Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Alrijne Hospital Amphia Hospital Catharina Ziekenhuis Eindhoven Haga Hospital IJsselland Jeroen Bosch Ziekenhuis Medical Center Haaglanden