A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,079
- 试验地点
- 1
- 主要终点
- Chicago Bowel Preparation Scale
研究概览
简要总结
The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.
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
- 是
入选标准
- •Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.
排除标准
- •Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
- •Patients who are pregnant.
- •Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
- •Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
- •Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.
研究组 & 干预措施
MiraLAX 306 g (Day-Prior)
MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
干预措施: MiraLAX (Drug)
MiraLAX 306 g (Day-Prior)
MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM
干预措施: Gatorade (Other)
MiraLAX 357 g (Day-Prior)
MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
干预措施: MiraLAX (Drug)
MiraLAX 357 g (Day-Prior)
MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.
干预措施: Gatorade (Other)
MiraLAX 306 g (Split-Dose)
MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
干预措施: MiraLAX (Drug)
MiraLAX 306 g (Split-Dose)
MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.
干预措施: Gatorade (Other)
MoviPrep (Split-Dose)
MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.
干预措施: MoviPrep (Drug)
SUPREP (Split-Dose)
SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.
干预措施: SUPREP (Drug)
结局指标
主要结局
Chicago Bowel Preparation Scale
时间窗: At completion of colonoscopy - day 1
The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).
次要结局
- Adequate/Inadequate Scale(At completion of colonoscopy - day 1)
- Boston Bowel Preparation Scale(At completion of colonoscopy - day 1)