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
  Purpose

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.


Condition Intervention Phase
Varicose Veins
Procedure: surgery
Drug: sclerotherapy with aethoxysclerol foam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: June 2006
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: surgery
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
Procedure: surgery
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
Experimental: sclerotherapy
foam sclerotherapy with aethoxysclerol foam
Drug: sclerotherapy with aethoxysclerol foam
foam sclerotherapy with aethoxysclerol foam

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010723

Locations
Austria
Medical University of Vienna, Department of General Dermatology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Kornelia Boehler, MD Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology
  More Information

Publications:
Responsible Party: Kornelia Boehler, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02010723     History of Changes
Other Study ID Numbers: 20060508, 255/2006
Study First Received: November 18, 2013
Last Updated: December 12, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
varicosis
foam sclerotherapy
surgery

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 21, 2014