Clinical trial NCT05746962: Efficacy of Magnetic Imaging Colonoscopy Applied to Beginner Endoscopists
Official title: Safety and Efficacy of Colonoscopy Magnetic Imaging Device for Beginner Endoscopist: a Prospective Randomized Single-center Single-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Neoplasms
Keywords: colonoscopy
loop formation
scopeguide
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of colonoscope loop formation
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
Secondary outcomes:
measure: loop type
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: loop location
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: cecal intubation time cecal intubation time and rate
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: cecal intubation rate cecal intubation time and rate
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: solving time for loop reduction
timeFrame: 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
measure: trial number of looping during loop reduction
timeFrame: during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: A method to eliminate the loop of colonoscope
timeFrame: during colonoscope insertion, the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: loop removal
timeFrame: during colonoscope insertion and after cecum arrival of colonoscope
measure: location of loop removal whether loop reduction success and location of loop reduction
timeFrame: during colonoscope insertion and after cecum arrival of colonoscope
measure: total examination time
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until withdrawal of the colonoscope from the cecum towards the anus
measure: withdrawal time
timeFrame: the time during withdrawal of the colonoscope towards the anus
measure: polyp detection rate
timeFrame: during whole colonoscopy examination
measure: adenoma detection rate
timeFrame: during whole colonoscopy examination
measure: total sedation dose
timeFrame: during whole colonoscopy examination
measure: length of total inserted colonoscope
timeFrame: after arrival at the cecum
measure: application of pressure
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: patient position change
timeFrame: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
measure: variance of blood pressure
timeFrame: during whole colonoscopy examination
measure: variance of heart rate
timeFrame: during whole colonoscopy examination
measure: variance of respiration rate
timeFrame: during whole colonoscopy examination
measure: variance of saturated oxygenation rate
timeFrame: during whole colonoscopy examination
measure: adverse events
timeFrame: during whole colonoscopy examination
measure: patients satisfaction (questionnaire)
timeFrame: during whole colonoscopy examination
measure: endoscopists satisfaction (questionnaire)
timeFrame: during whole colonoscopy examination
measure: evaluation of risk factors about loop formation
timeFrame: during whole colonoscopy examination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Han Jo Jeon
state: Seong Buk Gu
Study officials:
affiliation: borakeum@hanmail.net
name: Bora Keum
role: STUDY_DIRECTOR
References: