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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group that does not use the scopeguide screen | Active Comparator | 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 |
|
| Group using the scopeguide screen | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ScopeGuide Navigated Colonoscope | Device | colonoscopes equipped with ScopeGuide |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bora Keum | Contact | +82-2-920-6555 | borakeum@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Bora Keum | borakeum@hanmail.net | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Han Jo Jeon | Recruiting | Seoul | Seong Buk Gu | 02841 | South Korea |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Navigation screen | Device | ScopeGuide's 3D visualisation screen |
|
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |