Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Phase 4

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: surgery; Drug: sclerotherapy with aethoxysclerol foam

• Registration Number: NCT02010723
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2013-11-18
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-13
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• reflux in anterior accessory great saphenous vein (AAGSV) > 0,5 sek

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery	surgery	crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
sclerotherapy	sclerotherapy with aethoxysclerol foam	foam sclerotherapy with aethoxysclerol foam

Primary Outcome Measures

Name	Time	Method
duplex-sonographic recurrence after 3 years	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 Outcome Measures

Name	Time	Method
neovascularisation in the saphenofemoral junction	1 year and 3 years
duplex-sonographic recurrence after 1 year	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
clinical recurrence	1 year and 3 years	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

Trial Locations

Locations (1)

Medical University of Vienna, Department of General Dermatology; 🇦🇹 Vienna, Austria