Outcomes of a phase III randomized controlled trial comparing preventive versus delayed ligation of dorsal vascular complex during robot-assisted radical prostatectomy
The ligation of the dorsal vascular complex (DVC) during robot-assisted radical prostatectomy (RARP) can be done either before (preventive ligation, PL) or after (delayed ligation, DL) its transection. We evaluated in a prospective randomized setting whether a DL of the DVC impacted on perioperative, functional and oncological outcomes as compared to PL during RARP.
After IRB approval, patients submitted to RARP and provided an informed consent were randomized. RARP was performed through a transperitoneal approach with either PL (1-0 Monocryl® CT-1, before bladder neck dissection) or DL (3-0 Monocryl® UR-6, once the prostatectomy completed). Primary endpoint was estimated blood loss (EBL); considering significant a difference ?30 ml, a sample size of 226 patients were calculated (two-sided ? of 0.05 and 80% power). Secondary endpoints were: transfusion rate, positive surgical margins (PSMs), apical PSMs and 1-month PSA and continence (0-1 security pad/day). Differences were compared using Pearson chi-square test or Mann-Whitney test as appropriate (p