Prospective Randomized Trial Comparing the New Endovenous Procedures Versus Conventional Surgery for Varicose Veins Due to Great Saphenous Vein Incompetence

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: Endovenous Laser Ablation; Procedure: Radiofrequency ablation; Procedure: Foam Sclerotherapy; Procedure: High Ligation of the GSV

• Registration Number: NCT00621062
• Lead Sponsor: Uppsala University

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 stripping. Procedure (proof-of-concept) and patient related (clinical outcome) factors will be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Status Verified: 2011-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovenous Laser Ablation	Endovenous Laser Ablation	-
Radiofrequency ablation	Radiofrequency ablation	-
Foam Sclerotherapy	Foam Sclerotherapy	-
High Ligation of the GSV	High Ligation of the GSV	-

Primary Outcome Measures

Name	Time	Method
Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.	3 years

Secondary Outcome Measures

Name	Time	Method
Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.	3 years

Trial Locations

Locations (1)

Department of Vascular Surgery; Central Hospital of Västerås; 🇸🇪 Västerås, Sweden