1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,004
- 试验地点
- 10
- 主要终点
- Overall colon cleansing efficacy
研究概览
简要总结
Background and aims: Inpatients are at high risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution because of its effectiveness and safety profile. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported in an observational study among more than 1,000 inpatients. Thus, the present study is aimed at determining whether 1L-PEG outperforms 4L-PEG among inpatients, through a propensity score-matching between the two groups in order to correct for confounders.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.
排除标准
- •patients who underwent emergency or elective therapeutic colonoscopies (e.g. polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection)
- •patients who underwent bowel preparation outside the hospital
研究组 & 干预措施
1L-PEG
Hospitalized patients who are prescribed colonoscopy with 1L-polyethylene glycole (PEG) plus ascorbic acid as bowel preparation.
干预措施: 1L-PEG (Drug)
4L-PEG
Hospitalized patients who are prescribed colonoscopy with 4L-polyethylene glycole (PEG) as bowel preparation.
干预措施: 4L-PEG (Drug)
结局指标
主要结局
Overall colon cleansing efficacy
时间窗: Outcome will be assessed during colonoscopy
Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score ≥2 for each colon segment)
Right colon cleansing efficacy
时间窗: Outcome is assessed during colonoscopy
Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score ≥2 in the right colon)
次要结局
- Safety (hematocrit change)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
- Safety (serum creatinine imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
- Safety (glomerular filtration rate change)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
- Safety (serum sodium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
- Safety (serum magnesium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
- Safety (serum potassium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
- Safety (serum calcium imbalance)(within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy)
研究者
Lorenzo Fuccio
Professor of Gastroenterology
IRCCS Azienda Ospedaliero-Universitaria di Bologna