Simultaneous Combination of Bisacodyl Suppository Agent and 1L Polyethylene Glycol Plus Ascorbic Acid is Not Inferior and Comfortable Regimen Compared With 2L Polyethylene Glycol Plus Ascorbic Acid: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale (BBPS).
研究概览
简要总结
Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.
详细描述
Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018
Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.
Outcome measures: the Boston Bowel Preparation Scale (BBPS)
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •outpatients who were scheduled for colonoscopy between August 2017 and January 2018
排除标准
- •History of gastrointestinal tract surgery
- •History of inflammatory bowel disease
- •History of severe active colitis
- •History of chronic kidney disease
- •pregnant woman.
研究组 & 干预措施
2L PEG-Asc
2L PEG-Asc for bowel preparation
干预措施: 2L PEG-Asc (Drug)
1L PEG-Asc & 'Bisacodyl 10Mg Suppository
1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation
干预措施: Bisacodyl 10Mg Suppository (Drug)
1L PEG-Asc & 'Bisacodyl 10Mg Suppository
1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation
干预措施: 1L PEG-Asc (Drug)
结局指标
主要结局
Boston Bowel Preparation Scale (BBPS).
时间窗: 1 hour
4-point scoring system (0-3) applied to each of the 3 colon segments (right colon including cecum and ascending colon, transverse colon including transverse colon, hepatic and splenic flexure, left colon including descending colon, sigmoid colon, and rectum)
次要结局
未报告次要终点
研究者
Eun Ran Kim
Clinical associate professor
Samsung Medical Center