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Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Sponsored by St Vincent's Hospital Melbourne

About this trial

Last updated 5 years ago

Study ID

StVincentsMelbourneSTRIDENT1

Status

Unknown status

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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 develop such strategies.

What are the participation requirements?

Yes

Inclusion Criteria

- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

No

Exclusion Criteria

- Acute bowel obstruction requiring urgent surgical intervention

- Deemed by treating physician to have high risk of acute bowel obstruction

- Concurrent active perianal sepsis

- Internal fistulising disease in association with strictures (entero-enteric stulas)

- 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

- Pregnancy

- Inability to undergo MRI small bowel due to a contraindication.

Locations

Location

Status