search
Back to results

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
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring Varicose Veins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 22, 2015
Last Updated
August 17, 2017
Sponsor
Corporacion Parc Tauli
search

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

Learn more about this trial

Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

We'll reach out to this number within 24 hrs