Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists

Korea University Anam Hospital128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

128

Conditions

Colonic Neoplasms

Interventions

ScopeGuide Navigated ColonoscopeDEVICE

colonoscopes equipped with ScopeGuide

Navigation screenDEVICE

ScopeGuide's 3D visualisation screen

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Han Jo Jeon

Seoul, Seong Buk Gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

proportion of colonoscope loop formation

Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

Secondary Outcomes

loop type

Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

loop location

Time frame: 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

Time frame: 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

Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

solving time for loop reduction

Time frame: 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

Time frame: during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

Central Contacts

Bora Keum

CONTACT

+82-2-920-6555 borakeum@hanmail.net

Data from ClinicalTrials.gov

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A method to eliminate the loop of colonoscope

how to solve the looping of colonoscope, ex) clockwise rotation, anti-clockwise rotation

Time frame: 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

Time frame: 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

Time frame: during colonoscope insertion and after cecum arrival of colonoscope

total examination time

Time frame: 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)

Time frame: the time during withdrawal of the colonoscope towards the anus

polyp detection rate

Time frame: during whole colonoscopy examination

adenoma detection rate

Time frame: during whole colonoscopy examination

total sedation dose

total sedation dose during colonoscopy

Time frame: during whole colonoscopy examination

length of total inserted colonoscope

Time frame: after arrival at the cecum

application of pressure

nurse assissted abdominal pressure

Time frame: 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

Time frame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum

variance of blood pressure

Time frame: during whole colonoscopy examination

variance of heart rate

Time frame: during whole colonoscopy examination

variance of respiration rate

Time frame: during whole colonoscopy examination

variance of saturated oxygenation rate

Time frame: during whole colonoscopy examination

adverse events

bleeding, perforation, and mucosal abrasion during colonoscopic exam

Time frame: during whole colonoscopy examination

patients satisfaction (questionnaire)

assessment for pain score through the examination

Time frame: during whole colonoscopy examination

endoscopists satisfaction (questionnaire)

assessment for maneuverability and difficulty score about insertion through the examination

Time frame: during whole colonoscopy examination

evaluation of risk factors about loop formation

factors that make a colonoscope loop

Time frame: during whole colonoscopy examination