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Trial Title:
Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis: An Assessor-blinded, Randomized Controlled Trial
NCT ID:
NCT06538402
Condition:
Ulcerative Colitis
Familial Adenomatous Polyposis
Conditions: Official terms:
Adenomatous Polyposis Coli
Colitis
Colitis, Ulcerative
Conditions: Keywords:
ileal pouch-anal anastomosis
ulcerative colitis
familial adenomatous polyposis
randomized controlled trial
pouch function
quality of life
complications
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
10 cm pouch
Description:
A 10 cm pouch will be constructed
Arm group label:
10 cm
Intervention type:
Procedure
Intervention name:
15 cm pouch
Description:
A 15 cm pouch will be constructed
Arm group label:
15 cm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus
Country:
Denmark
Contact:
Last name:
Sanne Harsløf, MD PhD
Email:
sanne.harslof@rm.dk
Facility:
Name:
Hvidovre Hospital
Address:
City:
Hvidovre
Country:
Denmark
Contact:
Last name:
Frederik Rønne Pachler, MD PhD
Email:
fpachler@gmail.com
Start date:
September 1, 2024
Completion date:
September 1, 2038
Lead sponsor:
Agency:
Odense University Hospital
Agency class:
Other
Source:
Odense University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06538402
