Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.
详细描述
Low-volume preparations are gaining attention for higher acceptability. This study compares efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution in patients with inflammatory bowel disease-related colitis.
This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient acceptance, satisfaction, and related symptoms will be also recorded. The study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Adult outpatiets with IBD colitis undergoing colonoscopy
排除标准
- •Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency
- •Pregnant or breastfeeding women were also excluded
研究组 & 干预措施
4 Liter PEG
Colon preparation for colonoscopy: PEG 4 Liter before endoscopy
干预措施: Colon preparation for colonoscopy (Drug)
2 Liter PEG plus bisacodil
Colon preparation for colonoscopy: PEG 2 L before endoscopy
干预措施: Colon preparation for colonoscopy (Drug)
结局指标
主要结局
Efficacy
时间窗: During endoscopy within 24 hours after preparation
Quality of colon cleansing assesse with Ottawa bowel preparation score
次要结局
- Tollerability(during product assumption)
- safety(From drug intake to the end of colonoscopy)
- Compliance(during product assumption)
研究者
Gianpiero Manes
MD
Luigi Sacco University Hospital