10 cm versus 15 cm J-shaped ileal pouch after IPAA surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled trial comparing functional outcomes after construction of a 10 cm versus a 15 cm J-shaped ileal reservoir in primary ileal pouch-anal anastomosis. The primary outcome is bowel function correlated with patient-reported quality of life. Secondary outcomes include broader health-related quality of life measures and postoperative complications. Randomization occurs intraoperatively when the surgeon confirms both pouch lengths can be constructed without tension, and the trial is run at Danish surgical centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)
* Signed informed consent
* Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Hvidovre Hospital
  Hvidovre, Denmark Recruiting

Study contacts

• Study coordinator: Anders Mark-Christensen, MD, PhD
• Email: anders.mark.christensen2@rsyd.dk
• Phone: +45 51236691

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.