Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

December 12, 2013 updated by: Kornelia Boehler, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of General Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year and 3 years
neovascularisation in the saphenofemoral junction
Time Frame: 1 year and 3 years
1 year and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Kornelia Boehler, MD, Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060508
  • 255/2006 (Other Identifier: Ethikkommission medical university of vienna)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Varicose Veins

Clinical Trials on surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe