A prospective double blind randomized controlled trial of electrocoagulation versus radiofrequency treatment of the great saphenous vein in patients with varicose veins

• Grant number: 14/05913-7
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2014
• End date: July 31, 2016
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Nilo Mitsuru Izukawa
• Grantee: Nilo Mitsuru Izukawa
• Host Institution: Instituto Dante Pazzanese de Cardiologia (IDPC). Fundação Adib Jatene (FAJ). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Camila Baumann Beteli ; Fabio Henrique Rossi

Abstract

Lower extremity Chronic Venous Insufficiency is a prevalent disease that adversely affects an individual's Quality of Life. Varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. Endovenous electrocoagulation can selectively and safely cause Great Saphenous Vein (GSV) wall necrosis, but its clinical results had never been studied before. Objective: The objective of this study is to compare the endovenous electrocoagulation and radiofrequency varicose vein treatment results and quality of life improvement in a prospective double-blind randomized controlled clinical trial Methods: Consecutive patients with varicose veins and primary GSV reflux will be randomized to Electrocoagulation or Radiofrequency (VNUS-Closure FAST) endovenous treatment. The primary outcome measure will be GSV occlusion at 3 months after treatment. Secondary outcome measures will be pain, bruising and thrombosis occurrence in the immediate postoperative period, and the questionnaire Aberdeen, obtained preoperatively and 6 months postoperatively. For statistical analysis, we will use the Student's t test, the Mann-Whitney test and Pearson's correlation, considering positive statistical significance when a level of p <0.05. (AU)