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

NCT06845306 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1268

Last updated 2025-02-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vadim Kuznetsov

    lead NETWORK

Principal Investigators

  • Victor Kashchenko, Doctor of Medical Sciences · BELOOSTROV Clinic of High Technologies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-07-01
Completion
2026-09-01

Countries

  • Russia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06845306 on ClinicalTrials.gov