Impact of Endovenous Water Vapor Treatment on Quality of Life in Superficial Venous Insufficiency of the Lower Limbs

Not Applicable

• Conditions: Venous Insufficiency of Leg
• Interventions: Device: VBox Hybrid

• Registration Number: NCT04534244
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study First Posted: 2020-09-01
• Last Update Posted: 2020-09-01
• Study Start: 2020-10
• Primary Completion: 2022-10
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	VBox Hybrid	Endovenous steam treatment of the tributary veins

Primary Outcome Measures

Name	Time	Method
Comparison of the quality of life relative to the health of patients after endovenous steam treatment versus phlebectomy of the tributary veins	one month after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of the evolution of the quality of life relating to health of patients after endovenous steam treatment versus phlebectomy of the tributary veins	8-15 days, 3, 6, 9 and 12 months after the intervention	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.
Evaluation of the period of resumption of activity for people in activity after endovenous steam treatment versus phlebectomy of the tributary veins	up to 1 year	Duration of work stoppage for working people
Comparison of occlusion of the tributary veins after endovenous steam treatment versus phlebectomy of the tributary veins	8-15 days and one year after the intervention	Occlusion rate evaluated by Doppler ultrasound