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Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Primary Purpose

Varicose Veins

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
surgery
sclerotherapy with aethoxysclerol foam
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring varicosis, foam sclerotherapy, surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medical University of Vienna, Department of General Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

surgery

sclerotherapy

Arm Description

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

foam sclerotherapy with aethoxysclerol foam

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
neovascularisation in the saphenofemoral junction

Full Information

First Posted
November 18, 2013
Last Updated
December 12, 2013
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02010723
Brief Title
Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
Official Title
Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
varicosis, foam sclerotherapy, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery
Arm Type
Active Comparator
Arm Description
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
Arm Title
sclerotherapy
Arm Type
Experimental
Arm Description
foam sclerotherapy with aethoxysclerol foam
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
Intervention Type
Drug
Intervention Name(s)
sclerotherapy with aethoxysclerol foam
Intervention Description
foam sclerotherapy with aethoxysclerol foam
Primary Outcome Measure Information:
Title
duplex-sonographic recurrence after 3 years
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
duplex-sonographic recurrence after 1 year
Description
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
Time Frame
1 year
Title
clinical recurrence
Description
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
Time Frame
1 year and 3 years
Title
neovascularisation in the saphenofemoral junction
Time Frame
1 year and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kornelia Boehler, MD
Organizational Affiliation
Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of General Dermatology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
11503465
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. doi: 10.1055/s-2001-16280. German.
Results Reference
background
PubMed Identifier
18512547
Citation
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. doi: 10.1024/0301-1526.37.1.90.
Results Reference
background
PubMed Identifier
19201621
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.
Results Reference
background

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Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

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