Crohn Disease, Inflammatory Bowel Diseases, Stricture; Colon, Ulcerative Colitis
Conditions
Keywords
Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Intestinal stricture
Brief summary
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
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.
Interventions
None listed
Sponsors
Australasian Gastro Intestinal Research Foundation
St Vincent's Hospital Melbourne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of symptoms | 12 months | Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging features associated with development of symptoms (MRI). | 12 months | MaRIA |
| Imaging features associated with development of symptoms (Intestinal Ultrasound). | 12 months | Limberg's score |
| Biochemical features associated with development of symptoms | 12 months | CRP and calprotectin |
| Patient reported outcomes | 12 months | SF36 |
| Requirement for step up in drug therapy | 12 months | Need for additional drug therapy due to development of symptoms |
Countries
Australia
Outcome results
None listed