Status:
COMPLETED
Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Centrallasarettet Västerås
Conditions:
Varicose Veins
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Through a prospective RCT evaluate and compare the three new endovenous methods for great saphenous vein ablation (Radiofrequency, endovenous laser and foam sclerotherapy) versus high ligation and str...
Eligibility Criteria
Inclusion
- Clinical examinations by an experienced surgeon as well as duplex evaluation. Duplex evaluation of both the deep and the superficial system is required but not of the perforating vessels. It is performed by experienced BMA or surgeon with profound knowledge in vein diagnosis with duplex.
- Patients with primary varicose vein disease between age 18 to 75.
- Signature of informed consent.
- Varicose veins and duplex verified GSV incompetence defined as \>0,5 seconds reflux time after manual compression in upright position 60 degrees.
- Vein size \<20 mm in upright position 60 degrees, 2 cm below the SFJ.
- Minimum distance between skin and the GSV in the first 20 cm from the SFJ \> 5mm.
- CEAP classification C2-C5
- BMI \<35
Exclusion
- Non-consent for randomisation.
- Age \<18 years.
- Age \>75 years.
- Deep vein insufficiency in the same extremity (duplex verified).
- Vein size \>20mm in upright position 60 degrees below the SFJ.
- Meander and superficial veins with a distance of \<5mm to the skin surface ( RF or Laser cannot be applied).
- Patients with double GSV's and/or lateral accessory insufficient branch.
- Patients with cognitive disturbances, dementia or unable to understand for any reason the importance of follow up.
- Earlier operation with HL/S (recurrency).
- Operated for small saphenous vein (SSV) incompetence the last 3 months.
- Known ABI \<0,9 or history of intermittent claudication or peripheral pulselessness (clinical examination)in either extremity.
- Patients with recent cancer diagnosis or undergoing cancer treatment.
- BMI \>35.
- Patients with other known medical condition that contradict any of the treatments in the study.
- Minimum distance between skin and the GSV in the first 20 cm from the SFJ \>5mm.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00621062
Start Date
January 1 2008
End Date
January 1 2014
Last Update
February 3 2014
Active Locations (1)
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1
Department of Vascular Surgery; Central Hospital of Västerås
Västerås, Sweden, 72189