AVOID trial; a Prospective, Phase III, Multi-centre Randomised Controlled Trial
August 2024 – AVOID trial; a Prospective, Phase III, Multi-centre Randomised Controlled Trial using Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Assessment to Prevent Anastomotic Leakage in Minimally Invasive Colorectal Surgery.
Background – Anastomotic leakage (AL) is a severe postoperative complication in colorectal surgery, with an incidence up to 20% in rectal
resections. In its multifactorial aetiology, compromised bowel perfusion is considered a major contributing factor. Conventional perfusion assessment methods have a low predictive value for AL, highlighting the need for more accurate intraoperative diagnostic tests.
Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) is a technique that enables real-time assessment of intraoperative bowel perfusion. The aim of this study was to assess the clinical benefit of ICG NIR fluorescence bowel perfusion assessment in preventing AL.
Methods – This prospective, phase III, national multicentre randomised controlled trial included patients scheduled for laparoscopic or robotic colorectal surgery for benign and malignant diseases from eight participating hospitals in the Netherlands.
Patient allocation into the Fluorescence Guided Bowel Anastomosis group (FGBA) or Conventional Bowel group (CBA) was conducted randomly.
Findings – A total of 931 patients were included between 2 July 2020 and 21 February 2023 (FGBA group n=463: CBA-group n=481). The study population comprised of 485 (52.1%) men and 446 (47.9%) women.
Whilst the overall 90-day AL rate was not significantly different between FGBA and CBA groups, further exploration of specific sub-groups demonstrated a substantial reduction in AL rates among patients undergoing left sided and rectosigmoid resections.
- Indocyanine Green (ICG) use demonstrated significant improvement in leak rates for left-sided colectomy
- This phase III trial of 900+ patients showed a 5.2% reduction in anastomotic leak rates when ICG was used for left sided colectomy
- A leak rate of 12.8% was present in patients in non-ICG group v’s 7.6% when ICG was used in left sided colectomy group
- Patients who underwent rectosigmoid resection showed a 6.1% lower 90-day AL rate (FGBA group 8.6% V’s CBA group 14.7%)
Interpretation – Overall, the study unequivocally shows a statistically significant reduction in anastomotic leak rates when ICG is used for left sided colectomy.