Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: surgery
* Drug: sclerotherapy with aethoxysclerol foam


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery<br>crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia | Procedure: surgery<br>* crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia<br>|
| Experimental: sclerotherapy<br>foam sclerotherapy with aethoxysclerol foam | Drug: sclerotherapy with aethoxysclerol foam<br>* foam sclerotherapy with aethoxysclerol foam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duplex-sonographic recurrence after 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duplex-sonographic recurrence after 1 year | duplex-sonographic recurrence is defined as reverse blood flow of > 0.5 sec along the AAGSV in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group | 1 year | 
| clinical recurrence | Clinical recurrence is evaluated by determination of the current Clinical-Etiology- Anatomy- Pathophysiology (CEAP) classification and reappearance of new varicose veins in the treated area | 1 year and 3 years | 
| neovascularisation in the saphenofemoral junction |  | 1 year and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicosis, foam sclerotherapy, surgery