Uterine Myoma Clinical Trial
Official title:
Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? A Randomized Control Trial
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.
Objectives:
1. To assess the effect of preventive uterine artery occlusion during laparoscopic
myomectomy on ovarian reserve parameters;
2. 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.
The parameters that will be intraoperatively evaluated are the operation time, blood loss and
the complications of the surgical technique. Postoperative complications, improving clinical
symptoms, myomas recurrence and fertility are discussed at short and long term follow-up.
The ovarian reserve will be evaluated pre- and postoperatively for each patient. It will be
determined by plasmatic AMH (anti-Mullerian Hormone) and ultrasound antral follicle count.
Women with undetectable preoperative plasmatic AMH will be excluded from the study. Plasmatic
AMH and antral follicle count will be measured at 1, 3, 6, 12 and 24 months during the
postoperative follow-up.
Limitations:
The sample size is calculated in order to demonstrate a significant difference in plasmatic
AMH before and after myomectomy. Small differences are not highlighted in this study, but
they probably would not have any impact in clinical practice.
Impact of the study:
The results of this study could have a real impact on daily surgical practice. In case of
persistent alteration of ovarian reserve in the experimental group compared to the control
group, preventive uterine arteries occlusion during a laparoscopic myomectomy should only be
indicated in patients who do not wish pregnancy. If there is no significant impact on ovarian
reserve and a beneficial effect on reducing intraoperative blood loss and long-term
improvement of symptoms, it should be systematically proposed in all patients undergoing a
laparoscopic myomectomy.
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