Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.

Обзор

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.

Вмешательства

• Процедура myomectomy with placebo
  myomectomy after administration of placebo (control group)
• Процедура myomectomy with misoprostol
  myomectomiy after administration of misoprostol 400μg PO (experimental group)

Первичные конечные точки

• 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. [Срок оценки: during surgery]

Вторичные конечные точки (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. [Срок оценки: during surgery]
• Compare Hemoglobin level (in g/L) between experimental and control groups [Срок оценки: between day before surgery and day of surgery]
• Compare Hemoglobin level (in g/L) between laparotomy and laparoscopy surgery [Срок оценки: between day before surgery and day of surgery]
• Compare between experimental and control groups: Patient age [Срок оценки: at inclusion]
• Compare between laparotomy and laparoscopy: Patient age [Срок оценки: at inclusion]
• Compare between experimental and control groups: Patient BMI [Срок оценки: at inclusion]
• Compare between laparotomy and laparoscopy: Patient BMI [Срок оценки: at inclusion]
• Compare between experimental and control groups: Patient medical history [Срок оценки: at inclusion]
• Compare between laparotomy and laparoscopy: Patient medical history [Срок оценки: at inclusion]
• Compare between experimental and control groups: Patient comorbidities [Срок оценки: at inclusion]
• Compare between laparotomy and laparoscopy: Patient comorbidities [Срок оценки: at inclusion]
• Compare between experimental and control groups: Size of myoma [Срок оценки: at inclusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• CHU Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT06882824 · RBHP 2024 GREMEAU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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