2024-518544-21-00招募中4 期
A Randomised controlled trial to compare efficacy and tolerability of Plenvu® and Picoprep® as cleansing agents before colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Efficacy of plenvu is not inferior to picoprep
研究概览
简要总结
Aim of the study is to compare the efficacy and tolerability of the relatively new bowel preparation Plenvu® with the well established bowel preparation Picoprep® as cleansing agents before colonoscopy. This is to test whether the low volume Polyethylin Glycol-electrolytes lavage solution preparation Plenvu® would have non-inferior efficacy on bowel preparation compared with Picosulfate based Picoprep® with a better effect on compliance and tolerability.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Ambulant colonoscopy
- •Older than18
排除标准
- •Younger than 18
- •Patients with Phenylketonuria
- •Patients with Glucose-6-phosphate-dehydrogenase deficiency
- •Patients with rectum and/or colon resections
- •Known with severe heart failure
- •Known with severe renal failure (eGFR<30)*
- •Known with colonic stenosis
- •Pregnant or breastfeeding
- •Acute colonoscopy
- •Cancer screening program colonoscopy
- •Mentally retarded
- •Redo colonoscopy of patients included in this study and colonoscopy was canceled because of bad bowel preparation.
结局指标
主要结局
Efficacy of plenvu is not inferior to picoprep
Efficacy of plenvu is not inferior to picoprep
次要结局
- Tolerability of plenvu is not inferior to picoprep
研究者
Hayder Alqaisi
Scientific
Aalborg University Hospital
研究点 (1)
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