Comparison of Manual Syringe Infusion Method and Conventional Pump Infusion Method for Hysteroscopic Procedures: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The difference in the amount of distension medium used
研究概览
简要总结
This study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional pump infusion method to clarify if the manual syringe infusion method really needs less amount of distension medium.
详细描述
Hysteroscopy is frequently used for diagnosing abnormal uterine bleeding, endometrial polyp or submucous myoma. However, hysteroscopic procedure can cause morbidity and even mortality related to infusion distension medium. We had used a manual syringe infusion method to infuse fluid for distending the uterine cavity in our institute without significant morbidity, and it seems that this method need less amount of distension medium, and possible result in less possibility of hyponatremia. Therefore, the aim of this study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional infusion pump method to clarify if the manual syringe infusion method really needs less amount of distension medium during hysteroscopy.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 99 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.
排除标准
- •Female patients of less than twenty years-old.
结局指标
主要结局
The difference in the amount of distension medium used
时间窗: 1 day
The amount of distension medium used between the manual syringe infusion method and the conventional infusion pump method of hysteroscopic surgery
次要结局
- The difference of serum sodium and pain score, operation time(1 day)
研究者
Sheng-Mou Hsiao
Chief, Department of Obstetrics & Gynecology
Far Eastern Memorial Hospital
