Prospective evaluation with standardised criteria for postoperative complications after robotic-assisted laparoscopic radical prostatectomy.

Background: Very few studies have evaluated the risk of complications following robotic-assisted laparoscopic radical prostatectomy (RARP), and all were flawed by several methodological biases. Objective: To evaluate the prevalence of early complications and risk factors following RARP, reporting complications in agreement with the standardised Martin criteria. Design, setting, and participants: All 415 patients who underwent surgery for clinically localised prostate cancer from April 2005 to April 2009 at a single tertiary academic centre were prospectively studied. Intervention: RARP was performed by two surgeons with the same technique. Measurements: Complications were collected and reported according to the standardised Martin criteria. Results and limitations: One hundred and two complicationswere observed in 90 patients (21.6%), with bleeding (5.3%), lymphorrhoea (4.3%), and pelvic haematoma (2.4%) the most common ones. According to themodified Clavien system, 41 patients (10%) had grade 1, 37 (9%) had grade 2, 11 (3%) had grade 3, and 1 (0.2%) had grade 4 complications. On multivariable analysis, prostate volume (odds ratio: 0.985; p < 0.001) and the number of cases performed ( p < 0.001) were independent predictors of the occurrence of any grade complications. Considering grade 3 to 4 complications, only the number of cases performed by the surgeonswas significantly associatedwithmajor complications in a univariable analysis ( p < 0.001). The major limitation of the study is represented by the relatively small number of patients and events included in the analysis, resulting in the study being underpowered to identify some factors predicting any or high-grade complications. Conclusions: Applying standardised criteria to collect and report complications, we identified early complications in about 22% of our patients undergoing RARP. Although most of the patients experienced minor complications, 3% of them did experience grade 3 or 4 complications. Prostate volume and number of RARP performed by the surgeons were independent predictors of the occurrence of complications