Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.
试验速览
- 阶段
- 3 期
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- incidence of adhesive intestinal obstruction
研究概览
简要总结
This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea and the investigators hypothesized applying of adhesive preventing agent would reduce incidence of adhesive obstruction after gastrectomy.
详细描述
Adhesive bowel obstruction is relatively often complication in patients after abdominal surgery
Gastric cancer is the most frequent cancer in Korea.
The incidence of adhesive bowel obstruction would be increased in patients with gastric cancer, especially associated radical lymphadenectomy.
The causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of small intestine to small intestine, adhesion of the small intestine to other abdominal organs, and internal hernia.
Several studies reported efficacy of adhesive preventing agent after colorectal resection.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy
- •Informed consents
排除标准
- •Liver dysfunction
- •Renal failure
- •Past history of abdominal operation or small bowel obstruction
研究组 & 干预措施
guadix
guadix treatment
干预措施: GUARDIX-SG (Device)
GUARDIX
no guadix
结局指标
主要结局
incidence of adhesive intestinal obstruction
时间窗: up to 1 years after operation (every 3 month)
the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group
次要结局
未报告次要终点
研究者
Kyo Young Song
Professor
The Catholic University of Korea