Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

Sorlandet Hospital HF

Status: Terminated

Conditions: Inflammatory Bowel Disease; Colorectal Adenomas; Colorectal Cancer

Treatments: Procedure: Fujinon EC-450BI5 double-balloon colonoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01587872

SSK_DBC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

DBC

Experimental group

Description:

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

Treatment:

Procedure: Fujinon EC-450BI5 double-balloon colonoscope