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临床试验/NCT03380858
NCT03380858Unknown不适用

REINFORCEMENT ANASTOMOSIS IN ONCOLOGIC COLORECTAL SURGERY

National Cancer Institute, Naples1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2017年11月2日最近更新:
适应症

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

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

发起方
National Cancer Institute, Naples
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Rega

doctor

National Cancer Institute, Naples

研究点 (1)

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