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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05838196
Other study ID # 155436
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 24, 2023
Est. completion date November 1, 2024

Study information

Verified date May 2024
Source University College, London
Contact William Blad, BM BCh
Phone +447841581873
Email william.blad@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

After being provided with study information and providing written informed consent, participants attending the inflammatory bowel disease clinic will be randomised to standard of care or to receiving an ultrasound during the clinic appointment. This ultrasound result will be used to determine treatment decisions. Participants will have a 6 month follow-up to capture outcome data and further medical record review will be conducted at one year.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date November 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Age 16 years or above - Attending IBD clinic face-to-face - Able to give informed consent. - Belonging to one of the following groups: 1. New patients with high clinical suspicion of IBD 2. Known UC/IBD-U and possible flare 3. Known Crohn's and possible flare 4. Known IBD and assessing response to a new medication or following surgery 5. Known IBD and clinician planning endoscopic or radiological investigations Exclusion Criteria: - Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Point-of-care ultrasound
Point-of-care ultrasound performed during clinic appointment

Locations

Country Name City State
United Kingdom University College London Hospitals NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Does point of care ultrasound change clinical decision making in the IBD clinic Does the clinical decision made before ultrasound differ from that following ultrasound. Immediate
Secondary Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy) Using formalised imaging or endoscopy as gold standard for determining disease activity, compare findings on POCUS to determine sensitivity and specificity 6 months
Secondary Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care Using NHS cost tariffs, estimated costs for participants following standard of care to those receiving POCUS over the year following enrolment 1 year
Secondary Compare findings at POCUS when performed by a gastroenterologist or a radiologist POCUS will be performed by gastroenterologists or radiologist and outcomes on sensitivity/specificity will be compared between the two 6 months
Secondary Compare clinical disease activity scores when POCUS is used compared with standard of care Using disease activity score questionnaires (HBI (If Crohn's disease) or SCCAI (If ulcerative Colitis)) at baseline and six months. 6 months
Secondary Compare use of steroids with POCUS compared with standard of care Number of courses of steroids and total steroid dose over the duration of the trial 1 year
Secondary Compare haemaglobin levels when POCUS is used compared with standard of care Are there significant difference between the change in haemaglobin from baseline to six months in the POCUS group compared with standard of care 6 months
Secondary Compare CRP levels when POCUS is used compared with standard of care Are there significant difference between the change in CRP from baseline to six months in the POCUS group compared with standard of care 6 months
Secondary Compare Platelets when POCUS is used compared with standard of care Are there significant difference between the change in platelets from baseline to six months in the POCUS group compared with standard of care 6 months
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