Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

August 17, 2017 updated by: Elena González Cañas, Corporacion Parc Tauli

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital de Sabadell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of venous reflux
Time Frame: 2 years
Absence of venous reflux by duplex ultrasound
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Elena González Cañas, MD, Corporacion Parc Tauli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 2012/068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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