AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery
BMJ Open, vol. 12, pp. e051144
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.
Authors 10
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R.P. Meijer Aachen Centre for Human Drug Research (CHDR) Department of Surgery, Leiden University Medical Center
Leiden University Medical Center · Centre for Human Drug Research
Affiliation as printed
Centre for Human Drug Research, Leiden, South Holland, Netherlands
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Surgery, Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands
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Centre for Human Drug Research
Affiliation as printed
Centre for Human Drug Research, Leiden, South Holland, Netherlands
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Leiden University Medical Center
Affiliation as printed
Surgery, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands
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Leiden University Medical Center · Erasmus MC
Affiliation as printed
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands d.hilling@erasmusmc.nl
Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands
Department of Surgery, Leiden University Medical Center, Leiden, Netherlands
Cited by 36 stored of 36
Cited by patents worldwide 1 (Lens.org)
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METHOD AND APPARATUSWO2025191105A1 2025-09-18 Pending