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Service Development of POCUS in the IBD Clinic

NCT ID: NCT05838196

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Inflammatory Bowel Diseases

Keywords

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Intestinal ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control

Participant will follow standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Point-of-care Ultrasound

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

Group Type EXPERIMENTAL

Point-of-care ultrasound

Intervention Type DIAGNOSTIC_TEST

Point-of-care ultrasound performed during clinic appointment

Interventions

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Point-of-care ultrasound

Point-of-care ultrasound performed during clinic appointment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Blad, BM BCh

Role: PRINCIPAL_INVESTIGATOR

University College London Hospitals Trust

Locations

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University College London Hospitals NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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155436

Identifier Type: -

Identifier Source: org_study_id