Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT04712032
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04712032
Study Brief:
Protocol Section:
NCT04712032