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临床试验/NCT00559520
NCT00559520已完成4 期

The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2002年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
250
试验地点
2
主要终点
Weight

研究概览

简要总结

The role of preoperative oral immunonutrition in major vascular surgery.

The mean purpose of this study was to determine the prevalence of post-operative infection complications after major vascular surgery in group of patients with preoperative oral immunonutrition.

This group was compared to a control group.

Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on postoperative mortality (30 days), the medium length of stay in the hospital and the cost of treatment in the two groups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Screening
盲法
Double (Participant, Investigator)

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

  • Intervention planned since at least 5 days before surgery
  • Duration of hospitalization of at least 5 days

排除标准

  • Pregnant or lactating woman
  • Patient with severe renal insufficiency
  • Patient under 18 years old
  • Patient infected with HIV,hépatitis B or C

结局指标

主要结局

Weight

时间窗: before surgery, five days and thirty days after surgery

Arisen of an infectious complication

时间窗: during the period of 30 days following the surgery

Arisen of non infectious complication

时间窗: during the period of 30 days following the surgery

次要结局

  • Primary and secondary permeability(at 5 and 30 days after surgery)
  • Pain(at 5 and 30 days after surgery)
  • Healing(at 5 and 30 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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