Effecacy of Face-to-face Bowel Preparation for Afternoon Colonoscopy: a Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 658
- 试验地点
- 1
- 主要终点
- Adequate bowel preparation quality at the time of colonoscopy defined by Boston Bowel Preparation Scale rating scores≥6 among 2 groups.
研究概览
简要总结
The study compares the efficacy of bowel preparation between the face-to-face re-education(FFRE group) and normal education (no-FFRE group) in patients.
详细描述
Despite advances in bowel preparation methods,bowel preparation is inadequate in up to one-third of all colonoscopies in reported series.Inadequate bowel cleansing results in negative consequences for the examination, including incomplete visualisation of the colon, missed lesions, procedural difficulties, prolonged procedure time and reduced time interval until follow-up, and an estimated 12-22% increase in overall colonoscopy cost.
The adequacy of a bowel preparation is closely linked to patient compliance with both dietary and purge instructions.One study performed in Asia showed that non-compliance with bowel preparation instructions, lower education level, and a long wait for the colonoscopy appointment were independent risk factors for poor bowel preparation. Another study performed in China showed that telephone re-education（TRE) about the details of bowel preparation on the day before colonoscopy significantly improved the quality of bowel preparation and PDR. So,it is reasonable to hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.
The study compares the efficacy of bowel preparation between the face-to-face re-education (FFRE group) and telephone re-education (TRE group) in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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 had provided written informed consent
排除标准
- •history of colorectal surgery
- •severe colonic stricture or obstructing tumour
- •dysphagia
- •compromised swallowing reflex or mental status
- •significant gastroparesis or gastric outlet obstruction or 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>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •toxic colitis or megacolon
- •dehydration
- •disturbance of electrolytes
- •pregnancy or lactation
- •unable to give informed consent
- •haemodynamically unstable
研究组 & 干预措施
telephone re-education(TRE)
Subjects who are randomized into this group receive regular instructions at the time of their appointment to discuss colonoscopy (a nurse provides education of 5 minutes and meanwhilet sent a bookle to the patient) and a TRE which was conducted by a investigator at 15:00-17:00 on the day before colonoscopy.
干预措施: telephone re-education(TRE) (Behavioral)
face-to-face re-education (FFRE)
Subjects who are randomized into this group receive regular instructions on the day of their appointment to discuss colonoscopy and also a FFRE which was conducted by a investigator on the same-day of procedure at hospital.
干预措施: face-to-face re-education (FFRE) (Behavioral)
结局指标
主要结局
Adequate bowel preparation quality at the time of colonoscopy defined by Boston Bowel Preparation Scale rating scores≥6 among 2 groups.
时间窗: 5 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 2 groups.
次要结局
- Rate of compliance with instructions among 2 groups(5 months)
研究者
Yanqing Li
PhD,MD
Shandong University