Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- intestinal cleansing
研究概览
简要总结
The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS).
The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females
- •> 18 years and <85 years,
- •hemodynamically stable,
- •able to sign informed consent
- •requiring colonoscopy
- •anemia (loss of at least 2 g/dl of Hb) with or without active bleeding
排除标准
- •suspected or confirmed pregnancy,
- •hemodynamically unstable patients,
- •patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation,
- •toxic megacolon,
- •major colonic resection,
- •heart failure (Class III or IV NYHA),
- •severe liver failure,
- •end-stage renal disease
研究组 & 干预措施
High-Volume
Patients in the group were instructed to take 4 L of solution on the day before the colonoscopy
干预措施: High volume macrogol (Drug)
Low-Volume
Patients in the group were instructed to take 2 L of solution on the day before the colonoscopy
干预措施: Low volume macrogol (Drug)
结局指标
主要结局
intestinal cleansing
时间窗: during colonscopy procedure
Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level)
次要结局
未报告次要终点
研究者
OJETTI VERONICA
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS