Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis
NCT ID: NCT06316999
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2024-07-01
2025-06-04
Brief Summary
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Detailed Description
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1. Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
2. Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with Pouchitis
Transabdominal and transperineal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS.
Intestinal Ultrasound
Transabdominal and trans perineal ultrasound of the pouch
Interventions
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Intestinal Ultrasound
Transabdominal and trans perineal ultrasound of the pouch
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ulcerative colitis (UC)
* Status post ileal pouch anal anastomosis IPAA (completed all stages)
Exclusion Criteria
* Indeterminate colitis
* Status post IPAA for familial adenomatous polyposis (FAP)
* BMI \> 30 kg/m2
* Pregnant
* Decompensated Cirrhosis
* Inability to provide informed consent
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Darrell S. Pardi, M.D.
Principal Investigator
Principal Investigators
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Darrell Pardi, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-012169
Identifier Type: -
Identifier Source: org_study_id
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