Myoma;Uterus, Myomectomy; Surgical Blood Loss
Conditions
Keywords
myomectomy, surgical blood loss, misoprostol
Brief summary
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
PROCEDUREmyomectomy with placebo
myomectomy after administration of placebo (control group)
PROCEDUREmyomectomy with misoprostol
myomectomiy after administration of misoprostol 400μg PO (experimental group)
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | during surgery |
Secondary
| Measure | Time frame |
|---|---|
| Compare between experimental and control groups: Number of myoma | at inclusion |
| Compare between laparotomy and laparoscopy: Number of myoma | at inclusion |
| Compare between experimental and control groups: Time between tablet intake and incision | day of surgery |
| Compare between laparotomy and laparoscopy: Time between tablet intake and incision | day of surgery |
| Compare between experimental and control groups: Total operative time | during surgery |
| Compare between laparotomy and laparoscopy: Total operative time | during surgery |
| Compare between experimental and control groups: FIGO classification of myoma | at inclusion |
| 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. | during surgery |
| Compare Hemoglobin level (in g/L) between experimental and control groups | between day before surgery and day of surgery |
| Compare Hemoglobin level (in g/L) between laparotomy and laparoscopy surgery | between day before surgery and day of surgery |
| Compare between experimental and control groups: Patient age | at inclusion |
| Compare between laparotomy and laparoscopy: Patient age | at inclusion |
| Compare between experimental and control groups: Patient BMI | at inclusion |
| Compare between laparotomy and laparoscopy: Patient BMI | at inclusion |
| Compare between laparotomy and laparoscopy: FIGO classification of myoma | at inclusion |
| Compare between laparotomy and laparoscopy: Patient medical history | at inclusion |
| Compare between experimental and control groups: Patient comorbidities | at inclusion |
| Compare between laparotomy and laparoscopy: Patient comorbidities | at inclusion |
| Compare between experimental and control groups: Size of myoma | at inclusion |
| Compare between laparotomy and laparoscopy: Size of myoma | at inclusion |
| Compare between experimental and control groups: Transfusion rate in number of RBCs (Red Blood Cells). | during surgery |
| Compare between laparotomy and laparoscopy: Transfusion rate in number of RBCs (Red Blood Cells). | during surgery |
| Compare between experimental and control groups: Immediate post-operative complications | up to 8 weeks after surgery |
| Compare between laparotomy and laparoscopy: Immediate post-operative complications | 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 | 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 | between 2 hours after surgery until 1 month post-operative |
| Compare between experimental and control groups: Length of hospital stay after surgery in days | up to one week after surgery |
| Compare between laparotomy and laparoscopy: Length of hospital stay after surgery in days | up to one week after surgery |
| Compare between experimental and control groups: Patient medical history | at inclusion |
Countries
France
Contacts
Primary ContactLise LACLAUTRE
Outcome results
None listed