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临床试验/NCT01195623
NCT01195623已完成不适用

Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up

Uppsala University Hospital2 个研究点 分布在 1 个国家目标入组 293 人开始时间: 1997年11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
293
试验地点
2
主要终点
Rate of Re-do Surgery

研究概览

简要总结

Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led to an improvement in results. However two years is a short time, and with a longer follow-up other mechanisms for recurrence may become more important, e.g. neovascularization (new vessel formation) or progression of disease, hence the value of a detailed preoperative diagnosis may be diminished. The aim of this phase of the investigation is to study the results after 8 years, in particular what mechanisms for recurrences were most important.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with primary varicose veins

排除标准

  • pure cosmetic complaints
  • previous venous surgery or sclerotherapy
  • history of suspect or manifest deep venous thrombosis
  • active or healed venous ulceration
  • peripheral arterial disease
  • previous significant trauma to the leg
  • general illness
  • alcohol or drug abuse
  • unable to understand information

结局指标

主要结局

Rate of Re-do Surgery

时间窗: 7 years mean

number of reoperations (legs) in the two treatment arms

次要结局

  • Recurrence Rate(7 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lena Blomgren

MD, PhD

Uppsala University Hospital

研究点 (2)

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