Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000916246
Ethics application status
Approved
Date submitted
19/08/2008
Date registered
26/10/2009
Date last updated
26/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study assessing the predictive value of testing stool for blood prior to capsule endoscopy for the investigation of iron deficiency anaemia or obscure gastrointestinal bleeding
Scientific title
A prospective study assessing the predictive value of faecal occult blood testing prior to capsule endoscopy for the investigation of iron deficiency anaemia or obscure gastrointestinal bleeding
Universal Trial Number (UTN)
Trial acronym
FINCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obscure Gastrointestinal Bleeding 3579 0
Iron deficiency Anaemia 3580 0
Condition category
Condition code
Oral and Gastrointestinal 3739 3739 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients referred for capsule endoscopy will undergo two faecal occult blood tests (FOBT) within two weeks prior to the capsule endoscopy. The results of the FOBT will be correlated with clinically significant findings on the capsule endoscopy, to assess whether there is a correlation between the two.
Intervention code [1] 3295 0
Diagnosis / Prognosis
Intervention code [2] 241440 0
Treatment: Devices
Comparator / control treatment
The yield of clinically significant findings on capsule endoscopy will be compared in patients with positive FOBT and those with negative FOBT, to calculate the negative and positive predictive values of FOBT for significant findings on capsule endoscopy.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4639 0
The predictive value of a positive FOBT for a clinically significant findings on capsule endoscopy.

The yield of clinically significant findings on capsule endoscopy will be compared in patients with positive FOBT and those with negative FOBT, to calculate the negative and positive predictive values of FOBT for significant findings on capsule endoscopy.
Timepoint [1] 4639 0
The results of the FOBT will be collected once the results of the capsule endoscopy have been verified (within 1-2 weeks of the capsule endoscopy). Statistical analysis will occur at the conclusion of the study.
Secondary outcome [1] 257977 0
Nil
Timepoint [1] 257977 0
Nil

Eligibility
Key inclusion criteria
Adult > 18years
Clinically accepted indication for capsule endoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented small intestinal stricture
History of recurrent small bowel obstruction
Allergy or contraindication to picoprep or alternative bowel preparation regimens.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3756 0
Hospital
Name [1] 3756 0
St Vincent's Hospital - Melbourne
Country [1] 3756 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital - Melbourne
Address
35 Fitzroy St, Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 3371 0
None
Name [1] 3371 0
Address [1] 3371 0
Country [1] 3371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5816 0
St Vincent's Hospital Human Research and Ethics Committee (HREC)
Ethics committee address [1] 5816 0
Ethics committee country [1] 5816 0
Australia
Date submitted for ethics approval [1] 5816 0
Approval date [1] 5816 0
30/07/2009
Ethics approval number [1] 5816 0
1/08/0086

Summary
Brief summary
The main purpose of the study is to test whether a faecal test done before capsule endoscopy can identify those patients that are likely to have a significant result on the capsule endoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28861 0
Address 28861 0
Country 28861 0
Phone 28861 0
Fax 28861 0
Email 28861 0
Contact person for public queries
Name 12018 0
Dr Marios Efthymiou
Address 12018 0
35 Fitzroy St, Fitzroy, Victoria 3065
Country 12018 0
Australia
Phone 12018 0
+61392882211
Fax 12018 0
+61386781032
Email 12018 0
marios.efthymiou@svhm.org.au
Contact person for scientific queries
Name 2946 0
Dr Marios Efthymiou
Address 2946 0
35 Fitzroy St, Fitzroy, Victoria 3065
Country 2946 0
Australia
Phone 2946 0
+61392882211
Fax 2946 0
+61386781032
Email 2946 0
marios.efthymiou@svhm.org.au

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

Documents added manually
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Documents added automatically
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