Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00989560




Registration number
NCT00989560
Ethics application status
Date submitted
2/10/2009
Date registered
5/10/2009
Date last updated
13/01/2014

Titles & IDs
Public title
Post-operative Crohn's Endoscopic Recurrence Study
Scientific title
Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause
Secondary ID [1] 0 0
HREC-A 077/09
Universal Trial Number (UTN)
Trial acronym
POCER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - endoscopy

Active comparator: Active arm -

No intervention: Standard care arm -


Treatment: Surgery: endoscopy
patients receive best treatment and care with an additional endoscopy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Endoscopic recurrence of disease
Timepoint [1] 0 0
18 months

Eligibility
Key inclusion criteria
* clinical diagnosis of Crohn's and proven history of disease
* patient undergone surgical resection with creation of a primary anastomosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael A Kamm, MBBS MD FRCP FRACP
Address 0 0
St Vincent's Hospital, Melbourne; University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00989560