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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saphenous vein stripping | Active Comparator | Saphenous venous stripping surgical technique |
|
| CHIVA | Active Comparator | conservative hemodynamic treatment venous insufficiency (CHIVA) |
|
| Radiofrequency | Experimental | Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency | Procedure | Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of venous reflux | Absence of venous reflux by duplex ultrasound | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| CIVIQ | Venous quality of Life questionnaire - Spanish validated version | 2 years |
| SF-36 | 2 years | |
| VCSS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena González Cañas, MD | Corporacion Parc Taulà | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Sabadell | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32353592 | Derived | 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. |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Saphenous vein stripping | Procedure | Saphenous vein stripping |
|
| CHIVA | Procedure | conservative hemodynamic treatment venous insufficiency |
|
Venous Clinical Severity Score |
| 2 years |
| Surgical complications | Hematoma, echymosis, infection, bleeding, induration, neuritic pain | 1 month |