A Randomized Controlled Trial Comparing Efficacy and Acceptability of Split and Standard Dose Sodium Picosulphate/Magnesium Citrate for Bowel Cleansing Prior to Colonoscopy: the MAGIC-P Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 862
- 试验地点
- 1
- 主要终点
- Rate of adequate colon cleansing
研究概览
简要总结
This is an endoscopist-blinded, prospective, multicenter study involving adult outpatients aiming at evaluating whether sodium picosulphate/magnesium citrate split dosing is associated to higher efficacy and acceptability in comparison to the standard dose regimen in bowel cleansing before colonoscopy
详细描述
Picosulphate/magnesium citrate is a very effective, safe and tolerated low-volume preparation for colon cleansing. This study evaluates whether split dosing is associated to a further increase in efficacy and acceptability in comparison to the standard dose regimen. This is a multicenter, randomized, single-blind study performed in 15 endoscopic services in Italy.
Adult outpatients undergoing colonoscopy will receive picosulphate/magnesium citrate either in the standard dosing (group A, two sachets the day before endoscopy), or in the split dosing (group B, the second dose in the morning of colonoscopy). Bowel cleansing will be assessed using the Boston Scale (BBPS) and rated as adequate if >2 in each segment. Patient acceptance, satisfaction, and related symptoms will be also recorded.
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）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult outpatients
- •aged 18-85 yr
- •undergoing elective colonoscopy
排除标准
- •previous colon resection,
- •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),
- •renal failure (creatinine clearance<30 mL/minute),
- •phenylketonuria,
- •glucose-6-phosphate dehydrogenase deficiency,
- •pregnant or breastfeeding women
研究组 & 干预措施
Group A: standard regimen
Patients in the group A (standard regimen) will be instructed to take the two sachets of sodium picosulphate/magnesium citrate diluted in a glass of water 2-4 hours apart, starting at 5 pm the day before colonoscopy.
干预措施: Sodium picosulphate/magnesium Citrate (Drug)
Group B
Patients in the group B (split regimen) will be instructed to take the first sachet of sodium picosulphate/magnesium citrate at 7 pm the day before colonoscopy and the second one at 6 am in the morning on the day of colonoscopy.
干预措施: Sodium picosulphate/magnesium Citrate (Drug)
结局指标
主要结局
Rate of adequate colon cleansing
时间窗: 24 hrs
The primary endpoint of the study was the quality of overall colon cleansing, assessed by the endoscopist. Colon cleansing quality was dichotomized as "adequate" (score \> 2 in each colon segment) or "inadequate" (score \< 2 in one or more colon segments
次要结局
- Patients' acceptance, tolerability and compliance to the cleansing regimen(24 hrs)
研究者
Gianpiero Manes
Medical Doctor
Luigi Sacco University Hospital