Development and Validation of a Quality Assurance Score for Robot-assisted Radical Cystectomy: A 10-year Analysis.

OBJECTIVE: To develop quality assessment tool to evaluate surgical performance for robot-assisted radical cystectomy program. METHODS: A prospectively maintained quality assurance database of 425 consecutive robot-assisted radical cystectomies performed by a single surgeon between 2005 and 2015 was retrospectively reviewed. Potentially modifiable factors, related to the management and perioperative care of patients, were used to evaluate patient care. Criteria included the following: preoperative (administration of neoadjuvant chemotherapy); operative (operative time <6.5 hours and estimated blood loss <500 cc); pathologic (negative soft tissue surgical margins and lymph node yield ≥20); and postoperative (no high-grade complications, readmission, or noncancer-related mortality within 30 days).The Quality Cystectomy Score (QCS) was developed (1 star: achieving ≤2 criteria or mortality within 30 days; 2 stars: 3 or 4 criteria met; 3 stars: 5 or 6 criteria met; and 4 stars: 7 or all criteria met). Univariate and multivariate Cox proportional hazard regression models were fitted to test for the association between QCS and survival outcomes. RESULTS: Most patients (85%) achieved at least 3 stars, and more patients achieved 4 stars with time. High QCS was associated with better recurrence-free, cancer-specific, and overall survival (P values <.05). None of the patients with 1-star were alive at 1 year. Patients with 4 stars achieved the best survival rates (recurrence-free survival [62%], cancer-specific survival [70%], and overall survival [53%] at 5 years) (log rank P < .0001). CONCLUSION: Continuous assessment for quality improvement facilitated implementation and maintenance of robot-assisted program for bladder cancer.

Predictors of Complete Pathologic Response (pT0) to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Carcinoma.

UNLABELLED: No predictors of a complete pathologic response (pT0) to neoadjuvant chemotherapy (NAC) in muscle-invasive bladder carcinoma have been established. We performed a retrospective analysis of 50 patients to identify potential predictors. Our results showed that the presence of additional transitional cell variants on pathologic examination (mixed tumors) predicted against pT0, suggesting the avoidance of NAC and its morbidity in these patients with mixed tumors. BACKGROUND: Randomized trials have supported the use of cisplatin-based neoadjuvant chemotherapy (NAC) in muscle-invasive bladder carcinoma (MIBC) owing to the survival advantage, which has correlated with downstaging of the cancer to pT0. Only 30% to 40% of patients receiving NAC have attained a pT0 response at cystectomy; the remaining have either residual disease or progression. We aimed to identify the factors that could predict a pT0 response to NAC. PATIENTS AND METHODS: Of 336 patients who had undergone robotic cystectomy at our institute from May 2007 to March 2014, we identified 50 patients who had undergone NAC for MIBC. We conducted a retrospective study, dividing these 50 patients into 2 groups, those with and without a pT0. Factors, including age, histologic features, hydronephrosis at initial presentation, and chemotherapy type, were examined by both univariate and multivariate logistic regression analysis. RESULTS: Of the 50 patients, 14 (28%) had pT0 at cystectomy, 20 (40%) had progressive disease, and 16 (32%) had residual disease. The median age was 67.5 years, the median glomerular filtration rate at presentation was 87.5 mL/min, the patients had undergone a median of 3 NAC cycles, and the median time from the end of chemotherapy to surgery was 4 weeks. The odds of a pT0 response for pure urothelial carcinoma (UC) were approximately 11 times greater relative to cancers with transitional cell variant histologic features or mixed tumors (odds ratio 0.09, 95% confidence interval 0.021-0.380; P = .0011), including squamous, glandular differentiation, small cell, micropapillary, sarcomatoid, nested component, lymphoepithelioma-like, and plasmacytoid variants. CONCLUSION: The presence of pure UC favored a pT0 response to NAC compared with those with variant histologic features or mixed tumors. These potential predictors warrant prospective validation to allow the ideal selection of patients for NAC.

Surgical competency for urethrovesical anastomosis during robot-assisted radical prostatectomy: development and validation of the robotic anastomosis competency evaluation.

OBJECTIVE: To develop and validate an assessment tool for the performance of urethrovesical anastomosis (UVA). METHODS: A multicenter, prospective, observational study was conducted in 2 phases. Phase 1, development and content validation, used a panel of 5 experienced robotic surgeons to develop a 6-domain scoring system, Robotic Anastomosis Competence Evaluation (RACE), to assess technical skills for performing UVA. Phase 2, construct validation and reliability, used 5 blinded experienced robotic surgeons to rate UVA recordings of expert, advanced beginner, and novice groups. Content validation index was determined to report consensus in phase 1. Phase 2 involved comparison of RACE scores among the 3 groups. Wilcoxon rank-sum tests were used to compare RACE scores. RESULTS: Two rounds of Delphi methodology achieved consensus on language and content of RACE. Eight experts, 10 advanced beginners, and 10 novice robotic surgeons participated in the validation study. The overall score for the expert group (27.3) was higher than that of the advanced beginner (19.5; P = .04) and novice groups (13.6; P = .001). The advanced beginner and novice groups differed in overall scores (P = .03). CONCLUSION: RACE allows evaluation of surgical competence to perform UVA for robot-assisted radical prostatectomy, when using an inanimate model.

Augmented-reality-based skills training for robot-assisted urethrovesical anastomosis: a multi-institutional randomised controlled trial.

OBJECTIVE: To validate robot-assisted surgery skills acquisition using an augmented reality (AR)-based module for urethrovesical anastomosis (UVA). METHODS: Participants at three institutions were randomised to a Hands-on Surgical Training (HoST) technology group or a control group. The HoST group was given procedure-based training for UVA within the haptic-enabled AR-based HoST environment. The control group did not receive any training. After completing the task, the control group was offered to cross over to the HoST group (cross-over group). A questionnaire administered after HoST determined the feasibility and acceptability of the technology. Performance of UVA using an inanimate model on the daVinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) was assessed using a UVA evaluation score and a Global Evaluative Assessment of Robotic Skills (GEARS) score. Participants completed the National Aeronautics and Space Administration Task Load Index (NASA TLX) questionnaire for cognitive assessment, as outcome measures. A Wilcoxon rank-sum test was used to compare outcomes among the groups (HoST group vs control group and control group vs cross-over group). RESULTS: A total of 52 individuals participated in the study. UVA evaluation scores showed significant differences in needle driving (3.0 vs 2.3; P = 0.042), needle positioning (3.0 vs 2.4; P = 0.033) and suture placement (3.4 vs 2.6; P = 0.014) in the HoST vs the control group. The HoST group obtained significantly higher scores (14.4 vs 11.9; P 0.012) on the GEARS. The NASA TLX indicated lower temporal demand and effort in the HoST group (5.9 vs 9.3; P = 0.001 and 5.8 vs 11.9; P = 0.035, respectively). In all, 70% of participants found that HoST was similar to the real surgical procedure, and 75% believed that HoST could improve confidence for carrying out the real intervention. CONCLUSION: Training in UVA in an AR environment improves technical skill acquisition with minimal cognitive demand.

International Robotic Radical Cystectomy Consortium: A way forward.

Robot-assisted radical cystectomy (RARC) is an emerging operative alternative to open surgery for the management of invasive bladder cancer. Studies from single institutions provide limited data due to the small number of patients. In order to better understand the related outcomes, a world-wide consortium was established in 2006 of patients undergoing RARC, called the International Robotic Cystectomy Consortium (IRCC). Thus far, the IRCC has reported its findings on various areas of operative interest and continues to expand its capacity to include other operative modalities and transform it into the International Radical Cystectomy Consortium. This article summarizes the findings of the IRCC and highlights the future direction of the consortium.

Construct validation of the key components of Fundamental Skills of Robotic Surgery (FSRS) curriculum--a multi-institution prospective study.

BACKGROUND: Recent incorporation of simulation in surgical training necessitates developing validated platforms for training and assessment. A tool should fulfill the fundamental criteria of validation. OBJECTIVE: To report the ability of a simulation-based robotic training curriculum-Fundamental Skills of Robotic Surgery (FSRS)-to assess and distinguish between different performance levels of operator experience (construct validity). MATERIALS AND METHODS: This is a prospective multicenter observational study. Participants were classified as novice (0 robotic cases performed) and experts (>150 robotic cases performed). All participants were required to complete 4 key tasks in a previously validated FSRS curriculum: ball placement, coordinated tool control, fourth arm control, and needle handling and exchange. Using the metrics available in the simulator software, the performances of each group were compared to evaluate construct validation. RESULTS: A convenience cohort of 61 surgeons participated. Novice group (n = 49) consisted of 41 fellows/residents/medical students and 8 trained open/laparoscopic surgeons, whereas expert group consisted of 12 surgeons. The novice group had no previous robotic console experience, whereas the expert group had >150 prior robotic cases experience. An overall significant difference was observed in favor of the expert group in 4 skill sets (p < 0.05). Time to complete all 4 tasks was significantly shorter in the expert group (p < 0.001). The expert group displayed significantly lesser tool collision (p = 0.002) and reduced tissue damage (p < 0.001). In performing most tasks, the expert group's camera (p < 0.001) and clutch usage (p < 0.001) was significantly greater when compared with the novice group. CONCLUSION: The components of the FSRS curriculum showed construct validity. This validation would help in effectively implementing this curriculum for robot-assisted surgical training.

Effectiveness of a dedicated robot-assisted surgery training program.

INTRODUCTION: Robot-assisted surgery (RAS) has been integrated into the surgical armamentarium and generated wide-spread interest among practicing, non-robotic surgeons (NRS). While methods for training novice non-robotic surgeons have emerged, the effectiveness of these training programs has endured minimal scrutiny. This study aims to establish effectiveness of the RAST training program. MATERIALS AND METHODS: A formal RAST program was established at Roswell Park Cancer Institute (RPCI) in 2008. From July 2010 to October 2012, 43 non-robotic surgeons participated in the program. The 1 to 4 week program included the validated fundamentals skills of robotic surgery (FSRS) curriculum, hands-on bedside trouble-shooting training, case observation with an expert robotic surgeon, hands on surgical training (HoST) procedure modules, da Vinci robotic surgical hands-on experience and finally a compulsory animal laboratory utilizing the da Vinci. As part of our training and credentialing quality assurance program, all participants were prospectively evaluated employing a survey. This survey aimed to evaluate the enduring impact of the RAST through time-sensitive interventions that allowed participants to reacclimatize themselves to their prospective practice as independently performing surgeons. RESULTS: The survey responses received from the participating NRS were collected over 27 months, with a response rate of 84%. The average follow up period post-RAST completion was 6 months (2-19). Overall, participants felt that the FSRS curriculum (81%), bedside trouble shooting (7%), and animal laboratory (53%) were beneficial program features that enabled NRS to become adequately acquainted with the basic principles of RAS. Approximately 5 weeks after RAST program completion, 64% of surgeons performed robot-assisted surgery. The two most commonly performed procedures were robot-assisted radical prostatectomy and gastrointestinal surgeries where eight surgeons performed independently while 12 performed procedures under the supervision of an expert robotic surgeon. The overall conversion rate to open was reported to be 1.3%. CONCLUSIONS: A dedicated surgical training program focused on learning key steps of RAS enabled most participants to successfully incorporate and maintain their RAS skills in clinical practice.