NCT04712032

Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 978 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.

Conditions

• Colo-rectal Cancer
• Crohn Disease
• Resectable Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	ICG-guided bowel perfusion assessment	ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-07-01
• Completion: 2022-10-01
• First posted: 2021-01-15
• Last updated: 2021-01-15

Locations

1 site across 1 country: Netherlands