Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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

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Colorectal Cancer Colorectal Adenomas Inflammatory Bowel Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DBC

Double balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments.

Group Type EXPERIMENTAL

Fujinon EC-450BI5 double-balloon colonoscope

Intervention Type PROCEDURE

Colonoscopy with the test instrument

Interventions

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Fujinon EC-450BI5 double-balloon colonoscope

Colonoscopy with the test instrument

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes