Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02010723

Enrollment

Registered

2013-12-13

Start date

2006-06-30

Completion date

2012-02-29

Last updated

2013-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

Keywords

varicosis, foam sclerotherapy, surgery

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.

Interventions

PROCEDUREsurgery

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

DRUGsclerotherapy with aethoxysclerol foam

foam sclerotherapy with aethoxysclerol foam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026