Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast

Study Overview
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Brief Summary
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There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .

Detailed Description
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The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment. In this study there are no additional risk factors for the included study patients except the risk of surgery.

Official Title
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Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Procedure: Laser
* Procedure: Radiofrequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR) maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm Exclusion Criteria: surgical treatment of the saphenous vein in the past sclerotherapy of the saphenous vein in the past phlebitis or thrombosis of the saphenous vein surgical treatment of an venous ulcer in the past postthrombotic syndrome erysipelas of the leg in the past chronic treatment with pain-killers or chronic alcoholism pregnancy drug allergy against painkillers that are used in this study spinal anesthesia not possible compression bandage not possible patients with polyneuropathy patients with chronic pain persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast) participation on an other clinical trial that can interfere with this clinical trial missing written informed consent

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: 1470nm Laser<br>Patient with varicose vein treated with 1470nm Laser (Biolitec) | Procedure: Laser<br>* Endovenous Laser (1470nm) ablation of great or small saphenous vein<br>Procedure: Radiofrequency<br>* Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein<br>|
| Active Comparator: VNUS Closure Fast<br>Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System) | Procedure: Laser<br>* Endovenous Laser (1470nm) ablation of great or small saphenous vein<br>Procedure: Radiofrequency<br>* Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain (visual analogue scale) on the day of treatment | day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obliteration of the treated vein (GSV or SSV) | An ultrasound investigation of he treated vein is done to find out if the treated vein is fully obliterated or not. If it is not fully obliterated we want to find out if there is any pathological reflux in the vein. | day 10, month 3, month 12 | 
| Patient´s satisfaction after the intervention | The patient is asked about his/her satisfaction after intervention. This is measured on a numeric scale from 1 to 5 (like schoolmarks in austria or germany). 1=very good, 2=good, 3=average, 4=not so good, 5=bad) | day 10, month 3, month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovenous treatment, Laser, Vnus Closure Fast, Varicosis, great saphenous vein, small saphenous vein, Venous Insufficiency