Ten Versus Fifteen Centimeter Pouch in IPAA Surgery | NCT06538402

Studies
Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

NCT06538402

Sponsor

Odense University Hospital

Status

Recruiting

Last Update Posted

Jul 9, 2025Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Ulcerative Colitis
Familial Adenomatous Polyposis

Interventions

10 cm pouch
15 cm pouch

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2025Actual

Primary Completion Date

Jul 3, 2028Estimated

Completion Date

Jul 3, 2038Estimated

First Submitted Date

Aug 1, 2024

First Submission Date that Met QC Criteria

Aug 1, 2024

First Posted Date

Aug 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2025

Last Update Posted Date

Jul 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
10 cm	Experimental	Ileal reservoir length of 10 cm	Procedure: 10 cm pouch
15 cm	Active Comparator	Ileal reservoir length of 15 cm	Procedure: 15 cm pouch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
10 cm pouch	Procedure	A 10 cm pouch will be constructed	10 cm
15 cm pouch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1, 3, 5 and 10 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
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)	1, 3, 5 and 10 years after surgery
Short-form (SF)-36

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anders Mark-Christensen, MD, PhD	Contact	+45 51236691		anders.mark.christensen2@rsyd.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital	Recruiting	Aarhus			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D011125	Adenomatous Polyposis Coli

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided