NCT01873378已完成不适用
Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.
Azienda Ospedaliera S. Maria della Misericordia1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure.
研究概览
简要总结
The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •submucous myoma diagnosed by vaginal ultrasonography and confirmed by diagnostic hysteroscopy
- •premenopausal status
排除标准
- •present or past history of cancer
- •pregnancy
- •presence of associated multiple polyps
- •presence of > 2 myomas
- •associated nonhysteroscopic surgical procedures
研究组 & 干预措施
GnRH agonist pretreatment
Experimental
triptorelin 3.75 mg, im, monthly, three times
干预措施: Triptorelin 3.75 mg (Drug)
结局指标
主要结局
To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure.
时间窗: Just finished the surgical procedure.
次要结局
- Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).(Just finished the surgical procedure.)
研究者
Sandro Gerli
Assistant Professor
Azienda Ospedaliera S. Maria della Misericordia
研究点 (1)
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