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OpenTrials
Completed

NCT Number: NCT01701661

Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Operative treatment

Procedure

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

Conservative treatment

Other

Compression stockings class II

Primary outcomes

  1. Symptom relief

    Time frame: 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.

Secondary outcomes

  1. Quality of life

    Time frame: two years

    Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life).

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2012
First posted
Oct 5, 2012
Registry last updated
Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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