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临床试验/NCT02012010
NCT02012010已完成不适用

Comparison of Manual Syringe Infusion Method and Conventional Pump Infusion Method for Hysteroscopic Procedures: a Randomized Controlled Trial.

Far Eastern Memorial Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年12月6日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Far Eastern Memorial Hospital

研究点 (2)

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