Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2021
• Main ID: NCT04712032
• Date of registration: 14/01/2021
• Prospective Registration: No
• Primary sponsor: Leiden University Medical Center
• Public title: Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates AVOID
• Scientific title: A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
• Date of first enrolment: July 1, 2020
• Target sample size: 978
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04712032
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: Ruben Meijer, MD

• Name: Alexander Vahrmeijer, MD, PhD
• Affiliation: LUMC

• Name: Alexander Vahrmeijer, MD, PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Resectable Colorectal Carcinoma

Colo-rectal Cancer

Crohn Disease

Intervention(s)

Drug: ICG-guided bowel perfusion assessment

Primary Outcome(s)

90-days Anastomotic Leakage (AL) rate [Time Frame: 90 days]

Secondary Outcome(s)

complication rate [Time Frame: 90 days]

days in hospital stay [Time Frame: 90 days]

30-days Anastomotic Leakage ( AL) rate [Time Frame: 30 days]

mortality [Time Frame: 90 days]

Secondary ID(s)

P19.079

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

IJsselland

Haga Hospital

Medical Center Haaglanden

Catharina Ziekenhuis Eindhoven

Jeroen Bosch Ziekenhuis

Alrijne Hospital

Amphia Hospital