Post-operative Crohn's Endoscopic Recurrence Study (POCER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Kamm, University of Melbourne
ClinicalTrials.gov Identifier:
NCT00989560
First received: October 2, 2009
Last updated: January 10, 2014
Last verified: January 2014

October 2, 2009
January 10, 2014
August 2009
April 2013   (final data collection date for primary outcome measure)
Endoscopic recurrence of disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00989560 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post-operative Crohn's Endoscopic Recurrence Study
Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Crohn's Disease
Procedure: endoscopy
patients receive best treatment and care with an additional endoscopy
  • Active Comparator: Active arm
    Intervention: Procedure: endoscopy
  • No Intervention: Standard care arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00989560
HREC-A 077/09
Yes
Michael Kamm, University of Melbourne
University of Melbourne
Not Provided
Principal Investigator: Michael A Kamm, MBBS MD FRCP FRACP St Vincent's Hospital, Melbourne; University of Melbourne
Principal Investigator: Peter De Cruz, MBBS, FRACP St Vincent's Hospital, Melbourne; University of Melbourne
University of Melbourne
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP