Balloon Colonoscopy for Incomplete Colonoscopy

NCT ID: NCT00935857

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-12-31

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.

Conditions

Diverticulosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Balloon Colonoscopy

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

Group Type: EXPERIMENTAL

Single Balloon Colonoscopy

Intervention Type: DEVICE

Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.

Standard Colonoscopy

Colonoscopy using a standard adult colonoscope

Group Type: ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type: DEVICE

Use of the standard adult colonoscope to complete colonoscopy.

Interventions

Single Balloon Colonoscopy

Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.

Intervention Type: DEVICE

Standard Colonoscopy

Use of the standard adult colonoscope to complete colonoscopy.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Rajesh Keswani

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajesh N Keswani, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00008540

Identifier Type: -

Identifier Source: org_study_id