Delayed or Immediate Local Treatment of Veins

Study Overview
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Brief Summary
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Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism. This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.

Official Title
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Delayed or Immediate Local Treatment of Varicose Veins

Conditions
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Varicose Veins Leg

Intervention / Treatment
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* Procedure: Delayed sclerotherapy
* Procedure: Immediate phlebectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ultrasound verified insufficiency of great saphenous vein (GSV) GSV diameter 5-10 mm C2-C4 varicosities Most proximal insufficient branch in the distal thigh Written and signed informed consent Exclusion Criteria: Peripheral arterial disease Body mass index >40 Lymphoedema Known allergy to sclerosant Any known coagulopathy or history of deep vein thrombosis Severe illness Pregnancy

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 |
| --- | --- |
| Active Comparator: Immediate phlebectomy<br>Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities | Procedure: Immediate phlebectomy<br>* See arm description<br>|
| Experimental: Delayed treatment<br>Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required | Procedure: Delayed sclerotherapy<br>* See arm descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for sclerotherapy | Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. >C2 will be eligible for treatment. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Overall patient satisfaction and symptoms regarding varicosities and procedure at three months. Evaluated by the Aberdeen Varicose Veins Questionnaire (AVVQ). The AVVQ is a validated test, in which patients are asked to check boxes with regard to symptoms and quality of life (QoL). Scale 0-100, with 100 indicating worst possible QoL. | 3 months | 
| Occlusion rate of great saphenous vein | Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose veins, phlebectomy