NCT01587872

Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

Double-balloon Colonoscopy to Increase Cecal Intubation Rate in Technically Difficult Colonoscopies

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Sorlandet Hospital HF · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The aim of colonoscopy is to visualize the inside of the entire large bowel. Several factors can make the procedure difficult, and sometimes a complete examination is not possible. Complicating factors include poor bowel preparation and technical challenges such as differences in anatomy (long, redundant colonic segments), post-surgical adhesions, strictures and diverticulosis. A special endoscope with two inflatable balloons, originally designed to examine the small bowel, has been used for several years with success in such technically difficult colonoscopies. More recently a modified double-balloon instrument was designed specifically for colonoscopy, but the documentation of the performance of this instrument is limited. The aim of the present study is to investigate the performance of the double-balloon colonoscope in cases where conventional colonoscopy have failed due to technical difficulties.

Detailed description

This is a prospective cohort study to investigate the performance of the test instrument. The test instrument consists of a slim, flexible colonoscope with an overtube and an inflatable balloon on the tip of the colonoscope and the tip of the overtube. Patients are eligible for inclusion if conventional colonoscopy fails due to technical difficulties such as loop formation, long colonic segments or suspected adhesions. Written informed consent is required. The study procedures will be performed immediately after the failed conventional colonoscopy, or on a rescheduled appointment within four weeks.

Conditions

• Colorectal Cancer
• Colorectal Adenomas
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
PROCEDURE	Fujinon EC-450BI5 double-balloon colonoscope	Colonoscopy with the test instrument

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-04-30
• Last updated: 2014-04-14

Locations

1 site across 1 country: Norway