Trial Outcomes & Findings for Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis (NCT NCT06316999)
NCT ID: NCT06316999
Last Updated: 2026-08-12
Results Overview
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.
COMPLETED
NA
66 participants
2 hours per subject for ultrasound.
2026-08-12
Participant Flow
protocol goal was to enroll 109, only 66 subject signed consent, and took part in the study.
Of the 66 subject that signed consent and had testing 11 subject ultrasound images not used for analysis, due to technique of preforming ultrasound.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
technical issue with ultrasound recording, data not used for analysis
|
11
|
Baseline Characteristics
11 subjects that underwent exams did not have data to compare both the scope and ultrasound findings
Baseline characteristics by cohort
| Measure |
Patients With Pouchitis
n=66 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=55 Participants • 11 subjects that underwent exams did not have data to compare both the scope and ultrasound findings
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=55 Participants • 11 subjects that underwent exams did not have data to compare both the scope and ultrasound findings
|
|
Age, Categorical
>=65 years
|
21 Participants
n=55 Participants • 11 subjects that underwent exams did not have data to compare both the scope and ultrasound findings
|
|
Age, Continuous
|
55.11 age
n=55 Participants • 11 subjects that underwent exams did not have data to compare both the scope and ultrasound findings
|
|
Sex: Female, Male
Female
|
19 Participants
n=55 Participants • 11 subjects did not meet criteria for analysis based on ultrasound technigue.
|
|
Sex: Female, Male
Male
|
36 Participants
n=55 Participants • 11 subjects did not meet criteria for analysis based on ultrasound technigue.
|
PRIMARY outcome
Timeframe: 2 hours per subject for ultrasound.Population: 55 subject meet all requirements for use of their data for analysis.
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.
Outcome measures
| Measure |
Patients With Pouchitis
n=55 Participants
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
|
|---|---|
|
Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings
|
33 participants
|
Adverse Events
Patients With Pouchitis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place