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NOT YET RECRUITING
NCT06845306
PHASE3

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

Sponsor: Vadim Kuznetsov

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1268

Start Date

2025-06-01

Completion Date

2026-09-01

Last Updated

2025-02-25

Healthy Volunteers

No

Interventions

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

Locations (1)

BELOOSTROV Clinic of High Technologies

Vsevolozhsk District, Leningradskaya Oblast', Russia