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临床试验/NCT02049242
NCT02049242已完成不适用

Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials

Ataturk University2 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Estimating blood loss at the end of myomectomy

研究概览

简要总结

The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

详细描述

Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

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
16 Years 至 48 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • uterine myoma >12 weeks

排除标准

  • Pedunculated myoma, broad ligament myoma
  • Hb<10.5 g /dl

研究组 & 干预措施

Triple tourniquet

Active Comparator

干预措施: triple tourniquet (Procedure)

Single tourniquet

Active Comparator

干预措施: Single tourniquet (Procedure)

结局指标

主要结局

Estimating blood loss at the end of myomectomy

时间窗: 15 minutes postoperatifly

Surgical blood loss will be estimated by sum of the volume of suction fluid and blood loss quantitated by gravimetric method. During surgery, if it is possible, irrigation will not be done, surgical sponge and compress will not be used. * Suction fluid will be measured at the end of operation and volume of irrigation fluid will be subtracted from total suction volume. * Surgical drapes, sponges and towels will be weighted before and just after surgery. The blood loss will be estimated as differences in gram by weighing when 1ml blood supposed as 1 gr.

次要结局

  • Anti-Mullerian Hormone levels variation(6 weeks)
  • Volume in drains(7 days)
  • The amount of transfusions(7 Days)
  • A change in hemoglobin(At baseline and 48 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ragıp Atakan Al

Associate Professor

Ataturk University

研究点 (2)

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