Balloon Colonoscopy for Incomplete Colonoscopy

Not Applicable

Terminated

• Conditions: Diverticulosis
• Interventions: Device: Single Balloon Colonoscopy; Device: Standard Colonoscopy

• Registration Number: NCT00935857
• Lead Sponsor: Northwestern University

Brief Summary

Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to the other group. The primary endpoint of the study is a complete colonoscopy.

Detailed Description

Colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. Despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. These factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort.

Options for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. Non-endoscopic modalities include radiologic studies such as CT/MRI colonography as well as a retrograde barium study. Relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. Alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy Of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. In this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-12-03
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-23
• Last Update Submitted: 2014-09-23
• Results First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete

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Exclusion Criteria

• incomplete colonoscopy due only to poor bowel preparation or inadequate sedation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Balloon Colonoscopy	Single Balloon Colonoscopy	Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy).
Standard Colonoscopy	Standard Colonoscopy	Colonoscopy using a standard adult colonoscope

Primary Outcome Measures

Name	Time	Method
Complete Colonoscopy to the Cecum	Day of Procedure	Number of patients with a complete colonoscopy to the cecum

Secondary Outcome Measures

Name	Time	Method
Time (Minutes) to Cecum	Day of Procedure	Time, in minutes, until reaching cecum in each arm.
Procedural Complications	7 days post procedure	Number of patients with any procedural complications as assessed 7 days after procedure.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States