Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
Overview
- Phase
- Phase 4
- Intervention
- surgery
- Conditions
- Varicose Veins
- Sponsor
- Medical University of Vienna
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- duplex-sonographic recurrence after 3 years
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.
Investigators
Kornelia Boehler
MD
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •reflux in anterior accessory great saphenous vein (AAGSV) \> 0,5 sek
Exclusion Criteria
- •concomitant reflux in great saphenous vein (GSV)
- •reflux in the deep venous system (postthrombotic syndrome)
- •acute thrombosis
- •hypercoagulability
- •allergy to aethoxysclerol or local anesthetics
- •immobility
- •open foramen ovale
- •bacterial infection of the skin
- •pregnancy and breast feeding
- •peripheral arterial occlusive disease III, IV (PAOD)
Arms & Interventions
surgery
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
Intervention: surgery
sclerotherapy
foam sclerotherapy with aethoxysclerol foam
Intervention: sclerotherapy with aethoxysclerol foam
Outcomes
Primary Outcomes
duplex-sonographic recurrence after 3 years
Time Frame: 3 years
duplex-sonographic recurrence is defined as reverse blood flow of \> 0.5 sec along the anterior accessory great saphenous vein (AAGSV) in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group.
Secondary Outcomes
- neovascularisation in the saphenofemoral junction(1 year and 3 years)
- duplex-sonographic recurrence after 1 year(1 year)
- clinical recurrence(1 year and 3 years)