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

Abstract

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.

Radical Prostatectomy Without Prior Biopsy in Selected Patients Evaluated by 18 F-Labeled Prostate-Specific Membrane Antigen–Ligand Positron Emission Tomography/Computed Tomography and Multiparameter Magnetic Resonance Imaging: A Single-Center, Prospective, Single-Arm Trial

“…There is a tendency to perform fewer lymphadenectomies, as its uncertain oncological role is unbalanced by specific complications, such as lymphatic leakage and hydrocele. 27 With the prevalence of PSMA PET, whether lymphadenectomy should be performed on patients with negative results of lymph nodes on PSMA PET is still questioned. Sprute et al conducted a study 28 to assess the ability of 18 F-PSMA PET to detect the metastatic lymph nodes and showed a negative predictive value of 98.9% for detecting positive lymph nodes > 3 mm.…”