Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

Not Applicable

Terminated

• Conditions: Colorectal Adenomas; Inflammatory Bowel Disease; Colorectal Cancer
• Interventions: Procedure: Fujinon EC-450BI5 double-balloon colonoscope

• Registration Number: NCT01587872
• Lead Sponsor: Sorlandet Hospital HF

Brief 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-12
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Failed cecal intubation during conventional colonoscopy due to technical difficulties

Exclusion Criteria

• Failed cecal intubation due to insufficient bowel preparation
• Stenotic colonic lesions
• Patients decline
• Pregnancy
• Persons younger than 18 years
• Persons unable to comprehend the information given

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DBC	Fujinon EC-450BI5 double-balloon colonoscope	Double balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments.

Primary Outcome Measures

Name	Time	Method
Cecal intubation rate	2 hours	The primary outcome measure is a complete or non-complete colonoscopy with the test instrument. Completion is assessed at the end of each procedure.

Secondary Outcome Measures

Name	Time	Method
Detection of additional colonic pathology	2 hours	To assess if additional pathology is detected in segments of the colon reached with the test instrument that was not reached with a conventional colonoscope.

Trial Locations

Locations (1)

Sorlandet Hospital HF; 🇳🇴 Kristiansand, Norway