Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Evolution of ovarian reserve markers after myomectomy
研究概览
简要总结
Hysterectomy is an effective treatment used as a first-line approach for uterine myomas. Several others alternatives to hysterectomy have been developed in recent years for women wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound.
Myomectomy, particularly through minimally invasive surgery, is currently considered the conservative treatment of choice for patients wishing to preserve their fertility. However, three important issues should be considered: the risk of intra- and postoperative bleeding, the risk for recurring myomas, and the preservation of subsequent fertility.
Preventive uterine artery occlusion can be combined with laparoscopic myomectomy in order to avoid bleeding and improve uterine suture. Another expected long-term benefit is the improvement of treatment efficacy, leading to less symptoms and myomas recurrence. However, the effect of uterine arteries occlusion on the ovarian reserve of women of childbearing age has not yet been studied, which limits its clinical application.
详细描述
Objectives:
- To assess the effect of preventive uterine artery occlusion during laparoscopic myomectomy on ovarian reserve parameters;
- To evaluate the effect of preventive uterine artery occlusion during laparoscopic myomectomy on intra- and postoperative blood loss, operative time, clinical symptoms improvement, long-term recurrence of myomas and fertility.
Materials and methods:
Design: This is a prospective randomized single blind trial, including 60 women undergoing a laparoscopic myomectomy for symptomatic uterine myomas. Patients are randomized into two groups: a control group "myomectomy alone" and an experimental group "myomectomy with preventive uterine arteries occlusion".
Setting: The duration of the study will normally be 5 years and will take place at the University Hospitals of Geneva. The study will include about 20 women per year and follow-up will last 2 years. Inclusion criteria are: women of childbearing age, wishing to retain their uterus, having symptomatic uterine myomas and who are eligible for a laparoscopic myomectomy.
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
- Single (Participant)
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
- •over 18 years
- •signed the surgery consent form
- •capable of discernment understanding and accepting the risks and benefits of the operation
- •symptomatic : menorrhagia, breakthrough bleeding and / or pelvic pain and / or infertility and / or repeated spontaneous abortions.
- •uterine myoma or more, including at least one type of myoma FIGO 2-6 (International Federation of Gynecology and Obstetrics) objectified by ultrasound and / or pelvic MRI
- •laparoscopic approach is technically feasible (as recommended by the National College of Obstetrics and Gynecology French published in 2011): myoma single lower or equal to 9 cm or sum of the size of myomas in centimeters or less equal to 13 and number of myomas inferior to four.
- •Female patients of childbearing age younger than 45 years and having a plasma AMH (anti-Mullerian hormone) than 3 pmol / l.
- •Patients who accept a postoperative follow-up of 2 years
排除标准
- •pregnant patients.
- •who underwent radiological uterine artery embolization.
- •who have an undetectable AMH levels (<3 pmol / l).
- •over 45 years
结局指标
主要结局
Evolution of ovarian reserve markers after myomectomy
时间窗: Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative
It will be determined by plasmatic AMH and ultrasound antral follicle count
次要结局
- operative time(peroperative)
- Intra-and post-operative blood loss(peroperative)
- Clinical symptoms improvement: hypermenorrhea(1, 3, 6, 12 and 24 months postoperative)
- Clinical symptoms improvement: occuring of pregnancy(12 and 24 months postoperative)
- peroperative complications(peroperative)
- Clinical symptoms improvement: dysmenorrhea(1, 3, 6, 12 and 24 months postoperative)
- long-term recurrence of myomas(2 years)
研究者
Isabelle Streuli
Dr
University Hospital, Geneva