NCT06845306

The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery

Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,268 (estimated)
• Sponsor: Vadim Kuznetsov · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment. An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results. Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.

Conditions

• Colo-rectal Cancer
• Colonic Neoplasms Malignant

Interventions

Type	Name	Description
DRUG	ICG-guided bowel perfusion assessment	ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
OTHER	Conventional Bowel Anastomosis group	conventional perfusion assessment

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: Russia