Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Postoperative 2nd Day CRP
研究概览
简要总结
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat
comparing postoperative CRP level in each group
详细描述
To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat
comparing postoperative CRP level in each group
- post operative 2nd day CRP level
- post operative 4th day CRP level
- post operative IL-6, 10 level in 2nd, 4th day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pathologically proven adenocarcinoma in stomach
- •patients who are expected for R0 resection with distal gastrectomy
- •pre-operative clinical stage should be stage I
- •patients who is able to be followed up with in postoperative 30 days
- •patients whose CRP is normal before surgery
排除标准
- •patients who had an abdominal surgery
- •patients who received chemotherapy, radiotherapy before surgery
- •patients who received ESD before surgery
- •Patients who had an ascites on pre-operative CT scan
- •liver cirrhosis
- •cardiovascular disease (Ejection Fraction<50%)
- •serum creatinine > 1.4 mg/dL or BUN>26mg/dL
- •PT INR >1.2 or aPTT>45sec
- •uncontrolled diabetes
- •Crohn's disease, ulcerative colitis
- •patients who receives anti-coagulants
- •patients who need pre-operative steroid booster because of steroid treatment
- •pregnancy
- •patients who have allergic reaction to iodine
研究组 & 干预措施
ULTRACISION Harmonic Scalpel
Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy
干预措施: ULTRACISION Harmonic Scalpel (Device)
Ligasure Maryland
Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy
干预措施: Ligasure Maryland (Device)
Thunderbeat
Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy
干预措施: Thunderbeat (Device)
结局指标
主要结局
Postoperative 2nd Day CRP
时间窗: 2nd day
To check the postoperative 2nd day CRP level in each group
次要结局
- Postoperative 4th Day CRP(4th day)
- Postoperative 2nd Day IL-6(2nd day)
- Postoperative 4th Day IL-6(4th day)
- Postoperative 2nd Day IL-10 Level(2nd day)
- Postoperative 4th Day IL-10 Level(4th day)