The Comparative Study Between Bowel Preparation Method: 4L-split Dose of PEG Solution, Low-volume PEG Plus Ascorbic Acid Focusing on the Bowel Cleansing Efficacy, Patients' Affinity to Preparation Solution and Mucosal Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Comparison of colon cleansing between the two solutions using Ottawa scale
研究概览
简要总结
The purpose of this study is to compare the efficacy, acceptability and preparation-induced mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.
详细描述
This was a prospective randomized single-blinded clinical trial of ambulatory patients to assess the efficacy of bowel preparation and preparation-induced mucosal inflammation.
Endoscopists who were blinded to the preparation taken, assessed both bowel cleansing by using the Ottawa bowel preparation assessment tool and preparation-induced mucosal inflammation. Acceptability was assessed by questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who want colonoscopy purposing screening among adults between the age of 20~65
排除标准
- •Under the age of 20, older than 65, pregnant or lactating women, intestinal obstruction, structural intestinal disease, hypothyroidism, gastrointestinal motility, renal failure, congestive heart failure, liver failure, electrolyte abnormalities, who refused research informed consent, inflammatory bowel disease, the obvious symptoms of the disease in patients with lower gastrointestinal (bloody stools, diarrhea, etc.)
研究组 & 干预措施
4L-split Dose of PEG Solution
4L-split Dose of PEG Solution for bowel preparation
干预措施: Colonoscopy after bowel cleansing (Drug)
Low-volume PEG Plus Ascorbic Acid
Low-volume PEG Plus Ascorbic Acid for bowel preparation
干预措施: Colonoscopy after bowel cleansing (Drug)
结局指标
主要结局
Comparison of colon cleansing between the two solutions using Ottawa scale
时间窗: 3month
次要结局
未报告次要终点