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临床试验/NCT02799251
NCT02799251已完成不适用

Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study

Centre Hospitalier Universitaire de Saint Etienne20 个研究点 分布在 1 个国家目标入组 1,125 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,125
试验地点
20
主要终点
Presence of post operative infection

研究概览

简要总结

Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.

详细描述

Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis.

The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery. It is a multicenter French cohort study. Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery before surgery (day-0) as well 1, 3, 5 and 8 days after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.

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

  • patient undergoing digestive or thoracic cancer surgery under general anesthesia.

排除标准

  • pregnant women,
  • malignant blood disease,
  • allograft patient,
  • preoperative sepsis or preoperative systemic inflammatory response syndrome.

结局指标

主要结局

Presence of post operative infection

时间窗: 1 month

Patients undergoing general anesthesia for thoracic or digestive surgery could present lymphopenia. In this situation, the presence of post operative infection is notified. The correlation between lymphopenia and post operative infections is studied.

次要结局

  • Anesthetic and surgical parameters(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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