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Effectiveness and safety in comparison treatment of chronic venous insufficiency grave (CEAP 6): intravenous ablation radio waves versus intravenous ablation lasers versus sclerotherapy foam versus elastic compression

Grant number: 15/11429-3
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): April 01, 2016
Effective date (End): March 31, 2018
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:Marcone Lima Sobreira
Grantee:Bruno Medure Iwamoto
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

The most severe presentation of venous disease, venous ulcers open or healed, affects approximately 2 million people in Brazil, reaching up to 6 million people, considering the population over 70 years. Delayed healing process associated with a high recurrence rate, disability and loss of working days for the patients economically active, a major cause of absenteeism, and negative impact on quality of life of this patient. Compression therapy is considered the most effective clinical treatment for venous ulcers and recurrence must be prevented by treatment of venous hypertension. Evidence from randomized prospective studies suggest that ulcer recurrence is decreased with varicose vein surgery and also suggests superiority of minimally invasive intravenous interventions such as laser or radiofrequency ablation on the classic surgical treatment (stripping of the saphenous vein), once patients with active ulcerative are not usually subjected to conventional surgical treatment, or by the procedure constraints or limitations of the patient. So far there are a gap as the prospective randomized studies comparing minimally invasive techniques in the treatment of patients with active ulcer and well-conducted randomized trials are still needed to provide grade A evidence.This work aims to be the first randomized controlled clinical trial comparing endovascular techniques such as radio frequency (RF) and endolaser (ELVA) with foam sclerotherapy and clinical treatment of elastic compression in patients with advanced chronic venous insufficiency (CEAP VI), a view to answering questions about the level of evidence of the techniques used, thus filling a gap in the literature. It will be selected 108 (one hundred and eight) patients with varicose ulcers by primary chronic venous insufficiency, divided randomly into 4 groups, radiofrequency or laser or foam or elastic compression (control group) - all groups will receive elastic compression postoperatively. After the proposed procedures, the patients will be followed by ultrasound control after 7 days, 1 month, 3 months, 6 months and 01 years. The primary endpoint will be the healing of the wound and the secondary outcome will be the presence of recanalization of the great saphenous vein, presence of phlebitis, presence of hyperchromic spots, monthly healing rate and review the impact on quality of life (Venous Leg Qualit of Life Questionnaire (VLU-QoL-Br).