Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol. (HEMOMYOC)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Myomectomy; Surgical Blood Loss; Myoma;Uterus

Treatments: Procedure: myomectomy with misoprostol; Procedure: myomectomy with placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06882824

RBHP 2024 GREMEAU

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

treatment arm with misoprostol

Experimental group

Treatment:

Procedure: myomectomy with misoprostol

Placebo arm

Placebo Comparator group

Treatment:

Procedure: myomectomy with placebo