Evaluating Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis with Intestinal Ultrasound as a Diagnostic Tool
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-012169
NCT ID: NCT06316999
About this study
The purpose of this study is to establish normal sonographic parameters in patients with an ileal pouch-anal anastomosis (IPAA) and normal pouch function, and to evaluate the utility of Intestinal ultrasound (IUS) for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
* Adults (age ≥ 18 years)
* Diagnosis of ulcerative colitis (UC)
* Status post ileal pouch anal anastomosis IPAA (completed all stages)
Exclusion Criteria:
* Pediatric patients
* Indeterminate colitis
* Status post IPAA for familial adenomatous polyposis (FAP)
* BMI > 30 kg/m2
* Pregnant
* Cirrhosis
* Inability to provide informed consent
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/30/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Darrell Pardi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available