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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989560
First Posted: October 5, 2009
Last Update Posted: January 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Kamm, University of Melbourne
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Procedure: endoscopy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause

Resource links provided by NLM:


Further study details as provided by Michael Kamm, University of Melbourne:

Primary Outcome Measures:
  • Endoscopic recurrence of disease [ Time Frame: 18 months ]

Enrollment: 175
Study Start Date: August 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active arm Procedure: endoscopy
patients receive best treatment and care with an additional endoscopy
No Intervention: Standard care arm

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989560


Locations
Australia, Victoria
St Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
University of Melbourne
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Kamm, Professorial Fellow, Department of Medicine, University of Melbourne
ClinicalTrials.gov Identifier: NCT00989560     History of Changes
Other Study ID Numbers: HREC-A 077/09
First Submitted: October 2, 2009
First Posted: October 5, 2009
Last Update Posted: January 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes