Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010723
• Other study ID #: 20060508
• Secondary ID: 255/2006
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2013
• Last updated: December 12, 2013
• Start date: June 2006
• Est. completion date: February 2012

Study information

• Verified date: December 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Veins

Intervention

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

Drug:
• sclerotherapy with aethoxysclerol foam
foam sclerotherapy with aethoxysclerol foam

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of General Dermatology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (3)

Breu FX, Guggenbichler S, Wollmann JC; Second European Consensus Meeting on Foam Sclerotherapy. Duplex ultrasound and efficacy criteria in foam sclerotherapy from the 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37(1):90-5. — View Citation

Prinz N, Selzle K, Kamionek I, Sagoo KS, Leberig A, Kaiser R, Schonath M. [Surgery of the lateral accessory saphenous vein]. Zentralbl Chir. 2001 Jul;126(7):526-7. German. — View Citation

Theivacumar NS, Darwood RJ, Gough MJ. Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein (AAGSV): abolition of sapheno-femoral reflux with preservation of the great saphenous vein. Eur J Vasc Endovasc Surg. 2009 Apr;37(4):477-81. doi: 10.1016/j.ejvs.2008.11.035. Epub 2009 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	neovascularisation in the saphenofemoral junction		1 year and 3 years	No