The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- operation time
研究概览
简要总结
Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears .
In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.
The investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.
The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the diagnosis of gastric cancer
- •The patient who agrees to participate in this study by signing the informed consent form
排除标准
- •The patient who refuse to participate in this study
- •Have simultaneously other cancer
- •Underwent cancer therapy at past time
- •Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)
- •Have a previous upper gastrointestinal surgery
结局指标
主要结局
operation time
时间窗: 2 weeks later after operation
operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
amount of blood loss
时间窗: 2 weeks later after operation
amount of blood loss: an amount of blood loss during operation time
次要结局
- C-reactive protein(post operative day #0, #1, #5)
- total lymphocyte count(post operative day #0, #1, #5)
- postoperative complications(4 weeks later after operation)
- drainage from peritoneal cavity during hospital(2 weeks later after operation)