Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

Sorlandet Hospital HF62 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Interventions

Fujinon EC-450BI5 double-balloon colonoscopePROCEDURE

Colonoscopy with the test instrument

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sorlandet Hospital HF

Kristiansand, Norway

Outcomes

Primary Outcomes

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.

Time frame: 2 hours

Secondary Outcomes

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.

Time frame: 2 hours

Data from ClinicalTrials.gov

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