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
  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
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:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 10, 2014
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 30, 2014