Comparison of the Quantity of Bleeding and the Duration of Operation in Thoracoscopic Ventral Spondylodesis During Preparation With Monopolar Electrosurgery Compared to Ultrasound Scissors.
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- duration of the operation
研究概览
简要总结
This study was undertaken to investigate the effect of using ultrasound scissors in the preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with monopolar electrosurgery.
详细描述
One group of patients will be operated on using ultrasound scissors in the preparation during Thoracoscopic Ventral Spondylodesis. The other group will be operated on using Monopolar Electrosurgery.
The study is designed as a randomized trial. That means that all patients who have given their consent to participate in the study will be allocated to either ultrasound scissors or Monopolar Electrosurgery by chance.
A total of 40 patients will be included in this study. The study ends with finishing of the first day after the operation, there is no longer follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •fracture of vertebral bodies Th10-L2 with indication for operative treatment
排除标准
- •missing informed consent
- •mission indication for operative treatment
- •revision of the trailing edge
- •clotting inhibition therapy
- •ASA III/IV
- •pregnancy
- •malfunction of liver Child C
研究组 & 干预措施
Monopolar Electrosurgery
Preparation during the operation with Monopolar Electrosurgery
干预措施: electroscalpel (Erbe Vio 300; Aesculap AG) (Device)
Ultrasound scissors
Preparation during the operation with ultrasound scissors
干预措施: ultrasound scissors - Harmonic ACE (Device)
结局指标
主要结局
duration of the operation
时间窗: end of the scin suture at the end of operation
次要结局
- loss of blood during operation and at first day after the operation(24 hours after end of operation)
- length of stay at the hospital(day of discharge from hospitalization)
- trauma of internal organs during operation(end of the scin suure at the end of operation)