NCT02392585已完成不适用
Triple Tourniquet vs. Single Tourniquet to Reduce Haemorrhage During Myomectomy: a Prospective Randomised Controlled Trial
Ragıp Atakan Al2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3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
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Estimated 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.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Three or more uterine myoma
- •At least one myoma ≥ 8 cm, if there is less than three myoma
排除标准
- •Pedunculated myoma,
- •broad ligament myoma
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
Estimated blood loss at the end of myomectomy
时间窗: 15 minutes postoperatively
Surgical blood loss will be estimated by sum of the volume of suction fluid and blood loss quantitated by gravimetric method. 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 1.06 gr.
次要结局
- A change in hemoglobin(At baseline and 48 hours after surgery)
- Total operation time(5 minutes post operatively)
- Tourniquet time(5 minutes after tourniquet removed)
- Peri-operative complications(6 weeks)
- The amount of transfusions(7 Days)
- Volume in drains(7 days)
研究者
Ragıp Atakan Al
Assoc.Prof
Ataturk University
研究点 (2)
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