Impact of Salpingectomy on Ovarian Reserve, With Comparison Between Two Coagulation Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- AMH level
研究概览
简要总结
Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The principal objective of the present study is to assess the impact of salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve results between two coagulation techniques used in salpingectomy: bipolar electric energy versus ultrasound.
The study design is single-center, prospective, before-and-after, with open randomization between two groups defined by coagulation technique.
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
- None
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
- •Female subjects aged 18
- •Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication
排除标准
- •Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- •Pregnancy, ongoing or planned during the study period
- •History of bilateral salpingectomy
- •Salpingectomy associated with pelvic cancer
- •Oral hormonal contraception during the study period
- •Menopause
- •Inability to understand information provided
- •Not covered by a national health insurance scheme, prisoner or under administrative supervision.
结局指标
主要结局
AMH level
时间窗: 3 months post-surgery
次要结局
- index of vascular resistance in the ovarian vessels(1 and 3 months post-surgery)
- menopausal quality of life score(1 and 3 months post-surgery)
- AMH level(1 month post-surgery)