Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
研究概览
简要总结
This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.
详细描述
Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •outpatient colonoscopy for screening for other Gi related problems
排除标准
- •Severe Congestive Heart Failure (CHF),
- •Chronic Kidney Disease (CKD),
- •less than age 18 or more than 80 years
研究组 & 干预措施
miralax
miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire
干预措施: comparing 2 drugs on their effect on the bowel preparation for colonoscopy (Drug)
moviprep split dose
Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen
干预措施: comparing 2 drugs on their effect on the bowel preparation for colonoscopy (Drug)
结局指标
主要结局
Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
时间窗: Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2
To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.
次要结局
- Renal Function Pre and Post Bowel Prep (mg/dL)(Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).)
- Renal Function Pre and Post Bowel Prep - Continued (mmol/L)(Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).)