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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06496516




Registration number
NCT06496516
Ethics application status
Date submitted
3/07/2024
Date registered
11/07/2024
Date last updated
11/07/2024

Titles & IDs
Public title
Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis
Scientific title
Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis
Secondary ID [1] 0 0
109504
Universal Trial Number (UTN)
Trial acronym
TAPAS-UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Hospitalized patients with flare of ulcerative colitis -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic accuracy of transperineal ultrasound
Timepoint [1] 0 0
At enrolment and at week 10 after hospital discharge
Secondary outcome [1] 0 0
Additive diagnostic accuracy of transperineal ultrasound compared to transabdominal intestinal ultrasound
Timepoint [1] 0 0
At enrolment and at week 10 following hospital discharge
Secondary outcome [2] 0 0
Patient reported acceptability of transperineal ultrasound
Timepoint [2] 0 0
At enrolment and at week 10 following hospital discharge
Secondary outcome [3] 0 0
Additive diagnostic accuracy of transabdominal intestinal ultrasound compared to transperineal ultrasound
Timepoint [3] 0 0
At enrolment and at week 10 following hospital discharge

Eligibility
Key inclusion criteria
* Patients aged >= 18 years old
* Presentation with a moderate or severe flare of ulcerative colitis as defined by standard clinical and laboratory criteria
* Confirmed diagnosis of ulcerative colitis or clinical history consistent with the disease
* Ability to provide informed consent and willingness to comply with study protocols
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant women
* Patients with severe comorbidities for whom endoscopic assessment is contraindicated
* Patients with non-UC colitis (e.g. Crohn's colitis, ischaemic colitis)
* Patients with active perianal disease deemed by the study coordinators as severe enough to preclude the comfortable use of trans-perineal ultrasound

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 0 0
4575 - Birtinya

Funding & Sponsors
Primary sponsor type
Other
Name
Sunshine Coast Hospital and Health Service
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Our aim is to determine how useful transperineal ultrasound is to assess the severity of inflammation in patients with ulcerative colitis. At the moment, there is a small amount of evidence showing it may be just as good as flexible sigmoidoscopy for this purpose. It is a non-invasive test, which means if it is equivalent, it may reduce the need for invasive tests like flexible sigmoidoscopy in the future.

Patients admitted to hospital with a flare of ulcerative colitis will be invited to participate. Participants will undergo standard of care treatment and investigation. In addition to this, they will undergo a specialized non-invasive ultrasound test through the perineum (TPUS) as well as the abdomen (TA-IUS). The results from this will be compared to the current standard, flexible sigmoidoscopy. Patients will undergo repeat ultrasound and flexible sigmoidoscopy ten weeks after hospital discharge.

We aim to show that transperineal ultrasound is useful for assessing disease severity and predicting the treatment course of hospitalized patients, and may be able to replace flexible sigmoidoscopy in some circumstances.
Trial website
https://clinicaltrials.gov/study/NCT06496516
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lauren S White, MBBS
Address 0 0
Sunshine Coast Hospital and Health Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Adam S Haig, MD
Address 0 0
Country 0 0
Phone 0 0
0752020000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06496516