Transperineal Ultrasound for Assessing and Predicting Response in Hospitalized Patients with a Flare of Ulcerative Colitis

NCT06496516 | Not Yet Recruiting

• 1 other identifier: 109504
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Transperineal Ultrasound; Intestinal Ultrasound

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of transperineal ultrasound

  The diagnostic accuracy of transperineal ultrasound when compared to the gold standard of flexible sigmoidoscopy.

  At enrolment and at week 10 after hospital discharge

Secondary Outcomes (3)

• Additive diagnostic accuracy of transperineal ultrasound compared to transabdominal intestinal ultrasound

  At enrolment and at week 10 following hospital discharge

• Patient reported acceptability of transperineal ultrasound

  At enrolment and at week 10 following hospital discharge

• Additive diagnostic accuracy of transabdominal intestinal ultrasound compared to transperineal ultrasound

  At enrolment and at week 10 following hospital discharge

Study Arms (1)

Hospitalized patients with flare of ulcerative colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to the Sunshine Coast University Hospital meeting the listed eligibility criteria during the study recruitment period

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Coast Hospital and Health Service: lead

Study Sites (1)

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Lauren S White, MBBS

  Sunshine Coast Hospital and Health Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam S Haig, MD

CONTACT

0752020000; adam.haig@health.qld.gov.au

Lauren S White, MBBS

CONTACT

+61752020000

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

AU (1)