Nurse-led Educational Telephone Intervention for Bowel Preparation for Repeat Colonoscopy After Preparation Failure (RepeatPrep Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 657
- 试验地点
- 18
- 主要终点
- Adequate bowel cleansing for colonoscopy
研究概览
简要总结
This trial will evaluate the efficacy in colon cleansing of a nurse-led educational telephone intervention 24-48 hours before a colonoscopy, in selected participants with a previous inadequate bowel preparation.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with a colonoscopy with inadequate bowel preparation, for any indication and where the endoscopist considers that the colonoscopy should be repeated to optimize the visualization with a better bowel preparation. Participants must have been properly informed and they have to sign the inform consent.
排除标准
- •Hospitalized patients
- •Unwillingness to participate in the study
- •Inability to follow instructions: cognitive impairment or language barrier
- •Inability to use a telephone or not owning a telephone
- •Active inflammatory bowel disease
- •Severe renal impairment
- •Pregnancy of breast feeding
研究组 & 干预措施
Educational telephone intervention
This group will receive a nurse-led educational telephone intervention for bowel preparation 24-48 before the colonoscopy
干预措施: Educational telephone intervention (Behavioral)
Standard education for colonoscopy
The control group will receive standard education for bowel preparation at the time of colonoscopy scheduling
干预措施: Standard education for colonoscopy (Behavioral)
结局指标
主要结局
Adequate bowel cleansing for colonoscopy
时间窗: At the moment of colonoscopy
The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Adequate bowel cleansing will be defined as a BBPS of 2 or more points in every segment of the colon and inadequate bowel cleansing will be defined by at least one of the colon segments with less than 2 points.
次要结局
- Adenoma detection rate in the right colon(At the moment of colonoscopy)
- Overall serrated lesion detection rate(At the moment of colonoscopy)
- Serrated lesion detection rate in the right colon(At the moment of colonoscopy)
- Boston Bowel Preparation Scale(At the moment of colonoscopy)
- Barcelona Bowel Preparation Scale(At the momento of colonoscopy)
- Overall adenoma detection rate, as defined by the ratio of patients with at least one adenoma in the overall colon(At the moment of colonoscopy)
- Complete colonoscopy rate(At the moment of colonoscopy)
研究者
Marco Antonio Alvarez Gonzalez
Gastroenterologist deputy doctor, MD, PhD
Parc de Salut Mar