Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

Study Overview
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Brief Summary
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200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).

Official Title
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Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D

Conditions
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Varicose Veins, Venous Insufficiency

Intervention / Treatment
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* Procedure: Radiofrequency ablation
* Procedure: High ligation/stripping
* Device: Radiofrequency ablation catheter
* Procedure: Tumescent anesthesia
* Procedure: General anesthesia
* Device: Vein stripping catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insufficient great saphenous vein Possible to treat with both radiofrequency ablation and high ligation/stripping Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6 Exclusion Criteria: Previous intervention in the affected leg Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein. Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min Patient that is not able to perform plethysmography
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiofrequency ablation<br>Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia. | Procedure: Radiofrequency ablation<br> <br> Device: Radiofrequency ablation catheter<br> <br> * Other names: Covidien ClosureFast Catheter (7cm);Procedure: Tumescent anesthesia<br> <br> |
| Active Comparator: High ligation/stripping<br>Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia. | Procedure: High ligation/stripping<br> <br> * Other names: Open surgery;Procedure: General anesthesia<br> <br> Device: Vein stripping catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treated veins with recanalization using duplex. | Flow detected by duplex at the site of the treated vein. | 5 years | 
| Number of treated limbs with neovascularization using duplex and/or plethysmography. |  | 5 years | 
| Prediction of treatment outcome using plethysmography with superficial shut-down. | If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment. | 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VCSS score | The score of standardized examination protocol VCSS. | 5 years | 
| AVVQ score | The score of disease specific questionnaire AVVQ | 5 years | 
| EQ-5D score | The score of EQ-5D questionnaire | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency ablation, Plethysmography, Duplex ultrasound, High ligation/stripping