Balloon Colonoscopy Versus Repeat Standard Colonoscopy for Prior Incomplete Colonoscopy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Northwestern University
- 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
Rajesh Keswani
Assistant Professor of Medicine
Northwestern University
