NCT02893748撤回不适用
HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)
研究概览
简要总结
The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep vs the standard of care Split-dose PEG prep used prior to colonoscopy.
详细描述
The level of cleanliness will be recorded using the Boston Bowel Prep Score (BBPS) by an endoscopist who is blind to the randomized preparation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient referred to colonoscopy
- •Patient with high probability for poor prep due to one or more of the following:
- •Chronic constipation (Rome III functional constipation criteria)
- •Gastroparesis
- •Immobilization
- •History of poor prep
排除标准
- •Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study.
- •Patient is currently taking narcotics.
- •Patient has any of the contraindications listed below:
- •Cardiac: Congestive heart failure (NYHA class III or IV or EF < 50%)
- •GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
- •GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- •Abdominal surgery within the last 6 months
研究组 & 干预措施
1: HyGIeaCare Prep and Colonoscopy
Active Comparator
Patients will receive:
- HyGIeaCare Prep
- Colonoscopy
干预措施: HyGIeaCare Prep (Device)
1: HyGIeaCare Prep and Colonoscopy
Active Comparator
Patients will receive:
- HyGIeaCare Prep
- Colonoscopy
干预措施: Colonoscopy (Procedure)
2: Split-dose PEG Prep and Colonoscopy
Active Comparator
Patients will receive:
- Split-dose PEG
- Colonoscopy
干预措施: Colonoscopy (Procedure)
2: Split-dose PEG Prep and Colonoscopy
Active Comparator
Patients will receive:
- Split-dose PEG
- Colonoscopy
干预措施: polyethylene glycol (PEG) (Drug)
结局指标
主要结局
Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)
时间窗: Day 1 of colonoscopy
次要结局
- Evaluation of patient satisfaction using a Questionnaire(2 Days after colonoscopy)
- Evaluation of adverse events(2 Days after colonoscopy)
研究者
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