The Effects of An Addition of Water Enema to PEG for Colon Preparation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Bowel preparation quality using Ottawa Bowel Preparation Scale
研究概览
简要总结
The purpose of this study is to compare the preparation quality by using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening
详细描述
Background : Good bowel preparation improves the rate of polyp detection and the time of caecal intubation during colorectal cancer (CRC) screening.
Suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% CI, 35-49) and advanced adenoma miss rate up to 27% (95% CI, 17-41) The European Society of Gastrointestinal Endoscopy (ESGE) Guideline recommends a split regimen of 4L of polyethylene glycol (PEG) solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel preparation and the delay between the last dose of bowel preparation and colonoscopy should be minimized and no longer than 4 hours.
The investigators hypothesize that the addition of water enema to the standard PEG bowel preparation could provide the better quality of bowel preparation and then result in improvement in the rate of adenoma detection among participants scheduled for CRC screening with preparation to procedure interval > 8 hr.
The purpose of this study is to compare the preparation quality using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening. The secondary aim is to compare the effect of the standard PEG bowel preparation and the addition of water enema in terms of adenoma detection rate, the completeness of the examination, total and withdrawal time, safety and adverse events among those scheduled for CRC screening.
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)
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
- 是
入选标准
- •Patients scheduled for CRC screening
- •Bowel preparation using 3 liters of PEG solution
- •Colonoscopy performed at 8-16 hours after bowel preparation
排除标准
- •History of a failed bowel preparation
- •Previous colonic surgery
- •Uncontrolled underlying disease
- •Pregnancy
研究组 & 干预措施
No enema group
Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy without water enema.
Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication. The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale for evaluation of side effect, complication during PEG ingestion, enema and colonoscopy, and participant satisfactory.
干预措施: Water enema (Procedure)
Water enema group
Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy and enema with sterile water until stool was clear or patient felt discomfort but not exceed 3 liter, before colonoscopy.
Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication.The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale.
干预措施: Water enema (Procedure)
结局指标
主要结局
Bowel preparation quality using Ottawa Bowel Preparation Scale
时间窗: 1 days
Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record
次要结局
- The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate(1 days)
- The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times(1 day)
- The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events(3 days)
- The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination(1 day)
研究者
Somchai Leelakusolvong
Associate professor
Mahidol University