NCT03009604Unknown3 期
Does Simethicone Improve Operative Field in Gynecological Operations
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the degree of small & large bowel preparation
研究概览
简要总结
Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.
排除标准
- •History of allergic reaction to study drugs.
- •More than one scar of previous operation.
- •Suspicious of malignancy.
- •Psychiatric disorders.
研究组 & 干预措施
Simethicone
Experimental
women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation
干预措施: Simethicone (Drug)
Enema
Active Comparator
women take 3 rectal Enema (8:00 pm, 12:00 am & 8:00 am) and to fast over night before the operation.
干预措施: Enema (Drug)
结局指标
主要结局
the degree of small & large bowel preparation
时间窗: intraoperative
次要结局
未报告次要终点
研究者
Altayeb Abd alal Mostafa Mohammad
Dr
Assiut University
研究点 (1)
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