Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Varicose Veins Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454452
• Other study ID #: CEIC 2012/068
• Status: Completed
• Phase: N/A
• First received: May 22, 2015
• Last updated: August 17, 2017
• Start date: February 2013
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: August 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• Radiofrequency
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
• Saphenous vein stripping
Saphenous vein stripping
• CHIVA
conservative hemodynamic treatment venous insufficiency

Locations

Country	Name	City	State
Spain	Hospital de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of venous reflux	Absence of venous reflux by duplex ultrasound	2 years
Secondary	CIVIQ	Venous quality of Life questionnaire - Spanish validated version	2 years
Secondary	SF-36		2 years
Secondary	VCSS	Venous Clinical Severity Score	2 years
Secondary	Surgical complications	Hematoma, echymosis, infection, bleeding, induration, neuritic pain	1 month