Stricture Definition and Treatment (STRIDENT) Observational Study.

NCT ID: NCT03218202

Last Updated: 2019-09-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-09

Study Completion Date

2019-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with asymptomatic Crohn's disease strictures will be followed prospectively for 12 months using imaging (including MRI/intestinal ultrasound) and biochemical analyses (including CRP/calprotectin). Patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. Risk factors for progression of strictures and development of symptoms will be identified.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Stricture; Colon

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy but without associated symptoms

Exclusion Criteria

* Low rectal or anal strictures
* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
* Inability to give informed consent
* Suspected perforation of the gastrointestinal tract
* Inability to undergo MRI small bowel due to a contraindication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Australasian Gastro Intestinal Research Foundation

OTHER

Sponsor Role collaborator

St Vincent's Hospital Melbourne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Kamm

Professor of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emily Wright, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital Melbourne

Bronte Holt, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital Melbourne

Michael Kamm, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital Melbourne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SVHMelbourneSTRIDENT3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Remote Monitoring of IBD
NCT05886322 UNKNOWN