An interventional study of uterine myomectomy with preventive uterine arteries occlusion and laparoscopic uterine myomectomy without preventive uterine arteries occlusion in Uterine Myoma, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Treatment
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:
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 58 is close to the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic myomectomy with preventive uterine arteries occlusion
Procedure: uterine myomectomy with preventive uterine arteries occlusion
Laparoscopic myomectomy without preventive uterine arteries occlusion
Procedure: laparoscopic uterine myomectomy without preventive uterine arteries occlusion
laparoscopic uterine myomectomy with preventive uterine arteries occlusion
laparoscopic uterine myomectomy
Evolution of ovarian reserve markers after myomectomy
It will be determined by plasmatic AMH and ultrasound antral follicle count
Time frame: Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative
Intra-and post-operative blood loss
Blood loss will be estimated during the operation, and will be followed for the duration of hospital stay, an expected average of 3 days. furthermore, we will dose the hemoglobin before and after the intervention.
Time frame: peroperative
operative time
Time needed to realise the intervention from the incision to the cutaneous stitches
Time frame: peroperative
peroperative complications
it will be noticed the conversion in laparotomy, the blood transfusion, the organic and vessels lesions
Time frame: peroperative
Clinical symptoms improvement: hypermenorrhea
Evaluation of quantity of blood during menstruation with the PBAC scale (Pictorial Blood Assessment Chart) before and after the intervention
Time frame: 1, 3, 6, 12 and 24 months postoperative
Clinical symptoms improvement: dysmenorrhea
Evaluation of improvement of dysmenorrhea by asking patients the pain they have from 0 to 10 and their consumption of pain killers (NSAIDs and paracetamol) during menstruation.
Time frame: 1, 3, 6, 12 and 24 months postoperative
Clinical symptoms improvement: occuring of pregnancy
Evaluation of the occurence of pregnancy by asking women the number of pregnancy, of miscarriage, of abortion, of term pregnancy since the intervention
Time frame: 12 and 24 months postoperative
long-term recurrence of myomas
An US will be made at 1, 3, 6, 12 and 24 months to estimate the recidive of myoma. It will be considered a recidive when the myoma will be bigger than 20 mm
Time frame: 2 years
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Geneva