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

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

Abstract

Introduction: Anastomotic 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 analysis: A 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 dissemination: This 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 number: NCT04712032; NL7502.

Keywords: Gastrointestinal imaging; Gastrointestinal tumours; Inflammatory bowel disease; SURGERY.

Conflict of interest statement

Competing interests: ALV and LS are members of the Diagnostic Green advisory board. All other authors declare to have no competing interest concerning this work.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Surgical flowchart. CRF, case report form; ICG, indocyanine green; NIRF, near-infrared fluorescence.

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