Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Study Overview
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Brief Summary
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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.

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

Conditions
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Colo-rectal Cancer, Crohn Disease, Resectable Colorectal Carcinoma

Intervention / Treatment
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* Drug: ICG-guided bowel perfusion assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis; Patients aged over 18 years old; Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions; Signed informed consent prior to any study-mandated procedure; Exclusion Criteria: Known allergy or history of adverse reaction to ICG, iodine or iodine dyes; Severe liver or kidney insufficiency; Hyperthyroidism or a benign thyroid tumour; Pregnant or breastfeeding women; Scheduled for palliative surgery or terminal ill Scheduled for a diverting stoma 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; Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid; Emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: National randomized controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Image Guided Bowel Anastomosis group<br>ICG-guided perfusion assessment | Drug: ICG-guided bowel perfusion assessment<br>* ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.<br>|
| No Intervention: Conventional Bowel Anastomosis group<br>conventional perfusion assessment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-days Anastomotic Leakage (AL) rate | Anastomotic leakage rate | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days Anastomotic Leakage ( AL) rate | Anastomotic leakage rate | 30 days | 
| complication rate |  | 90 days | 
| mortality |  | 90 days | 
| days in hospital stay |  | 90 days |