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Spots Global Cancer Trial Database for Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

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Trial Identification

Brief Title: Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

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

Study ID: NCT04712032

Study Description

Brief 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands

Contact Details

Name: Alexander Vahrmeijer, MD, PhD

Affiliation: LUMC

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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