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临床试验/NCT03613376
NCT03613376已完成不适用

Compression And Functional Ability After Endovenous Varicose Vein Treatment

Oulu University Hospital2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2018年5月21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
109
试验地点
2
主要终点
Post-operative pain

研究概览

简要总结

Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)

研究设计

研究类型
Interventional
分配方式
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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
  • Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
  • Distal varicose vein insufficiency suitable for sclerotherapy
  • Patient willingness to participate

排除标准

  • History of pulmonary embolism or deep venous thrombosis
  • Large (>12mm) truncal vein diameter
  • CEAP C5-C6
  • Antithrombotic medication (ASA accepted)

结局指标

主要结局

Post-operative pain

时间窗: 10days recorded daily

Visual Analog Scale (VAS) 0-100mm

次要结局

  • Aberdeen Varicose Veins Questionnaire (AVVQ)(Assessed preoperatively and at 2 months)
  • Time required returning to full activity(14 days)
  • Postoperative pigmentation(at 2 months)
  • Functional ability, other than pain(10 days recorded daily)
  • Visual appearance of varicose veins, patient assessment(Preoperatively and at 2 months)
  • Signs of deep venous thrombosis hematoma(Assessed at 2 months and earlier if necessary)
  • Time required returning to normal activity(14 days)
  • Visual appearance of varicose veins, expert assessment(Preoperatively and at 2 months)

研究者

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

Toni Pihlaja

Vascular specialist

Oulu University Hospital

研究点 (2)

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