Benchmarking PASADENA Consensus along the Learning Curve of Robotic Radical Cystectomy with Intracorporeal Neobladder: CUSUM Based Assessment.

Abstract

(1) Aim: Robot assisted radical cystectomy (RARC) with intacorporeal neobladder (iN) is a challenging procedure. There is a paucity of reports on RARC-iN, the extracorporeal approach being the most used. The aim of our study was to assess the learning curve of RARC-iN and to test its performance in benchmarking Pasadena consensus outcomes. (2) Material and methods: The single-institution learning curve of RARC-iN was retrospectively evaluated. Demographic, clinical and pathologic data of all patients were recorded. Indications to radical cystectomy included muscle invasive bladder cancer (pT ≥ 2) or recurrent high grade non muscle invasive bladder cancer. The cumulative sum (CUSUM) technique, one of the methods developed to monitor the performance and quality of the industrial sector, was adopted by the medical field in the 1970s to analyze learning curves for surgical procedures. The learning curve was evaluated using the following criteria: 1. operative time (OT) <5 h; 2. 24-h Hemoglobin (Hb) drop <2 g/dl; 3. severe complications (according to the Clavien classification system) <30%; 4. positive surgical margins <5%; and 5. complete lymph-node dissection defined as more than 16 nodes. Benchmarking of all five items on quintile analysis was tested, and a failure rate <20% for any outcome was set as threshold. (3) Results: the first 100 consecutive RARC-iN patients were included in the analysis. At CUSUM analysis, RARC required 20 cases to achieve a plateau in terms of operative time (defined as more than 3 consecutive procedures below 300 min). Hemoglobin drop, PSM and number of removed lymph-nodes did not change significantly along the learning curve. Overall, 41% of the patients presented at least one complication. Low-grade and high-grade complication rates were 30% and 17%, respectively. When assessing the benchmarks of all five Pasadena consensus outcomes on quintile analysis, a plateau was achieved after the first 60 cases. (4) Conclusions: RARC-iN is a challenging procedure. The potential impact of the learning curve on significant outcomes, such as high grade complications and positive surgical margins, has played a detrimental effect on its widespread adoption. According to this study, in tertiary referral centers, 60 procedures are sufficient to benchmark all outcomes defined in Pasadena RARC consensus.