Clinical trial NCT02454452: Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency
Official title: Comparative Randomized Clinical Study to Evaluate the Efficacy of Radiofrequency vs Surgical Technique of Internal Saphenous Vein Stripping and CHIVA Technique in the Treatment of Chronic Venous Insufficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Keywords: Varicose Veins
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.

Detailed description: A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care.

The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm.

Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.

Eligibility criteria: Inclusion Criteria:

* Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* Recurrent varicose veins
* Post-thrombotic syndrome.
* Patients with active malignancies or severe ischemic heart disease.
* Serious liver disease
* Thrombophilia.
* Serious psychiatric diseases

Primary outcomes:
measure: Absence of venous reflux
timeFrame: 2 years
Secondary outcomes:
measure: CIVIQ
timeFrame: 2 years
measure: SF-36
timeFrame: 2 years
measure: VCSS
timeFrame: 2 years
measure: Surgical complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell
state: Barcelona
Study officials:
affiliation: Corporacion Parc Taulí
name: Elena González Cañas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez Canas E, Florit Lopez S, Vilagut RV, Guevara-Noriega KA, Santos Espi M, Rios J, Soto SN, Gimenez Gaibar A. A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):101-112. doi: 10.1016/j.jvsv.2020.04.019. Epub 2020 Apr 28.