Hemopatch to Prevent Lymphatic Leak after Robotic Prostatectomy and Pelvic Lymph Node Dissection: A Randomized Controlled Trial.

Abstract

Simple SummaryThis trial investigated the use of Hemopatch, a novel hemostatic patch, during robotic-assisted prostate and lymph node surgery for prostate cancer. The researchers hypothesize that the use of Hemopatch could decrease lymph leak from the surgical bed, which is reflected by the drain output volume. The result shows that patients who underwent surgeries with Hemopatch had a lower drain output volume in total and per day, comparatively. In conclusion, Hemopatch use should be considered in prostate cancer surgery.This study investigates whether the application of Hemopatch, a novel hemostatic patch, could prevent lymphatic leak after robotic-assisted radical prostatectomy (RARP) and bilateral pelvic lymph node dissection (BPLND). This is a prospective, single-center, phase III randomized controlled trial investigating the efficacy of Hemopatch in preventing lymphatic leak after RARP and BPLND. Participants were randomized to receive RARP and BPLND, with or without the use of Hemopatch, with an allocation ratio of 1:1. The primary outcome is the total drain output volume. The secondary outcomes include blood loss, operative time, lymph node yield, duration of drainage, drain output per day, hospital stay, transfusion and 30-day complications. A total of 32 patients were recruited in the study. The Hemopatch group had a significantly lower median total drain output than the control group (35 mL vs. 180 mL, p = 0.022) and a significantly lower drain output volume per day compared to the control group (35 mL/day vs. 89 mL/day, p = 0.038). There was no significant difference in the other secondary outcomes. In conclusion, the application of Hemopatch in RARP and BPLND could reduce the total drain output volume and the drain output volume per day. The use of Hemopatch should be considered to prevent lymphatic leakage after RARP and BPLND.