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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm with misoprostol | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myomectomy with placebo | Procedure | myomectomy after administration of placebo (control group) |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | +33473754963 | promo_internet_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Sophie GREMEAU | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D063186 | Uterine Myomectomy |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D011459 | Prostaglandins E, Synthetic |
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| myomectomy with misoprostol | Procedure | myomectomiy after administration of misoprostol 400μg PO (experimental group) |
|
| 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 experimental and control groups: Patient medical history | 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: FIGO classification of myoma | at inclusion |
| Compare between laparotomy and laparoscopy: FIGO classification of myoma | at inclusion |
| 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: 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 |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |