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.
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'
St Vincent's Hospital Melbourne
300 participants
Jul 5, 2008
Interventional
Conditions
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.
Eligibility
Inclusion Criteria2
- Adult >18 years
- Clinically accepted indication for Balloon enteroscopy. Willingness to participate
Exclusion Criteria1
- Any contraindication to Balloon Enteroscopy.
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Interventions
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.
Locations(1)
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ACTRN12609000917235