Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Varicose Veins

Treatments: Procedure: surgery; Drug: sclerotherapy with aethoxysclerol foam

Study type: Interventional

Funder types: Other

Identifiers

NCT02010723

20060508

255/2006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

surgery

Active Comparator group

Description:

crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia

Treatment:

Procedure: surgery

sclerotherapy

Experimental group

Description:

foam sclerotherapy with aethoxysclerol foam

Treatment:

Drug: sclerotherapy with aethoxysclerol foam