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

Abstract

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.

Indocyanine green fluorescence imaging during laparoscopic rectal cancer surgery could reduce the incidence of anastomotic leakage: A single institutional retrospective cohort study

“…It has been suggested that RCTs might have some aws, such as sample size and endpoint selection [32]. Several RCTs are currently ongoing to prove the clinical bene t of routine use of ICG uorescence [33,34]. In this study, while operating time was signi cantly associated with AL incidence after laparoscopic rectal cancer surgery, male sex and tumor location tended to be associated with AL.…”

Indocyanine Green Fluorescence Guided Surgery in Colorectal Surgery

“…Nevertheless, this is yet to be proven in well-conducted and powered randomized control trials. Hopefully, the results of the AVOID study will provide the evidence needed to dissolve any ensuing skepticism on this modality [ 15 ]. A recently published Delphi consensus of international experts on the use of ICG further supported the use of ICG for anastomotic perfusion assessment (100% consensus reached), as well as issues such as timing and dosage of ICG for perfusion assessment during colorectal surgery [ 108 , 109 ].…”

“…One of these metanalyses [ 14 ] reported that the weighted mean rate of change in the surgical plan due to ICG imaging was 9.6% (95% CI 7.3–11.8). Currently, another phase III multicenter randomized controlled trial is being launched (NCT04712032; NL7502) [ 15 ] aiming to provide high quality evidence regarding the role of ICG in the reduction of clinically relevant ALs. The current literature reports that ICG assessment is a safe and rapid means of assessing anastomotic perfusion/bowel perfusion ( Figure 2 ) and may result in reduction of AL.…”

Indocyanine green fluorescence imaging during laparoscopic rectal cancer surgery could reduce the incidence of anastomotic leakage: a single institutional retrospective cohort study

“…It has been suggested that RCTs might have some flaws, such as sample size and endpoint selection [ 33 ]. However, several RCTs are currently ongoing to prove the clinical benefit of routine use of ICG fluorescence [ 34 , 35 ], such as Essential Trial, whose results remain unpublished. In this study, while operating time was significantly associated with AL incidence after laparoscopic rectal cancer surgery, male sex and tumor location tended to be associated with AL.…”