Comparison of Treatments in Venous Insufficiency

Study Overview
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Brief Summary
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Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers. The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.

Detailed Description
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In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.

Official Title
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The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Procedure: Operative treatment
* Procedure: Laser ablation
* Procedure: Foam sclerotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with chronic superficial vein insufficiency patient must be 20-70 years old degree of difficulty of vein insufficiency C2-C4 average diameter of refluxing great saphenous vein 4 -10 mm patient is agreeable to the study Exclusion Criteria: peripheral atherosclerotic occlusive disease lymphoedema severe concomitant disease venous ulcers or unclassified skin changes BMI more than 40 pregnancy allergy to the foam used in sclerotherapy or to local anaesthetics coagulation disorder bilateral vein insufficiency (equal symptoms)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Operative treatment<br>vein stripping | Procedure: Operative treatment<br>* In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.<br>* Other names: Vein stripping;|
| Other: Laser ablation<br>Ultrasound guided laser ablation | Procedure: Laser ablation<br>* In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.<br>* Other names: Ultrasound guided laser ablation;|
| Other: Foam sclerotherapy<br>Ultrasound guided foam sclerotherapy | Procedure: Foam sclerotherapy<br>* Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.<br>* Other names: Ultrasound guided foam sclerotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recanalization or reflux of the treated venous trunk | Results will be verified by Duplex scanning | at 1 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom relief | Symptoms will be evaluated by using CEAP-classification and degree of disability | at 1 and 12 months | 
| Complications related to procedure | At 1 month follow-up immediate complications will be recorded. At 12 months follow-up appearance of late complications and pain and incapacity for work due to the procedure will be recorded. | at 1 and 12 months | 
| Quality of life | Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life) | at 1 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicose veins, oedema