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Recruiting Not applicable

Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

NCT06538402 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-07-03
Last updated
2025-07-09

Condition(s) studied

Ulcerative ColitisFamilial Adenomatous Polyposis

Investigational drug(s) / intervention(s)

10 cm pouch15 cm pouch

10 cm pouch: A 10 cm pouch will be constructed

15 cm pouch: A 15 cm pouch will be constructed

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Pouch dysfunction score — 1, 3, 5 and 10 years after surgery
    Ranges from 0 to 7.5, where a low score indicates good bowel function will little to no impact on quality of life

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark Recruiting
Hvidovre Hospital Hvidovre Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06538402 on ClinicalTrials.gov ↗ ← All trials in Denmark