REINFORCEMENT ANASTOMOSIS IN ONCOLOGIC COLORECTAL SURGERY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- fistula incidence
研究概览
简要总结
In colorectal surgery about 30% of postoperative mortality is attributed to anastomotic leak, whit an incidence range between 1.8% and 15.9%. Preventing the anastomotic leak can therefore bring benefits to the patient and the health system. To date we have technologically advanced suturizers and the correct realization (well-vascularized margins, not in tension, etc.) remains crucial to prevent anastomotic dehiscence. Experimental results demonstrate that modified cyanacrylate is a suitable potential "reinforcement" on intestinal anastomoses (manual or linear intra-corporeal). Applied after mechanical anastomosis, it polymerizes in a short time, closing the spaces of the suture line between one point and the other, expressing an adhesive, hemostatic and sealing action on the tissues, also creating an effective antiseptic barrier towards of the most common infectious or pathogenic agents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •patients undergoing to oncologic colorectal surgery with colorectal anastomosis
排除标准
- •refuse informed consent
- •patients undergoing to oncologic colorectal surgery without colorectal anastomosis
结局指标
主要结局
fistula incidence
时间窗: From day of surgery up to 30 postoperative days
次要结局
- infection(From day of surgery up to 30 postoperative days)
- anastomitic bleeding(From day of surgery up to 30 postoperative days)
研究者
Daniela Rega
doctor
National Cancer Institute, Naples
