Ten Versus Fifteen Centimeter Pouch in IPAA Surgery
TESTIMONY
Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedStudy Start
First participant enrolled
July 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 3, 2038
July 9, 2025
July 1, 2025
3 years
August 1, 2024
July 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pouch dysfunction score
Ranges from 0 to 7.5, where a low score indicates good bowel function will little to no impact on quality of life
1, 3, 5 and 10 years after surgery
Secondary Outcomes (4)
Short Inflammatory Bowel Disease Questionnaire
1, 3, 5 and 10 years after surgery
Short-form (SF)-36
1, 3, 5 and 10 years after surgery
Postoperative complications using the Comprehensive Complication Index (CCI)
90 days after surgery
Pouch failure
1, 3, 5 and 10 years after surgery
Study Arms (2)
10 cm
EXPERIMENTALIleal reservoir length of 10 cm
15 cm
ACTIVE COMPARATORIleal reservoir length of 15 cm
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital
Aarhus, Denmark
Hvidovre Hospital
Hvidovre, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2024
First Posted
August 5, 2024
Study Start
July 3, 2025
Primary Completion (Estimated)
July 3, 2028
Study Completion (Estimated)
July 3, 2038
Last Updated
July 9, 2025
Record last verified: 2025-07