Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Not Applicable

Withdrawn

• Conditions: Redundant Colon
• Interventions: Device: goggle balloon; Other: water immersion only

• Registration Number: NCT02359409
• Lead Sponsor: Indiana University

Brief Summary

This study aims to look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons.

Detailed Description

About 5% of colonoscopies are technically difficult because the colon is elongated or redundant. There is an increased risk of the colonoscope not reaching the cecum in these cases. One solution to this is to try to keep the colon shorter by not insufflating it with gas. In order to achieve that, in these cases the investigators typically fill the colon with water, which does not distend the colon as much. Another technique, which can improve visualization, is to use a device called the goggle balloon. This is a small balloon filled with a few mL of water which fits over the end of the colonoscope and pushes the colonic mucosa away from the end of the scope so that the luminal direction can be visualized with minimal insufflation. In patients with normal colons, the goggle balloon can be used to insert the colonoscope to the cecum with virtually no air or water filling. We aim to study if the goggle balloon can be used to help complete the colonoscopy in patients with redundant colons.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-01-30
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Primary Completion: 2017-03-28
• Study Completion: 2017-03-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Referral for incomplete colonoscopy

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Exclusion Criteria

Known stricture or narrowing of the colon, prior colon resection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
water immersion with goggle balloon	goggle balloon	Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique
water immersion only	water immersion only	Colonoscopy will be performed using the water immersion technique.

Primary Outcome Measures

Name	Time	Method
number of subjects with complete colonoscopy in each arm	2 years

Secondary Outcome Measures

Name	Time	Method
Time to cecal intubation in each arm	2 years

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States