2024-513617-13-00招募中2 期
Prevention of HEMOrhagic risk in upper MYOmeCTomy by use of Misoprostol.
University Hospital Of Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss measured in mL (volume in the suction and blood volumes in the compresses after weighing) according to the randomization group.
研究概览
简要总结
Evaluation of intraoperative blood loss during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) regardless of the type of surgery.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 43
- •Symptomatic myomas (hemorrhages, pain or infertility)
- •Indication for myomectomy by laparoscopy Fibroid ≤ 10cm or number ≤ 4 fibroids
- •Indication for myomectomy by laparotomy Fibroid > 10cm, Number > 4 fibroids
- •OTAU possible intraoperatively (Clip on uterine artery and Placement of a turnstile)
排除标准
- •History of major uterine surgery or myomectomy (excluding myomectomy by hysteroscopy)
- •Allergy to misoprostol
- •Patient on aspirin or anticoagulant
- •Patients with a hemostasis disorder
- •Patient with hypersensitivity to misoprostol and/or other prostaglandins or to any of the excipients of the product
- •Malnourished patients
- •Patients with hepatic or renal impairment
- •Pregnancy, suspected ectopic pregnancy and breastfeeding women.
结局指标
主要结局
Intraoperative blood loss measured in mL (volume in the suction and blood volumes in the compresses after weighing) according to the randomization group.
Intraoperative blood loss measured in mL (volume in the suction and blood volumes in the compresses after weighing) according to the randomization group.
次要结局
- Depending on the randomization group, compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level
- Depending on the randomization group, compare: Demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment.
- Depending on the randomization group, compare: Characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas.
- Depending on the randomization group, compare the duration between taking the tablet and anesthetic induction then the incision
- Depending on the randomization group, compare the duration between incision or pneumoperitoneum and closure
- Depending on the randomization group, compare the accounting for the number of RGCs transfused.
- Depending on the randomization group, compare the collection of early postoperative complications.
- Depending on the randomization group, compare : EVA at H+2, H+6 D1 M1.
- Depending on the randomization group, compare : Length of hospitalization in days.
- Depending on the type of surgery compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level
- Depending on the type of surgery compare the demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment.
- Depending on the type of surgery compare the characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas.
- Depending on the type of surgery compare the duration between taking the tablet and anesthetic induction then the incision
- Depending on the type of surgery compare the duration between incision or pneumoperitoneum and closure.
- Depending on the type of surgery compare the accounting for the number of RGCs transfused.
- Depending on the type of surgery compare the collection of early postoperative complications.
- Depending on the type of surgery compare EVA at H+2, H+6 D1 M1
- Depending on the type of surgery compare the length of hospitalization in days.
- Intraoperative blood loss measured in mL (volume in aspiration and blood volumes in compresses after weighing) according to the randomization group and surgical technique.
研究者
Lise Laclautre
Scientific
University Hospital Of Clermont-Ferrand
研究点 (1)
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