Overview

Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Alrijne Hospital
Amphia Hospital
Catharina Ziekenhuis Eindhoven
Haga Hospital
IJsselland
Jeroen Bosch Ziekenhuis
Medical Center Haaglanden
Criteria
Inclusion Criteria:

1. Scheduled for laparoscopic or robotic-assisted colorectal resection with primary
anastomosis;

2. Patients aged over 18 years old;

3. Has the ability to communicate well with the Investigator in the Dutch language and
willing to comply with the study restrictions;

4. Signed informed consent prior to any study-mandated procedure;

Exclusion Criteria:

1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;

2. Severe liver or kidney insufficiency;

3. Hyperthyroidism or a benign thyroid tumour;

4. Pregnant or breastfeeding women;

5. Scheduled for palliative surgery or terminal ill

6. Scheduled for a diverting stoma

7. Any condition that the investigator considers to be potentially jeopardizing the
patients well-being or the study objectives (following a detailed medical history and
physical examination;

8. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol,
nitrofurantoin, probenecid;

9. Emergency surgery