Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: myomectomy with placebo, myomectomy with misoprostol.
- Who it may be relevant to
- Registry conditions: Myoma;Uterus, Myomectomy; Surgical Blood Loss. Basic parameters: 18 years — 43 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
In France, uterine fibroids or leiomyomas are the most common benign tumour in women of childbearing age. In 30% of cases, fibroids are symptomatic (menorrhagia, anaemia, pain), in which case surgical management is indicated. This is known as myomectomy, and can be performed by hysteroscopy, laparoscopy (laparoscopy) or laparotomy, depending on the number, size and position of the fibroids. Intraoperative bleeding is the main surgical difficulty. For this reason, a number of studies have focused on ways of minimizing the risk of bleeding. A good surgical indication, prevention of anaemia (iron deficiency) and transient occlusion of the uterine arteries during surgery help to reduce this risk. There are also drugs available to reduce intraoperative bleeding, but few studies have been carried out to assess their real effectiveness. One such product is Misoprostol, commonly used in gynecology. Its muscle-contracting properties suggest that it could have a beneficial effect on bleeding during surgery. What's more, this treatment has been used for many years and is reputed to be very well tolerated. The most frequent side effects are digestive, with a risk of abdominal pain in the form of cramps, nausea or vomiting. The investigators therefore decided to set up the HEMOMYOC study to demonstrate a significant reduction in bleeding during laparotomy or laparoscopic myomectomy after taking oral misoprostol in combination with transient occlusion of the uterine arteries, compared with placebo. It would seem that the ease of use and good tolerance of misoprostol, in combination with transient occlusion of the uterine arteries, could be of real benefit in preventing intraoperative morbidity in myomectomies, whatever the surgical approach. To date, no studies have been carried out in this area.
Interventions
- Procedure myomectomy with placebo
myomectomy after administration of placebo (control group) - Procedure myomectomy with misoprostol
myomectomiy after administration of misoprostol 400μg PO (experimental group)
Primary outcome measures
- Evaluation of intraoperative blood loss (in milliliters) during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) regardless of type of surgery. [Time frame: during surgery]
Secondary outcome measures (12)
- Evaluate intraoperative blood loss (in milliliters) during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) according to surgical technique, laparoscopy and laparotomy. [Time frame: during surgery]
- Compare Hemoglobin level (in g/L) between experimental and control groups [Time frame: between day before surgery and day of surgery]
- Compare Hemoglobin level (in g/L) between laparotomy and laparoscopy surgery [Time frame: between day before surgery and day of surgery]
- Compare between experimental and control groups: Patient age [Time frame: at inclusion]
- Compare between laparotomy and laparoscopy: Patient age [Time frame: at inclusion]
- Compare between experimental and control groups: Patient BMI [Time frame: at inclusion]
- Compare between laparotomy and laparoscopy: Patient BMI [Time frame: at inclusion]
- Compare between experimental and control groups: Patient medical history [Time frame: at inclusion]
- Compare between laparotomy and laparoscopy: Patient medical history [Time frame: at inclusion]
- Compare between experimental and control groups: Patient comorbidities [Time frame: at inclusion]
- Compare between laparotomy and laparoscopy: Patient comorbidities [Time frame: at inclusion]
- Compare between experimental and control groups: Size of myoma [Time frame: at inclusion]
Eligibility criteria
Inclusion criteria
- Patient aged 18 to 43
- Symptomatic myomas (bleeding, pain or infertility)
- Indication for laparoscopic myomectomy Fibroma ≤ 10cm or number ≤ to 4 fibroids
- Indication for myomectomy by laparotomy Fibroma > 10cm, Number > to 4 fibroids
- OTAU possible intraoperatively (Clip on uterine artery and tourniquet placement)
- Speak and understand French
- Affiliated with a social security scheme.
Exclusion criteria
- History of major uterine surgery or myomectomy (excluding hysteroscopic myomectomy)
- Allergy to misoprostol and lactose
- Patients with hypersensitivity to misoprostol and/or other prostaglandins or to any of the product's excipients.
- Patients taking aspirin or anti-coagulants
- Patients with haemostasis disorders
- Malnourished patients
- Patients with hepatic or renal insufficiency
- Pregnancy, suspected ectopic pregnancy and breast-feeding women.
- Minors
- Guardianship, curatorship, deprived of liberty, safeguard of justice
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU Clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT06882824 · RBHP 2024 GREMEAU