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.

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.

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.

Development and validation of a composite scoring system for robot-assisted surgical training--the Robotic Skills Assessment Score.

BACKGROUND: A standardized scoring system does not exist in virtual reality-based assessment metrics to describe safe and crucial surgical skills in robot-assisted surgery. This study aims to develop an assessment score along with its construct validation. MATERIALS AND METHODS: All subjects performed key tasks on previously validated Fundamental Skills of Robotic Surgery curriculum, which were recorded, and metrics were stored. After an expert consensus for the purpose of content validation (Delphi), critical safety determining procedural steps were identified from the Fundamental Skills of Robotic Surgery curriculum and a hierarchical task decomposition of multiple parameters using a variety of metrics was used to develop Robotic Skills Assessment Score (RSA-Score). Robotic Skills Assessment mainly focuses on safety in operative field, critical error, economy, bimanual dexterity, and time. Following, the RSA-Score was further evaluated for construct validation and feasibility. Spearman correlation tests performed between tasks using the RSA-Scores indicate no cross correlation. Wilcoxon rank sum tests were performed between the two groups. RESULTS: The proposed RSA-Score was evaluated on non-robotic surgeons (n = 15) and on expert-robotic surgeons (n = 12). The expert group demonstrated significantly better performance on all four tasks in comparison to the novice group. Validation of the RSA-Score in this study was carried out on the Robotic Surgical Simulator. CONCLUSION: The RSA-Score is a valid scoring system that could be incorporated in any virtual reality-based surgical simulator to achieve standardized assessment of fundamental surgical tents during robot-assisted surgery.

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.

The first 100 consecutive, robot-assisted, intracorporeal ileal conduits: evolution of technique and 90-day outcomes.

BACKGROUND: Robot-assisted radical cystectomy (RARC) has evolved over the last few years to become an acceptable alternative option to open radical cystectomy. Most series of RARC used an open approach to urinary diversion. Even though robot-assisted intracorporeal urinary diversion (RICUD) is the natural extension of RARC, few centers have reported their experiences with RICUD in general, and in particular, of robot-assisted intracorporeal ileal conduits (RICIC). OBJECTIVE: To report our experience with RICIC using the Marionette technique. DESIGN, SETTING, AND PARTICIPANTS: The first 100 consecutive patients who underwent RARC and RICIC, and had ≥ 3 mo of postoperative follow-up were included in this study. Patients were divided into four groups of 25 patients each to study the evolution of our surgical technique. INTERVENTION: RICIC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Intraoperative, pathologic, and 90-d postoperative outcomes for the four groups and the overall cohort were compared using the Fisher exact test (categorical variables) and the Kruskal-Wallis test (continuous variables). Continuous variables were reported as median (range) and categorical variables were specified as frequency (percentage). RESULTS AND LIMITATIONS: Overall operative and specific diversion times were 352 and 123 min, respectively. Estimated blood loss was 300 ml, lymph node yield was 24, and positive surgical margin rate was 4%. Length of hospital stay increased from 7 d for group 1 to 9 d for group 4. The overall 90-d complication rate was 81%; 19% of complications were high grade. Infections were the most common complications, representing 31% of all complications. There were no statistically significant intergroup differences except in diversion time, intraoperative transfusions, and length of stay. CONCLUSIONS: RICIC diversion is safe, feasible, and reproducible. Larger series with longer follow-up are needed to validate the procedure and define its place in the minimally invasive urologic armamentarium. Quality of life studies need to be conducted to compare benefits of intracorporeal urinary diversion.

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.

Short-term patient-reported quality of life after robot-assisted radical cystectomy using the Convalescence and Recovery Evaluation.

OBJECTIVE: To determine the short-term health status of patients after robot-assisted radical cystectomy using the Convalescence and Recovery Evaluation (CARE). Radical cystectomy and urinary diversion in patients with invasive bladder cancer can have a significant effect on patients' quality of life. METHODS: A total of 91 patients completed the CARE preoperatively and postoperatively. The CARE scores were calculated from postoperative day 7 to 90. Outcome measures were calculated using the CARE difference index (CDI), defined as the difference between the baseline CARE and postoperative day 7 CARE scores. The primary outcome was the time taken to recover 90% of the CDI. RESULTS: The mean age at robot-assisted radical cystectomy was 69 years (range 42-86). Of the 91 patients, 68 (74%) were men, 38 underwent extracorporeal urinary diversion, 52 underwent intracorporeal urinary diversion, and 1 underwent no diversion. A comparison of the preoperative and postoperative day 7 scores demonstrated a 48% decline in the total CARE score. The decline in specific CARE domains was 14%, 34%, 56%, and 66% against baseline for the cognition, pain, gastrointestinal, and activity domains, respectively. The mean time to recover 90% of the CDI for the total CARE score was 63 days. The mean time to recover 90% of the CDI for the pain, cognition, and activity domains was 33, 57, and 82 days, respectively. Patients did not recover 90% of the CDI for the gastrointestinal domain within the 90-day follow-up period. CONCLUSION: Patients who underwent robot-assisted radical cystectomy approached preoperative baseline levels within 90 days using the CARE in the total CARE, pain, cognition, and activity domains but not in the gastrointestinal domain.

Does body mass index impact the performance of robot-assisted intracorporeal ileal conduit?

BACKGROUND AND PURPOSE: Body mass index (BMI) has been shown to influence perioperative outcomes for patients undergoing open radical cystectomy and urinary diversion. The impact of BMI on robot-assisted intracorporeal ileal conduit has not been studied. PATIENTS AND METHODS: All patients undergoing robot-assisted radical cystectomy (RARC) with ileal conduit at our institution were offered intracorporeal ileal conduit beginning May 2009. Fifty-six consecutive patients underwent robot-assisted radical cystectomy with intracorporeal ileal conduit from May of 2009 to July 2010. Patients were categorized into three groups based on BMI: Normal (BMI < 25 kg/m(2)), overweight (BMI=25-29 kg/m(2)), and obese (BMI ≥ 30 kg/m(2)). The effect of BMI on intraoperative and postoperative outcomes was assessed by retrospective review of a comprehensive RARC quality assurance database. RESULTS: Median age at cystectomy was 72 (range 42-87 y), and 75% of patients were male. Median follow-up for the entire cohort was 5 months (range 12 d-16 mos). Median BMI was 27 kg/m(2) (range 19-47 kg/m(2)), and 75% of patients were overweight or obese. Age, ASA score, and overall operative time were not significantly different among the normal, overweight, and obese patients. Median urinary diversion times were 95, 151, and 124 minutes for normal, overweight, and obese patients, respectively (P=0.13). CONCLUSIONS: Robot-assisted intracorporeal ileal conduit can be safely performed in all body mass indices. Further studies are needed to assess long-term conduit function and stomal complications.

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.

Validation of Robotic Surgery Simulator (RoSS).

Recent growth of daVinci Robotic Surgical System as a minimally invasive surgery tool has led to a call for better training of future surgeons. In this paper, a new virtual reality simulator, called RoSS is presented. Initial results from two studies - face and content validity, are very encouraging. 90% of the cohort of expert robotic surgeons felt that the simulator was excellent or somewhat close to the touch and feel of the daVinci console. Content validity of the simulator received 90% approval in some cases. These studies demonstrate that RoSS has the potential of becoming an important training tool for the daVinci surgical robot.

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.

Is patient outcome compromised during the initial experience with robot-assisted radical cystectomy? Results of 164 consecutive cases.

OBJECTIVE: • Robot-assisted radical cystectomy (RARC) remains controversial in terms of oncologic outcomes, especially during the initial experience. The purpose of this study was to evaluate the impact of initial experience of robotic cystectomy programs on oncologic outcomes and overall survival. PATIENTS AND METHODS: • Utilizing a prospectively maintained, single institution robotic cystectomy database, we identified 164 consecutive patients who underwent RARC since November 2005. • After stratification by age group, gender, pathologic T stage, lymph node status, surgical margin status, and sequential case number; we used chi-squared analyses to correlate sequential case number to operative time, surgical blood loss, lymph node yield, and surgical margin status. • We also addressed the relationship between complications and sequential case number. We then utilized Cox proportional hazard modeling and Kaplan-Meier survival analyses to correlate variables to overall mortality. RESULTS: • Sequential case number was not significantly associated with increased incidence of complications, surgical blood loss, or positive surgical margins (P= 0.780, P= 0.548, P= 0.545). Case number was, however, significantly associated with shorter operative time and mean number of lymph nodes retrieved (P < 0.001, P < 0.001). • Sequential case number was not significantly associated with survival; however, tumour stage, the presence of lymph node metastases, and positive surgical margins were significantly associated with death. • Although being the largest of its kind, this was a small study with short follow-up when compared to open cystectomy series. CONCLUSION: • Initial experience with RARC did not affect the incidence of positive surgical margins, operative/postoperative complications, or overall survival in a single-institution series.

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.