Evaluation of different approaches to define expert benchmark scores for new robotic training simulators based on the Medtronic HUGO™ RAS surgical robot experience.

New robot-assisted surgery platforms being developed will be required to have proficiency-based simulation training available. Scoring methodologies and performance feedback for trainees are currently not consistent across all robotic simulator platforms. Also, there are virtually no prior publications on how VR simulation passing benchmarks have been established. This paper compares methods evaluated to determine the proficiency-based scoring thresholds (a.k.a. benchmarks) for the new Medtronic Hugo™ RAS robotic simulator. Nine experienced robotic surgeons from multiple disciplines performed the 49 skills exercises 5 times each. The data were analyzed in 3 different ways: (1) include all data collected, (2) exclude first sessions, (3) exclude outliers. Eliminating the first session discounts becoming familiar with the exercise. Discounting outliers allows removal of potentially erroneous data that may be due to technical issues, unexpected distractions, etc. Outliers were identified using a common statistical technique involving the interquartile range of the data. Using each method above, mean and standard deviations were calculated, and the benchmark was set at a value of 1 standard deviation above the mean. In comparison to including all the data, when outliers are excluded, fewer data points are removed than just excluding first sessions, and the metric benchmarks are made more difficult by an average of 11%. When first sessions are excluded, the metric benchmarks are made easier by an average of about 2%. In comparison with benchmarks calculated using all data points, excluding outliers resulted in the biggest change making the benchmarks more challenging. We determined that this method provided the best representation of the data. These benchmarks should be validated with future clinical training studies.

A randomized double-blind controlled proof-of-concept study of alanyl-glutamine for reduction of post-myomectomy adhesions.

STUDY OBJECTIVE: To test the hypothesis that intraperitoneal instillation of a single bolus dose of l-alanyl-l-glutamine (AG) will reduce the incidence, extent and/or severity of adhesions following myomectomy and establish preliminary safety and tolerability of AG in humans. DESIGN: Phase 1,2 Randomized, double-blind, placebo-controlled study (DBRCT). SETTING: Tertiary care gynecology surgical centre. PATIENTS: Thirty-eight women who underwent myomectomies by laparoscopy (N = 38; AG-19 vs Placebo-19) or laparotomy (N = 10; AG-5 vs Placebo-5) with a scheduled second-look laparoscopy (SLL) 6-8 weeks later. Thirty-two patients in the laparoscopy arm completed SLL. INTERVENTIONS: Bolus dose of AG or normal saline solution control (0.9% NaCl) administered intraperitoneally immediately prior to suture closure of the laparoscopic ports. The average dose was 170 mL of AG or control based on a dosing scheme of 1 g/kg bodyweight. MEASUREMENTS: Digital recordings obtained for all procedures. The primary endpoint was reduction in the incidence, severity and extent of post-operative adhesions analyzed by intention-to-treat (ITT) approach. Three independent, blinded reviewers evaluated all operative video recordings to assess presence of adhesions. Post-hoc analysis assessed presence or absence of adhesions in the peritoneal cavity. Secondary endpoints assessed safety and tolerability of AG. MAIN RESULTS: Administration of AG reduced the incidence, severity and/or extent of post-operative adhesions (p = 0.046). The presence of adhesions in the AG group was lower than in the Control group (p = 0.041). Adhesion improvement was achieved in 15 of 15 (100%) in the AG group versus 5 of 17 (29.6%) in the placebo group. No serious adverse events were reported. No differences in safety parameters were observed. CONCLUSIONS: Intraperitoneal l-alanyl-l-glutamine reduced adhesion formation in all patients following laparoscopic myomectomy. Complete absence of adhesions was achieved at all abdominal sites in 93% of patients. Results confirm AG's known effects on cellular mechanisms of adhesiogenesis and lay the foundation for new adhesion prophylaxis research and treatment.

Incidence and risk factors of intrauterine adhesions after myomectomy.

Objective: To determine the incidence and risk factors for intrauterine adhesions (IUAs) after minimally invasive and open myomectomy and hysteroscopic myomectomy (HM). Design: Retrospective cohort study. Setting: University-affiliated fertility center. Patients: Patients aged ≥18 years undergoing robotic-assisted or conventional laparoscopic minimally invasive myomectomy, abdominal myomectomy, or HM between January 2007 and January 2017. Only patients who underwent uterine cavity evaluation within 12 months of surgery via hysteroscopy or hysterosalpingography were included. Patients were excluded if they had a history of IUA before myomectomy. Interventions: Not applicable. Main Outcome Measures: The primary outcomes of this study were the presence and severity of IUA. The secondary outcomes were the identification of risk factors for IUA formation. The severity of IUAs was scored by 2 investigators using a previously published grading system by March et al. Results: Of 1,315 patients who underwent myomectomy, 173 (13.2%) met the inclusion criteria. Intrauterine adhesions were identified in 9.3% of all patients, 75.0% of which were classified as minimal. The incidence of IUA did not vary by modality: 8.6%, minimally invasive myomectomy; 7.8%, abdominal myomectomy; and 11.8%, HM. There were no differences in incidence of IUA by the number or size of fibroids removed. Of patients with IUA, 87.5% had submucosal fibroids resected compared with 58.6% without IUA. Conclusions: The incidence of postoperative IUA in women undergoing myomectomy of any modality is relatively low (9.3%) and does not vary by modality alone. Most IUAs are of minimal degree. The presence of submucosal fibroids is associated with an increased risk of IUA in all modalities.

Reproductive surgery: decreasing skills and advancing technology-an existential conundrum.

Our article endeavors to be both a review of the recent past and a preview of the future of reproductive surgery. By reflecting on the rate of technological advancement over the past decade, we attempt to predict the trajectory of the next. We also delve into the changing nature and practical challenges of the practice of gynecologic surgery for the reproductive endocrinology and infertility subspecialist. We will explain how technological advances may alter our perception and expectations regarding the indications, timing and extent of surgical intervention in the infertile patient and in the patient seeking preservation of fertility. This review does not aim to be comprehensive, choosing instead to focus on those innovations that hold, in our view, true potential to shape the future of surgical practice. Ours is primarily a technology review. As such, it does not focus on novel surgical techniques, including uterine transplantation and ovarian tissue transplantation.

Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach.

STUDY OBJECTIVE: To compare the number of days required to return to daily activities after laparoscopic hysterectomy with 2 tissue extraction methods: manual morcellation via colpotomy or minilaparotomy. Secondary outcomes were additional measures of patient recovery, perioperative outcomes, containment bag integrity, and tissue spillage. DESIGN: Multicenter prospective cohort study and follow-up survey (Canadian Task Force classification II-2). SETTING: Two tertiary care academic centers in northeastern United States. PATIENTS: Seventy women undergoing laparoscopic hysterectomy with anticipated need for manual morcellation. INTERVENTIONS: Tissue extraction by either contained minilaparotomy or contained vaginal extraction method, along with patient-completed recovery diary. MEASUREMENTS AND MAIN RESULTS: Recovery diaries were returned by 85.3% of participants. There were no significant differences found in terms of average pain at 1, 2, or 3 weeks after surgery or in time to return to normal activities. Patients in both groups used narcotic pain medication for an average of 3 days. After adjusting for patient body mass index, history of prior surgery, uterine weight, and surgeon, there were no differences found for blood loss, operative time, length of stay, or incidence of any intra- or postoperative complication between groups. All patients had benign findings on final pathology. More cases in the vaginal contained extraction group were noted to have bag leakage on postprocedure testing (13 [40.6%] vs 3 [8.3%] tears in vaginal and minilaparotomy groups, respectively; p = .003). CONCLUSION: Regarding route of tissue extraction, contained minilaparotomy and contained vaginal extraction methods are associated with similar patient outcomes and recovery characteristics.

Uterine Transplantation: A Survey of Perceptions and Attitudes of American Reproductive Endocrinologists and Gynecologic Surgeons.

OBJECTIVE: To determine whether reproductive endocrinologists and minimally invasive surgeons support uterine transplantation as a treatment option for absolute uterine factor infertility (AUFI). DESIGN: A cross-sectional study (Canadian Task Force classification II-2). SETTING: A Web-based survey. PATIENTS: Physician members of the American Society of Reproductive Medicine (ASRM) and the American Association of Gynecologic Laparoscopists (AAGL). INTERVENTIONS: A Web-based questionnaire administered between January and February 2017. MEASUREMENTS AND MAIN RESULTS: Support for (strongly agree or agree) or opposition to (strongly disagree or disagree) various aspects of uterine transplantation were described using descriptive statistics and analyzed using chi-square tests. A total of 414 physicians (ASRM: 49.5%, AAGL: 50.5%) responded to the Web-based survey; 43.7% were female, 52.4% were between the ages of 45 and 65 years, and 73.4% were white. Nearly fifty-six percent supported women being allowed to donate or receive a transplanted uterus. Fifty-four percent strongly agreed or agreed that uterine transplantation carried an acceptable risk for donors, 28.0% for the recipient and 21.0% for the infant. Forty-two percent agreed that uterine transplantation should be considered a therapeutic option for women with AUFI, whereas 19.6% felt it should be covered by insurance. Nearly 45% of respondents felt uterine transplantation to be ethical. The most common ethical concerns regarding uterine transplantation were related to medical or surgical complications to the recipient (48.8%). CONCLUSION: Just under half of the reproductive endocrinologists and minimally invasive surgeons surveyed find uterine transplantation to be an ethical option for patients with AUFI. Important concerns remain regarding the risk to donors, recipients, and resulting infants, all contributing to only a minority currently recommending it as a therapeutic option.

A Survey of Public Opinion in the United States Regarding Uterine Transplantation.

STUDY OBJECTIVE: To evaluate the opinions and attitudes of the general public regarding uterine transplantation (UTx) in the United States. DESIGN: A cross-sectional study (Canadian Task Force classification II-2). SETTING: A Web-based survey. PATIENTS: A nationally representative sample of adult US residents by age and sex. INTERVENTIONS: A Web-based questionnaire administered in November 2016. MEASUREMENTS AND MAIN RESULTS: Respondents who supported UTx were compared with those who were opposed using log binomial regression to calculate relative risk ratios and 95% confidence intervals. Of the 1444 respondents recruited, 1337 (93%) completed the survey. Ninety respondents (6%) disagreed with the use of in vitro fertilization for any indication and were excluded. Of the remaining 1247 respondents, 977 (78%) supported and 48 (4%) opposed allowing women to undergo UTx. Respondents with higher yearly incomes and education level were more likely to agree that "taking the uterus from one person and putting it into another person is ethical." Respondents who answered that UTx is safe for the donor, recipient, and baby were more likely to believe that UTx is an acceptable, ethical alternative to a gestational carrier. Forty-five percent of respondents believed that UTx should be covered by insurance, whereas 24% did not. CONCLUSION: The majority of respondents in a sample of US residents support UTx, find it ethical, and believe that it is an acceptable alternative to a gestational carrier although support varies. These findings suggest that the US public is in favor of uterine transplantation as a treatment for uterine factor infertility.

Robotic Assistance Confers Ambidexterity to Laparoscopic Surgeons.

STUDY OBJECTIVE: To examine whether a robotic surgical platform can complement the fine motor skills of the nondominant hand, compensating for the innate difference in dexterity between surgeon's hands, thereby conferring virtual ambidexterity. DESIGN: Crossover intervention study (Canadian Task Force classification II-1). SETTING: Centers for medical simulation in 2 tertiary care hospitals of Harvard Medical School. PARTICIPANTS: Three groups of subjects were included: (1) surgical novices (medical graduates with no robotic/laparoscopic experience); (2) surgeons in training (postgraduate year 3-4 residents and fellows with intermediate robotic and laparoscopic experience); and (3) advanced surgeons (attending surgeons with extensive robotic and laparoscopic experience). INTERVENTIONS: Each study group completed 3 dry laboratory exercises based on exercises included in the Fundamentals of Laparoscopic Surgery (FLS) curriculum. Each exercise was completed 4 times: using the dominant and nondominant hands, on a standard laparoscopic FLS box trainer, and in a robotic dry laboratory setup. Participants were randomized to the handedness and setting order in which they tackled the tasks. MEASUREMENTS AND MAIN RESULTS: Performance was primarily measured as time to completion, with adjustments based on errors. Means of performance for the dominant versus nondominant hand for each task were calculated and compared using repeated-measures analysis of variance. A total of 36 subjects were enrolled (12 per group). In the laparoscopic setting, the mean overall time to completion of all 3 tasks with the dominant hand differed significantly from that with the nondominant hand (439.4 seconds vs 568.4 seconds; p = .0008). The between-hand performance difference was nullified with the robotic system (374.4 seconds vs 399.7 seconds; p = .48). The evaluation of performance for each individual task also revealed a statistically significant disparate performance between hands for all 3 tasks when the laparoscopic approach was used (p = .003, .02, and .01, respectively); however, no between-hand difference was observed when the tasks were performed robotically. On analysis across the 3 surgeon experience groups, the performance advantage of robotic technology remained significant for the surgical novice and intermediate-level experience groups. CONCLUSION: Robot-assisted laparoscopy may eliminate the operative handedness observed in conventional laparoscopy, allowing for virtual ambidexterity. This ergonomic advantage is particularly evident in surgical trainees. Virtual ambidexterity may represent an additional aspect of surgical robotics that facilitates mastery of minimally invasive skills.

Coaxial robot-assisted laparoendoscopic single-site myomectomy.

We report our experience with coaxial robot-assisted laparoendoscopic single-site (RA-LESS) myomectomy, including a detailed description of the technique and outcomes from our first 21 cases. This was a retrospective cohort study carried out at the reproductive endocrinology and gynecologic oncology divisions at two academic medical centers. RA-LESS myomectomy was performed with the da Vinci Si Surgical System (Intuitive Surgical, Inc, Sunnyvale, CA, USA) employing standard rigid 8 or 5 mm instrumentation in a coaxial arrangement through a standard laparoendoscopic single-site (LESS) port (GelPOINT Advanced Access Platform, Applied Medical, Rancho Santa Margarita, CA, USA). Cases were completed between October 2011 and November 2013. Twenty-one patients underwent surgery. Mean age (±SD) was 38.1 ± 5.8 years, and mean BMI was 29.4 ± 4.7 kg/m2. Menorrhagia, pelvic pressure, and urinary frequency were the main presenting symptoms. Mean diameter of the largest tumor was 5.7 ± 1.9 cm (median 5.9 cm, range 2.1-9.5 cm), while mean number of tumors removed was 2.2 ± 1.8, ranging from 1 to 8 per surgery. Mean operative time was 154.2 ± 55.2 min (median 152 min, range 85-290 min). Mean blood loss was 57.9 ± 53.7 cc (median 50 cc, range 5-200 cc) and length of hospital stay ranged between 0 and 3 days (median 0). All procedures were successfully performed without conversion to conventional LESS surgery, multi-port laparoscopy or laparotomy. RA-LESS myomectomy with coaxial use of standard rigid instrumentation is a safe and reproducible addition to the minimally invasive surgeons' armamentarium, with excellent cosmetic and postoperative outcomes in selected patients. Further investigation is needed to define the patient groups that will most benefit from it.

Hereditary leiomyomatosis and renal cell cancer: Cutaneous lesions & atypical fibroids.

OBJECTIVE: To report a diagnosis of hereditary leiomyomatosis and renal cell cancer (HLRCC) syndrome following initial presentation with multiple cutaneous lesions. DESIGN: Case report. DESIGN CLASSIFICATION: N/A. SETTING: Academic tertiary care center. PATIENTS: 27-year-old nulligravid woman who presented with multiple red-brown lesions on her skin found to have cutaneous and uterine leiomyoma. INTERVENTIONS: Biopsy of cutaneous lesions and fertility sparing robot-assisted laparoscopic myomectomy (RALM). MAIN OUTCOME MEASURESS: Histological assessment of uterine leiomyoma. RESULTSS: Pathologic examination of uterine leiomyoma revealed diffuse atypia and fumarate hydratase loss phenotype concerning for genetic syndrome. Follow-up DNA sequencing via Sanger sequencing confirmed a pathogenetic R2333H mutation consistent with HLRCC. CONCLUSIONS: Consideration of HLRCC on differential diagnosis when patients present with cutaneous nodules and atypical or early onset uterine leiomyoma provides opportunity for early surveillance, family member testing, and more thoughtful surgical planning. PRECIS: 27-year-old woman with multiple cutaneous lesions is found to have uterine leiomyomas and undergoes robotic myomectomy. Genetic testing of uterine leiomyomas reveals mutation in fumarate hydratase, etiologic in hereditary leiomyomatosis and renal cell cancer (HLRCC).

Current trends and controversies in reproductive surgery.

Even in the context of the expansion of assisted reproductive technologies (ART), reproductive surgery continues to fulfill its deserved place in the arsenal of fertility treatments. Rather than being competitive, these two avenues of treatment can optimize fertility care when utilized as an adjunct to one another. Surgical indications and techniques in modern reproductive surgery continue to evolve based on new information about the effects of pelvic pathology on infertility and new technology. This review aims to disentangle some of the common clinical dilemmas facing reproductive specialists in regard to the effect of benign gynecologic pathology on fertility and the relevance of surgical intervention in enhancing or preserving fertility in women. To this end, we focus on the management of intramural myomata, adenomyosis, ovarian and peritoneal endometriosis and teratomas in women of reproductive age. In addition, we also review the role of recently developed techniques in the field of ovarian tissue preservation as well as uterine transplantation.

The Role of Hysteroscopic and Robot-assisted Laparoscopic Myomectomy in the Setting of Infertility.

Fibroids, the most common gynecologic condition in women of reproductive age, have traditionally been treated with hysterectomy. As more women delay childbearing, myomectomy becomes an essential component of the gynecologist's armamentarium. Minimally invasive approaches to myomectomy have been shown to decrease morbidity and reduce care-related costs, while improving reproductive outcomes. Hysteroscopic myomectomy is a reproducible and easily learned technique for the treatment of submucosal fibroids. Robot-assisted laparoscopic myomectomy overcomes most of the technical challenges of laparoscopic myomectomy for intramural and subserosal fibroids. The combined adoption of these technologies will allow more patients with fibroids to benefit from a minimally invasive approach.

Contained tissue extraction using power morcellation: prospective evaluation of leakage parameters.

BACKGROUND: Safe tissue removal is a challenge for minimally invasive procedures such as myomectomy, supracervical hysterectomy, or total hysterectomy of a large uterine specimen. There is concern regarding disruption or dissemination of tissue during this process, which may be of particular significance in cases of undetected malignancy. Contained tissue extraction techniques have been developed in an effort to mitigate morcellation-related risks. OBJECTIVE: The objective of the study was to quantify perioperative outcomes of contained tissue extraction using power morcellation, specifically evaluating parameters of tissue or fluid leakage from within the containment system. STUDY DESIGN: This was a study including a multicenter prospective cohort of adult women who underwent minimally invasive hysterectomy or myomectomy using a contained power morcellation technique. Blue dye was applied to the tissue specimen prior to removal to help identify cases of fluid or tissue leakage from within the containment system. RESULTS: A total of 76 patients successfully underwent the contained power morcellation protocol. Mean time for the contained morcellation procedure was 30.2 minutes (±22.4). The mean hysterectomy specimen weight was 480.1 g (±359.1), and mean myomectomy specimen weight was 239.1 g (±229.7). The vast majority of patients (73.7%) were discharged home the same day of surgery. Final pathological diagnosis was benign in all cases. Spillage of dye or tissue was noted in 7 cases (9.2%), although containment bags were intact in each of these instances. CONCLUSION: Findings are consistent with prior work demonstrating the feasibility of contained tissue extraction; however, further refinement of this technique is warranted.

Robotic single-site myomectomy: a step-by-step tutorial.

OBJECTIVE: To provide a step-by-step description of our published technique of single-site robot-assisted laparoscopic myomectomy with the goal of promoting its safe adoption. DESIGN: Surgical video tutorial. SETTING: University medical center. PATIENT(S): Ten women undergoing single-site robot-assisted laparoscopic myomectomy between November 2014 and March 2015. INTERVENTION(S): A 2.5-cm vertical incision is made within the umbilicus, through which a multilumen single-site port (da Vinci Single-Site; Intuitive Surgical) is seated. An 8.5-mm 0-degree laparoscope is introduced, and the teleoperator (da Vinci Si Surgical Platform; Intuitive Surgical) is docked, allowing subsequent placement of two curved 5-mm instrument cannulae. Two wristed, semirigid needle drivers are loaded onto robotic arms 1 and 2. An 8-mm assistant cannula is also placed through the multilumen single-site port; a flexible 2-mm CO2 laser fiber and all conventional 5-mm laparoscopic instruments are introduced through this cannula as needed. Intramyometrial dilute vasopressin is injected, and fibroid enucleation is performed. The hysterotomy is repaired in layers with unidirectional barbed suture (Stratafix; Ethicon). The teleoperator is undocked. The single-site port is exchanged for a self-retaining wound retractor with gel-sealed cap. An endoscopic pouch is placed in the abdomen, and the specimen is placed within the pouch. The edges of the pouch are exteriorized. Extracorporeal tissue extraction is performed with a scalpel. A running mass closure of the fascia and peritoneum is performed, followed by a subcuticular closure of the skin. MAIN OUTCOME MEASURE(S): Median number and size of fibroids removed, specimen weight, operative time, estimated blood loss, and perioperative complications. RESULT(S): The technique described in our video was successfully employed in our first 10 patients. The median number of fibroids removed was 2.5 (range: 1-8); the median size of the largest myoma was 6 cm (range: 4-8 cm); the median specimen weight was 70 g (range: 26-154 g); the median operating time was 202 minutes (range: 141-254 minutes); the median blood loss was 87.5 mL (range: 10-300 mL). No conversions to multiport robotic or open myomectomy occurred. No major complications occurred, and no patients required blood transfusion. CONCLUSION(S): Robot-assisted laparoscopic single-site myomectomy employing a multilumen port and wristed, semirigid needle drivers is a safe and reproducible technique. Our technique allows surgeons to offer myomectomy and contained, extracorporeal tissue extraction via a single 2.5-cm umbilical incision in select patients with low tumor burden.