Approach to radical hysterectomy for cervical cancer after the Laparoscopic Approach to Cervical Cancer trial and associated complications: a National Surgical Quality Improvement Program study.

BACKGROUND: The Laparoscopic Approach to Cervical Cancer study results revolutionized our understanding of the best surgical management for this disease. After its publication, the guidelines state that the standard and recommended approach for radical hysterectomy is an open abdominal approach. Nevertheless, the effect of the Laparoscopic Approach to Cervical Cancer trial on real-world changes in the surgical approach to radical hysterectomy remains elusive. OBJECTIVE: This study aimed to investigate the trends and routes of radical hysterectomy and to evaluate postoperative complication rates before and after the Laparoscopic Approach to Cervical Cancer trial (2018). STUDY DESIGN: The National Surgical Quality Improvement Program registry was used to examine radical hysterectomy for cervical cancer performed between 2012 and 2022. This study excluded vaginal radical hysterectomies and simple hysterectomies. The primary outcome measures were the trends in the route of surgery (minimally invasive surgery vs laparotomy) and surgical complication rates, stratified by periods before and after the publication of the Laparoscopic Approach to Cervical Cancer 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 3611 patients included, 2080 (57.6%) underwent laparotomy, and 1531 (42.4%) underwent minimally invasive radical hysterectomy. There was a significant increase in the minimally invasive surgery approach from 2012 to 2017 (45.6% in minimally invasive surgery in 2012 to 75.3% in minimally invasive surgery in 2017; P<.01) and a significant decrease in minimally invasive surgery from 2018 to 2022 (50.4% in minimally invasive surgery in 2018 to 11.4% in minimally invasive surgery in 2022; P<.001). The rate of minor complications was lower in the period before the Laparoscopic Approach to Cervical Cancer trial than after the trial (317 [16.9%] vs 288 [21.3%], respectively; P=.002). The major complication rates were similar before and after the Laparoscopic Approach to Cervical Cancer trial (139 [7.4%] vs 78 [5.8%], respectively; P=.26). The rates of blood transfusions and superficial surgical site infections were lower in the period before the Laparoscopic Approach to Cervical Cancer trial than in the period after the 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 minimally invasive surgery vs laparotomy radical hysterectomy during the entire study period, patients in the minimally invasive surgery group had lower rates of minor complications than in those in the laparotomy group (190 [12.4%] vs 472 [22.7%], respectively; P<.001), and the rates of major complications were similar in both groups (100 [6.5%] in the minimally invasive surgery 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 minimally invasive surgery group than in the laparotomy group (2.4% vs 12.7% and 0.6% vs 3.4%, respectively; P<.001; for both comparisons), and the rate of deep incisional surgical site infections was lower in the minimally invasive surgery group than in the laparotomy group (0.2% vs 0.7%, respectively; P=.048). In the multiple logistic regression analysis, the route of radical hysterectomy was not independently associated with the occurrence of major complications (adjusted odds ratio, 1.02; 95% confidence interval, 0.63-1.65). CONCLUSION: Although the proportion of minimally invasive radical hysterectomies decreased abruptly after the Laparoscopic Approach to Cervical Cancer trial, there was no change in the rate of major postoperative complications. In addition, the hysterectomy route was not associated with major postoperative complications.

Surgical treatment of colorectal endometriosis: an updated review.

PURPOSE OF REVIEW: This review aims to summarize recent literature on the surgical treatment of colorectal endometriosis. RECENT FINDINGS: The last decade has seen a surge in the number of studies on bowel endometriosis, with a focus on preoperative evaluation, perioperative management, surgical approach, and surgical outcomes. Many of these studies have originated from large-volume referral centers with varying surgical approaches and philosophies. Colorectal surgery for endometriosis seems to have a positive impact on patient symptoms, quality of life, and fertility. However, these benefits must be weighed against a significant risk of postoperative complications and the potential for long-term bowel or bladder dysfunction, especially for more radical procedures involving the lower rectum. Importantly, most studies regarding surgical technique and outcomes have been limited by their observational design. SUMMARY: The surgical management of bowel endometriosis is complex and should be approached by a multidisciplinary team. Methodical preoperative evaluation, including appropriate imaging, is vital for surgical planning and patient counseling. The decision to perform a more conservative or radical excision is nuanced and remains an area of controversy. High quality studies in the form of multicenter randomized controlled trials are needed before clear recommendations can be made.

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.

Development and validation of a simulation model for laparoscopic myomectomy.

BACKGROUND: Simulation is an important adjunct to traditional surgical training, allowing for repetitive practice of new skills without compromising patient safety. Although several simulation models have been described and evaluated for gynecologic procedures, there is a lack of such models for laparoscopic myomectomy. OBJECTIVE: This study aimed to design a low-cost, low-fidelity laparoscopic myomectomy simulation model and to assess the model's validity as a training tool. STUDY DESIGN: The model was constructed using a "cup turner" foam cylinder, felt, a 2-inch stress ball, self-adhesive bandage wrap, multipurpose sealing wrap, red marker, and hook-and-loop fastener. Participants were recruited at a quaternary care academic center and at the Society for Gynecologic Surgeons Annual Scientific Meeting. The simulation task involved the following 2 steps: fibroid enucleation and hysterotomy repair. Validity evidence was collected by comparing expert and novice simulation task performances. Video recordings were scored by 2 blinded reviewers using the Global Operative Assessment of Laparoscopic Skills scale (5-20 points) and a modified Global Operative Assessment of Laparoscopic Skills scale (5-35 points), incorporating 3 novel domains specific to laparoscopic myomectomy. The Mann-Whitney U test was used to compare the task completion times and performance scores. Interrater reliability of scoring was assessed using the interclass correlation coefficient. Validity was also assessed with a post-task survey regarding the model's realism, utility, and educational effect. RESULTS: The total cost to construct each model was under $5. A 3:1 ratio was used to recruit 15 novices and 5 experts. The median time to task completion was shorter for experts than for novices (11.8 vs 20.1 minutes; P=.004). The experts scored higher than the novices on both the Global Operative Assessment of Laparoscopic Skills scale (median 19 [range 13-20] vs 10 [6-17.5]; P=.007) and the modified Global Operative Assessment of Laparoscopic Skills scale (31.5 [21.5-33.5] vs 18.5 [13.5-32]; P=.009). The interclass correlation coefficient was 0.95 for the Global Operative Assessment of Laparoscopic Skills scores and 0.96 for the modified Global Operative Assessment of Laparoscopic Skills scores. Most of the participants agreed that the model closely approximated the feel of fibroid enucleation (70% [14/20]) and suturing the uterus (80% [16/20]). All the participants agreed that the model was useful for learning or teaching laparoscopic myomectomy. CONCLUSION: This study demonstrates evidence supporting the validity of a novel, low-cost laparoscopic myomectomy model and a novel assessment scale for laparoscopic myomectomy training. This simulation model provides a targeted training tool that allows learners to focus on the key aspects of laparoscopic myomectomy and may improve readiness for the operating room.

The Impact of Race and Ethnicity on Use of Minimally Invasive Surgery for Myomas.

STUDY OBJECTIVE: To determine whether minimally invasive surgery (MIS) for uterine myomas is used differentially based on race and ethnicity. DESIGN: Retrospective cohort study. SETTING: Quaternary care academic hospital in the United States. PATIENTS: Patients undergoing hysterectomy or myomectomy for uterine myomas between March 15, 2015, and March 14, 2020 (N = 1311). Cases involving correction of pelvic organ prolapse, malignancy, peripartum hysterectomy, or combined procedures with nongynecologic specialties were excluded. Racial/ethnic composition of the study population was 40.0% non-Hispanic white (white), 27.9% non-Hispanic black (black), 14.0% Hispanic, 13.7% non-Hispanic Asian (Asian), and 4.3% non-Hispanic American Indian/Alaska Native/Pacific Islander/Other. INTERVENTIONS: Hysterectomy, myomectomy. MEASUREMENTS AND MAIN RESULTS: Of the 1311 cases, 35.9% were minimally invasive hysterectomy, 16.4% abdominal hysterectomy, 35.6% minimally invasive myomectomy, and 12.1% abdominal myomectomy. MIS rates were 94.7% among fellowship-trained minimally invasive gynecologic surgery subspecialists, 44.2% among obstetrics and gynecology specialists, and 46.8% among gynecologic oncologists. There were disparities in surgeon type based on race/ethnicity, with 59.8% of white patients having undergone surgery with a minimally invasive gynecologic surgery subspecialist vs 44.0% of black patients and 45.7% of Hispanic patients. Black and Hispanic patients were less likely to undergo MIS overall vs white patients (adjusted odds ratio [aOR] 0.33, 95% confidence interval [CI] 0.22-0.48 and aOR 0.44, 95% CI 0.28-0.72, respectively). Black and Hispanic patients undergoing hysterectomy were less likely than white patients to undergo MIS (aOR 0.33, 95% CI 0.21-0.51 and aOR 0.35, 95% CI 0.20-0.60, respectively). There were no significant differences in rates of MIS based on race/ethnicity for myomectomies nor differences in major or minor complications by race/ethnicity overall. CONCLUSION: At a quaternary care institution, black and Hispanic patients were significantly less likely than white patients to undergo MIS for uterine myomas, particularly for hysterectomy.

Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial.

BACKGROUND: A major barrier to intrauterine device use is fear of pain during insertion. Trials exploring analgesic interventions for intrauterine device insertion have yielded mixed results, and no standardized pain management guidelines currently exist for this procedure. In an abortion-related study, self-administered lidocaine gel over a prolonged time interval showed promise as a method of pain control. OBJECTIVE(S): The objective of the study was to assess pain control with intrauterine device insertion after patient-administered lidocaine gel compared with placebo. STUDY DESIGN: We conducted a randomized, blinded trial of women undergoing levonorgestrel or copper intrauterine device insertion in an outpatient gynecology clinic between July 2016 and April 2017. Participants self-administered either 20 mL of 2% lidocaine gel or placebo gel vaginally at least 15 minutes prior to intrauterine device insertion. No other analgesics were administered. The primary outcome was pain during intrauterine device insertion, measured on a 100-mm visual analog scale (0 being no pain and 100 being worst pain imaginable). Secondary outcomes included anticipated and baseline pain and pain with speculum insertion and tenaculum placement. In a postprocedure questionnaire, participants reported acceptability of vaginal gel and willingness to wait for pain control. Median values were assessed because of the nonnormal distribution of visual analog scale scores using the Mann-Whitney U test. Predictors of intrauterine device insertion pain were assessed using a multiple linear regression. RESULTS: In total, 220 women were randomized and 215 were included in analysis (108 in lidocaine gel, 107 in placebo gel groups). Median (range) time from gel administration to speculum insertion was 21 (14-74) and 20 (12-43) minutes in the lidocaine and placebo groups, respectively (P = .13). The median pain scores during intrauterine device insertion were not significantly different: 65 (1-99) mm in the lidocaine group and 59 (5-100) mm in the placebo group (P = .09). Among secondary outcome time points, only median pain scores at speculum insertion were significantly different between the lidocaine and placebo groups (7 [0-81] mm vs 11 [0-80] mm, respectively; P = .046). Anticipated pain and menstrual pain were both predictors of pain with intrauterine device insertion. The majority of women in both groups found the amount of vaginal leakage following gel insertion to be acceptable (>80%). Ninety-two percent of participants (n = 194) stated they would be willing to wait before intrauterine device placement for a potential analgesic effect. CONCLUSION: Self-administered lidocaine gel at least 15 minutes before intrauterine device insertion does not appear to reduce pain compared with placebo but may help with speculum insertion. We found that women are willing to extend visit time to gain pain control. Self-administration of local anesthetic is acceptable to patients and should be considered in future research.

Immunizing adolescents: a selected review of recent literature and US recommendations.

PURPOSE OF REVIEW: To provide a clinically relevant synopsis of the latest research and recommendations regarding adolescent immunizations. RECENT FINDINGS: Immunization is an important and effective strategy for preventing morbidity and mortality in adolescents. Although there has been progress in recent years, coverage rates in the US remain suboptimal, particularly for the human papillomavirus vaccine. Much work has been done to better understand and address the barriers to adolescent immunization, so that all teens may be protected against serious vaccine-preventable diseases. In addition, several recent studies have focused on the effectiveness of current adolescent vaccines and the development of new vaccines to protect against additional types of human papillomavirus and serotype B Neisseria meningitidis. Decreased pertussis vaccine effectiveness has led to new recommendations for pregnant women, including adolescents, to protect them and their young infants. The present review highlights selected literature on acellular pertussis, meningococcal, and human papillomavirus vaccines. Research findings on various strategies to improve adolescent vaccine uptake are also discussed in this review. SUMMARY: Research on adolescent immunizations and their delivery continues to have an impact on clinical practice and will shape future guidelines. Through this work, we can learn how best to protect adolescents against vaccine-preventable diseases.

Child and adolescent immunizations: selected review of recent US recommendations and literature.

PURPOSE OF REVIEW: To provide a clinically relevant summary of the latest research and recommendations regarding childhood and adolescent immunizations. RECENT FINDINGS: Childhood vaccination has dramatically reduced pediatric morbidity and mortality in the United States. Recent research on childhood and adolescent immunizations has focused on expanding the use of current vaccines for additional subpopulations as well as the development of new vaccines. In particular, data confirming the safety and immunogenicity of vaccines in various groups of children have shaped national guidelines. Furthermore, studies on vaccine uptake, cost-effectiveness, and impact of vaccination have reinforced the importance of adhering to these guidelines. More work needs to be done by providers and parents to increase vaccination coverage rates to better protect children and adolescents from these serious diseases. In this article, selected recent publications and recommendations on the following vaccines are reviewed: influenza, meningococcal conjugate, childhood and adolescent/adult formulations of diphtheria and tetanus toxoids and acellular pertussis, pneumococcal conjugate, and human papillomavirus. SUMMARY: Research on childhood and adolescent vaccinations continues to shape future guidelines. Through this work, we can learn how to optimize the protection of all children and adolescents against vaccine-preventable diseases.