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
Overall, 243 patients were randomized from August 2016 to August 2017 (136 patients with PL and 107 with DL). A shift from DL to PL was observed in 26 patients (24%) and from PL to DL in 8 (6%). These patients were excluded from final analysis. The two groups had comparable baseline characteristics (table 1). EBL was higher in DL group (mean 91±120 SD vs 107±134 SD in PL and DL respectively) but not significant (p=0.251). Two patients (1.6%) in PL and 1 (1.3%) in DL group required transfusion (p=0.854). PSM rate was 19% and 21% in PL and DL, respectively (p=0.712); among patients with PSM apical involvement was significantly higher in PL group (58% vs 23%, p=0.027). 1- 3- 6- and 12-months median PSA values were comparable between groups. No differences in terms of 1- 3- and 6-months continence rate were found (84% vs 76% p=0.207, 95% vs 91% p=0.4, 97.2% vs 97.9% p=0.807, respectively).
A DL of the DVC is not detrimental on perioperative outcomes and it could play a protective role in managing the prostate apex. These findings could allow the surgeon to opt for the best method tailored on patient needs and disease characteristics.