Balloon Colonoscopy for Incomplete Colonoscopy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diverticulosis

Intervention / Treatment
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* Device: Single Balloon Colonoscopy
* Device: Standard Colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon Colonoscopy<br>Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy). | Device: Single Balloon Colonoscopy<br>* Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.<br>|
| Active Comparator: Standard Colonoscopy<br>Colonoscopy using a standard adult colonoscope | Device: Standard Colonoscopy<br>* Use of the standard adult colonoscope to complete colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Colonoscopy to the Cecum | Number of patients with a complete colonoscopy to the cecum | Day of Procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balloon Enteroscopy, Looping