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

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.

Study Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Stricture; Colon

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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3065
      • St. Vincent's Hospital Melbourne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) without symptoms who are incidentally found to have a stricture on CT, MRI or endoscopy.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St Vincent's Hospital Melbourne
• Collaborators: Australasian Gastro Intestinal Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Crohn Disease; Intestinal stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Pathological Conditions, Anatomical; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Constriction, Pathologic; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: SVHMelbourneSTRIDENT3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No