Stricture Definition and Treatment (STRIDENT) Observational Study.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stricture Definition and Treatment (STRIDENT) Observational Study.

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Stricture; Colon

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of symptoms | Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging features associated with development of symptoms (MRI). | MaRIA | 12 months | 
| Imaging features associated with development of symptoms (Intestinal Ultrasound). | Limberg's score | 12 months | 
| Biochemical features associated with development of symptoms | CRP and calprotectin | 12 months | 
| Patient reported outcomes | SF36 | 12 months | 
| Patient reported outcomes | IBDQ | 12 months | 
| Requirement for step up in drug therapy | Need for additional drug therapy due to development of symptoms | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Intestinal stricture