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Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

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ClinicalTrials.gov Identifier: NCT02454452
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Elena González Cañas, 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.

Condition or disease Intervention/treatment Phase
Varicose Veins Procedure: Radiofrequency Procedure: Saphenous vein stripping Procedure: CHIVA Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Active Comparator: Saphenous vein stripping
Saphenous venous stripping surgical technique
Procedure: Saphenous vein stripping
Saphenous vein stripping

Active Comparator: CHIVA
conservative hemodynamic treatment venous insufficiency (CHIVA)
Procedure: CHIVA
conservative hemodynamic treatment venous insufficiency

Experimental: Radiofrequency
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
Procedure: Radiofrequency
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter




Primary Outcome Measures :
  1. Absence of venous reflux [ Time Frame: 2 years ]
    Absence of venous reflux by duplex ultrasound


Secondary Outcome Measures :
  1. CIVIQ [ Time Frame: 2 years ]
    Venous quality of Life questionnaire - Spanish validated version

  2. SF-36 [ Time Frame: 2 years ]
  3. VCSS [ Time Frame: 2 years ]
    Venous Clinical Severity Score

  4. Surgical complications [ Time Frame: 1 month ]
    Hematoma, echymosis, infection, bleeding, induration, neuritic pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454452


Locations
Spain
Hospital de Sabadell
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Principal Investigator: Elena González Cañas, MD Corporacion Parc Taulí

Responsible Party: Elena González Cañas, MD, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02454452     History of Changes
Other Study ID Numbers: CEIC 2012/068
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Elena González Cañas, Corporacion Parc Tauli:
Varicose Veins

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases