RecruitingACTRN12609000917235

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'


Sponsor

St Vincent's Hospital Melbourne

Enrollment

300 participants

Start Date

Jul 5, 2008

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two instruments used to examine and treat conditions of the small intestine: single-balloon enteroscopy and double-balloon enteroscopy. Both involve passing a long flexible tube down through the mouth or up through the bowel to reach the small intestine, which is otherwise hard to access. Researchers want to find out which technique reaches more of the small bowel, gets better results, and has fewer complications. You may be eligible if: - You are 18 years or older - You have a clinically accepted reason to have a balloon enteroscopy - You are willing to participate You may NOT be eligible if: - You have any medical reason (contraindication) that makes balloon enteroscopy unsafe for you Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Entero

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)

Australia

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ACTRN12609000917235