Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean Intubation Time (MIT)
研究概览
简要总结
The primary aim of this study is
- to explore the usefulness of abdominal compression on intubation.
Other aims include
- to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure
- to get the knowledge of the formation of colon loops and its frequency
- to clarify the impact of intubation with loops on adenoma detection rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment
排除标准
- •Pregnant female patients
- •Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
- •Patients who had previous abdominal surgery
- •Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
- •Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
- •Patients who have inadequate bowel preparation
- •Patients who reject to participate in this study
研究组 & 干预措施
Control Group
Colonoscopy is completed without abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process.
Experimental Group 2 (Monitoring)
Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression by his subjective judgement.
干预措施: Abdominal Compression (Behavioral)
Experimental Group 1 (Guiding)
Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown both to investigators for study and to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression according to the guidance of magnetic endoscopic imaging system.
干预措施: Abdominal Compression (Behavioral)
Experimental Group 1 (Guiding)
Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown both to investigators for study and to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression according to the guidance of magnetic endoscopic imaging system.
干预措施: Guidance of Magnetic Endoscopic Imaging (MEI) System (Device)
结局指标
主要结局
Mean Intubation Time (MIT)
时间窗: At the end of the procedure, up to 1 hour
MIT refers to the mean of intubation time. Intubation time refers to the time spent on the intubation procedure. Intubation is defined as the procedure during which the tip of the colonoscope reaches the cecum from the anus.
次要结局
- Polyp Detection Rate (PDR)(At the end of the procedure, up to 1 hour)
- Severe Adverse Event Rate (SAER)(The day of the procedure, 24 hours)
- Cecal Intubation Rate (CIR)(At the end of the procedure, up to 1 hour)
- Adenoma Detection Rate (ADR)(At the end of the procedure, up to 1 hour)
- Pain Score (PS)(During the procedure, up to 1 hour)
研究者
En-Da Yu
Surgical Professor, Vice Director of Department of Colorectal Surgery and Center of GI Endoscopy
Changhai Hospital