Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Corporacion Parc Tauli

Status: Completed

Conditions: Varicose Veins

Treatments: Procedure: Saphenous vein stripping; Procedure: CHIVA; Procedure: Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT02454452

CEIC 2012/068

Details and patient eligibility

About

Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.

Full description

A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care.

The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm.

Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
• Age > 18 years
• Informed consent

Exclusion criteria

• Recurrent varicose veins
• Post-thrombotic syndrome.
• Patients with active malignancies or severe ischemic heart disease.
• Serious liver disease
• Thrombophilia.
• Serious psychiatric diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 3 patient groups

Saphenous vein stripping

Active Comparator group

Description:

Saphenous venous stripping surgical technique

Treatment:

Procedure: Saphenous vein stripping

CHIVA

Active Comparator group

Description:

conservative hemodynamic treatment venous insufficiency (CHIVA)

Treatment:

Procedure: CHIVA

Radiofrequency

Experimental group

Description:

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Treatment:

Procedure: Radiofrequency