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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT03781206
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years, any sex;
* Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications;
* Normal water contrast enema prior to surgery;
* Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;
* Both immunosuppressant and biological medications are allowed for IBD patients.
Exclusion Criteria:
* Patients age at screening \< 18 years;
* Pregnant or breastfeeding women;
* Neurodegenerative disorders or psychiatric diseases;
* Contraindications or hypersensitivity to the use of the investigational product or its components;
* Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments;
* Patients with post-operative bleeding (to be assessed 24 hours after surgery).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03781206
Study Brief:
Protocol Section:
NCT03781206