Safety and Efficacy of High Dose Bowel Preparation Solutions for Patients With Difficult To Clean Colons For Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Bowel Cleanliness
研究概览
简要总结
The purpose of this study is to document the safety and effectiveness of high doses of liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a poorly cleaned colon.
详细描述
Most of our patients use a standard dose of Gatorade (64 oz) and a tasteless laxative powder called MiraLAX (306 g) to clean their colons out for a colonoscopy. Occasionally, patients have chosen to use other FDA approved solutions to clean their colons including NuLYTELY, GoLytely, MoviPrep and SuPREP. Rarely patients choose to use high doses of MagCitrate.
Despite drinking all their liquid to clean their colon, a few patients have difficult to clean out colons and the quality of their colonoscopy preparation was not good. No one has ever studied what liquids to give these patients when they have another colonoscopy. Most doctors recommend using higher than standard doses of bowel cleaning liquids, but the safety and effectiveness of these higher doses has never been studied.
Patients will already have been assigned a higher than standard dose of a bowel cleaning liquid of their choice for their planned colonoscopy. This is our standard of care for cleaning out the colons of patients who previous had colonoscopies with colons that were not adequately cleaned. If the patient chooses to participate in this study, the plans to clean their colon will remain unchanged.
Before and during the study: The subject will clean out thier colon in the days before their colonoscopy just as they would have if they were not part of the study. They will be asked to fill out a short questionnaire before the colonoscopy about their experience with the liquid and the clean out process.
We would like to obtain a blood test (basic metabolic profile) that looks at each subject's kidney function within 3 months before their colonoscopy and before the IV is started for the colonoscopy. This involves a simple needle stick to draw 1 teaspoon (5 ml) of blood. If the subject had had blood tests done for other reasons within 3 months of their colonoscopy, these results can be used in place of the first blood sample.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study if they had a previous colonoscopy with an inadequate preparation.
排除标准
- •Patients who are pregnant.
- •Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
研究组 & 干预措施
Step 1
Patients who had inadequate preparations for colonoscopy with a standard dose of bowel cleansing agent.
干预措施: Bowel Preparation (Drug)
Step 2
Patients who had inadequate preparations for colonoscopy with a step 1 dose of bowel cleansing agent.
干预措施: Bowel Preparation (Drug)
Step 3
Patients who had inadequate preparations for colonoscopy with a step 2 dose of bowel cleansing agent.
干预措施: Bowel Preparation (Drug)
Step 4
Patients who had inadequate preparations for colonoscopy with a step 3 dose of bowel cleansing agent.
干预措施: Bowel Preparation (Drug)
Step 5
Patients who had inadequate preparations for colonoscopy with a step 4 dose of bowel cleansing agent.
干预措施: Bowel Preparation (Drug)
结局指标
主要结局
Bowel Cleanliness
时间窗: at colonoscopy
Measured by the Chicago Bowel Preparation Scale
次要结局
- Bowel Cleanliness(at colonoscopy)
- Electrolyte changes(at colonoscopy)
- Patient tolerance(1-2 days before colonoscopy measured at colonoscopy)