Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Saphenous vein stripping

Saphenous venous stripping surgical technique

Group Type ACTIVE_COMPARATOR

Saphenous vein stripping

Intervention Type PROCEDURE

Saphenous vein stripping

CHIVA

conservative hemodynamic treatment venous insufficiency (CHIVA)

Group Type ACTIVE_COMPARATOR

CHIVA

Intervention Type PROCEDURE

conservative hemodynamic treatment venous insufficiency

Radiofrequency

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Group Type EXPERIMENTAL

Radiofrequency

Intervention Type PROCEDURE

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Interventions

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Radiofrequency

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Intervention Type PROCEDURE

Saphenous vein stripping

Intervention Type PROCEDURE

CHIVA

conservative hemodynamic treatment venous insufficiency

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No