Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy: Phase 4 Prospective Multicenter Real Life Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 601
- 试验地点
- 5
- 主要终点
- Assess the quality of the bowel preparation assessed by Bubble scale
研究概览
简要总结
Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.
Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for colonoscopy as part of CRC screening, using the bowel preparation with fixed low-dose of simethicone combined with Macrogol 4000 (PEG)
- •aged 50-75 years,
- •with no family history of CRC or personal history of colon polyps but with a positive Faecal Immunochemical Test (FIT), with a family history of CRC or personal history of colon polyps,
- •requiring surveillance colonoscopy after 5 years if diagnosed with one or two tubular adenomas <10 mm in diameter (low-risk group) or after 3 years if diagnosed with at least 3 adenomas or any adenoma at least 10 mm in diameter or with high-grade dysplasia, according to French recommendations during the study inclusion period.
排除标准
- 未提供
结局指标
主要结局
Assess the quality of the bowel preparation assessed by Bubble scale
时间窗: During procedure
Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)
时间窗: During procedure
次要结局
- volume of bowel preparation ingested(immediately post procedure)
- Colonoscope removal time(immediately post procedure)
- The frequency of adverse events (AEs)(within 10 minutes post procedure)
- Caecal intubation rate(immediately post procedure.)