Journal Article

AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery

Faber, Robin A, Denise, E, van Wely, Bob J., Braak, Jeffrey P B M, Faraj, Dashti, Coen, I.M, Hein Putter, J, Holman, Fabian .A., Mieog, J Sven D, Brouwers, Mark A.M., Sikkenk, Daan J., Meijer, Ruben P J, Bijlstra, Okker D., Bloemen, Johanne G., Stassen, Laurents P.S., Bijlstra, Okker D, Meershoek-Klein Kranenbarg, Elma, Gobardhan, Paul D., Faber, Robin A., Burggraaf, Koos, Putter, Hein, Mieog, Sven D., Vahrmeijer, Alexander L, van der Valk, Maxime J.M., Bodegom, Annelies, Consten, Esther C.J., Meijer, Ruben P.J., Boersma, Fran, Kauwenbergh, Tessa, Hilling, Denise E, Braak, Jeffrey P.B.M., Vahrmeijer, Alexander L., Meershoek-Klein Kranenbarg, E., Aukema, Hilling Tjeerd S., Bosscha, Koop, Wullaert, Lissa, Peeters, Koen C.M.J., Steup, Willem-Hans, Marinelli, Andreas W.K.S., Doornebosch, Pascal G., Neijenhuis, Peter A.

2022

Overview

IntroductionAnastomotic leakage (AL) is one of the major complications after colorectal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Several cohort studies have shown that indocyanine green (ICG) combined with fluorescent near-infrared imaging is a feasible and reproducible technique for real-time intraoperative imaging of tissue perfusion, leading to reduced leakage rates after colorectal resection. Unfortunately, these studies were not randomised. Therefore, we propose a randomised controlled trial to assess the value of ICG-guided surgery in reducing AL after colorectal surgery.Methods and analysisA multicentre, randomised controlled clinical trial will be conducted to assess the benefit of ICG-guided surgery in preventing AL. A total of 978 patients scheduled for colorectal surgery will be included. Patients will be randomised between the Fluorescence Guided Bowel Anastomosis group and the Conventional Bowel Anastomosis group. The primary endpoint is clinically relevant AL (defined as requiring active therapeutic intervention or reoperation) within 90 days after surgery. Among the secondary endpoints are 30-day clinically relevant AL, all-cause postoperative complications, all-cause and AL-related mortality, surgical and non-surgical reinterventions, total surgical time, length of hospital stay and all-cause and AL-related readmittance.Ethics and disseminationThis protocol has been approved by the Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) and is registered at ClinicalTrials.gov and trialregister.nl. The results of this study will be reported through peer-reviewed publications and conference presentations.Trial registration numberNCT04712032; NL7502.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Anastomosis, Surgical - adverse effects / Anastomotic Leak - prevention & control / Colorectal surgery / Colorectal Surgery - adverse effects / Digestive System Surgical Procedures - adverse effects / Gastrointestinal imaging / Gastrointestinal tumours / Hospitals / Humans / Indocyanine Green - therapeutic use / Inflammatory bowel disease / Iodine / Laparoscopy / Patients / Robotics / Surgeons / Surgery