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临床试验/NCT03989648
NCT03989648Unknown不适用

Comparison of the Adequacy of Exsanguination Between Esmarch Bandages and Simple Leg Elevation in Minimally Invasive Total Knee Arthroplasty : A Randomized Controlled Trial

Navamindradhiraj University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Fromme-Boezaart surgical field scale

研究概览

简要总结

To compare the adequacy of exsanguination in the surgical field between the use of the Esmarch bandages elevation and the simple leg elevation.

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary osteoarthritis of knee

排除标准

  • There are deep vein thrombosis and pulmonary embolism
  • There are bleeding disorder,hypercoagulability,peripheral arterial disease and chronic venous insufficiency
  • Take blood clotting pills
  • Have had total knee arthroplasty
  • BMI > 30

结局指标

主要结局

Fromme-Boezaart surgical field scale

时间窗: Immediate after surgery

Fromme-Boezaart surgical field scale is visual assessment of surgical field using a 6-point scale (min=0, max=5) 0 mean No bleeding 1. mean Slight bleeding ; no suctioning of blood required 2. mean Slight bleeding ; occasional suctioning required. Surgical field not threatened 3. mean Slight bleeding ; frequent suctioning required. Bleeding threatens surgical filed a few seconds after suction is removed 4. mean Moderate bleeding ; frequent suctioning required. Bleeding threatens surgical field directly after suction is removed 5. mean Severe bleeding ; constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible 0=best possible operating conditions and dryness of the surgical field; 5= worst possible conditions

次要结局

  • Numerical rating scale: NRS at 24 hrs(24 hours after surgery)
  • Numerical rating scale: NRS at 72 hrs(72 hours after surgery)

研究者

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

Satit Thiengwittayaporn

Associate Professor

Navamindradhiraj University

研究点 (2)

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