Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000917235
Ethics application status
Approved
Date submitted
16/04/2008
Date registered
26/10/2009
Date last updated
26/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised controlled trial comparing the Efficacy and Clinical Outcomes of Single and Double Balloon Enteroscopy in patients referred for Balloon Enteroscopy for investigation or treatment of small bowel conditions.
Scientific title
A randomised controlled trial comparing the Efficacy and Clinical Outcomes of Single and Double Balloon Enteroscopy in patients referred for balloon enteroscopy for investigation or treatment of small bowel conditions'
Universal Trial Number (UTN)
Trial acronym
SINGLE-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balloon Enteroscopy 3066 0
Small bowel conditions 252053 0
Condition category
Condition code
Surgery 252250 252250 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adult males and females referred for Balloon Enteroscopy for investigation or treatment of small bowel conditions will be randomised either to Single Balloon enteroscopy (SBE) or Double Balloon Enteroscopy (DBE).

Single Balloon technology is designed to allow examination of the small bowel utilising a single balloon that maybe inflated or deflated to aid propulsion into the bowel. This is unique as the current alternative of double balloon enteroscopy requires two balloons that need to be independently controlled. Utilising a single balloon limits the complexity of the procedure.

Study duration will be 2 years and patients will be recruited over 18months.

Each patient will undergo one procedure.
Intervention code [1] 2809 0
Treatment: Devices
Comparator / control treatment
Double Balloon Enteroscopy (DBE).

DBE involves using an instrument (enteroscope) with a flexible shaft containing a camera at one end that can be steered and advanced into the small bowel; either by beginning at the mouth or beginning at the anus. Movement of this enteroscope through the bowel is assisted by two balloons, one which is attached to the enteroscope and one which is attached to a flexible tube through which the enteroscope is passed through. With a combination of steering, pushing and pulling the instrument, as well as inflating and deflating the two balloons, the instrument can be safely passed into the small bowel.

Study duration will be 2 years and patients will be recruited over 18 months.

Each patient will undergo one procedure, lasting approximately 60-90minutes.
Control group
Active

Outcomes
Primary outcome [1] 4103 0
Diagnostic yield. The diagnostic yield will be calculated by considering the number of procedures in which clinically significant positive findings were identified as a proportion of the total procedures undertaken. This will be done for both Double Balloon Enteroscopy and Single Balloon Enteroscopy and the results will be compared.
Timepoint [1] 4103 0
Conclusion of Study
Secondary outcome [1] 257974 0
Therapeutic yield. The therapeutic yield will be calculated by considering the number of procedures in which therapeutic intervention was undertaken as a proportion of the total procedures undertaken. This will be done for both Double Balloon Enteroscopy and Single Balloon Enteroscopy and the results will be compared.
Timepoint [1] 257974 0
Conclusion of Study
Secondary outcome [2] 257975 0
Depth of insertion. This will be measured on withdrawal of the enteroscope. The measurement will be from the ileocaecal valve for procedures via colon and the pylorus for procedures via the mouth.

Two methods will be used:

(1) estimation every 5cm after training with a marked probe
(2) counting the number of small bowel folds encountered
Timepoint [2] 257975 0
Interim analysis once 100 patients have been recruited.
Secondary outcome [3] 257976 0
Health care utilisation. We will record the number of hospital admissions related to the indication for enteroscopy up to 6 months before enteroscopy as well 6 months post enetroscopy. The two will be compared.
Timepoint [3] 257976 0
6 months post closing of recruitment.

Eligibility
Key inclusion criteria
Adult >18 years
Clinically accepted indication for Balloon enteroscopy. Willingness to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any contraindication to Balloon Enteroscopy.

Study design
Purpose of the study
Diagnosis
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3313 0
Hospital
Name [1] 3313 0
St Vincent's Hospital Melbourne
Country [1] 3313 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
35 Fitzroy St, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 251280 0
None
Name [1] 251280 0
Address [1] 251280 0
Country [1] 251280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5298 0
St Vincent's Hospital Human Research and Ethics Committee (HREC) A
Ethics committee address [1] 5298 0
Fitzroy ST, Fitzroy,
Victoria 3065
Ethics committee country [1] 5298 0
Australia
Date submitted for ethics approval [1] 5298 0
Approval date [1] 5298 0
04/07/2008
Ethics approval number [1] 5298 0
1/08/0035

Summary
Brief summary
The main purpose of the study is to compare two different instruments that are used to assess and treat conditions of the small bowel.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28538 0
Address 28538 0
Country 28538 0
Phone 28538 0
Fax 28538 0
Email 28538 0
Contact person for public queries
Name 11695 0
Dr Marios Efthymiou
Address 11695 0
35 Fitzroy St,
Fitzroy, VIC 3065
Country 11695 0
Australia
Phone 11695 0
+61392882211
Fax 11695 0
+61386781032
Email 11695 0
[email protected]
Contact person for scientific queries
Name 2623 0
Dr Marios Efthymiou
Address 2623 0
35 Fitzroy St, Fitzroy, VIC 3065
Country 2623 0
Australia
Phone 2623 0
+61392882211
Fax 2623 0
+61386781032
Email 2623 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.