NCT04519593Unknown不适用
ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma
Mother and Child Clinic Saint-Petersburg2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2020年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Blood loss
研究概览
简要总结
A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.
详细描述
Primary endpoints
• Assess the volume of blood loss
Secondary endpoints
- Compare the rates of intra- and postoperative complications, the necessity of blood transfusion, length of surgery, length of hospital and ICU stay, and leiomyoma symptoms relief
- Determine the procedure impact on fertility by evaluating the level of anti-mullerian hormone, pregnancy rates, pregnancy complications, and the way of delivery
Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic uterine leiomyoma
- •Size of leiomyoma node >5 cm based on imaging
- •Leiomyoma node types 3, 4, 5, 6 according to The International Federation of Gynecology and Obstetrics (FIGO) classification or type 2 not feasible to be removed during hysteroscopy
- •Single or multiple nodes
- •Absent contraindications for laparoscopic myomectomy
- •Voluntarily signed informed consent to participate in the study
排除标准
- •Age < 18 years
- •Asymptomatic uterine leiomyoma
- •Size of leiomyoma node <5 cm based on imaging
- •Absence of leiomyoma node types 3, 4, 5, 6 according to FIGO classification and type 2 not feasible to be removed during hysteroscopy
- •Planned simultaneous hysteroscopy with leiomyoma node excision
- •Current pregnancy and breastfeeding
- •Suspicion of a malignant uterine tumor
- •Prior uterine leiomyoma surgery
- •Contraindications for laparoscopic myomectomy
- •Lack of decision-making capacity hindering signing the consent to participate in the study
结局指标
主要结局
Blood loss
时间窗: At the end of the intervention
Evaluation of blood loss volume
次要结局
- Impact on fertility(During 18 months since the intervention)
- Treatment characteristics(During 6 months since the intervention)
研究者
Andrey Dubinin, MD, PhD
Gynecologist
Mother and Child Clinic Saint-Petersburg
研究点 (2)
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