NCT02086435已完成不适用
A Randomized Controlled Trial on Intracorporeal Versus Extracorporeal Morcellation With Endobag Extraction in Patients Undergoing Laparoscopic Myomectomy: Clinical Efficacy and Safety Outcomes
University Magna Graecia2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications
- •Presence of at least one uterine myoma larger than 4 cm
- •Aged between 18 and 40 years
排除标准
- •Presence of uterine neoformations suspicious for malignancy
- •Medical major disorders associated
- •Acute or chronic psychiatric disorders
- •Ascertained Premenstrual syndrome
- •Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment
- •Presence of calcified fibroids ultrasound examination
- •Presence of adnexal lesions
- •Detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding
- •Abnormal PAP test
- •Positive Pregnancy Test
- •Previous use of laparoscopic surgery increased
结局指标
主要结局
Operative time
时间窗: The day of surgery
calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field
次要结局
- Postoperative pain(The day of patient discharge, average 4 day after surgery)
- Total operative time(The day of surgery)
- Handling of morcellation(The day of surgery)
- Blood loss(2 hours after the end of surgery)
- Postoperative hospital stay(The day of patient discharge, average 4 day after surgery)
- Rate of complications(The day of patient discharge, average 4 day after surgery)
研究者
Fulvio Zullo
Full Professor Obstetric Gynecology
University Magna Graecia
研究点 (2)
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