Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer: Multicenter Prospective Randomized Comparison Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Time to drain removal
研究概览
简要总结
This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer.
详细描述
We investigate the effect on drainage amount of Bio-absorbable Felt(NEOVEIL®) after D1+b or D2 lymphadenectomy with distal gastrectomy for early gastric cancer.
This study is an randomised controlled trial undertaken in 7 centers in South Korea. Patients with stage I-II gastric cancer who is going to have curative distal gastrectomy with D1+b or D2 lymphadenectomy are randomly assigned to use bio-absorbable felt(NEOVEIL®) or not to use it. Block randomisation will be done by a central interactive computerised system, stratified by center.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologic confirmed gastric adenocarcinoma
- •Patients who underwent laparoscopic distal gastrectomy.
- •preoperative clinical stage I diagnosed with esophagogastroduodenoscopy,endoscopic ultrasonography and computerized tomography.
- •patients who underwent more than D1+b lymphadenectomy
排除标准
- •Vulnerable participants (pregnant women, under 20 year old, and so on)
- •liver or renal disease (Ex. liver cirrhosis, end stage renal disease)
- •Transfusion is needed preoperatively or postoperatively due to bleeding
- •Preoperative or intraoperative evaluation confirm ascites.
- •Patients who use anticoagulant preoperatively or postoperatively
结局指标
主要结局
Time to drain removal
时间窗: two weeks
Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding.
次要结局
- total amount of exudate drainage(two weeks)