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.

Effect of pre-operative warm-up on trainee intraoperative performance during robot-assisted hysterectomy: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective was to study the effect of immediate pre-operative warm-up using virtual reality simulation on intraoperative robot-assisted laparoscopic hysterectomy (RALH) performance by gynecology trainees (residents and fellows). METHODS: We randomized the first, non-emergent RALH of the day that involved trainees warming up or not warming up. For cases assigned to warm-up, trainees performed a set of exercises on the da Vinci Skills Simulator immediately before the procedure. The supervising attending surgeon, who was not informed whether or not the trainee was assigned to warm-up, assessed the trainee's performance using the Objective Structured Assessment for Technical Skill (OSATS) and the Global Evaluative Assessment of Robotic Skills (GEARS) immediately after each surgery. RESULTS: We randomized 66 cases and analyzed 58 cases (30 warm-up, 28 no warm-up), which involved 21 trainees. Attending surgeons rated trainees similarly irrespective of warm-up randomization with mean (SD) OSATS composite scores of 22.6 (4.3; warm-up) vs 21.8 (3.4; no warm-up) and mean GEARS composite scores of 19.2 (3.8; warm-up) vs 18.8 (3.1; no warm-up). The difference in composite scores between warm-up and no warm-up was 0.34 (95% CI: -1.44, 2.13), and 0.34 (95% CI: -1.22, 1.90) for OSATS and GEARS respectively. Also, we did not observe any significant differences in each of the component/subscale scores within OSATS and GEARS between cases assigned to warm-up and no warm-up. CONCLUSION: Performing a brief virtual reality-based warm-up before RALH did not significantly improve the intraoperative performance of the trainees.

ERAS implementation in an urban patient population undergoing gynecologic surgery.

BACKGROUND: Enhanced recovery after surgery (ERAS) protocols improve outcomes. We investigated ERAS implementation in a population with comorbid conditions, inadequate insurance, and barriers to healthcare undergoing gynecologic surgery. OBJECTIVE: To investigate ERAS implementation in publicly insured/uninsured patients undergoing gynecologic surgery on hospital length of stay (LOS), 30-day hospital readmission rates, opioid administration, and pain scores. STUDY DESIGN: Data were obtained pre- and post-ERAS implementation. Patients undergoing gynecologic surgery with private insurance, public insurance, and uninsured were included (N = 589). LOS, readmission <30 days, opioid administration, and pain scores were assessed. RESULTS: Implementation of ERAS led to shorter LOS 1.75 vs. 1.49 days (p = 0.008). Average pain scores decreased from 3.07 pre-ERAS vs. 2.47 post-ERAS (p = <0.001). Opioid use decreased for ERAS patients (67.22 vs. 33.18, p = <0.001). Hospital readmission rates were unchanged from 8.2% pre-ERAS vs. 10.3% post-ERAS (p = 0.392). CONCLUSIONS: ERAS decreased pain scores and opioid use without increasing LOS or readmissions.

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.

Enhanced Recovery after Surgery in Gynecology: A Review of the Literature.

Enhanced recovery after surgery (ERAS), or "fast-track" protocol, aims to minimize the physiologic stress of surgery and optimize the rehabilitation of patients. However, there is limited data in obstetrics and gynecology. We reviewed the published literature on ERAS programs in gynecology to evaluate the outcomes and potential key elements for a successful program. Fifty studies were evaluated. We recommend preoperative counseling to the patient, no bowel preparation, an opioid-sparing multimodal approach to pain management, goal-directed fluid management, minimally invasive surgery when possible, and early mobilization and feeding. This is a multidisciplinary team effort and requires active patient participation in the process.

A Laparoendoscopic Single-site Surgical Approach to Laparoscopic Salpingectomy.

STUDY OBJECTIVE: To demonstrate a laparoendoscopic single-site (LESS) surgical approach to salpingectomy. DESIGN: A technical video showing step-by-step a LESS surgical approach to salpingectomy (Canadian Task Force classification level III). Institutional review board approval was not required for this study. SETTING: Of all gynecologic cancer types, ovarian cancer has the highest mortality rate and is the fifth leading cause of cancer deaths among women [1,2]. The leading theory of epithelial ovarian carcinogenesis indicates that serous, endometrioid, and clear cell ovarian carcinomas originated from the fallopian tube and endometrium and not directly from the ovary itself [1-10]. This has led to the use of prophylactic salpingectomy as a theoretical form of ovarian cancer risk reduction at the time of hysterectomy or as a means of tubal sterilization. Prophylactic salpingectomy does not appear to increase the risk of complications and appears to be safe [2]. Ovarian function does not seem to be compromised by salpingectomy based on serum markers or response rates with in vitro fertilization [11-16]. A LESS approach may reduce the morbidity associated with the placement of multiple ports and can improve cosmetic outcomes. Prophylactic LESS bilateral salpingo-oohorectomy was shown to be feasible and safe for high-risk patients for ovarian cancer [17]. INTERVENTIONS: Laparoscopic salpingectomy at the time of hysterectomy or as a means of tubal sterilization using the LESS technique. CONCLUSION: This is a simple and reproducible technique for preventing major complications associated with LESS salpingectomy. This approach permits easier specimen retrieval because of the large solitary incision that is made. There is a significant improvement in cosmetic satisfaction when compared with a traditional laparoscopic approach in the setting of prophylactic risk reduction surgery [18].

The sticky business of adhesion prevention in minimally invasive gynecologic surgery.

PURPOSE OF REVIEW: The negative impact of postoperative adhesions has long been recognized, but available options for prevention remain limited. Minimally invasive surgery is associated with decreased adhesion formation due to meticulous dissection with gentile tissue handling, improved hemostasis, and limiting exposure to reactive foreign material; however, there is conflicting evidence on the clinical significance of adhesion-related disease when compared to open surgery. Laparoscopic surgery does not guarantee the prevention of adhesions because longer operative times and high insufflation pressure can promote adhesion formation. Adhesion barriers have been available since the 1980s, but uptake among surgeons remains low and there is no clear evidence that they reduce clinically significant outcomes such as chronic pain or infertility. In this article, we review the ongoing magnitude of adhesion-related complications in gynecologic surgery, currently available interventions and new research toward more effective adhesion prevention. RECENT FINDINGS: Recent literature provides updated epidemiologic data and estimates of healthcare costs associated with adhesion-related complications. There have been important advances in our understanding of normal peritoneal healing and the pathophysiology of adhesions. Adhesion barriers continue to be tested for safety and effectiveness and new agents have shown promise in clinical studies. Finally, there are many experimental studies of new materials and pharmacologic and biologic prevention agents. SUMMARY: There is great interest in new adhesion prevention technologies, but new agents are unlikely to be available for clinical use for many years. High-quality effectiveness and outcomes-related research is still needed.

Comparison of cost and operative outcomes of robotic hysterectomy compared to laparoscopic hysterectomy across different uterine weights.

Operative cost and outcomes between robotic and laparoscopic hysterectomy across different uterine weights. Retrospective cohort study including patients undergoing robotic and laparoscopic hysterectomy for benign disease at an Academic university hospital. One hundred and ninety six hysterectomies were identified (101 robotic versus 95 laparoscopic). Demographic and surgical characteristics were statistically equivalent. Robotic group had a higher body mass index (±SD) (32.9 ± 6.5 versus 30.4 ± 7.1, p 0.012) and more frequent history of adnexal surgery (12.9 versus 4.2%, p 0.031). Laparoscopic group had a higher number of concurrent salpingectomy (81 versus 66.3%, p 0.02). Estimated blood loss did not differ between procedures. Compared to robotic hysterectomies, laparoscopic procedures added 47 min (CI: 31-63 min; p < 0.001) of operative time, costed $1648 more (CI: 500-2797; p = 0. 005) and had triple the odds of having an overnight admission (OR = 2.94 CI: 1.34-6.44; p = 0.007). After stratification of cases by uterine weight, the mean operative time difference between the two groups in uteri between 750 and 1000 g and in uteri >1000 g was 81.3 min (CI: 51.3-111.3, p < 0.0001) and 70 min (CI: 26-114, p < 0.005), respectively, in favor of the robotic group. Mean direct cost difference in uteri between 750 and 1000 g and uteri >1000 g was 1859$ (CI: 629-3090, p < 0.006) and 4509$ (CI: 377-8641, p < 0.004), respectively, also in favor of the robotic group. In expert hands, robotic hysterectomy for uteri weighing more than 750 g may be associated with shorter operative time and improved cost profile.

Gynecologic robotic laparoendoscopic single-site surgery: prospective analysis of feasibility, safety, and technique.

OBJECTIVE: Multiple reports suggest that laparoendoscopic single-site surgery is technically feasible, safe, and effective in treating a variety of gynecological disease processes. The study purpose was to assess the feasibility and safety of a novel robotic single-site platform (R-LESS) for the surgical treatment of benign and malignant gynecological conditions. STUDY DESIGN: A single-institution, prospective analysis of 40 women treated with R-LESS on the gynecology and gynecological oncology services from June 2013 through March 2014. Women undergoing hysterectomy or adnexal surgery for either a benign or malignant gynecological condition were offered robotic single-site surgery during the study period of June 1, 2013, through April 1, 2014. Patients underwent surgery through a single 2.5-3.0 cm umbilical incision with a multichannel port and utilizing the da Vinci robotic single-site platform. Two surgeons with extensive laparoendoscopic single-site experience participated. RESULTS: Forty patients had R-LESS performed. Procedures included total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, salpingo-oophorectomy, ovarian cystectomy, excision of endometriosis, and a combined case of total laparoscopic hysterectomy and cholecystectomy. Median age and body mass index were 42 years and 28.2 kg/m(2), respectively. Median operating time, defined as the interval between incision start to closure, was 134 minutes (range, 84-311 minutes). Median vaginal cuff closure was 21 minutes (range, 9-77 minutes). Overall, there appeared to be a linear relationship between vaginal cuff closure time, console time, and operating time with number of cases performed. Procedures were successfully performed via R-LESS in 92.5% of cases; 2 cases required 1 additional port and there was 1 conversion to traditional multiport robotic surgery. There was 1 major postoperative complication (2.5%) and 1 readmission (2.5%). After a median follow-up period of 230 days (range, 61-256), there have been no postoperative hernias diagnosed. CONCLUSION: We present one of the first series of robotic laparoendoscopic single-site surgery for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, R-LESS is feasible and safe in select patients. Further studies are needed to better define the ideal gynecological procedures to perform using robotic single-site surgery and to assess the benefits and costs of R-LESS compared with multiport robotic and conventional laparoscopic approaches.

Complications Following Extended Freeze Endometrial Cryoablation in Uteri with Previous Uterine Incisions: A Case Report.

BACKGROUND: Endometrial cryoablation causes cryonecrosis of the endometrial lining as treatment for abnormal uterine bleeding in premenopausal women who have no desire for future fertility. Extended freezes to potentially improve efficacy have been described in the literature, although no associated complications have been reported. CASE: We present 2 cases of ureteral stricture and sigmoid colon perforation in separate patients following extended freeze cryoendometrial ablation. Both patients had a preexisting uterine scar from prior cesarean section or myomectomy. CONCLUSION: Patients with a prior uterine incision may be at increased risk for complications from extended freeze endometrial cryoablation.

Contained power morcellation within an insufflated isolation bag.

OBJECTIVE: To describe a technique for contained power morcellation within an insufflated isolation bag at the time of uterine specimen removal during minimally invasive gynecologic procedures. METHODS: Over the study period of January 2013 to April 2014, 73 patients underwent morcellation of the uterus or myomas within an insufflated isolation bag at the time of minimally invasive hysterectomy or myomectomy. This technique involves placing the specimen into a large plastic bag within the abdomen, exteriorizing the opening of the bag, insufflating the bag within the peritoneal cavity, and then using a power morcellator within the bag to remove the specimen in a contained fashion. Procedures were performed at four institutions and included multiport laparoscopy, single-site laparoscopy, multiport robot-assisted laparoscopy, or single-site robot-assisted laparoscopy. Demographic and perioperative characteristics were collected for the cases. RESULTS: Surgical specimen morcellation within an insufflated isolation bag was successfully used in all cases. The median operative time was 114 minutes (range 32-380 minutes), median estimated blood loss was 50 mL (range 10-500 mL), and the median specimen weight was 257 g (range 53-1,481 g). There were no complications related to the contained morcellation technique nor was there visual evidence of tissue dissemination outside of the isolation bag. CONCLUSION: Morcellation within an insufflated isolation bag is a feasible technique. Methods for morcellating uterine tissue in a contained manner may provide an option to minimize the risks of open power morcellation while preserving the benefits of minimally invasive surgery. LEVEL OF EVIDENCE: II.

Laparoscopy in the morbidly obese: physiologic considerations and surgical techniques to optimize success.

The objectives of this review were to analyze the literature describing the benefits of minimally invasive gynecologic surgery in obese women, to examine the physiologic considerations associated with obesity, and to describe surgical techniques that will enable surgeons to perform laparoscopy and robotic surgery successfully in obese patients. The Medline database was reviewed for all articles published in the English language between 1993 and 2013 containing the search terms "gynecologic laparoscopy" "laparoscopy," "minimally invasive surgery and obesity," "obesity," and "robotic surgery." The incidence of obesity is increasing in the United States, and in particular morbid obesity in women. Obesity is associated with a wide range of comorbid conditions that may affect perioperative outcomes including hypertension, atherosclerosis, angina, obstructive sleep apnea, and diabetes mellitus. In obese patients, laparoscopy or robotic surgery, compared with laparotomy, is associated with a shorter hospital stay, less postoperative pain, and fewer wound complications. Specific intra-abdominal access and trocar positioning techniques, as well as anesthetic maneuvers, improve the likelihood of success of laparoscopy in women with central adiposity. Performing gynecologic laparoscopy in the morbidly obese is no longer rare. Increases in the heaviest weight categories involve changes in clinical practice patterns. With comprehensive and thoughtful preoperative and surgical planning, minimally invasive gynecologic surgery may be performed safely and is of particular benefit in obese patients.

Laparoendoscopic single-site surgery for management of adnexal masses in pregnancy: case series.

The incidence of adnexal masses in pregnancy is estimated to be 1% to 4%. In select cases, surgical intervention is required. Recent studies have demonstrated that laparoscopy during pregnancy is safe and confers many advantages over laparotomy. Herein we present a series of nine cases collected prospectively that demonstrate the feasibility, safety, and putative benefits of laparoendoscopic single-site surgery for treatment of adnexal masses in pregnant women.

Hysteroscopic sterilization success in outpatient vs office setting is not affected by patient or procedural characteristics.

STUDY OBJECTIVE: To determine factors associated with hysteroscopic sterilization success and whether it differs between the operating room and office settings. DESIGN: Retrospective cohort analysis (Canadian Task Force classification II-2). SETTING: Major university medical center. PATIENTS: Six hundred thirty-eight women who underwent hysteroscopic sterilization between July 1, 2005, and June 30, 2011. MEASUREMENTS AND MAIN RESULTS: Data collected included age, body mass index, previous office procedures, previous cesarean section, and presence of myomas or retroverted uterus. Place of surgery, experience of surgeon, insurance type, bilateral device placement, compliance with hysterosalpingography, and confirmation of occlusion were also recorded. Bivariate analysis of patient characteristics between groups was performed using χ(2) and independent t tests, and identified confounders and associated variables. Multivariate analysis was performed using logistic regression to assess for association and to adjust for confounders. Procedures were performed in the operating room (57%) or in the office (43%). There was no association between success in bilateral device placement or occlusion and any patient characteristic, regardless of surgery setting. Private insurance, patient age, and performance of procedures in the office setting were positively associated with likelihood of compliance with hysterosalpingography. CONCLUSION: Successful device placement and tubal occlusion are independent of patient age, body mass index, or setting of the procedure. Association between insurance type and completing hysterosalpingography illustrates an important public health problem. Patients who fail to undergo hysterosalpingography to confirm tubal occlusion may unknowingly be at risk of pregnancy and increased risk of ectopic pregnancy.