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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
myomectomy after administration of placebo (control group)
myomectomiy after administration of misoprostol 400μg PO (experimental group)
CHU Clermont-Ferrand
Clermont-Ferrand, Clermont-Ferrand, France
RECRUITINGEvaluation 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
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
Compare between laparotomy and laparoscopy: Size of myoma
Time frame: at inclusion
Compare between experimental and control groups: FIGO classification of myoma
Time frame: at inclusion
Compare between laparotomy and laparoscopy: FIGO classification of myoma
Time frame: at inclusion
Compare between experimental and control groups: Number of myoma
Time frame: at inclusion
Compare between laparotomy and laparoscopy: Number of myoma
Time frame: at inclusion
Compare between experimental and control groups: Time between tablet intake and incision
Time frame: day of surgery
Compare between laparotomy and laparoscopy: Time between tablet intake and incision
Time frame: day of surgery
Compare between experimental and control groups: Total operative time
Time frame: during surgery
Compare between laparotomy and laparoscopy: Total operative time
Time frame: during surgery
Compare between experimental and control groups: Transfusion rate in number of RBCs (Red Blood Cells).
Time frame: during surgery
Compare between laparotomy and laparoscopy: Transfusion rate in number of RBCs (Red Blood Cells).
Time frame: during surgery
Compare between experimental and control groups: Immediate post-operative complications
Time frame: up to 8 weeks after surgery
Compare between laparotomy and laparoscopy: Immediate post-operative complications
Time frame: up to 8 weeks after surgery
Compare between experimental and control groups: Pain assessments at different times: VAS (Visual analogue scale from 0 : no pain to 10 : worst pain) at h+2, h+6 D1 M1
Time frame: between 2 hours after surgery until 1 month post-operative
Compare between laparotomy and laparoscopy: Pain assessments at different times: VAS (Visual analogue scale from 0 : no pain to 10 : worst pain) at h+2, h+6 D1 M1
Time frame: between 2 hours after surgery until 1 month post-operative
Compare between experimental and control groups: Length of hospital stay after surgery in days
Time frame: up to one week after surgery
Compare between laparotomy and laparoscopy: Length of hospital stay after surgery in days
Time frame: up to one week after surgery
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