The Effects and Tolerability of a Prescribed Low Residue Diet the Day Before Colonoscopy on the Cleanliness of the Colon vs. the Traditional Clear Liquid, Day Before Diet With the Use of the Clenpiq Bowel Purgative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Statistical equivalence of the clear liquid and low residue cohorts
研究概览
简要总结
The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.
详细描述
This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Investigator will be ignorant of how preparation was taken
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
- •All subjects age 18-80 requiring colonoscopy for appropriate indications
排除标准
- •Active diarrhea (Greater than 3 unformed stools daily)
- •Constipation (Less than 3 spontaneous bowel movements per week) Each within 2 weeks of the scheduled Colonoscopy.
- •Additional exclusion criteria would include;
- •Subjects with a history of inflammatory bowel disease
- •Colonic resection of any length
- •Pregnant women
- •American Society of Anesthesiologists (ASA) score greater than 3
- •Body Mass Index (BMI) greater than 50
- •Previous reaction to this bowel preparation or contraindications to taking Clenpiq per the package labeling guidelines.
- •Subjects unable to give their own informed consent.
结局指标
主要结局
Statistical equivalence of the clear liquid and low residue cohorts
时间窗: During Colonoscopy Up to 24 hours
Using the Boston Bowel Preparation Score, the 3 sections of the colon will be graded on adequacy of preparation at the colonoscopy
次要结局
- Polyp Detection Rate(Post Procedure Up to 24 hours)