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Completed

NCT Number: NCT02010723

Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Department of General Dermatology

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surgery

Procedure

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

sclerotherapy with aethoxysclerol foam

Drug

foam sclerotherapy with aethoxysclerol foam

Primary outcomes

  1. 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

  1. duplex-sonographic recurrence after 1 year

    Time frame: 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

  2. clinical recurrence

    Time frame: 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

  3. neovascularisation in the saphenofemoral junction

    Time frame: 1 year and 3 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2013
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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