Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- rate of amenorrhea
研究概览
简要总结
Menometrorrhagia is the first cause of consultation in gynecology. Etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia .
In case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. Currently, a new system, Lina LibrataTM is available on the market. This system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. Specially, it does not require dilatation of uterus's cervix and it reduces the pain. The investigator make hypothesis that the use of the system Lina LibrataTM does not cause pain and can be thus used under local anesthetic in ambulatory surgery. With the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of Lina LibrataTM system in the treatment of functional idiopathic menometrorrhagia. Secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 38 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women from 40 to 50 years old
- •Not menopausal women
- •Do not want pregnancy
- •Having dysfunctional bleeding
- •informed and signed consent
排除标准
- •Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc
- •Pregnancy or wish to have later pregnancy
- •Endometrium cancer (or suspicious of cancer) or precancerous conditions of the endometrium
- •Anatomical conditions (i-e history of caesarian, transmural myomectomy) or pathological conditions (i-e long term treatment) which can weaken myometrium
- •Genital or urinary infection at the time of the procedure
- •Intra uterine device
- •Pelvic inflammation
- •Inability to understand information provided
- •Not covered by a national health insurance scheme, prisoner or under administrative supervision
结局指标
主要结局
rate of amenorrhea
时间窗: 4 weeks
次要结局
- assessment of menorrhagia on Higham's score(6 months after surgery)
- per-operative complications(per surgery day 0)
- post-operative complications(post surgery day 0)
- evolution of hemoglobinemia(6 months after surgery)
- measure of symptoms improvement(at month 6)
- recurrences of menorrhagia(at month 6)
- measure of quality of life(at month 6)
- pain score(one month after surgery (Month 1))