LINE Re-education Before Colonoscopy to Confirm Optimal Bowel Cleansing: A Prospective, Colonoscopist-blinded, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Adequate bowel preparation
研究概览
简要总结
This is a prospective, colonoscopist-blinded, randomized, controlled study with consecutive outpatients undergoing colonoscopy in Taipei Medical University Hospital.The study would comply with the standards of the Declaration of Helsinki and current ethical guidelines. It have been approval by Taipei Medical University Institutional Review Board.
详细描述
Written informed consent will be obtained from all the patients. Patients will be randomized to either the LINE re-education or control group for colon preparation at the time of appointment for colonoscopy by using consecutively numbered envelopes that will contain the treatment assignments, which will be generated by a computer-allocated random digit number, in a 1:1 ratio. At least two LINE accounts for all patients or their relatives living together will be recorded in case of failure to contact. All patients will be instructed not to tell colonoscopists, nurses and investigators before, during and after the procedure about their preparation method and when they receive instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
All patients will be instructed not to tell colonoscopists, nurses and investigators before, during and after the procedure about their preparation method and when they receive instructions.
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
- •Outpatients aged 18-80 years undergoing colonoscopy who will provide written informed consent will be eligible for participation in the study.
排除标准
- •history of colorectal surgery;
- •severe colonic stricture or obstructing tumor;
- •uncooperative mental status;
- •significant ileus;
- •known or suspected bowel obstruction or perforation;
- •severe chronic renal failure (creatinine clearance <30 ml/min);
- •severe congestive heart failure (New York Heart Association class III or IV);
- •uncontrolled hypertension (systolic blood pressure >180 mm Hg, diastolic blood pressure>100 mm Hg);
- •liver cirrhosis;
- •toxic colitis or megacolon;
- •active gastrointestinal bleeding;
- •dehydration or disturbance of electrolytes;
- •pregnancy or lactation; and
- •hemodynamically unstable.
研究组 & 干预措施
300 Randomized to re-education group
LINE re-education of colon preparation
干预措施: LINE re-education (Behavioral)
300 Randomized to control group
education of colon preparation 1 time in hospital
结局指标
主要结局
Adequate bowel preparation
时间窗: Day 1
total Ottawa score \<6 or Boston bowel preparation scale ≥ 6
次要结局
- cecal intubation rate(Day 1)
- colon polyp detection rate(Day 1)