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Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02010723
First Posted: December 13, 2013
Last Update Posted: December 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kornelia Boehler, Medical University of Vienna
November 18, 2013
December 13, 2013
December 13, 2013
June 2006
February 2012   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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
  • 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
  • neovascularisation in the saphenofemoral junction [ Time Frame: 1 year and 3 years ]
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
Intervention Model: Parallel Assignment
Masking: None (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)
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT02010723
20060508
255/2006 ( Other Identifier: Ethikkommission medical university of vienna )
Yes
Not Provided
Not Provided
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