Ten Versus Fifteen Centimeter Pouch in IPAA Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOdense University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
10 cm pouch
Procedure/SurgeryA 10 cm pouch will be constructed
15 cm pouch
Procedure/SurgeryA 15 cm pouch will be constructed
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: 10 cmExperimental treatment 1 intervention
Group B: 15 cmActive comparator 1 intervention
Trial outcomes
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
Time frame
1, 3, 5 and 10 years after surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov