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NCT00989560 Clinical Trial

Post-operative Crohn's Endoscopic Recurrence Study

Crohn's Disease Clinical Trial

— POCER  

Official title:
Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00989560
Other study ID # HREC-A 077/09
Secondary ID
Status Completed
Phase Phase 3
First received October 2, 2009
Last updated January 10, 2014
Start date August 2009
Est. completion date April 2013

Study information
Verified date January 2014
Source University of Melbourne
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

- patient undergone surgical resection with creation of a primary anastomosis

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• endoscopy
patients receive best treatment and care with an additional endoscopy

Locations
Country Name City State
Australia St Vincent's Hospital Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endoscopic recurrence of disease 18 months No
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