Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: CHIVA; Procedure: Radiofrequency; Procedure: Saphenous vein stripping

• Registration Number: NCT02454452
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Primary Completion: 2015-07
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHIVA	CHIVA	conservative hemodynamic treatment venous insufficiency (CHIVA)
Radiofrequency	Radiofrequency	Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
Saphenous vein stripping	Saphenous vein stripping	Saphenous venous stripping surgical technique

Primary Outcome Measures

Name	Time	Method
Absence of venous reflux	2 years	Absence of venous reflux by duplex ultrasound

Secondary Outcome Measures

Name	Time	Method
CIVIQ	2 years	Venous quality of Life questionnaire - Spanish validated version
SF-36	2 years
VCSS	2 years	Venous Clinical Severity Score
Surgical complications	1 month	Hematoma, echymosis, infection, bleeding, induration, neuritic pain

Trial Locations

Locations (1)

Hospital de Sabadell; 🇪🇸 Sabadell, Barcelona, Spain