Status:
RECRUITING
Ten Versus Fifteen Centimeter Pouch in IPAA Surgery
Lead Sponsor:
Odense University Hospital
Conditions:
Ulcerative Colitis
Familial Adenomatous Polyposis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.
Detailed Description
The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anasto...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 3 2038
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06538402
Start Date
July 3 2025
End Date
July 3 2038
Last Update
July 9 2025
Active Locations (2)
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1
Aarhus University Hospital
Aarhus, Denmark
2
Hvidovre Hospital
Hvidovre, Denmark