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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03218202




Registration number
NCT03218202
Ethics application status
Date submitted
7/07/2017
Date registered
14/07/2017
Date last updated
3/09/2019

Titles & IDs
Public title
Stricture Definition and Treatment (STRIDENT) Observational Study.
Scientific title
Stricture Definition and Treatment (STRIDENT) Observational Study.
Secondary ID [1] 0 0
SVHMelbourneSTRIDENT3
Universal Trial Number (UTN)
Trial acronym
STRIDENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Crohn Disease 0 0
Ulcerative Colitis 0 0
Stricture; Colon 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development of symptoms
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Imaging features associated with development of symptoms (MRI).
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Imaging features associated with development of symptoms (Intestinal Ultrasound).
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Biochemical features associated with development of symptoms
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Patient reported outcomes
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Patient reported outcomes
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Requirement for step up in drug therapy
Timepoint [6] 0 0
12 months

Eligibility
Key inclusion criteria
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI
or endoscopy but without associated symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/08/2019
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Gastro Intestinal Research Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03218202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emily Wright, MBBS PhD
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03218202