Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kornelia Boehler, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02010723
First received: November 18, 2013
Last updated: December 12, 2013
Last verified: December 2013

November 18, 2013
December 12, 2013
June 2006
February 2012   (final data collection date for primary outcome measure)
duplex-sonographic recurrence after 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT02010723 on ClinicalTrials.gov Archive Site
  • duplex-sonographic recurrence after 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: No ]
    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
  • neovascularisation in the saphenofemoral junction [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
Comparison of Surgery Versus Foam 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Varicose Veins
  • 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
  • Active Comparator: surgery
    crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
    Intervention: Procedure: surgery
  • Experimental: sclerotherapy
    foam sclerotherapy with aethoxysclerol foam
    Intervention: Drug: sclerotherapy with aethoxysclerol foam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2012
February 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT02010723
20060508, 255/2006
Yes
Kornelia Boehler, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Kornelia Boehler, MD Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology
Medical University of Vienna
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP