Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- impact on ovarian reserve, in terms of reduction of serum AMH levels
研究概览
简要总结
The aim of this study is to compare two different laparoscopic surgical techniques (endometrioma stripping vs ethanol sclerotherapy) in terms of ovarian reserve (AMH levels), recurrence rate and pain relief.
详细描述
Patients with pelvic pain (VAS score≥4) and ultrasound diagnosis of endometrioma > 4cm candidate to surgical removal of endometrioma will be randomized into 2 group. One Group will undergo laparoscopical stripping technique; the other one will undergo laparoscopic aspiration and sclerotherapy using 95% ethanol.
The women will be introduced with both operative options and they will be informed about the randomization . After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity & parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), symptoms related to endometriosis (through VAS score), fertility history including any fertility treatment in the past and planned pregnancy after the operation.
The laparoscopy will take place in Fondazione Policlinico Gemelli IRCSS, Roma. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a Nelathon catheter. Ethanol will be left in the cyst for 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy.
The women will be followed at 1 , 3 , 6 and 12 months after the surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18-35 years old
- •Women with ultrasound diagnosis of ovarian endometrioma ≥4cm (with or without deep infiltrating endometriosis)
- •History of dysmenorrhea and/or chronic pelvic pain
- •candidates for elective laparoscopy due to endometriosis.
排除标准
- •- Previous surgery for ovarian endometriosis
- •Evidence of premature ovarian failure (follicle stimulating hormone ≥40 international units/L)
- •Endocrinal disorders that might affect ovarian function (e.g., polycystic ovary syndrome, thyroid dysfunction, hyperprolactinemia)
- •Ultrasound suspicious of ovarian malignant disease according IOTA criteria
- •endometrial cyst < 4 cm. • ethanol sensitivity.
结局指标
主要结局
impact on ovarian reserve, in terms of reduction of serum AMH levels
时间窗: up to 12 months after the laparoscopy
The AMH levels will be evaluated 1 month before the surgery and 1, 6 and 12 months after surgery.
次要结局
- endometrioma recurrence rate for the two surgical techniques(up to 12 months after the laparoscopy)
- pain relief after surgery(up to 12 months after the laparoscopy)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart