Double-balloon Colonoscopy to Increase Colonoscopy Completion Rate

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01587872

Enrollment

Registered

2012-04-30

Start date

2011-10-31

Completion date

2014-04-30

Last updated

2014-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenomas, Colorectal Cancer, Inflammatory Bowel Disease

Keywords

Colonoscopy, Colorectal cancer, Screening colonoscopy

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.

Interventions

PROCEDUREFujinon EC-450BI5 double-balloon colonoscope

Colonoscopy with the test instrument

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026