Post-operative Crohn's Endoscopic Recurrence Study

Last updated: January 10, 2014
Sponsor: University of Melbourne
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Colic

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT00989560
HREC-A 077/09
  • Ages > 18
  • All Genders

Study Summary

This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint is the severity of endoscopic recurrence. In addition, tissue will be collected for microbiological and immunological analysis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • clinical diagnosis of Crohn's and proven history of disease

  • patient undergone surgical resection with creation of a primary anastomosis

Exclusion

Exclusion Criteria:

  • endoscopically inaccessible anastomosis by standard colonoscopy

  • presence of an end stoma

  • pregnancy

  • suspected perforation of the gastrointestinal tract

  • presence of certain unsuitable comorbidities

Study Design

Total Participants: 175
Study Start date:
August 01, 2009
Estimated Completion Date:
April 30, 2013

Connect with a study center

  • St Vincent's Hospital

    Melbourne, Victoria 3065
    Australia

    Site Not Available

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