Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy.
研究概览
简要总结
Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult diabetic outpatients referred for elective colonoscopy
排除标准
- •patients < 18 years of age or > 75 yrs of age,
- •known or suspected pregnancy,
- •known or suspected renal failure,
- •unstable angina,
- •acute coronary syndrome,
- •decompensated congestive heart failure,
- •decompensated liver failure,
- •known or suspected bowel obstruction,
- •major psychiatric illness,
- •solid organ transplant patients,
- •known allergies to PEG-ELS or bisacodyl,
- •prior alimentary tract surgery or refusal to consent to the study.
研究组 & 干预措施
Golytely + placebo
4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill
干预措施: Golytely (polyethylene glycol electrolyte lavage solution) and placebo (Drug)
Golytely Split + placebo
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill
干预措施: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo (Drug)
Golytely Split + Bisacodyl
split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
干预措施: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl (Drug)
结局指标
主要结局
Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy.
时间窗: Day 1
The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist.
次要结局
- Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.(24 hours)