THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- operation duration time
研究概览
简要总结
This research is planned as a randomised double-blind controlled trial. interventions to reduce haemorrhage during laparoscopic myomectomy for fiboids is important. İntraoperative Tranexamic acid usage can reduce haemorrhage and related symptoms when given during laparoscopic myomectomy. There is no randomised controlled trials in literature about tranexamic acid usage in laparoscopic gynecological operations.
详细描述
researchers planned this trial by firstly randomising the patients. 1 gr tranexamic acid in 100 ml salin will bi given by initial of the anesthesia of the patient, the other group will be taken only 100ml saline solution. Randomising will be double blind and only anesthesiologist will see if the paient is in working group or control group. Than researchers provide laparoscopic myomectomy with same prothocol to each patient. At the end of the operation, researchers will record all the parameters during operation like; operation starting and ending time, the amount of bleeding, time of suturing, the size, location and count of myoma uteri, complications, weight of myoma uteri and the change of haemoglobine levels before and after operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •myoma uteri
- •appropiate for laparoscopy
排除标准
- •malignancy
研究组 & 干预措施
TRANEXAMİC ACİD
. 1 gr tranexamic acid in 100 ml salin given in 15 minutes
干预措施: Tranexamic Acid 100 MG/ML (Drug)
NO TRANEXAMİC ACİD
100 ml salin solution
干预措施: Placebos (Drug)
结局指标
主要结局
operation duration time
时间窗: 0 minute - 180 minute
time between initial and end of the surgery
amount of bleeding during operation
时间窗: 0 minute - 180 minute
total amount of bleeding during surgery
次要结局
未报告次要终点
研究者
MERAL TUĞBA ÇİMŞİR
ASSOCIATE PROFESSOR
Alkü Alanya Education and Research Hospital