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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT04722757
Eligibility Criteria:
Inclusion Criteria:
1. Patients with UC or IBD-U refractory to medical therapy or with dysplasia
2. Patients undergoing a 1-, 2-stage, 3-stage approach
3. Between 18 years old and 60 years old.
4. Speak English and/or primary language of recruiting center.
5. Provide informed consent
Exclusion Criteria:
1. Patients with familial adenomatous polyposis (FAP);
2. Patients with contraindications for laparoscopic surgery including previous laparotomy, toxic megacolon and chronic obstructive pulmonary disease (COPD) Gold III or higher;
3. Patients still taking steroids at the time of proctectomy and IPAA construction. A wash-out period of 8 weeks will be considered for all treatments before performing the pouch construction.
4. Patients with confirmed or suspected colorectal cancer;
5. Patients with primary sclerosing cholangitis (PSC)
6. Patients needing a hand-sewn anastomosis;
7. Redo-pouch surgery
8. Pregnancy and lactation (tested by a urinary pregnancy test)
9. Patients undergoing an urgent or emergent proctocolectomy. Those patients are still eligible if they undergo a subtotal colectomy first and a completion proctectomy in a second stage.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04722757
Study Brief:
Protocol Section:
NCT04722757