NCT02454452

Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency	Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
PROCEDURE	Saphenous vein stripping	Saphenous vein stripping
PROCEDURE	CHIVA	conservative hemodynamic treatment venous insufficiency

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-07-01
• Completion: 2017-08-01
• First posted: 2015-05-27
• Last updated: 2017-08-22

Locations

1 site across 1 country: Spain