Safety Profile of Robot-Assisted Radical Prostatectomy: A Standardized Report of Complications in 3317 Patients

Background: Previous studies attempting to assess complications after robot-assisted radical prostatectomy (RARP) are limited by their small numbers, short follow-up, or lack of risk factor analysis. Objective: To document complications after RARP by strict application of standardized reporting criteria. Design, setting, and participants: Between January 2005 and December 2009, 3317 consecutive patients underwent RARP at a tertiary referral center. Median follow-up was 24.2 mo (interquartile range: 12.4-36.9). Intervention: Transperitoneal RARP was performed by one of five surgeons-two experienced, three beginners. Measurements: Complications were captured by exhaustive review of multiple datasets, including our prospective prostate cancer database, claimsdata, and electronicmedical and institutional morbidity and mortality records, and reported according to the Martin-Donat criteria. Complications were stratified by type (medical/surgical), Clavien classification, and timing of onset. Multivariable analysis of factors predictive of complications was performed. Results and limitations: The median hospitalization time was 1 d. There were 368 complications in 326 patients (9.8%), including a transfusion rate of 2.2%. We detected 79 medical complications in 78 patients (2.4%) and 289 surgical complications in 264 patients (8.0%). There were 242 minor (Clavien 1-2) and 126 major (Clavien 3-5) complications. Two hundred ninety-nine (81.3%) complications occurred within 30 d, 17 (4.6%) within 31-90 d, and 52 (14.1%) after 90 d from surgery. On multivariable analysis, preoperative prostate-specific antigen values and cardiac comorbidity were predictive for medical complications, whereas age, gastroesophageal reflux disease, and biopsy Gleason score were predictive of surgical complications. Limitations of this study include representing results from a single high-volume referral center and not including the learning curve of the two most experienced surgeons. Conclusions: RARP is a safe operation, with an overall complication rate of 9.8%. Most complications occurred within 30 d of surgery. (C) 2011 Published by Elsevier B.V. on behalf of European Association of Urology.