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

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.
ClinicalTrials.gov Identifier: NCT00989560
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Michael Kamm, University of Melbourne

Tracking Information
First Submitted Date  ICMJE October 2, 2009
First Posted Date  ICMJE October 5, 2009
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE August 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2009)
Endoscopic recurrence of disease [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00989560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-operative Crohn's Endoscopic Recurrence Study
Official Title  ICMJE Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Crohn's Disease
Intervention  ICMJE Procedure: endoscopy
patients receive best treatment and care with an additional endoscopy
Study Arms  ICMJE
  • Active Comparator: Active arm
    Intervention: Procedure: endoscopy
  • No Intervention: Standard care arm
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2012)
175
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2009)
150
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00989560
Other Study ID Numbers  ICMJE HREC-A 077/09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Kamm, University of Melbourne
Study Sponsor  ICMJE University of Melbourne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Melbourne
Verification Date January 2014

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