Safety and Efficacy of Colonoscopy Magnetic Imaging Device for Beginner Endoscopist: a Prospective Randomized Single-center Single-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- proportion of colonoscope loop formation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 19-80
- •the patient who visit to examine the colonoscopy
排除标准
- •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
结局指标
主要结局
proportion of colonoscope loop formation
时间窗: the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum
proportion of colonoscope loop formation
次要结局
- loop removal(during colonoscope insertion and after cecum arrival of colonoscope)
- endoscopists satisfaction (questionnaire)(during whole colonoscopy examination)
- 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)
- withdrawal time(the time during withdrawal of the colonoscope towards the anus)
- application of pressure(the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum)
- variance of heart rate(during whole colonoscopy examination)
- variance of respiration rate(during whole colonoscopy examination)
- 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)
- location of loop removal whether loop reduction success and location of loop reduction(during colonoscope insertion and after cecum arrival of colonoscope)
- length of total inserted colonoscope(after arrival at the cecum)
- variance of saturated oxygenation rate(during whole colonoscopy examination)
- patients satisfaction (questionnaire)(during whole colonoscopy examination)
- evaluation of risk factors about loop formation(during whole colonoscopy examination)
- 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)
- variance of blood pressure(during whole colonoscopy examination)
- adverse events(during whole colonoscopy examination)
- loop type(the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum)
- loop location(the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum)
- 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)
- 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)
- 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)
- polyp detection rate(during whole colonoscopy examination)
- adenoma detection rate(during whole colonoscopy examination)
- total sedation dose(during whole colonoscopy examination)
- patient position change(the time from the insertion of the colonoscope tip into the anal verge until reaching the cecum)
研究者
Keum, Bo Ra
Professor of Division of Gastroenterology and Hepatology, Department of Internal Medicine
Korea University Anam Hospital