Comparison of Complication and Readmission Rates Between Robot-Assisted and Open Radical Cystectomy: Results From the Randomized RAZOR Clinical Trial

摘要

PURPOSE: We assessed differences in complications and readmissions between robot-assisted radical cystectomy (RARC) and open radical cystectomy (ORC). MATERIALS AND METHODS: This study uses data from the per-protocol population of the Randomized Robotic-Assisted vs Open Radical Cystectomy (RAZOR) study, a multicenter, open-label, phase 3, noninferiority clinical trial. RAZOR enrolled across 15 academic medical centers in the United States between 2011 and 2014. The median follow-up was 2 years. Complications up to 90 days using the Clavien-Dindo classification, and readmissions at 90 days and 1 year postoperatively were compared. Multivariable logistic regression analyses were performed to determine any predictors of major complications and of postsurgery readmission. RESULTS: < .001, at 1 year). CONCLUSIONS: No significant differences in major complications and readmission rates between ORC and RARC were noted. Patient frailty was an important predictor of these outcomes, and special attention needs to be taken in ensuring appropriate patient selection and preoperative preparation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01157676.