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The medical device is no longer available for the clinical trial
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Treatment of the tributary veins by phlebectomy | |
| Experimental group | Experimental | Endovenous steam treatment of the tributary veins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBox Hybrid | Device | Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one month after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of secondary complications after endovenous steam treatment versus phlebectomy of the tributary veins | The frequency, nature and severity of adverse events or immediate complications: hematomas, infections and burns requiring or not requiring intervention | 8-15 days, 1, 6 and 12 months after the intervention |
Inclusion Criteria:
Exclusion Criteria:
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| 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 | 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 | up to 1 year |
| Comparison of postoperative pain after endovenous steam treatment versus phlebectomy of the tributary veins |
Assessment of daily pain by the visual analogue pain assessment scale for 8 days. The scores range from zero where the respondent has the most pain to 10 where the respondent has the least pain. |
| Daily for the first 8 days after surgery |
| Comparison of the clinical improvement felt by the patient | Clinical improvement felt by the patient assessed by the Venous Clinical Severity Score (VCSS). Scores that can be obtained range between 0 and 30. Low values indicate better outcomes. | 1, 6 months and one year after the intervention |
| Evaluation of the economic impact of endovenous steam treatment in the management of superficial venous insufficiency of the lower limbs (cost-utility and cost-effectiveness analyzes) | Estimation of the differential cost-result ratio, evaluation of utility via EQ-5D Low values indicate better outcomes | 8-15 days, 1, 3, 6, 9 and 12 months after the intervention |