10 cm versus 15 cm J-shaped ileal pouch after IPAA surgery
Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis
This trial will see if a 10 cm or a 15 cm J-pouch gives better bowel function and quality of life for people having IPAA for ulcerative colitis or familial adenomatous polyposis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Trial ID | NCT06538402 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults undergoing primary IPAA for ulcerative colitis or familial adenomatous polyposis with intact sphincter function and sufficient small bowel reach to allow either a 10 cm or 15 cm pouch are ideal candidates.
Not a fit: Patients with Crohn's disease, poor sphincter control, insufficient small-bowel reach, or those undergoing staged or revision pouches are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, selecting the optimal pouch length could improve bowel function and quality of life and may reduce pouch-related complications.
How similar studies have performed: Observational series and surgical reports suggest pouch length can influence function, but randomized comparisons are limited, so this specific randomized approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.