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

Background: Very few studies have evaluated the risk of complications followingrobotic-assisted laparoscopic radical prostatectomy (RARP), and all were flawed byseveral methodological biases.Objective: To evaluate the prevalence of early complications and risk factors followingRARP, reporting complications in agreement with the standardised Martin criteria.Design, setting, and participants: All 415 patients who underwent surgery for clinicallylocalised prostate cancer from April 2005 to April 2009 at a single tertiary academiccentre were prospectively studied.Intervention: RARP was performed by two surgeons with the same technique.Measurements: Complications were collected and reported according to the standardisedMartin 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 mostcommon 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 thenumber of cases performed ( p < 0.001) were independent predictors of the occurrenceof any grade complications. Considering grade 3 to 4 complications, only the number ofcases performed by the surgeonswas significantly associatedwithmajor complications in aunivariable analysis ( p < 0.001). The major limitation of the study is represented by therelatively small number of patients and events included in the analysis, resulting in thestudy being underpowered to identify some factors predicting any or high-grade complications.Conclusions: Applying standardised criteria to collect and report complications, weidentified early complications in about 22% of our patients undergoing RARP. Althoughmost of the patients experienced minor complications, 3% of them did experience grade 3or 4 complications. Prostate volume and number of RARP performed by the surgeons wereindependent predictors of the occurrence of complications.