The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 531
- 试验地点
- 1
- 主要终点
- The proportion of straight passage through the sigmoid colon without loop formation
研究概览
简要总结
A prospective, single-center, single-blind, randomized controlled study to compare the proportion of straight passage through the sigmoid colon without loop formation between conventional colonoscope passage, left colon water exchange colonoscope passage, and cap-assisted left colon water exchange colonoscope passage through the sigmoid colon
详细描述
- Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
- Randomize patients into 3 interventional groups based on R script (version 4.4.1), including (1) Group 1: Conventional colonoscope passage, (2) Group 2: left colon water exchange colonoscope passage, (3) Group 3: cap-assisted left colon water exchange colonoscope passage.
- Collecting variables which consist of primary and secodary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-80 years
- •sedation colonoscopy
排除标准
- •History of colorectal surgery
- •Clinical suspicion of, or pathologically confirmed, colorectal cancer
- •Presence of any "alarm" symptom or sign-hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination
- •Pregnancy or lactation
- •Known or suspected gastrointestinal obstruction
- •Diagnosed inflammatory bowel disease
- •Use of antiplatelet or anticoagulant therapy (e.g., aspirin, warfarin) within 7 days before colonoscopy or any documented coagulation disorder
- •Current enrolment in another clinical study or participation in any clinical trial within the previous 60 days
- •Requirement for emergency colonoscopy
- •Any other condition that, in the investigators' judgment, renders the patient unsuitable for inclusion in the study
研究组 & 干预措施
conventional colonoscope passage
Use conventional colonoscope passage through the sigmoid colon
干预措施: Conventional colonoscope passage (Procedure)
left colon water exchange colonoscope passage
Use left colon water exchange colonoscope passage through the sigmoid colon
干预措施: left colon water exchange colonoscope passage (Procedure)
Cap-assisted left colon water exchange colonoscope passage
Use Cap-assisted left colon water exchange colonoscope passage through the sigmoid colon
干预措施: cap-assisted left colon water exchange colonoscope passage (Procedure)
结局指标
主要结局
The proportion of straight passage through the sigmoid colon without loop formation
时间窗: immediately after the procedure
次要结局
- Cecal intubation rate(immediately after the procedure)
- Cecal intubation time(immediately after the procedure)
- Time of insertion to cecum(immediately after the procedure)
- Colonoscope insertion failure rate(immediately after the procedure)
- Adenoma detection rate(2 weeks after the procedure)