Hemopatch to Prevent Lymphatic Leak after Robotic Prostatectomy and Pelvic Lymph Node Dissection: A Randomized Controlled Trial.
Jeremy Yuen Chun TeohAlex Qinyang LiuViolet Wai-Fan YuenFranco Pui-Tak LaiSteffi Kar-Kei YuenSamson Yun-Sang ChanJulius Ho-Fai WongJoseph Kai-Man LiMandy Ho-Man TamPeter Ka-Fung ChiuSamuel Chi-Hang YeeChi-Fai NgPublished in: Cancers (2022)
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.
Keyphrases
- lymph node
- radical prostatectomy
- phase iii
- prostate cancer
- randomized controlled trial
- sentinel lymph node
- rectal cancer
- open label
- neoadjuvant chemotherapy
- robot assisted
- double blind
- clinical trial
- ejection fraction
- adipose tissue
- newly diagnosed
- cardiac surgery
- squamous cell carcinoma
- study protocol
- systematic review
- phase ii
- patient reported outcomes
- patient reported