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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
endoscopy
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Active arm

Standard care arm

Arm Description

Outcomes

Primary Outcome Measures

Endoscopic recurrence of disease

Secondary Outcome Measures

Full Information

First Posted
October 2, 2009
Last Updated
January 10, 2014
Sponsor
University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT00989560
Brief Title
Post-operative Crohn's Endoscopic Recurrence Study
Acronym
POCER
Official Title
Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active arm
Arm Type
Active Comparator
Arm Title
Standard care arm
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
endoscopy
Intervention Description
patients receive best treatment and care with an additional endoscopy
Primary Outcome Measure Information:
Title
Endoscopic recurrence of disease
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Kamm, MBBS MD FRCP FRACP
Organizational Affiliation
St Vincent's Hospital, Melbourne; University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter De Cruz, MBBS, FRACP
Organizational Affiliation
St Vincent's Hospital, Melbourne; University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
34035441
Citation
Teh JJ, Berendsen EM, Hoedt EC, Kang S, Zhang J, Zhang F, Liu Q, Hamilton AL, Wilson-O'Brien A, Ching J, Sung JJY, Yu J, Ng SC, Kamm MA, Morrison M. Novel strain-level resolution of Crohn's disease mucosa-associated microbiota via an ex vivo combination of microbe culture and metagenomic sequencing. ISME J. 2021 Nov;15(11):3326-3338. doi: 10.1038/s41396-021-00991-1. Epub 2021 May 25.
Results Reference
derived
PubMed Identifier
27076772
Citation
Wright EK, Kamm MA, Dr Cruz P, Hamilton AL, Ritchie KJ, Bell SJ, Brown SJ, Connell WR, Desmond PV, Liew D. Cost-effectiveness of Crohn's disease post-operative care. World J Gastroenterol. 2016 Apr 14;22(14):3860-8. doi: 10.3748/wjg.v22.i14.3860.
Results Reference
derived
PubMed Identifier
25855073
Citation
Wright EK, Kamm MA, De Cruz P, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Sparrow MP, Florin TH, Gibson PR, Debinski H, Gearry RB, Macrae FA, Leong RW, Kronborg I, Radford-Smith G, Selby W, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Desmond PV. Effect of intestinal resection on quality of life in Crohn's disease. J Crohns Colitis. 2015 Jun;9(6):452-62. doi: 10.1093/ecco-jcc/jjv058. Epub 2015 Apr 8.
Results Reference
derived
PubMed Identifier
25620670
Citation
Wright EK, Kamm MA, De Cruz P, Hamilton AL, Ritchie KJ, Krejany EO, Leach S, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Jakobovits SL, Florin TH, Gibson PR, Debinski H, Macrae FA, Samuel D, Kronborg I, Radford-Smith G, Selby W, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Day AS, Desmond PV, Gearry RB. Measurement of fecal calprotectin improves monitoring and detection of recurrence of Crohn's disease after surgery. Gastroenterology. 2015 May;148(5):938-947.e1. doi: 10.1053/j.gastro.2015.01.026. Epub 2015 Jan 22.
Results Reference
derived
PubMed Identifier
25542620
Citation
De Cruz P, Kamm MA, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Gibson PR, Sparrow M, Leong RW, Florin TH, Gearry RB, Radford-Smith G, Macrae FA, Debinski H, Selby W, Kronborg I, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Desmond PV. Crohn's disease management after intestinal resection: a randomised trial. Lancet. 2015 Apr 11;385(9976):1406-17. doi: 10.1016/S0140-6736(14)61908-5. Epub 2014 Dec 24.
Results Reference
derived

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Post-operative Crohn's Endoscopic Recurrence Study

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