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.

Short-term patient reported health-related quality of life (HRQL) outcomes after robot-assisted radical cystectomy (RARC).

OBJECTIVE: To determine short-term health-related quality of life (HRQL) outcomes after robot-assisted radical cystectomy (RARC) using the Bladder Cancer Index (BCI) and European Organisation for Research and Treatment of Cancer (EORTC) Body Image Scale (BIS). PATIENTS AND METHODS: All patients undergoing RARC were enrolled in a quality assurance database. The patients completed two validated questionnaires, BCI and BIS, preoperatively and at standardised postoperative intervals. The primary outcome measure was difference in interval and baseline BCI and BIS scores. Complications were identified and classified by Clavien grade. RESULTS: In all, 43 patients completed pre- and postoperative questionnaires There was a decline in the urinary domain at 0-1 month after RARC (P = 0.006), but this returned to baseline by 1-2 months. There was a decline in the bowel domain at 0-1 month (P < 0.001) and 1-2 months (P = 0.024) after RARC, but this returned to baseline by 2-4 months. The decline in BCI scores was greatest for the sexual function domain, but this returned to baseline by 16-24 months after RARC. Body image perception using BIS showed no significant change after RARC except at the 4-10 months period (P = 0.018). CONCLUSIONS: Based on BCI and BIS scores HRQL outcomes after RARC show recovery of urinary and bowel domains ≤6 months. Longer follow-up with a larger cohort of patients will help refine HRQL outcomes.

Simulation-based robot-assisted surgical training: a health economic evaluation.

OBJECTIVE: To determine the overall cost effectiveness of surgical skills training on Robotic Surgical Simulator (RoSS). METHODS: This study evaluates the cost analysis of utilizing RoSS for robot-assisted surgical training, at Roswell Park Center for Robotic Surgery. Trainees were queried for time spent on the RoSS console over a period of 1 year, starting from June 2010 to June 2011. Time spent was converted to training time consumed on robotic console, resulting in loss of OR time and revenue. The mechanical durability of the RoSS was also determined. RESULTS: 105 trainees spent 361 h on the RoSS. This duration converted to 73 robot-assisted radical prostatectomy cases, and 72 animal lab sessions. RoSS prevented a potential loss of $600,000, while 72 animal labs would have cost more than $72,000 without including initial robot installation, annual maintenance and personnel expenses. The mechanical durability testing determined breakdown at 180 and 360 h for master control and pinch device, which were repaired under warranty. CONCLUSION: RoSS is a cost effective surgical simulator for implementation of a simulation-based robot-assisted surgical training program.

Fundamental skills of robotic surgery: a multi-institutional randomized controlled trial for validation of a simulation-based curriculum.

OBJECTIVE: To develop and establish effectiveness of simulation-based robotic curriculum--fundamental skills of robotic surgery (FSRS). METHODS: FSRS curriculum was developed and incorporated into a virtual reality simulator, Robotic Surgical Simulator (RoSS). Fifty-three participants were randomized into an experimental group (EG) or control group (CG). The EG was asked to complete the FSRS and 1 final test on the da Vinci Surgical System (dVSS). The dVSS test consisted of 3 tasks: ball placement, suture pass, and fourth arm manipulation. The CG was directly tested on the dVSS then offered the chance to complete the FSRS and re-tested on the dVSS as a crossover (CO) group. RESULTS: Sixty-five percent of participants had never formally trained using laparoscopic surgery. Ball placement: the EG demonstrated shorter time (142 vs 164 seconds, P = .134) and more precise (1.5 vs 2.5 drops, P = .014). The CO took less time (P <.001) with greater precision (P <.001). Instruments were rarely lost from the field. Suture pass: the EG demonstrated better camera utilization (4.3 vs 3.0, P = .078). Less instrument loss occurred (0.5 vs 1.1, P = .026). Proper camera usage significantly improved (P = .009). Fourth arm manipulation: the EG took less time (132 vs 157 seconds, P = .302). Meanwhile, loss of instruments was less frequent (0.2 vs 0.8, P = .076). Precision in the CO improved significantly (P = .042) and camera control and safe instrument manipulation showed improvement (1.5 vs 3.5, 0.2 vs 0.9, respectively). CONCLUSION: FSRS curriculum is a valid, feasible, and structured curriculum that demonstrates its effectiveness by significant improvements in basic robotic surgery skills.

Complications after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium.

BACKGROUND: Complication reporting is highly variable and nonstandardized. Therefore, it is imperative to determine the surgical outcomes of major oncologic procedures. OBJECTIVE: To describe the complications after robot-assisted radical cystectomy (RARC) using a standardized and validated reporting methodology. DESIGN, SETTING, AND PARTICIPANTS: Using the International Robotic Cystectomy Consortium (IRCC) database, we identified 939 patients who underwent RARC, had available complication data, and had at least 90 d of follow-up. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Complications were analyzed and graded according to the Memorial Sloan-Kettering Cancer Center (MSKCC) system and were defined and stratified by organ system. Secondary outcomes included identification of preoperative and intraoperative variables predicting complications. Logistic regression models were used to define predictors of complications and readmission. RESULTS AND LIMITATIONS: Forty-one percent (n=387) and 48% (n=448) of patients experienced a complication within 30 and 90 d of surgery, respectively. The highest grade of complication was grade 0 in 52%, grade 1-2 in 29%, and grade 3-5 in 19% patients. Gastrointestinal, infectious, and genitourinary complications were most common (27%, 23%, and 17%, respectively). On multivariable analysis, increasing age group, neoadjuvant chemotherapy, and receipt of blood transfusion were independent predictors of any and high-grade complications, respectively. Thirty and 90-d mortality was 1.3% and 4.2%, respectively. As a multi-institutional database, a disparity in patient selection, operating standards, postoperative management, and reporting of complications can be considered a major limitation of the study. CONCLUSIONS: Surgical morbidity after RARC is significant when reported using a standardized reporting methodology. The majority of complications are low grade. Strict reporting of complications is necessary to advocate for radical cystectomy (RC) and helps in patient counseling.

Impact of surgeon and volume on extended lymphadenectomy at the time of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium (IRCC).

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Lymph node dissection and it's extend during robot-assisted radical cystectomy varies based on surgeon related factors. This study reports outcomes of robot-assisted extended lymphadenectomy based on surgeon experience in both academic and private practice settings. OBJECTIVE: To evaluate the incidence of, and predictors for, extended lymph node dissection (LND) in patients undergoing robot-assisted radical cystectomy (RARC) for bladder cancer, as extended LND is critical for the treatment of bladder cancer but the role of minimally invasive surgery for extended LND has not been well-defined in a multi-institutional setting. PATIENTS AND METHODS: Used the International Robotic Cystectomy Consortium (IRCC) database. In all, 765 patients who underwent RARC at 17 institutions from 2003 to 2010 were evaluated for receipt of extended LND. Patients were stratified by age, sex, clinical stage, institutional volume, sequential case number, and surgeon volume. Logistic regression analyses were used to correlate variables to the likelihood of undergoing extended LND. RESULTS: In all, 445 (58%) patients underwent extended LND. Among all patients, a median (range) of 18 (0-74) LNs were examined. High-volume institutions (≥100 cases) had a higher mean LN yield (23 vs 15, P < 0.001). On univariable analysis, surgeon volume, institutional volume, and sequential case number were associated with likelihood of undergoing extended LND. On multivariable analysis, surgeon volume [odds ratio (OR) 3.46, 95% confidence interval (CI) 2.37-5.06, P < 0.001] and institution volume [OR 2.65, 95% CI 1.47-4.78, P = 0.001) were associated with undergoing extended LND. CONCLUSIONS: Robot-assisted LND can achieve similar LN yields to those of open LND after RC. High-volume surgeons are more likely to perform extended LND, reflecting a correlation between their growing experience and increased comfort with advanced vascular dissection.

Novel knot tying technique for robot-assisted surgery.

Robot-assisted surgery has seen significant advancements in recent years, with dedicated training opportunities to acquire adequate skills. With improved degree of rotation and movement offered by the robot arm, newer techniques of knot tying need to be developed. Here we present a novel method of knot tying to help place a secure knot, especially with short suture length.

Status of Robot-Assisted Radical Cystectomy (RARC) in 2012.

Robot-assisted radical cystectomy (RARC) for bladder cancer is increasingly becoming popular in specialist centres around the world. RARC has the advantage of being minimally invasive and also the dexterity of the instruments allow reconstruction such as ileal conduit urinary diversion or neobladder formation. Starting from the initial series demonstrating the feasibility of RARC and extended pelvic lymph node dissection, we now have mature series demonstrating equal oncological and functional outcomes in the medium term follow-up. In addition, literature suggests decreased hospital stay, less blood loss equating to less blood transfusion and a trend towards decreased complications as well. In the near future we would anticipate further refinement and reduced operating times with increased benefits for the patient undergoing RARC.

Content validation of a novel robotic surgical simulator.

OBJECTIVE: • To assess the content validity of an early prototype robotic simulator. Minimally invasive surgery poses challenges for training future surgeons. The Robotic Surgical Simulator (RoSS) is a novel virtual reality simulator for the da Vinci Surgical System. PATIENTS AND METHODS: • Participants attending the 2010 International Robotic Urology Symposium were invited to experience RoSS. Afterwards, participants completed a survey regarding the appropriateness of the simulator as a teaching tool. RESULTS: • Forty-two subjects including surgeons experienced with robotics (n= 31) and novices (n= 11) participated in this study. • Eighty per cent of the entire cohort had an average of 4 years of experience with robot-assisted surgery. • Eleven (26%) novices lacked independent robot-assisted experience. The expert group comprised 17 (41%) surgeons averaging 881 (160-2200) robot-assisted cases. Experts rated the 'clutch control' virtual simulation task as a good (71%) or excellent (29%) teaching tool. • Seventy-eight per cent rated the 'ball place' task as good or excellent but 22% rated it as poor. • Twenty-seven per cent rated the 'needle removal' task as an excellent teaching tool, 60% rated it good and 13% rated it poor. • Ninety-one per cent rated the 'fourth arm tissue removal' task as good or excellent. • Ninety-four per cent responded that RoSS would be useful for training purposes. • Eighty-eight per cent felt that RoSS would be an appropriate training and testing format before operating room experience for residents. • Seventy-nine per cent indicated that RoSS could be used for privileging or certifying in robotic surgery. CONCLUSION: • Results based on expert evaluation of RoSS as a teaching modality illustrate that RoSS has appropriate content validity.

Defining morbidity of robot-assisted radical cystectomy using a standardized reporting methodology.

BACKGROUND: Adverse event reporting is highly variable and nonstandardized in urologic literature, especially for robot-assisted radical cystectomy (RARC). OBJECTIVE: We sought to better characterize complications in patients after RARC using a standardized reporting methodology. DESIGN, SETTING, AND PARTICIPANTS: Using a prospectively maintained, single-institution database, we identified 156 consecutive patients who underwent RARC with at least 90 d of follow-up. Complications were analyzed and graded according to the Memorial Sloan-Kettering Cancer Center (MSKCC) system and were defined and stratified by organ system. MEASUREMENTS: Logistic regression models were used to define predictors of complications. Cox proportional hazard modeling and Kaplan-Meier survival analyses were used to correlate complications and 90-d mortality. RESULTS AND LIMITATIONS: Fifty-two percent (81 of 156) of patients experienced a complication within 90 d of surgery. Sixty-five percent (102 of 156) of patients experienced a postoperative complication at a median follow-up of 9 mo. The highest grade of complication was grade 1 in 30 patients (19%), grade 2 in 34 patients (22%), and grade 3-5 in 38 patients (24%). Twenty-one percent (33 of 156) of patients required hospital readmission. Gastrointestinal, infectious, and genitourinary complications were most common (31%, 25%, and 13%, respectively). The 90-d mortality rate was 5.8%. CONCLUSIONS: When reported using strict guidelines, surgical morbidity after RARC is significant, but the majority of complications are low grade. Despite the high prevalence of low-grade complications, the mortality rate was acceptably low. Stringent reporting of complications after RARC is essential for counseling patients, assessing surgical quality, and allowing comparisons with open radical cystectomy and among institutions.