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临床试验/NCT04069650
NCT04069650已完成不适用

Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Major complication occurency

研究概览

简要总结

Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.

Free flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.

Among them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.

Malnutrition is not associated with a higher risk for free flap failure in the oral cavity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • every consenting patients undergoing free flap reconstruction of the oral cavity

排除标准

  • unable to give consent

结局指标

主要结局

Major complication occurency

时间窗: 1 month

in the first-month post-operative period, complications leading to flap loss

次要结局

  • Minor complication occurency(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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