The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Serum FSH and E2 assays
研究概览
简要总结
The purpose of this study is to investigate the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.
详细描述
Laparoscopic cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. In the present study, with the combined use of serum hormonal evaluation and ultrasound examination, we planned to prospectively investigate the ovarian reserve after the excision of benign ovarian cysts. The damage to ovarian reserve will be evaluated through a 12-months follow-up after the application of bipolar, ultrasonic scalpel electrocoagulation or suture during ovarian cystectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Age 18-40 years
- •Uni/bilateral ovarian cyst(s) without clinical and sonographic suspicion of ovarian cancer
- •Regular menstrual cycles defined as cycle length between 25 and 35 days in the 6 months before surgery
- •Agreement to be enrolled in the study
排除标准
- •Prior ovarian surgery
- •Surgical necessity to perform adnexectomy
- •Known endocrine disease
- •Post operative pathologic diagnosis was not benign ovarian cyst
- •Oral contraceptive use before surgery
研究组 & 干预措施
1
Laparoscopic ovarian cystectomy using bipolar
干预措施: Ovarian cystectomy (Procedure)
2
Laparoscopic ovarian cystectomy using ultrasonic scalpel
干预措施: Ovarian cystectomy (Procedure)
3
Laparotomic ovarian cystectomy using suture
干预措施: Ovarian cystectomy (Procedure)
结局指标
主要结局
Serum FSH and E2 assays
时间窗: 12 months
次要结局
- Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity(12 months)