Balloon Colonoscopy for Incomplete Colonoscopy

Northwestern University

Status: Terminated

Conditions: Diverticulosis

Treatments: Device: Single Balloon Colonoscopy; Device: Standard Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00935857

STU00008540

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Balloon Colonoscopy

Experimental group

Description:

Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy).

Treatment:

Device: Single Balloon Colonoscopy

Standard Colonoscopy

Active Comparator group

Description:

Colonoscopy using a standard adult colonoscope

Treatment:

Device: Standard Colonoscopy