Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Study Overview
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Brief Summary
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Magnetic endoscopic imaging (scopeguide) is known to be helpful for colonoscope insertion, especially beginner endoscopist. In this trial, study was designed to show the efficacy and safety pertinent to scopeguide use in detail.

Detailed Description
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Colorectal cancer is one of the most commonly diagnosed malignancies worldwide. Colorectal cancer screening significantly reduced the incidence and mortality, and colonoscopy is generally recognized as a standard method. Among them, magnetic endoscopic imaging (MEI, Scopeguide, Magnetic Enhanced Instrument, Olympus, Japan) is a non-radiological imaging instrument that can display the three-dimensional configuration and position of the colonoscope in the abdominal cavity in real time. This study aims to investigate the effectiveness of colonoscopy by measuring the insertion-related index of the colonoscopy according to the scope guide for only beginners of endoscopy.

Official Title
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Safety and Efficacy of Colonoscopy Magnetic Imaging Device for Beginner Endoscopist: a Prospective Randomized Single-center Single-blind Study

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Device: ScopeGuide Navigated Colonoscope
* Device: Navigation screen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 19-80 the patient who visit to examine the colonoscopy Exclusion Criteria: the patient who has a pacemaker the patient who has electronic devices in the body bowel obstruction and bleeding glomerulus filter rate < 30 inflammatory bowel disease, pregnancy previous history of bowel resection and abdominal surgery who refuse to write the informed consent previous history of allergic reaction to sedative drugs and beans, egg SBP <80, SpO2<90

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group that does not use the scopeguide screen<br>The control group should remove the looping of colonoscope by looking at the general colonoscopy screen The control group cannot use scopeguide screen Scopeguide screen is blinded by an opaque wrapping paper | Device: ScopeGuide Navigated Colonoscope<br>* colonoscopes equipped with ScopeGuide<br>|
| Experimental: Group using the scopeguide screen<br>The experimental group uses a general endoscopic image during colonoscopic insertion The experimental group should remove the looping of colonoscope by looking at the scopeguide screen | Device: ScopeGuide Navigated Colonoscope<br>* colonoscopes equipped with ScopeGuide<br>Device: Navigation screen<br>* ScopeGuide's 3D visualisation screen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of colonoscope loop formation | proportion of colonoscope loop formation | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| loop type | loop type | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| loop location | loop location | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| cecal intubation time cecal intubation time and rate | cecal intubation time | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| cecal intubation rate cecal intubation time and rate | success rate of cecal intubation | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| solving time for loop reduction | solving time for loop reduction | during colonoscope insertion, from the time that recognizes the loop and tries to resolve the looping of colonoscope to the time that completely resolved the colonoscope looping | 
| trial number of looping during loop reduction | number of loop reduction trial | during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| A method to eliminate the loop of colonoscope | how to solve the looping of colonoscope, ex) clockwise rotation, anti-clockwise rotation | during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| loop removal | success or failure of loop removal | during colonoscope insertion and after cecum arrival of colonoscope | 
| location of loop removal whether loop reduction success and location of loop reduction | the colonic location where loop reduction success | during colonoscope insertion and after cecum arrival of colonoscope | 
| total examination time | total examination time | the time from the insertion of the colonoscope tip into the anal verge until withdrawal of the colonoscope from the cecum towards the anus | 
| withdrawal time | withdrawal time (=examination time - cecal intubation time) | the time during withdrawal of the colonoscope towards the anus | 
| polyp detection rate | polyp detection rate | during whole colonoscopy examination | 
| adenoma detection rate | adenoma detection rate | during whole colonoscopy examination | 
| total sedation dose | total sedation dose during colonoscopy | during whole colonoscopy examination | 
| length of total inserted colonoscope | length of total inserted colonoscope | after arrival at the cecum | 
| application of pressure | nurse assissted abdominal pressure | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| patient position change | patient position change during colonoscope insertion | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | 
| variance of blood pressure | variance of blood pressure | during whole colonoscopy examination | 
| variance of heart rate | variance of heart rate | during whole colonoscopy examination | 
| variance of respiration rate | variance of respiration rate | during whole colonoscopy examination | 
| variance of saturated oxygenation rate | variance of saturated oxygenation rate | during whole colonoscopy examination | 
| adverse events | bleeding, perforation, and mucosal abrasion during colonoscopic exam | during whole colonoscopy examination | 
| patients satisfaction (questionnaire) | assessment for pain score through the examination | during whole colonoscopy examination | 
| endoscopists satisfaction (questionnaire) | assessment for maneuverability and difficulty score about insertion through the examination | during whole colonoscopy examination | 
| evaluation of risk factors about loop formation | factors that make a colonoscope loop | during whole colonoscopy examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, loop formation, scopeguide