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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
978
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
Leiden University Medical Center
Leiden, South Holland, Netherlands
RECRUITING90-days Anastomotic Leakage (AL) rate
Anastomotic leakage rate
Time frame: 90 days
30-days Anastomotic Leakage ( AL) rate
Anastomotic leakage rate
Time frame: 30 days
complication rate
Time frame: 90 days
mortality
Time frame: 90 days
days in hospital stay
Time frame: 90 days
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