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.

Interactive video module and simulated model for uterine manipulation during laparoscopic hysterectomy.

BACKGROUND: Hysterectomy is one of the most common gynecologic surgeries, with an increasing proportion of hysterectomies performed by a laparoscopic approach. Uterine manipulation is critical for patient safety and surgical efficiency; however, the most junior member of the surgical team assumes the responsibility of uterine manipulation, commonly without preparation. The objective of our study was to determine whether kinesthetic learning using a low-cost simulated pelvic model while learning the uterine manipulation maneuvers of a laparoscopic hysterectomy improves learning efficacy and application efficiency compared to an interactive video module alone. METHODS: Our randomized control trial at an academic medical center included forty first-year and second-year medical students. Participants were randomized to the intervention group that used a low-cost simulated pelvic model for kinesthetic learning during the video module or the control group who only had the interactive video module to learn the uterine manipulation maneuvers of a laparoscopic hysterectomy. RESULTS: Participants in the intervention group were less likely to make unnecessary movements with demonstration of both pelvic side walls (right wall: control 78.9%, intervention 42.9%, p < 0.027; left wall: control 94.7%, intervention 66.7%, p < 0.046), and this was more pronounced in novice first-year participants (p < 0.009). Additionally, participants in the intervention group reported higher perceived preparedness (100% versus 71.4% in control group, p < 0.037). However, there was no difference in verbal or physical cues required, time per task, or force used between the groups. CONCLUSION: Kinesthetic practice may not be required for learning the uterine manipulation maneuvers of a laparoscopic hysterectomy, but it may be beneficial for more novice learners and to increase learners' perceived preparedness. Our novel interactive video module alone may be sufficient to prepare learners to perform uterine manipulation maneuvers prior to the operating room.

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.

Endometriosis biomarkers of the disease: an update.

PURPOSE OF REVIEW: Endometriosis is a complex benign gynaecologic condition with heterogenous presentations and a large impact on the global healthcare system and on the quality of life for millions of women. Currently, the gold standard for diagnosis involves direct visualization of lesions during surgery confirmed by histopathological diagnosis, resulting in an average delay in its initial diagnosis of 8-10 years. Therefore, the search for noninvasive diagnostic testing options has been subject to a large body of research. RECENT FINDINGS: Multiple potential biomarkers have been explored for noninvasive testing for endometriosis, including glycoproteins, inflammatory cytokines, immunological molecules, angiogenesis markers, hormones, micro RNAs (miRNAs), proteomics, metabolomics, genomics and the microbiome. SUMMARY: Although there are challenges to consider, areas for real promise and advancement in the noninvasive diagnosis of endometriosis are currently being explored with real promise in the area of miRNAs, proteomics, metabolomics, genomics and the microbiome.

Surgical Science-Simbionix Robotic Hysterectomy Simulator: Validating a New Tool.

STUDY OBJECTIVE: To gather validity evidence for and determine acceptability of Surgical Science-Simbionix Hysterectomy Modules for the DaVinci Xi console simulation system (software; 3D Systems by Simbionix [now Surgical Science-Simbionix], Littleton, CO, and hardware; Intuitive Surgical, Inc., Sunnyvale, CA) and evaluate performance benchmarks between novice and experienced or expert surgeons. DESIGN: Prospective education study (Messick validity framework). SETTING: Multicenter, academic medical institutions. PARTICIPANTS: Residents, fellows, and faculty in obstetrics and gynecology were invited to participate at 3 institutions. Participants were categorized by experience level: fewer than 10 hysterectomies (novice), 10 to 50 hysterectomies (experienced), and more than 50 hysterectomies (expert). A total of 10 novice, 10 experienced, and 14 expert surgeons were included. INTERVENTIONS: Participants completed 4 simulator modules (ureter identification, bladder flap development, colpotomy, complete hysterectomy) and a qualitative survey. Simulator recordings were reviewed in duplicate by educators in minimally invasive gynecologic surgery using the Modified Global Evaluative Assessment of Robotic Skills (GEARS) rating scale. MEASUREMENTS AND MAIN RESULTS: Most participants felt that the simulator realistically simulated robotic hysterectomy (64.7%) and that feedback provided by the simulator was as or more helpful than feedback from previous simulators (88.2%) but less helpful than feedback provided in the operating room (73.5%). Participants felt that this simulator would be helpful for teaching junior residents. Simulator-generated metrics correlated with GEARS performance for the bladder flap and ureter identification modules in multiple domains including total movements and total time for completion. GEARS performance for the bladder flap module correlated with experience level (novice vs experienced/expert) in the domains of interest and total score but did not consistently correlate for the other procedural modules. Performance benchmarks were evaluated for the bladder flap module for each GEARS domain and total score. CONCLUSION: The modules were well received by participants of all experience levels. Individual simulation modules appear to better discriminate between novice and experienced/expert users than overall simulator performance. Based on these data and participant feedback, the use of individual modules in early residency education may be helpful for providing feedback and may ultimately serve as 1 component of determining readiness to perform robotic hysterectomy.

Persistent Pelvic Pain in Patients With Endometriosis.

As our understanding of chronic pain conditions, including endometriosis-related pain and chronic pelvic pain evolves, the evaluation and management of patients should reflect our increasing appreciation of the role of central sensitization, comorbid conditions and biopsychosocial factors on the pain experience and treatment outcomes. This review provides a systematic approach to persistent pain in patients with endometriosis. Expanding the evaluation and treatment of endometriosis-related pain by all health care providers could limit unnecessary surgical interventions and best meet our patient's needs.

Robotic Surgery: The Impact of Simulation and Other Innovative Platforms on Performance and Training.

OBJECTIVE: To review the current status of robotic training and the impact of various training platforms on the performance of robotic surgical trainees. DATA SOURCES: Literature review of Google Scholar and PubMed. The search terms included a combination of the following: "robotic training," "simulation," "robotic curriculum," "obgyn residency robotic training," "virtual reality robotic training," "DaVinci training," "surgical simulation," "gyn surgical training." The sources considered for inclusion included peer-reviewed articles, literature reviews, textbook chapters, and statements from various institutions involved in resident training. METHODS OF STUDY SELECTION: A literature search of Google Scholar and PubMed using terms related to robotic surgery and robotics training, as mentioned in the "Data Sources" section. RESULTS: Multiple novel platforms that use machine learning and real-time video feedback to teach and evaluate robotic surgical skills have been developed over recent years. Various training curricula, virtual reality simulators, and other robotic training tools have been shown to enhance robotic surgical education and improve surgical skills. The integration of didactic learning, simulation, and intraoperative teaching into more comprehensive training curricula shows positive effects on robotic skills proficiency. Few robotic surgery training curricula have been validated through peer-reviewed study, and there is more work to be completed in this area. In addition, there is a lack of information about how the skills obtained through robotics curricula and simulation translate into operating room performance and patient outcomes. CONCLUSION: Data collected to date show promising advances in the training of robotic surgeons. A diverse array of curricula for training robotic surgeons continue to emerge, and existing teaching modalities are evolving to keep up with the rapidly growing demand for proficient robotic surgeons. Futures areas of growth include establishing competency benchmarks for existing training tools, validating existing curricula, and determining how to translate the acquired skills in simulation into performance in the operating room and patient outcomes. Many surgical training platforms are beginning to expand beyond discrete robotic skills training to procedure-specific and team training. There is still a wealth of research to be done to understand how to create an effective training experience for gynecologic surgical trainees and robotics teams.

Vaginal Diazepam for Nonrelaxing Pelvic Floor Dysfunction: The Pharmacokinetic Profile.

BACKGROUND: Vaginal diazepam is frequently used to treat pelvic floor tension myalgia and pelvic pain despite limited knowledge of systemic absorption. AIM: To determine the pharmacokinetic and adverse event profile of diazepam vaginal suppositories. METHODS: We used a prospective pharmacokinetic design with repeated assessments of diazepam levels. Eight healthy volunteers were administered a 10-mg compounded vaginal diazepam suppository in the outpatient gynecologic clinic. Serum samples were collected at 0, 45, 90, 120, and 180 minutes; 8, 24, and 72 hours; and 1 week following administration of a 10-mg vaginal suppository. The occurrence of adverse events was assessed using the alternate step and tandem walk tests, the Brief Confusion Assessment Method, and numerical ratings. Plasma concentrations of diazepam and active long-acting metabolites were measured. Pharmacokinetic parameters were calculated by standard noncompartmental methods. RESULTS: The mean peak diazepam concentration (Cmax) of 31.0 ng/mL was detected at a mean time (Tmax) of 3.1 hours after suppository placement. The bioavailability was found to be 70.5%, and the mean terminal elimination half-life was 82 hours. The plasma levels of temazepam and nordiazepam peaked at 0.8 ng/mL at 29 hours and 6.4 ng/mL at 132 hours, respectively. Fatigue was reported by 3 of 8 participants. CLINICAL IMPLICATIONS: Serum plasma concentrations of vaginally administered diazepam are low; however the half-life is prolonged. STRENGTHS & LIMITATIONS: Strengths include use of inclusion and exclusion criteria aimed at mitigating clinical factors that could adversely impact diazepam absorption and metabolism, and the use of an ultrasensitive LC-MS/MS assay. Limitations included the lack of addressing the efficacy of vaginal diazepam in lieu of performing a pure pharmacokinetic study with healthy participants. CONCLUSION: Vaginal administration of diazepam results in lower peak serum plasma concentration, longer time to peak concentration, and lower bioavailability than standard oral use. Providers should be aware that with diazepam's long half-life, accumulating levels would occur with chronic daily doses, and steady-state levels would not be reached for up to 1 week. This profile would favor intermittent use to allow participation in physical therapy and intimacy. Larish AM, Dickson RR, Kudgus RA, et al. Vaginal Diazepam for Nonrelaxing Pelvic Floor Dysfunction: The Pharmacokinetic Profile. J Sex Med 2019;16;763-766.

Teaching learners to raise the roof: a vaginal surgery simulator for apical suspension.

INTRODUCTION AND HYPOTHESIS: The objective was to discuss the importance of apical suspension following vaginal hysterectomy and demonstrate a surgical model to aide in educating learners on a variety of apical suspension procedures. METHODS: Rates of pelvic organ prolapse are not insignificant following hysterectomy. Re-support of the vaginal apex should be performed at the time of hysterectomy in those with or without a diagnosis of prolapse. Exposure to vaginal apical support procedures may be limited owing to declining rates of vaginal hysterectomy and limited trainee work hours. Surgical models are increasingly being used to supplement operating room experience. The model we present was originally developed for hysterectomy, although its design allows for teaching a variety of apical support procedures that incorporate the uterosacral ligament (USL) for support. We demonstrate performing a USL suspension, internal McCall suture, and modified McCall suture using the model. RESULTS: The model is constructed from readily available supplies, is multi-use, and inexpensive. It allows learners to identify relevant anatomy, understand/visualize surgical steps, and practice suturing technique. CONCLUSION: Pelvic organ prolapse is common in women, although opportunities to teach apical suspension procedures may be limited. The proposed vaginal surgery simulator can be used to supplement the experience of gynecological surgery trainees with apical suspension procedures.

Choosing a women's health career.

BACKGROUND: In 2005, in response to a decline in residency applications in obstetrics and gynecology (OB GYN), the American College of Obstetrics and Gynecology Presidential Task Force outlined strategies for attracting medical students to OB GYN. Application rates have increased since then, but little is known about which interventions are effective. We aimed to identify modifiable and nonmodifiable variables that may contribute to students choosing OB GYN for their careers; this information could be used to inform curriculum design, faculty development, and innovative exposures to women's health. METHODS: This qualitative study received institutional review board approval. Eligible participants were students who applied or recently matched into OB GYN residency programs from the class of 2014-2016 at our institution. Students were interviewed with open-ended questions and a Likert-type survey. Thematic analysis was performed. RESULTS: Ten qualitative interviews were completed and analyzed. Intrinsic themes such as the potential for a meaningful job in women's health, advocacy for women, or empowerment of women were identified as factors contributing to participant career choice. Extrinsic themes such as positive impressions during the clinical clerkship and welcoming teams were also identified. Most students indicated that the clerkship was the most influential experience. CONCLUSIONS: Participants identified important events, including some that even preceded medical school that guided them toward OB GYN. The data guide us to consider the importance of emphasizing the unique combination of characteristics in OB GYN and improving the learning environment in the clerkship as a way to encourage student recruitment.