The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

Study Overview
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Brief Summary
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Colonoscopy is an important procedure for diagnosing and treating diseases of the colon. In Canada, up to 13% all colonoscopies do not examine the full colon and are therefore incomplete. Incomplete colonoscopies happen for a number of reasons but are often due to twists and turns in the colon that make the colonoscopy difficult to perform and uncomfortable for the patient. This randomized study is being done to test a new colonoscopy system called the Scope Guide that shows an exact 3-dimensional picture of how the colonoscopy is positioned in the patient's abdomen. We hypothesize that the use of the Scope Guide for colonoscopy will improve measures of colonoscopy quality including rate of complete examination, patient comfort, polyp detection rate, insertion time, amount of sedation required, and need for abdominal compression.

Official Title
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The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Device: Magnetic Endoscopic Imaging (MEI) colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be over the age of 18 presenting for out-patient colonoscopy to the endoscopy unit at the VG Site. Exclusion Criteria: Inability or unwillingness to provide written informed consent. Previous incomplete or difficult colonoscopy (i.e. independent indication for use of Scope Guide). Colonoscopist not participating in trial. Current pregnancy. Cardiac pacemaker or any other type of implantable stimulator. Previous colectomy, hemicolectomy, segmental colon resection, or ileocecal resection.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard colonoscopy<br> | |
| Experimental: Magnetic endoscopic imaging colonoscopy<br> | Device: Magnetic Endoscopic Imaging (MEI) colonoscopy<br>* Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation rate |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort |  | baseline | 
| Amount of sedation required |  | baseline | 
| Polyp detection rate |  | baseline | 
| Use of abdominal compression |  | baseline | 
| Insertion time |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indicators, Quality