Delayed or Immediate Local Treatment of Varicose Veins
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins Leg
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Need for sclerotherapy
- Last Updated
- 3 years ago
Overview
Brief Summary
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.
This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
Investigators
Maarit Venermo
Professor of Vascular Surgery
Helsinki University Central Hospital
Eligibility Criteria
Inclusion Criteria
- •Ultrasound verified insufficiency of great saphenous vein (GSV)
- •GSV diameter 5-10 mm
- •C2-C4 varicosities
- •Most proximal insufficient branch in the distal thigh
- •Written and signed informed consent
Exclusion Criteria
- •Peripheral arterial disease
- •Body mass index \>40
- •Lymphoedema
- •Known allergy to sclerosant
- •Any known coagulopathy or history of deep vein thrombosis
- •Severe illness
- •Pregnancy
Outcomes
Primary Outcomes
Need for sclerotherapy
Time Frame: 3 months
Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. \>C2 will be eligible for treatment.
Secondary Outcomes
- Occlusion rate of great saphenous vein(36 months)
- Patient satisfaction(3 months)