Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis: An Assessor-blinded, Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Ulcerative Colitis; Familial Adenomatous Polyposis
• Interventions: Procedure: 15 cm pouch; Procedure: 10 cm pouch

• Registration Number: NCT06538402
• Lead Sponsor: Odense University Hospital

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 anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.

Secondary aims include health-related quality of life measures and postoperative complications.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-05
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Study Start: 2024-09-01
• Primary Completion: 2028-09-01
• Study Completion: 2038-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 cm	15 cm pouch	Ileal reservoir length of 15 cm
10 cm	10 cm pouch	Ileal reservoir length of 10 cm

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Short Inflammatory Bowel Disease Questionnaire	1, 3, 5 and 10 years after surgery	Consists of 10 questions with a total score range from 10 (poor health-related quality of life) to 70 (good health-related quality of life)
Short-form (SF)-36	1, 3, 5 and 10 years after surgery	Consists of questions relating to 8 domains of life with a total score ranging from 0-100, with lower numbers indicating worse health status
Postoperative complications using the Comprehensive Complication Index (CCI)	90 days after surgery	The CCI is a continuous scale, where each postoperative complication as defined by Clavien-Dindo is assigned a weigth based on its severity. A total summarized score taking all complications into account is thus generated.
Pouch failure	1, 3 and 5 years after surgery	Hazard ratio of pouch failure defined as an intended permanent ileostomy with or without pouch excision

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark