Evaluation of Information Provided to Patients Provided About Bowel Preparation for Morning Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments
研究概览
简要总结
Background: In randomized controlled trials, split-dose bowel preparation for colonoscopy has been shown to provide better bowel cleansing than day before bowel preparation. However, people who volunteer to be in clinical trials may be more adherent to a challenging bowel preparation regimen than people in the general community undergoing colonoscopy. This may be especially true for colonoscopies scheduled for the morning, when the later dose of the split-dose bowel preparation would be administered in the early morning hours. Hence the results of the available trials may not be applicable to patients undergoing morning colonoscopy in routine medical practices.
Aims: To compare the effectiveness of mandatory split-dose bowel preparation to optional split-dose bowel preparation protocols for morning colonoscopies in a non-inferiority pragmatic trial.
Anticipated results and significance: The study will produce a better understanding of the most effective approach to bowel preparation for early morning colonoscopies and suggest specific recommendations for colonoscopy practice.
详细描述
Patient will be randomized by the central booking office. Patient experience survey will be administered prior to colonoscopy. Chart review will be done to obtain data from the medical records and endoscopy reports. Please see outcomes and planned analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 18 years of age or older
- •Must have colonoscopy appointment with any 4 of the participating GI doctors at Health Sciences Centre-Winnipeg
- •Must use 4 liter type of bowel preparation
排除标准
- •Has colonoscopy appointment with non-participating GI doctor and/or a non-participating endoscopy hospital/clinic
- •Patient and/or referral doctor requested a non-4 liter bowel preparation
结局指标
主要结局
Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments
时间窗: At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Proportion with adequate cleansing as measured by Boston Bowel Preparation Scale Score ≥2 in all segments. Boston Bowel Preparation Scale Score is reported as score of 0 to 3 in 3 segments of the colon. The score is then summed for a total score of 0 to 9. Higher Boston score, better quality of bowel cleanliness.
次要结局
- Composite with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment; phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation.(Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months)
- Endoscopic Outcome 4: polyps during colonoscopy(At the scheduled colonoscopy procedure, expected average within 3 months)
- Patient experience data outcome 1: use of split dose bowel preparation(Before scheduled colonoscopy procedure, expected average within 3 months)
- Patient experience data outcome 2: complete intake of all of the prescribed laxative(Before scheduled colonoscopy procedure, expected average within 3 months)
- Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation(Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months)
- Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5)(Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months)
- Amount of laxative intake(In the 24 hours before the scheduled colonoscopy,expected average within 3 months)
- Proportion with split dose laxative intake(In the 24 hours before the scheduled colonoscopy,expected average within 3 months)
- Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)(At the scheduled colonoscopy procedure, expected average within 3 months)
- Endoscopic Outcome 2: Withdrawal time during colonoscopy performance(At the scheduled colonoscopy procedure, expected average within 3 months)
- Endoscopic Outcome 3: total time for performance of colonoscopy(At the scheduled colonoscopy procedure, expected average within 3 months)
- Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy(Before scheduled colonoscopy procedure, expected average within 3 months)
- Patient experience data outcome 4: Sleep in night before colonoscopy(Before scheduled colonoscopy procedure, expected average within 3 months)
- Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10)(Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months)
研究者
Harminder Singh
Associate Professor of Medicine
University of Manitoba