Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Bowel Preparation Before Colonoscopy: A Multicentre, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,329
- 主要终点
- Adequate bowel preparation rate
研究概览
简要总结
Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years old, male or female
- •To undergo screening, surveillance and diagnostic colonoscopy
- •Signed written informed consent
排除标准
- •Subjects with therapeutic colonoscopy for colorectal polyps
- •Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding
- •Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon
- •Subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis
- •Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration
- •Subjects with constipation (<3 times a week, difficult defecation, dry stool, less amount)
- •Subjects with serious cardiac and cerebrovascular diseases,suffering from metabolic disease or endocrine disease
- •Subjects who had previously undergone colorectal resection
- •Women with positive pregnancy tests or pregnancy plans, and women in lactation or allergic to the investigational drugs and their ingredients
- •Subjects who are participating in other clinical trials or receiving special drugs
- •Subjects with any other conditions that the investigator considered inappropriate for inclusion
研究组 & 干预措施
1L PEG + 50g Magnesium sulfate (Group A)
Take 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy
干预措施: 1L PEG + 50g magnesium sulfate (Drug)
3L PEG alone (Group B)
Take 3L polyethylene glycol for bowel preparation before colonoscopy
干预措施: 3L PEG (Drug)
4L PEG alone (Group C)
Take 4L polyethylene glycol for bowel preparation before colonoscopy
干预措施: 4L PEG (Drug)
结局指标
主要结局
Adequate bowel preparation rate
时间窗: 30minutes
Defined as the proportion of participants with score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale
次要结局
- Excellent bowel preparation rate(30minutes)
- BBPS score (including total score, left colon, transverse colon, and right colon)(30minutes)
- Adenoma detection rate(10 days)
- Bowel preparation completion rate(30minutes)
- Electrolyte levels(8 hours)