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Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? (ORAM)

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ClinicalTrials.gov Identifier: NCT02563392
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Lauriane Ramyead, University Hospital, Geneva

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Uterine Myoma Procedure: uterine myomectomy with preventive uterine arteries occlusion Procedure: laparoscopic uterine myomectomy without preventive uterine arteries occlusion Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? A Randomized Control Trial
Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Arm Intervention/treatment
Experimental: Uterine arteries occlusion
Laparoscopic myomectomy with preventive uterine arteries occlusion
Procedure: uterine myomectomy with preventive uterine arteries occlusion
laparoscopic uterine myomectomy with preventive uterine arteries occlusion

Active Comparator: No uterine arteries occlusion
Laparoscopic myomectomy without preventive uterine arteries occlusion
Procedure: laparoscopic uterine myomectomy without preventive uterine arteries occlusion
laparoscopic uterine myomectomy




Primary Outcome Measures :
  1. Evolution of ovarian reserve markers after myomectomy [ Time Frame: 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


Secondary Outcome Measures :
  1. Intra-and post-operative blood loss [ Time Frame: peroperative ]
    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.

  2. operative time [ Time Frame: peroperative ]
    Time needed to realise the intervention from the incision to the cutaneous stitches

  3. peroperative complications [ Time Frame: peroperative ]
    it will be noticed the conversion in laparotomy, the blood transfusion, the organic and vessels lesions

  4. Clinical symptoms improvement: hypermenorrhea [ Time Frame: 1, 3, 6, 12 and 24 months postoperative ]
    Evaluation of quantity of blood during menstruation with the PBAC scale (Pictorial Blood Assessment Chart) before and after the intervention

  5. Clinical symptoms improvement: dysmenorrhea [ Time Frame: 1, 3, 6, 12 and 24 months postoperative ]
    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.

  6. Clinical symptoms improvement: occuring of pregnancy [ Time Frame: 12 and 24 months postoperative ]
    Evaluation of the occurence of pregnancy by asking women the number of pregnancy, of miscarriage, of abortion, of term pregnancy since the intervention

  7. long-term recurrence of myomas [ Time Frame: 2 years ]
    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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • pregnant patients.
  • who underwent radiological uterine artery embolization.
  • who have an undetectable AMH levels (<3 pmol / l).
  • over 45 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563392


Contacts
Contact: Lauriane Ramyead, Dre lauriane.ramyead@hcuge.ch
Contact: Jean Dubuisson, Dr jean.dubuisson@hcuge.ch

Locations
Switzerland
Hôpitaux Universitaires de Genève, Service de gynécologie Recruiting
Geneva, Switzerland, 1206
Contact: Lauriane Ramyead, Dr       lauriane.ramyead@hcuge.ch   
Sub-Investigator: Marie I Streuli, Dr         
Sub-Investigator: Jean Dubuisson, Dr         
Sub-Investigator: Patrick Petignat, Dr         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Director: Patrick Petignat, Pr University Hospital, Geneva

Responsible Party: Lauriane Ramyead, Dr, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02563392     History of Changes
Other Study ID Numbers: 14-129
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases