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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Kamm, University of Melbourne
ClinicalTrials.gov Identifier:
NCT00989560
First received: October 2, 2009
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  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
Procedure: standard best practice post-operative care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Endoscopic recurrence of disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: August 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 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 Procedure: standard best practice post-operative care
Patients receive best treatment and care currently available

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 2, 2009
Last Updated: March 12, 2012
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013