Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose : A Single Center, Operator Blinded, Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale
研究概览
简要总结
Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy, same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing for morning colonoscopy was validated. To date, there was no study which compared the bowel cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The aim of current study is to compare the bowel cleansing efficacy, adverse events, and patient's tolerability between the two group.
Subjects who underwent colonoscopy for various reasons were included. After agreeing to participate in the study, study participants were randomly assigned to split dose or same day dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15 minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose group, bowel cleansing was started from 5AM for subjects who were scheduled to receive colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested 2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy.
Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and laboratory tests were checked before colonoscopy. Study participants completed questionnaire which contained patient's satisfaction, tolerability, and adverse event during bowel cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared between the two groups. Successful bowel cleansing was estimated 85% for split dose group.
The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352 subjects will be recruited.
详细描述
Randomization and blinding:
Randomization will be done using computer generated randomization list. A specialized nurse will explain the method of bowel cleansing. Investigators (endoscopists) are blinded to bowel cleansing method.
Endpoint:
Primary end point is successful bowel cleansing rated by Boston bowel preparation (BBPS) scale. Successful bowel cleansing is defined as all segment is 2 or 3 points. Endoscopists will assess BBPS when colonoscopy withdrawal.
Secondary end point was patient's tolerability and safety profile including adverse events. Patient's satisfaction to the different bowel cleansing method and adverse events (nausea, vomiting, dizziness, fatigue) will be investigated by questionnaire before colonoscopy. Blood test will be done before colonoscopy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all subjects who undergo colonoscopy for various reasons.
排除标准
- •hemodynamic instability
- •ileus or bowel obstruction
- •active inflammatory bowel disease
- •advanced colon cancer
研究组 & 干预措施
Same-day dose group
Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.
干预措施: Polyethylene Glycol (PEG) (Drug)
Split-dose group
Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.
干预措施: Polyethylene Glycol (PEG) (Drug)
结局指标
主要结局
Boston Bowel Preparation Scale
时间窗: Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal
Primary endpoint=Successful bowel cleansing (all segmental score 2 or above) \* Boston bowel preparation scale (0-9) Sum of 3 segment of bowel. 0=inadequate 1. poor 2. good 3. excellent
次要结局
未报告次要终点
研究者
Tae-Geun Gweon
Clinical associate professor
Incheon St.Mary's Hospital
