What is the Purpose of this Study?
The primary objective of this study is to perform a non-inferiority, randomized controlled trial to determine if pouch-related functional outcomes following ta-IPAA are not worse than after tabd-IPAA one year after surgery in UC. The COREFO questionnaire will be used to evaluate the functional outcome. Secondary objective is to assess pouch-related functional outcome within a year after surgery, measured at several intervals from surgery. This will include the assessment of COREFO questionnaire at 3 and 6 months. Other functional questionnaires will be used at 3, 6 and 12 months to measure the impact on urogenital function.
Eligibility
- 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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Functional Outcomes of Transanal Ileal Pouch-Anal Anastomosis Compared to Laparoscopic or Open Ileal Pouch-Anal Anastomosis: a Multi-Center, Randomized, Parallel-Group, Non-Inferiority Trial.