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

Venous Insufficiency of Leg Clinical Trial

— INVOLVE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04534244
• Other study ID #: API/2020/103
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: February 2023

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: February 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

Device:
• VBox Hybrid
Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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