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Clinical Trials/NCT00935857
NCT00935857TerminatedNot Applicable

Balloon Colonoscopy Versus Repeat Standard Colonoscopy for Prior Incomplete Colonoscopy: A Randomized Controlled Trial

Northwestern University2 sites in 1 country30 target enrollmentStarted: April 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
30
Locations
2
Primary Endpoint
Complete Colonoscopy to the Cecum

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Complete Colonoscopy to the Cecum

Time Frame: Day of Procedure

Number of patients with a complete colonoscopy to the cecum

Secondary Outcomes

  • Time (Minutes) to Cecum(Day of Procedure)
  • Procedural Complications(7 days post procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rajesh Keswani

Assistant Professor of Medicine

Northwestern University

Study Sites (2)

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