Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy
研究概览
简要总结
The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side effect and subsequent fertility.
详细描述
Hysteroscopic myomectomy is the referent surgical treatment for submucous myoma. But intrauterine adhesion rate was evaluated about 7 to 15% after this procedure. The investigators hypothetically believe that application of HYALOBARRIER Gel at the end of the procedure, could be reduce the mean intrauterine rate to 50%. Thus, the investigators performed a multicenter (n = 20) prospective study non randomized in 220 patients with submucous myoma < 3 cm of diameter, evaluated by preoperative ultrasound. The investigators prefer this study design, because the principal reason is the number of enrolled patient were more 200 patients in each group with a double blind randomized study. Now, in all patients, after hysteroscopic myomectomy which performed with a same technique in each center (bipolar coagulation and physiologic serum), a diagnostic hysteroscopy was performed at 2 month to determinate the existence of intrauterine adhesion. Secondary end points were in this study the tolerance and side effects of HYALOBARRIER Gel and the subsequent fertility at 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 45 aged-patients
- •hysteroscopic diagnosis of one submucous myoma with less than 3cm diameter requiring operative hysteroscopy with saline type 0, 1 or 2
- •negative plasmatic βHCG test
- •non opposition
- •patients with social security
排除标准
- •multiple submucous myomas type 0, 1 or 2
- •presurgical embolization
- •presurgical impregnation with GnRH agonist
- •coagulative disorders
- •malignancies
- •uncontrolled diabetes
- •operative hysteroscopy with glycine
- •known hypersensitivity to HyalobarrierR Gel Endo
- •infection of the surgical area concerned
结局指标
主要结局
The formation of postsurgical uterine synechiae rate with HyalobarrierR Gel Endo in hysteroscopic myomectomy
时间窗: between 4 and 8 weeks after initial hysteroscopic myomectomy
次要结局
- the number of participants with adverse events as a measure of safety and tolerability during the time of the study(2 years)
- Postsurgical fertility with evaluation of number of participants who became pregnant after surgery, spontaneously and/or after assisted reproductive technologies(2 years)