Shabnam Rehman

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.

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.

Understanding Avoidance, Refusal, and Abandonment of Chemotherapy Before and After Cystectomy for Bladder Cancer

OBJECTIVE To analyze trends in perioperative chemotherapy and optimize use of neoadjuvant chemotherapy for bladder cancer. METHODS From 2005-2012, 284 consecutive patients underwent robot-assisted radical cystectomy at our facility. Patients with disease ≥ T2 and nodal involvement and positive surgical margins were reviewed and considered candidates for referral to medical oncology for chemotherapy. The study was conducted in two phases: phase 1 included 242 consecutive patients between 2005 and 2011, and phase 2 analyzed the effect of changes in 42 patients during a 1-year period (2011-2012). RESULTS In phase 1, 148 patients (61%) were candidates for neoadjuvant chemotherapy (NAC). Consultation for NAC was sought for 44 patients (29%), and 104 (71%) did not receive consultation. Of the 44 patients, 36% received NAC, 7% refused, 32% were recommended for immediate cystectomy, and 25% did not receive NAC for other reasons. Phase 2 was more stringent, with a multidisciplinary approach. Significant improvement in referral and NAC use was seen. About 78% vs 30% of patients were seen by medical oncology for consideration of NAC before robot-assisted radical cystectomy and 71% vs 36% received NAC compared with phase 1. The NAC utilization rate improved from 10.8% to 55% over 1 year with a diligent multidisciplinary approach. Medical comorbidities were the main reason for patients not receiving adjuvant chemotherapy (AC; 30% and 33%). CONCLUSION A multidisciplinary approach and coordination of services can help optimize the use of neoadjuvant chemotherapy for bladder cancer.

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

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

600,000, while 72 animal labs would have cost more than

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

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.

Combination of the histone deacetylase inhibitor vorinostat with bevacizumab in patients with clear-cell renal cell carcinoma: a multicentre, single-arm phase I/II clinical trial

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 groups 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.

A single-center experience of chemotherapy for muscle-invasive bladder cancer after radical cystectomy.

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).

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

Background:Class II histone deacetylase (HDAC) inhibitors induce hypoxia-inducible factor-1 and -2α degradation and have antitumour effects in combination with vascular endothelial growth factor (VEGF) inhibitors. In this study, we tested the safety and efficacy of the HDAC inhibitor vorinostat and the VEGF blocker bevacizumab in metastatic clear-cell renal cell carcinoma (ccRCC) patients previously treated with different drugs including sunitinib, sorafenib, axitinib, interleukin-2, interferon, and temsirolimus.Methods:Patients with up to two prior regimens were eligible for treatment, consisting of vorinostat 200 mg orally two times daily × 2 weeks, and bevacizumab 15 mg kg−1 intravenously every 3 weeks. The primary end points were safety and tolerability, and the proportion of patients with 6 months of progression-free survival (PFS). Correlative studies included immunohistochemistry, FDG PET/CT scans, and serum analyses for chemokines and microRNAs.Results:Thirty-six patients were enrolled, with 33 evaluable for toxicity and efficacy. Eighteen patients had 1 prior treatment, 13 patients had 2 prior treatments, and 2 patients were treatment naïve. Two patients experienced grade 4 thrombocytopenia and three patients had grade 3 thromboembolic events during the course of exposure. We observed six objective responses (18%), including one complete response and five partial responses. The proportion of patients with PFS at 6 months was 48%. The median PFS and overall survival were 5.7 months (confidence interval (CI): 4.1–11.0) and 13.9 months (CI: 9.8–20.7), respectively. Correlative studies showed that modulation of specific chemokines and microRNAs were associated with clinical benefit.Conclusions:The combination of vorinostat with bevacizumab as described is relatively well tolerated. Response rate and median PFS suggest clinical activity for this combination strategy in previously treated ccRCC.

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

318 Background: Muscle invasive bladder cancer (MIBC) is a chemo-sensitive disease that responds to therapy before or after curative-intent radical cystectomy (RC). Neoadjuvant chemotherapy (NAC) improves overall survival by 5-8% in current meta-analyses. Adjuvant chemotherapy (AC) has shown benefit but is less rigorously tested. METHODS We retrospectively reviewed the cystectomy database at our institute from 2005-2011 and analyzed patients who have received NAC or AC for MIBC. The Log rank test was used to compare survival between groups and Cox regression models were used for adjusted comparisons of survival. RESULTS 45 patients (p) (13 NAC and 32 AC) were evaluated with a mean age of 65.5 years (50-82), including 77% males and 23% females. Patients were most commonly offered chemotherapy because of co-morbidities and performance status. NAC was most commonly gemcitabine (G)/cisplatin (n=9) and AC was usually G/platinum (n=27). Sixty-nine percent of patients were downstaged and 23% had a complete pathologic response following NAC. Three p in AC group had positive margins; all of these cases were T4 cancers. Pathologic staging showed 84% ≥T3 and 53% node positive disease. Patients receiving AC had a mean interval of 64.8 days (42-129) to the start of treatment. NAC and AC patients received median 4.1 (3-7) and 4.5 cycles (1-12), respectively, throughout entire course of treatment. The median overall survival (OS) was 24.5 months (m) (17.1 m-not reached) and 24-month survival rate was 47%. Progression free survival (PFS) was 12.3 m (8.5-23.5 m) for all patients. There was no difference for OS or PFS based on age, gender, time after surgery to first dose of therapy, or mode of therapy (NAC or AC). When adjusted for number of cycles completed, a trend toward improved median OS (not reached vs. 22 m p= 0.092 ) and a significant PFS improvement (28.5 vs 11.5 m p=0.026) with NAC vs. AC was observed. Grade 3-4 urologic toxicity was negligible in both groups, however the AC group had a higher percentage of grade 3-4 hematologic toxicity. CONCLUSIONS Despite a small sample size, results from our series favor NAC based upon efficacy and tolerability for patients with locally invasive bladder cancer.