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临床试验/NCT01701661
NCT01701661已完成不适用

Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2004年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
1
主要终点
Symptom relief

研究概览

简要总结

Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare compression therapy with compression stockings and surgery eliminating superficial venous reflux in patients with duplex ultrasound verified superficial venous reflux without skin changes or ulceration.

详细描述

Superficial venous reflux is common in adult population. Uncomplicated disease, where there is no skin changes but varicose veins with or without leg swelling, can be totally asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually caused by increased venous pressure. Varicose veins may also cause cosmetic problem. Compression stockings relief the symptoms as they normalize venous pressure. In surgical treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim of the study is to compare conservative treatment with compression stockings with surgical treatment of superficial venous reflux. In operative treatment the great saphenous vein or lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the trunk. If the main trunk has been removes previously, axial refluating veins are removed or ligated according to the DUS finding. The patients in both groups are examined at the baseline and followed up to two years by ultrasound scanning. Patients clinical classification, venous disability score, venous disease severity score, anatomical path of reflux as well as quality of life are studied at the baseline, at one year follow-up and two years follow-up.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients with chronic superficial vein insufficiency
  • •patient must be 20-70 years old
  • •degree of difficulty of vein insufficiency C2-C3
  • •venous disability score 1-2
  • •patient is agreeable to the study

排除标准

  • •peripheral atherosclerotic occlusive disease
  • •lymphoedema
  • •severe concomitant disease (ASA 3-5)
  • •venous ulcers or unclassified skin changes
  • •BMI more than 35

研究组 & 干预措施

conservative treatment

Active Comparator

Compression stockings class II

干预措施: conservative treatment (Other)

Operative treatment

Active Comparator

stripping of main trunk or if previously removed, removal or ligating the refloating trunk

干预措施: Operative treatment (Procedure)

结局指标

主要结局

Symptom relief

时间窗: two years

Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination.

次要结局

  • Quality of life(two years)

研究者

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

Maarit Venermo

MD,PhD

Helsinki University Central Hospital

研究点 (1)

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