Ulcerative Colitis, Pouchitis
Conditions
Keywords
Ileal Pouch Anal Anastomosis
Brief summary
Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).
Detailed description
AIMS: 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.
Interventions
DIAGNOSTIC_TESTIntestinal Ultrasound
Transabdominal and trans perineal ultrasound of the pouch
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 * Decompensated Cirrhosis * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings | 2 hours per subject for ultrasound. | Radiologists were blinded to pouchoscopy with biopsy results and evaluated the intestinal ultrasound of the pouch for each patient; assessing whether normal healthy pouch or inflammation was present. Those results were then compared to gold standard of pouchoscopy with biopsies to confirm accuracy. The number (n(%)) of participants with abnormal ultrasound findings confirmed with gold standard are reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDarrell Pardi, MD
Mayo Clinic
Participant flow
Recruitment details
protocol goal was to enroll 109, only 66 subject signed consent, and took part in the study.
Pre-assignment details
Of the 66 subject that signed consent and had testing 11 subject ultrasound images not used for analysis, due to technique of preforming ultrasound.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 55.11 age |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
None listed