Introduction

The ligation of the dorsal vascular complex (DVC) during robot-assisted radical prostatectomy (RARP) can be done both before (preventive ligation, PL) or after (delayed ligation, DL) its transection, given the haemostatic effect exerted by the pneumoperitoneum. _x000D_ The aim of this study is to compare outcomes of RARP with preventive ligation versus delayed ligation of the DVC in a phase III randomized controlled trial.

Methods

After IRB approval, a prospective randomized controlled trail is recruiting patients submitted to RARP at our institution since February 2015. Exclusion criteria are: congenital or acquired coagulation disorders and salvage radical prostatectomy. After obtaining an informed consent, patients are randomized into treatment arms on a 1:1 ratio. _x000D_ RARP is performed according to the Patel technique, by 2 experienced robotic surgeons, with PL (1-0 Monocryl® CT-1, after the opening of endopelvic fascia and before bladder neck dissection) or DL (3-0 Monocryl® UR-6, once the prostatectomy is completed). _x000D_ Patients&[prime] characteristics and data are recorded in a prospective maintained database._x000D_ The primary endpoint is estimated blood loss (EBL) during prostatectomy (considering significant a difference of 30 ml or higher). Secondary endpoints are: transfusion rate, positive surgical margins (PSMs) in general and apical PSMs in particular and 1-month PSA and continence (defined as the use of 0 pad or 1 security pad per day). Pearson&[prime]s chi-square test was applied to all variables, with a chi-square probability of 0.05 or less considered statistically significant.

Results

Overall, 154 patients were randomized from February 2015 to August 2016 (86 patients with PL and 68 with DL). The two groups had comparable preoperative features and no statistically significant differences were found in term of primary and secondary endpoints with the exception of the rate of apical PSMs, higher in the PL group (table 1).

Conclusions

A DL of the DVC is associated to a greater blood loss, even without any clinical significance, and seems to be protective on the risk of apical PSMs, with no detrimental effects on perioperative course and functional outcomes.

Funding

None