Familial Adenomatous Polyposis, Ulcerative Colitis
Conditions
Keywords
ileal pouch-anal anastomosis, ulcerative colitis, familial adenomatous polyposis, randomized controlled trial, pouch function, quality of life, complications
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.
Interventions
PROCEDURE10 cm pouch
A 10 cm pouch will be constructed
PROCEDURE15 cm pouch
A 15 cm pouch will be constructed
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, 5 and 10 years after surgery | Hazard ratio of pouch failure defined as an intended permanent ileostomy with or without pouch excision |
Countries
Denmark
Contacts
Primary ContactAnders Mark-Christensen, MD, PhD
Outcome results
None listed