Service Development of POCUS in the IBD Clinic

NCT05838196 | Completed

• 1 other identifier: 155436
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care.

Conditions

Inflammatory Bowel Diseases

Keywords

Intestinal ultrasound

Outcome Measures

Primary Outcomes (1)

• Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care

  Time in days for when a new medication is started, dose changed, medication stopped, or surgery performed following the clinic appointment

  6 months

Secondary Outcomes (9)

• Does point of care ultrasound change clinical decision making in the IBD clinic

  Immediate

• Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy)

  6 months

• Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care

  1 year

• Compare findings at POCUS when performed by a gastroenterologist or a radiologist

  6 months

• Compare clinical disease activity scores when POCUS is used compared with standard of care

  6 months

Study Arms (2)

Control

NO INTERVENTION

Participant will follow standard of care

Point-of-care Ultrasound

EXPERIMENTAL

Participant will receive point-of-care ultrasound at time of clinic appointment and clinician will use result to inform treatment decision

Diagnostic Test: Point-of-care ultrasound

Interventions

Point-of-care ultrasound DIAGNOSTIC_TEST

Point-of-care ultrasound performed during clinic appointment

Point-of-care Ultrasound

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16 years or above
• Attending IBD clinic face-to-face
• Able to give informed consent.
• Belonging to one of the following groups:
• New patients with high clinical suspicion of IBD
• Known UC/IBD-U and possible flare
• Known Crohn's and possible flare
• Known IBD and assessing response to a new medication or following surgery
• Known IBD and clinician planning endoscopic or radiological investigations

You may not qualify if:

• Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals NHS Trust

London, NW1 2PG, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• William Blad, BM BCh

  University College London Hospitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 1, 2023
• Study Start: April 24, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)