Clinical trial NCT04534244: Impact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs
Official title: Management of Tributary Veins in Superficial Venous Insufficiency of the Lower Limbs: Impact of Endovenous Steam Treatment Versus Phlebectomy on Quality of Life
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Venous Insufficiency of Leg
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
* Signature of the informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
* Affiliation to a French social security scheme or beneficiary of such a scheme
* Patient with a reflux of the tributary veins, associated or not with a reflux of the large saphenous veins
* Patient with a reflux of the tributary veins already treated for a reflux at the saphenous level
* Clinical stage between C2 and C5 (from the CEAP classification). Diameter of the vein between 3 and 13 mm
* Patient treated with one or two lower limbs
* Patient able to understand and complete a quality of life questionnaire

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
* Subject without health insurance
* Pregnant woman
* Subject in the period of exclusion from another study or provided for by the "national file of volunteers"
* Patient with an absolute or relative contraindication to the treatment of his varicose veins by an endovenous technique
* Venous insufficiency at the expense of the small saphenous vein
* Patient with a history of venous thrombosis
* Patient with hemostasis disorders
* Patient with an associated severe pathology (cancer, heart failure, renal failure)
* Patient treated with sclerotherapy

Primary outcomes:
measure: Comparison of the quality of life relative to the health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
timeFrame: one month after the intervention
Secondary outcomes:
measure: Comparison of the evolution of the quality of life relating to health of patients after endovenous steam treatment versus phlebectomy of the tributary veins
timeFrame: 8-15 days, 3, 6, 9 and 12 months after the intervention
measure: Comparison of occlusion of the tributary veins after endovenous steam treatment versus phlebectomy of the tributary veins
timeFrame: 8-15 days and one year after the intervention
measure: Evaluation of the period of resumption of activity for people in activity after endovenous steam treatment versus phlebectomy of the tributary veins
timeFrame: up to 1 year
Other outcomes:
measure: Comparison of secondary complications after endovenous steam treatment versus phlebectomy of the tributary veins
timeFrame: 8-15 days, 1, 6 and 12 months after the intervention
measure: Comparison of postoperative pain after endovenous steam treatment versus phlebectomy of the tributary veins
timeFrame: Daily for the first 8 days after surgery
measure: Comparison of the clinical improvement felt by the patient
timeFrame: 1, 6 months and one year after the intervention
measure: 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)
timeFrame: 8-15 days, 1, 3, 6, 9 and 12 months after the intervention
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