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临床试验/NCT07616115
NCT07616115已完成不适用

Clinical Outcomes and Quality of Life Analysis After Concomitant or Sequential Varicose Vein Resection Following Great Saphenous Vein Stripping in Patients With Lower Limb Varicose Veins

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1

研究概览

简要总结

The goal of this clinical trial is to compare two surgical approaches for treating varicose veins in the lower limbs in adults: performing varicose vein removal at the same time as great saphenous vein stripping (concomitant) versus performing great saphenous vein treatment alone.

The main questions it aims to answer are:

  • Do clinical outcomes differ between these approaches?
  • Does quality of life improve differently depending on which surgical approach is used?

Participants will:

  • Undergo great saphenous vein stripping for lower limb varicose veins with or without simultaneous varicose vein ressection
  • Be assigned to have varicose vein resection either at the same time or in a subsequent procedure
  • Complete quality of life assessments before and after surgery

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 70 years
  • Varicose veins of the lower limbs with great saphenous vein insufficiency and surgical indication (CEAP C2-C6)
  • Signed informed consent

排除标准

  • Concomitant small saphenous vein insufficiency in the treated limb
  • Previous deep vein thrombosis in the treated limb
  • Previous deep venous insufficiency in the treated limb
  • Previous varicose vein surgery
  • Previous venous interventions (e.g. foam sclerotherapy)
  • Comorbidity or condition that impairs postoperative assessment (e.g. orthopedic diseases of the lower limbs)

研究者

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

Nelson Wolosker

Vascular Surgeon, Hospital Israelita Alber Einstein

Hospital Israelita Albert Einstein

研究点 (1)

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