Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- endometrioma recurrence
研究概览
简要总结
The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate
详细描述
Only patients who sign informed consent will be included. Only patients wishing for future pregnancy will be involved in the study. Expected number of enrolled subjects is 160 ( 80 in each arm) Patients with endometrioma and planned surgery to remove it will be randomized either to laparoscopic sclerotherapy with 96% ethanol or cystectomy. First AMH sample will be taken day before surgery. If other endometriosis lesions (deep or superficial) are present, they may be also resected during this surgery.
Ethanol sclerotherapy description: classical laparoscopic approach - small (max1cm) fenestration of endometrioma - aspiration of endometrioma contents- foley catheter insertion- ballon inflation inside of the cyst- instillation with 96% ethanol which is left in the cyst for 10min- aspiration of ethanol and flushing with saline.
Cystectomy: classical laparoscopic approach- large fenestration of endometrioma - aspiration of endometrioma contents- indentification of ovary/ endometrioma tissue and plane between the ovarian capsule and cyst wall is developed using a mix of blunt and sharp dissection - if bleeding is present it is stopped by cautious bipolar coagulation
visit 1 - surgery time (AMH day before surgery, age, BMI, endometriosis extent, gravidity/ parity, endometriosis residue after surgery, pain levels) visit 2- 3 months after surgery : Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 3+4 - 6/12months after surgery: AMH, Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 5- 24 months after surgery: Ultrasound, complications, pregnancy, asissted reproduction, pain levels
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •IOTA benign endometrioma
- •bilateral or unilateral endometrioma measuring 30 or more milimeters
- •patients with unfinished reproductive plans
排除标准
- •bilateral recurrence of endometrioma
- •recurrent endometrioma if the other ovary is not present or patient had cystectomy on the other ovary
- •suspision for ovarian malignancy
- •signs of inflammatory pelvic disease
- •disagreement with participation in the study
结局指标
主要结局
endometrioma recurrence
时间窗: Measuring change of endometrioma size (in case of recurrence) at 3, 6, 12 and 24 months after surgery
recurrence described as endometrioma measuring 20 or more milimeters on ultrasound
complications
时间窗: 0-12 months
recording all complications related to surgery, classified according Clavien Dindo
AMH dynamics
时间窗: Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery
Measuring AMH level in blood
次要结局
- pregnancy rate(0-24 months after surgery)
- Asissted reproduction methods succes rate(0-24 months after surgery)
- deliveries(24 months)
研究者
Katarina Ivankova
Medical doctor at Endometriosis centre, Institute for the mother and child care
Institute for the Care of Mother and Child, Prague, Czech Republic