Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

Study Overview
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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.

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.

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

Conditions
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Colorectal Cancer, Colorectal Adenomas, Inflammatory Bowel Disease

Intervention / Treatment
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* Procedure: Fujinon EC-450BI5 double-balloon colonoscope


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBC<br>Double balloon colonoscopy will be attempted in cases where conventional colonoscopy failed due to technical difficulties such as looping or redundant colonic segments. | Procedure: Fujinon EC-450BI5 double-balloon colonoscope<br>* Colonoscopy with the test instrument<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of additional colonic pathology | 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. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Colorectal cancer, Screening colonoscopy