Colonic Neoplasms
Conditions
Keywords
colonoscopy, loop formation, scopeguide
Brief summary
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
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.
Interventions
DEVICEScopeGuide Navigated Colonoscope
colonoscopes equipped with ScopeGuide
DEVICENavigation screen
ScopeGuide's 3D visualisation screen
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of colonoscope loop formation | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | proportion of colonoscope loop formation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| loop type | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | loop type |
| cecal intubation time cecal intubation time and rate | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | cecal intubation time |
| cecal intubation rate cecal intubation time and rate | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | success rate of cecal intubation |
| 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 | solving time for loop reduction |
| trial number of looping during loop reduction | during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | number of loop reduction trial |
| A method to eliminate the loop of colonoscope | during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | how to solve the looping of colonoscope, ex) clockwise rotation, anti-clockwise rotation |
| loop removal | during colonoscope insertion and after cecum arrival of colonoscope | success or failure of loop removal |
| location of loop removal whether loop reduction success and location of loop reduction | during colonoscope insertion and after cecum arrival of colonoscope | the colonic location where loop reduction success |
| 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 | total examination time |
| withdrawal time | the time during withdrawal of the colonoscope towards the anus | withdrawal time (=examination time - cecal intubation time) |
| polyp detection rate | during whole colonoscopy examination | polyp detection rate |
| adenoma detection rate | during whole colonoscopy examination | adenoma detection rate |
| loop location | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | loop location |
| length of total inserted colonoscope | after arrival at the cecum | length of total inserted colonoscope |
| application of pressure | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | nurse assissted abdominal pressure |
| patient position change | the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum | patient position change during colonoscope insertion |
| variance of blood pressure | during whole colonoscopy examination | variance of blood pressure |
| variance of heart rate | during whole colonoscopy examination | variance of heart rate |
| variance of respiration rate | during whole colonoscopy examination | variance of respiration rate |
| variance of saturated oxygenation rate | during whole colonoscopy examination | variance of saturated oxygenation rate |
| adverse events | during whole colonoscopy examination | bleeding, perforation, and mucosal abrasion during colonoscopic exam |
| patients satisfaction (questionnaire) | during whole colonoscopy examination | assessment for pain score through the examination |
| endoscopists satisfaction (questionnaire) | during whole colonoscopy examination | assessment for maneuverability and difficulty score about insertion through the examination |
| evaluation of risk factors about loop formation | during whole colonoscopy examination | factors that make a colonoscope loop |
| total sedation dose | during whole colonoscopy examination | total sedation dose during colonoscopy |
Countries
South Korea
Contacts
Primary ContactBora Keum
Outcome results
None listed