Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

Odense University Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Ulcerative Colitis Familial Adenomatous Polyposis

Interventions

10 cm pouchPROCEDURE

A 10 cm pouch will be constructed

15 cm pouchPROCEDURE

A 15 cm pouch will be constructed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Denmark

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1, 3, 5 and 10 years after surgery

Secondary Outcomes

Short Inflammatory Bowel Disease Questionnaire

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)

Time frame: 1, 3, 5 and 10 years after surgery

Short-form (SF)-36

Consists of questions relating to 8 domains of life with a total score ranging from 0-100, with lower numbers indicating worse health status

Time frame: 1, 3, 5 and 10 years after surgery

Postoperative complications using the Comprehensive Complication Index (CCI)

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.

Time frame: 90 days after surgery

Pouch failure

Hazard ratio of pouch failure defined as an intended permanent ileostomy with or without pouch excision

Time frame: 1, 3, 5 and 10 years after surgery

Central Contacts

Anders Mark-Christensen, MD, PhD

CONTACT

+45 51236691 anders.mark.christensen2@rsyd.dk

Data from ClinicalTrials.gov

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