Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas - a Prospective Case Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- endometrioma recurrence rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard cystectomy treatment - a prospective case control study.
详细描述
Women who are candidates for elective laparoscopy for the treatment of ovarian ensometriomas will be assigned to one of two groups - a) standard cystectomy treatment, b) aspiration and sclerotherapy using 95% ethanol. The women will be introduced with both operative options and they will choose which one they prefer. 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), AFC (Antral Follicle Count), symptoms related to endometriosis (through a questionnaire), fertility history including any fertility treatment in the past and planned pregnancy after the operation.
The laparoscopy will take place in Meir Medical Center. 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 foley catheter. Ethanol will be left in the cyst for a maximum of 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 4 and 6 months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with endometrial cyst ≥ 4 cm.
- •candidates for elective laparoscopy due to endometriosis.
- •age 18-45 years
排除标准
- •endometrial cyst < 4 cm.
- •an emergency surgery.
- •age <18 or >45
- •women with a history of tubal ovarian abscess (TOA).
- •high index of suspision for ovarian malignancy.
- •ethanol sensitivity.
研究组 & 干预措施
study group - sclerotherapy
Aspiration and Sclerotherapy of endometriomas.
干预措施: Aspiration and Sclerotherapy of endometriomas. (Procedure)
study group - sclerotherapy
Aspiration and Sclerotherapy of endometriomas.
干预措施: Ethanol (Drug)
control group - cystectomy
cystectomy of endometriomas.
干预措施: cystectomy of endometriomas. (Procedure)
结局指标
主要结局
endometrioma recurrence rate
时间窗: up to 6 months after the laparoscopy
Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the sclerotherapy took place.
次要结局
- Measure of efficacy of the treatment by questionnaire(4 months and 6 months after the laparoscopy)
- length of hospital stay(participants will be followed for the duration of hospital stay, an expected average of 2 days)
- length of surgery(intraoperative)
- complication rate(during the surgery and until one month after the surgery.)
- Ovarian reserve(4 months and 6 months after the laparoscopy)