The prevalence of superficial chronic venous insufficiency (CVI) of the lower limbs is estimated at 18 million French people. The number of patients operated for varicose veins is around 300,000 per year. Post-operative complications such as venous ulcer, venous thrombosis and varicose vein rupture require a lot of medical care. Varicose veins are responsible for a decrease in quality of life and represents 1 to 2% of total health expenditure. Currently, operating techniques tend towards minimally invasive procedures in order to minimize the surgical trauma, improve patient comfort and reduce the time of postoperative work stoppages. This study aims to compare two surgical techniques for the treatment of superficial chronic venous insufficiency of the lower limbs : phlebectomy, the gold-standard technique, and endovenous steam treatment. Several studies have already been carried out on endovenous steam treatment for saphenous veins but none has been published concerning the tributary veins.The main objective of INVOLVE is to assess the quality of life of patients 1 month after surgery. Clinical improvement and economic impact will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux
Comparison of the quality of life relative to the health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
Questionnaire : VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) : target dimension " VEINES-QoL symptom summary score ". High values indicate better outcomes.
Time frame: one month after the intervention
Comparison of the evolution of the quality of life relating to health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
Questionnaires : VEnous INsufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym), 36-Item Short Form Survey Instrument (SF36). The scores range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Time frame: 8-15 days, 3, 6, 9 and 12 months after the intervention
Comparison of occlusion of the tributary veins after endovenous steam treatment versus phlebectomy of the tributary veins
Occlusion rate evaluated by Doppler ultrasound
Time frame: 8-15 days and one year after the intervention
Evaluation of the period of resumption of activity for people in activity after endovenous steam treatment versus phlebectomy of the tributary veins
Duration of work stoppage for working people
Time frame: up to 1 year
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