Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
研究概览
简要总结
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
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
- Double (Participant, Care Provider)
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
- •Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
- •Ages will be from 18 years of age and older
排除标准
- •Chronic kidney disease
- •Previous diagnosis of congestive heart failure
- •History of bowel obstruction
- •History of solid organ transplant
- •Pregnancy
研究组 & 干预措施
1
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
干预措施: lubiprostone (Drug)
2
split-dose PEG solution without dietary restrictions plus placebo pretreatment
干预措施: placebo (Drug)
结局指标
主要结局
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
时间窗: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid
次要结局
- Patient Satisfaction With the Prep Measured by 5 Point Likert Scale(measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period))
- Procedure Time(measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period))
- The Number of Polyps Detected on Examination(measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period))
研究者
Joel Z. Stengel
Gastroenterology Fellow
Brooke Army Medical Center