Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Randomized Clinical Study to Evaluate the Efficacy of Radiofrequency vs Surgical Technique of Internal Saphenous Vein Stripping and CHIVA Technique in the Treatment of Chronic Venous Insufficiency.

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: Radiofrequency
* Procedure: Saphenous vein stripping
* Procedure: CHIVA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saphenous vein stripping<br>Saphenous venous stripping surgical technique | Procedure: Saphenous vein stripping<br>* Saphenous vein stripping<br>|
| Active Comparator: CHIVA<br>conservative hemodynamic treatment venous insufficiency (CHIVA) | Procedure: CHIVA<br>* conservative hemodynamic treatment venous insufficiency<br>|
| Experimental: Radiofrequency<br>Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter | Procedure: Radiofrequency<br>* Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of venous reflux | Absence of venous reflux by duplex ultrasound | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIVIQ | Venous quality of Life questionnaire - Spanish validated version | 2 years | 
| SF-36 |  | 2 years | 
| VCSS | Venous Clinical Severity Score | 2 years | 
| Surgical complications | Hematoma, echymosis, infection, bleeding, induration, neuritic pain | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Veins