Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy by the Abdominal Route: Prospective,Randomized, Multicenter and Pilot Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 主要终点
- The proportion of patients with endometrial synechiae
研究概览
简要总结
PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)
详细描述
Myomas are a common pathology affecting a large population of women of reproductive age. Depending on their location and the patient's symptoms, surgical removal of fibroids may be indicated.
Interstitial or subserous myomas are accessible through the abdominal route (laparotomy or minimally invasive surgery).
The impact of this surgery on the endometrial cavity and the risk of post-surgery synechiae is poorly understood, although it is essential, especially in a population of women wishing to preserve their fertility. In order to reduce and prevent endometrial synechia formation, we suggest PREVENDO study which consist in the systematic intracavitary placement of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) immediately after surgery in patients undergoing abdominal myomectomy or polymyomectomy (laparotomy, laparoscopy, robot-assisted laparoscopy) and the evaluation of the proportion of endometrial synechiae 6 weeks after surgery in patients during diagnostic hysteroscopy performed 6 weeks after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Of childbearing age
- •Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy
- •FIGO 2 to 6 classification myomas
排除标准
- •History of intra uterine synechia treatment
- •Uterine malformation
- •Patients under legal protection measure (guardianship or curatorship) or under security measure
- •Pregnant or breastfeeding women
- •Absence of health insurance; or patient with AME
- •Absence of free, informed and written consent
- •Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy)
- •Patient with upper genital infection
- •Hypersensibility to hyaluronic acid
结局指标
主要结局
The proportion of patients with endometrial synechiae
时间窗: 6 weeks after surgery (+/-2weeks)
The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery.
次要结局
- Proportion of patients with increased of menstrual bleeding or menstrual bleeding time(6 weeks after surgery (+/- 2 weeks))
- The quality of life(6 weeks after surgery (+/- 2 weeks))
- Spontaneous pelvic pain(6 weeks after surgery (+/- 2 weeks))
- Metrorragia(6 weeks after surgery (+/- 2 weeks))
- Proportion of patients with moderate or severe endometrial synechiae(6 weeks after surgery (+/-2 weeks))
- Dysmenorrhea(6 weeks after surgery (+/- 2 weeks))