Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates (AVOID)

Leiden University Medical Center (LUMC)

Status and phase: Unknown; Phase 3

Conditions: Colo-rectal Cancer; Resectable Colorectal Carcinoma; Crohn Disease

Treatments: Drug: ICG-guided bowel perfusion assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04712032

P19.079

Details and patient eligibility

About

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.

Enrollment: 978 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

978 participants in 2 patient groups

Image Guided Bowel Anastomosis group

Experimental group

Description:

ICG-guided perfusion assessment

Treatment:

Drug: ICG-guided bowel perfusion assessment

Conventional Bowel Anastomosis group

No Intervention group

Description:

conventional perfusion assessment