跳至主要内容
临床试验/NCT03772821
NCT03772821终止不适用

Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study

Centre Hospitalier Universitaire Dijon7 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2019年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
163
试验地点
7
主要终点
Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)

研究概览

简要总结

No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or other), but as of yet, investigators do not have proof of such an effect. The proposed study would follow a prospective, continuous, multicentre cohort of patients to describe the type, frequency and factors that contribute to local and general complications of surgery on the femoral bifurcation. This information is essential in the choice of the best revascularization technique for the femoral artery, which is frequently the site used for interventions in vascular conditions.

Surgeries will be performed in the normal manner. The research will be based on medical data collected during patient management. A measurement of the incision/scar will be taken once the procedure has been performed, either immediately after surgery or after a period of time, during post-operative consultation. Participation in this research will last 3 months from the day of the intervention.

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 who has not opposed participation in the study
  • Age > 18 years old
  • All patients with an open surgical approach to the common femoral artery and/or femoral bifurcation, uni or bilateral, with or without endovascular or open procedure

排除标准

  • Patient with homolateral surgery of the femoral triangle which has not yet healed
  • Person subject to court-ordered protection (curatorship, guardianship)
  • Pregnant, parturient or breastfeeding woman
  • Adult unable to consent
  • Patient who refuses to participate in the study

结局指标

主要结局

Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)

时间窗: Between Day 0 and Day 90

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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