorrhage during a laparoscopic myomectomy are not well studied and no risk stratification tool specific for identifying the need for a blood transfusion during a laparoscopic myomectomy currently exists in the literature. OBJECTIVE: This study aimed to identify risk factors for intraoperative and postoperative blood transfusion during laparoscopic myomectomies and to develop a risk stratification tool to determine the risk for requiring a blood transfusion. STUDY DESIGN: This was a retrospective cohort study of the American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2020. Women who underwent a laparoscopic (conventional or robotic) myomectomy were included. Women who received 1 or more blood transfusions within 72 hours after the start time of a laparoscopic myomectomy were compared with those who did not require a blood transfusion. A multivariable analysis was performed to identify risk factors independently associated with the risk for transfusion. Two risk stratification tools to determine the need for a blood transfusion were developed based on the multivariable results, namely (1) based on preoperative factors and (2) based on preoperative and intraoperative factors. RESULTS: During the study period, 11,498 women underwent a laparoscopic myomectomy. Of these, 331(2.9%) required a transfusion. In a multivariable regression analysis of the preoperative factors, Black or African American and Asian races, Hispanic ethnicity, bleeding disorders, American Society of Anesthesiologists class III or IV classification, and a preoperative hematocrit value ≤35.0% were independently associated with the risk for transfusion. Identified intraoperative factors included specimen weight >250 g or ≥5 intramural myomas and an operation time of ≥197 minutes. A risk stratification tool was developed in which points are assigned based on the identified risk factors. The mean probability of transfusion can be calculated based on the sum of the points. CONCLUSION: We identified preoperative and intraoperative independent risk factors for a blood transfusion among women who underwent a laparoscopic myomectomy. A risk stratification tool to determine the risk for requiring a blood transfusion was developed based on the identified risk factors. Further studies are needed to validate this tool.