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

Management of Tributary Veins in Superficial Venous Insufficiency of the Lower Limbs: Impact of Endovenous Steam Treatment Versus Phlebectomy on Quality of Life

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 Overview

• Status: Unknown
• Conditions: Venous Insufficiency of Leg
• Intervention / Treatment: Device: VBox Hybrid

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; Treatment of the tributary veins by phlebectomy
EXPERIMENTAL: Experimental group; Endovenous steam treatment of the tributary veins	Device: VBox Hybrid; Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (ACTUAL): September 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: API/2020/103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No