NCT03817788已完成4 期
Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy
Dong Yang1 个研究点 分布在 1 个国家目标入组 586 人开始时间: 2019年4月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 586
- 试验地点
- 1
- 主要终点
- Cleansing quality
研究概览
简要总结
This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatients meet the following criteria: 1) age 18-60 years; 2) BMI 18.9-28; 3) Heart, lung, liver, and kidney function can tolerate colonoscopy; 4) Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent
排除标准
- •colorectal surgery history (except appendectomy); 2) patients with intestinal obstruction, incomplete obstruction, intestinal hemorrhage; 3) patients with renal insufficiency; 4) patients with hirschsprung disease; 5) patients with inflammatory bowel disease during active period, which affects intestinal observation; 6) patients who are bedridden and lose the moving ability ; 7) have a history of severe mental illness; 8) pregnant or lactating women; 9) patients with other clinical conditions considered by some researchers should not participate in the trial.
研究组 & 干预措施
polyethylene glycol group (group P)
Active Comparator
For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy
干预措施: polyethylene glycol (Drug)
sodium phosphate group (group S)
Experimental
For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy
干预措施: sodium phosphate (Drug)
结局指标
主要结局
Cleansing quality
时间窗: during the procedure of colonoscopy
The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.
次要结局
- the degree of difficulty of the procedure(at the end of the procedure of colonoscopy)
- polyps or other endoscopic lesions(at the end of the procedure of colonoscopy)
- patient tolerance(before the procedure of colonoscopy)
- the duration of the procedure(during the procedure of colonoscopy)
- patient pain(at the end of the procedure of colonoscopy)
研究者
Dong Yang
Doctor
Jilin University
研究点 (1)
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