Clinical trial NCT06882824: Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
Official title: Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myoma;Uterus
Myomectomy; Surgical Blood Loss
Keywords: myomectomy
surgical blood loss
misoprostol
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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:

* Previous abdominal surgery (excluding appendectomy) 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

Primary outcomes:
measure: 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.
timeFrame: during surgery
Secondary outcomes:
measure: 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.
timeFrame: during surgery
measure: Compare Hemoglobin level (in g/L) between experimental and control groups
timeFrame: between day before surgery and day of surgery
measure: Compare Hemoglobin level (in g/L) between laparotomy and laparoscopy surgery
timeFrame: between day before surgery and day of surgery
measure: Compare between experimental and control groups: Patient age
timeFrame: at inclusion
measure: Compare between laparotomy and laparoscopy: Patient age
timeFrame: at inclusion
measure: Compare between experimental and control groups: Patient BMI
timeFrame: at inclusion
measure: Compare between laparotomy and laparoscopy: Patient BMI
timeFrame: at inclusion
measure: Compare between experimental and control groups: Patient medical history
timeFrame: at inclusion
measure: Compare between laparotomy and laparoscopy: Patient medical history
timeFrame: at inclusion
measure: Compare between experimental and control groups: Patient comorbidities
timeFrame: at inclusion
measure: Compare between laparotomy and laparoscopy: Patient comorbidities
timeFrame: at inclusion
measure: Compare between experimental and control groups: Size of myoma
timeFrame: at inclusion
measure: Compare between laparotomy and laparoscopy: Size of myoma
timeFrame: at inclusion
measure: Compare between experimental and control groups: FIGO classification of myoma
timeFrame: at inclusion
measure: Compare between laparotomy and laparoscopy: FIGO classification of myoma
timeFrame: at inclusion
measure: Compare between experimental and control groups: Number of myoma
timeFrame: at inclusion
measure: Compare between laparotomy and laparoscopy: Number of myoma
timeFrame: at inclusion
measure: Compare between experimental and control groups: Time between tablet intake and incision
timeFrame: day of surgery
measure: Compare between laparotomy and laparoscopy: Time between tablet intake and incision
timeFrame: day of surgery
measure: Compare between experimental and control groups: Total operative time
timeFrame: during surgery
measure: Compare between laparotomy and laparoscopy: Total operative time
timeFrame: during surgery
measure: Compare between experimental and control groups: Transfusion rate in number of RBCs (Red Blood Cells).
timeFrame: during surgery
measure: Compare between laparotomy and laparoscopy: Transfusion rate in number of RBCs (Red Blood Cells).
timeFrame: during surgery
measure: Compare between experimental and control groups: Immediate post-operative complications
timeFrame: up to 8 weeks after surgery
measure: Compare between laparotomy and laparoscopy: Immediate post-operative complications
timeFrame: up to 8 weeks after surgery
measure: 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
timeFrame: between 2 hours after surgery until 1 month post-operative
measure: 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
timeFrame: between 2 hours after surgery until 1 month post-operative
measure: Compare between experimental and control groups: Length of hospital stay after surgery in days
timeFrame: up to one week after surgery
measure: Compare between laparotomy and laparoscopy: Length of hospital stay after surgery in days
timeFrame: up to one week after surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Anne-Sophie GREMEAU
role: PRINCIPAL_INVESTIGATOR
References: