Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

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

Study Overview

• Status: Withdrawn
• Conditions: Redundant Colon
• Intervention / Treatment: Other: water immersion only; Device: goggle balloon

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Referral for incomplete colonoscopy

Exclusion Criteria:

Known stricture or narrowing of the colon, prior colon resection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: water immersion only; Colonoscopy will be performed using the water immersion technique.	Other: water immersion only; Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique.
Experimental: water immersion with goggle balloon; Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique	Device: goggle balloon; Colonoscopy will be performed using the water immersion technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of subjects with complete colonoscopy in each arm	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to cecal intubation in each arm	2 years

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Douglas K Rex, MD, IU Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 28, 2017
• Study Completion (Actual): March 28, 2017

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IndianaU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No