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Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

NCT ID: NCT02010723

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Varicose Veins

Keywords

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varicosis foam sclerotherapy surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

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

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

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

sclerotherapy

foam sclerotherapy with aethoxysclerol foam

Group Type EXPERIMENTAL

sclerotherapy with aethoxysclerol foam

Intervention Type DRUG

foam sclerotherapy with aethoxysclerol foam

Interventions

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surgery

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

Intervention Type PROCEDURE

sclerotherapy with aethoxysclerol foam

foam sclerotherapy with aethoxysclerol foam

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Kornelia Boehler

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kornelia Boehler, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology

Locations

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Medical University of Vienna, Department of General Dermatology

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 11503465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18512547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19201621 (View on PubMed)

Other Identifiers

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255/2006

Identifier Type: OTHER

Identifier Source: secondary_id

20060508

Identifier Type: -

Identifier Source: org_study_id