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

Uppsala University

Status: Completed

Conditions: Varicose Veins

Treatments: Procedure: High Ligation of the GSV; Procedure: Endovenous Laser Ablation; Procedure: Foam Sclerotherapy; Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00621062

RAFPELS

Details and patient eligibility

About

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.

Enrollment: 540 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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540 participants in 4 patient groups

High Ligation of the GSV

Active Comparator group

Treatment:

Procedure: High Ligation of the GSV

Endovenous Laser Ablation

Active Comparator group

Treatment:

Procedure: Endovenous Laser Ablation

Radiofrequency ablation

Active Comparator group

Treatment:

Procedure: Radiofrequency ablation

Foam Sclerotherapy

Active Comparator group

Treatment:

Procedure: Foam Sclerotherapy