Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency
Primary Purpose
Varicose Veins
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radiofrequency
Saphenous vein stripping
CHIVA
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring Varicose Veins
Eligibility 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
Sites / Locations
- Hospital de Sabadell
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Saphenous vein stripping
CHIVA
Radiofrequency
Arm Description
Saphenous venous stripping surgical technique
conservative hemodynamic treatment venous insufficiency (CHIVA)
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
Outcomes
Primary Outcome Measures
Absence of venous reflux
Absence of venous reflux by duplex ultrasound
Secondary Outcome Measures
CIVIQ
Venous quality of Life questionnaire - Spanish validated version
SF-36
VCSS
Venous Clinical Severity Score
Surgical complications
Hematoma, echymosis, infection, bleeding, induration, neuritic pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02454452
Brief Title
Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Varicose Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saphenous vein stripping
Arm Type
Active Comparator
Arm Description
Saphenous venous stripping surgical technique
Arm Title
CHIVA
Arm Type
Active Comparator
Arm Description
conservative hemodynamic treatment venous insufficiency (CHIVA)
Arm Title
Radiofrequency
Arm Type
Experimental
Arm Description
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency
Intervention Description
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
Intervention Type
Procedure
Intervention Name(s)
Saphenous vein stripping
Intervention Description
Saphenous vein stripping
Intervention Type
Procedure
Intervention Name(s)
CHIVA
Intervention Description
conservative hemodynamic treatment venous insufficiency
Primary Outcome Measure Information:
Title
Absence of venous reflux
Description
Absence of venous reflux by duplex ultrasound
Time Frame
2 years
Secondary Outcome Measure Information:
Title
CIVIQ
Description
Venous quality of Life questionnaire - Spanish validated version
Time Frame
2 years
Title
SF-36
Time Frame
2 years
Title
VCSS
Description
Venous Clinical Severity Score
Time Frame
2 years
Title
Surgical complications
Description
Hematoma, echymosis, infection, bleeding, induration, neuritic pain
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena González Cañas, MD
Organizational Affiliation
Corporacion Parc Taulí
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32353592
Citation
Gonzalez Canas E, Florit Lopez S, Vilagut RV, Guevara-Noriega KA, Santos Espi M, Rios J, Soto SN, Gimenez Gaibar A. A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):101-112. doi: 10.1016/j.jvsv.2020.04.019. Epub 2020 Apr 28.
Results Reference
derived
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Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency
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