Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Phase 3

• Conditions: Colo-rectal Cancer; Resectable Colorectal Carcinoma; Crohn Disease
• Interventions: Drug: ICG-guided bowel perfusion assessment

• Registration Number: NCT04712032
• Lead Sponsor: Leiden University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15
• Primary Completion: 2022-07-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 978

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Image Guided Bowel Anastomosis group	ICG-guided bowel perfusion assessment	ICG-guided perfusion assessment

Primary Outcome Measures

Name	Time	Method
90-days Anastomotic Leakage (AL) rate	90 days	Anastomotic leakage rate

Secondary Outcome Measures

Name	Time	Method
days in hospital stay	90 days
mortality	90 days
complication rate	90 days
30-days Anastomotic Leakage ( AL) rate	30 days	Anastomotic leakage rate

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands