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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT05610995
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. ASA score 1-3
3. Colonic or rectal resection with anastomosis
4. Minimally invasive surgery
5. Patient living close to the hospital (\<1 hour drive)
6. Patient accompanied for 48 hours
7. Body Mass Index \< 40
8. Patient information and signature of consent
9. Patient affiliated to a social insurance plan
10. A pregnancy test must be performed before inclusion in women of childbearing age.
Non-inclusion Criteria:
1. Socially isolated patient and/or no 3G cell signal
2. Severe comorbidities defined as any of these characteristics:
1. Severe malnutrition (albumin \<30g/l)
2. Severe anemia \< 80 g/dl
3. Insulin-dependent diabetes type 1
e. Patient under anticoagulation f. Severe renal insufficiency
3. History of psychiatric illness with medication requirements
4. Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection)
5. Patient not wishing to enter the study
6. Patient in a period of exclusion from another study or ongoing participation in an interventional study
Exclusion Criteria:
1. Stoma preparation
2. Per operative conversion to laparotomy
3. CHUNG score \> 8
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05610995
Study Brief:
Protocol Section:
NCT05610995