The Bowel CLEAnsing: A National Initiative
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,476
- 试验地点
- 10
- 主要终点
- Bowel cleansing according to the Boston Scale
研究概览
简要总结
The purpose of this study is to compare diet, type of bowel preparation and time of colonoscopy to determine if one method is better than the other and, if they are the same, identify the one which is the most convenient for the patients.
详细描述
The objective of the current proposed trial is thus to compare the cleanliness achieved with PEG high-volume (2L+2L) split-dose versus PEG (1L+1L)+Bisacodyl low-volume split-dose, or PEG high volume (4L) non-split day before versus PEG low volume (2L) non-split same day preparation, according to time of endoscopy (early or later), as well as assess the role of diet (low residue or clear liquid diet) according to these different Canadian outpatient preparation regimens.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •18 years or older
- •Able to comprehend the trial
- •Have an indication for full colonoscopy
排除标准
- •Subjects are excluded from enrollment into the study if any of the following are present:
- •General exclusion criteria:
- •Subject refusal
- •Previous bowel preparation in the last 14 days
- •Pregnancy or breastfeeding
- •Reduced mobility
- •Medical/Endoscopic exclusion criteria:
- •Suspected or diagnosed with bowel obstruction
- •Any colonic surgery
- •Toxic megacolon
- •Ischemic colitis
- •Decompensated heart failure
- •Severe acute renal failure
- •Severe liver disease
- •Severe electrolyte imbalance
研究组 & 干预措施
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid
干预措施: Early colonoscopy (stratified) (Other)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid
干预措施: High volume PEG split-dose (Drug)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid
干预措施: Clear liquid diet (Other)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid
干预措施: Early colonoscopy (stratified) (Other)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue
干预措施: High volume PEG split-dose (Drug)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue
干预措施: Low residue diet (Other)
1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue
干预措施: Early colonoscopy (stratified) (Other)
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid
干预措施: Low volume PEG split-dose (Drug)
1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid
干预措施: Clear liquid diet (Other)
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue
干预措施: Low volume PEG split-dose (Drug)
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue
干预措施: Low residue diet (Other)
1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue
干预措施: Early colonoscopy (stratified) (Other)
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid
干预措施: High volume PEG non split, day before (Drug)
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid
干预措施: Clear liquid diet (Other)
1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid
干预措施: Early colonoscopy (stratified) (Other)
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue
干预措施: High volume PEG non split, day before (Drug)
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue
干预措施: Low residue diet (Other)
1) Early colonoscopy; 2) High-dose, day before; 3)Low residue
干预措施: Early colonoscopy (stratified) (Other)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid
干预措施: High volume PEG split-dose (Drug)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid
干预措施: Clear liquid diet (Other)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid
干预措施: Later colonoscopy (stratified) (Other)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue
干预措施: High volume PEG split-dose (Drug)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue
干预措施: Low residue diet (Other)
1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue
干预措施: Later colonoscopy (stratified) (Other)
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid
干预措施: Low volume PEG split-dose (Drug)
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid
干预措施: Clear liquid diet (Other)
1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid
干预措施: Later colonoscopy (stratified) (Other)
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue
干预措施: Low volume PEG split-dose (Drug)
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue
干预措施: Low residue diet (Other)
1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue
干预措施: Later colonoscopy (stratified) (Other)
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid
干预措施: Low volume PEG non split, same day (Drug)
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid
干预措施: Clear liquid diet (Other)
1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid
干预措施: Later colonoscopy (stratified) (Other)
1) Later colonoscopy; 2) Low volume day before; 3)Low residue
干预措施: Low volume PEG non split, same day (Drug)
1) Later colonoscopy; 2) Low volume day before; 3)Low residue
干预措施: Low residue diet (Other)
1) Later colonoscopy; 2) Low volume day before; 3)Low residue
干预措施: Later colonoscopy (stratified) (Other)
结局指标
主要结局
Bowel cleansing according to the Boston Scale
时间窗: Day of colonoscopy
次要结局
- Specific lesional rates identified according to pathology(up to 30 days)
- % of preparation taken by the subject(Day of colonoscopy)
- Subject travel time to endoscopy unit (hrs)(Day of colonoscopy)
- Incontinence(Day of colonoscopy)
- Right colon polyp detection rate(Day of colonoscopy)
- Subject willingness to repeat the preparation (survey)(Day of colonoscopy)
- Withdrawal time and total procedural time(Day of colonoscopy)
- Cecal or ileal intubation rate for colonoscopies(Day of colonoscopy)
- Polyp detection and polypectomy rate(Day of colonoscopy)
- Montreal score compared to BBPS(Day of colonoscopy)
- Ottawa Bowel Preparation Scores compared to BBPS(Day of colonoscopy)
- Fecal Immunochemical Test value(Day of colonoscopy)
研究者
Alan Barkun
Gatroenterologist
McGill University Health Centre/Research Institute of the McGill University Health Centre