Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 682
- 试验地点
- 1
- 主要终点
- incidence of VTE
研究概览
简要总结
This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.
详细描述
Venous thromboembolism (VTE) is common and often fatal complication in patients with cancer.
Gastric cancer is the most frequent cancer in Korea.
The incidence of VTE would be increased in patients with gastric cancer, especially associated surgery.
However, the incidence and optimal prophylactic method associated with cancer surgery are not well studied in Asian patients.
Most Korean surgeon concerns regarding the increased postoperative bleeding associated with low molecular weight heparin(LMWH)prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 diagnosed as gastric cancer
- •Elective and curative under general anesthesia
- •ECOG score 0-2
- •ASA score 3 or less than 3
- •Informed consents
排除标准
- •2nd primary cancer
- •VTE history within one year
- •Anticoagulation history
- •Allergic to heparin
- •Pregnancy or expected pregnancy
研究组 & 干预措施
intermittent pneumatic compression
another arm include intermittent pneumatic compression plus low molecular weight heparin
干预措施: low molecular weight heparin (Drug)
结局指标
主要结局
incidence of VTE
时间窗: up to 30 days after operation
The incidence of VTE between mechanical method only group and mechnical plus LMWH group.
次要结局
- Adverse event(up to 30 days after operation)
研究者
Kyo Young Song
Associate Professor
The Catholic University of Korea