Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Guardianship, curatorship, deprived of liberty, safeguard of justice
研究组 & 干预措施
treatment arm with misoprostol
干预措施: myomectomy with misoprostol (Procedure)
Placebo arm
干预措施: myomectomy with placebo (Procedure)
结局指标
主要结局
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.
时间窗: during surgery
次要结局
- Compare between laparotomy and laparoscopy: Length of hospital stay after surgery in days(up to one week after surgery)
- 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)
- 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)