Varicose Veins Clinical Trial
Official title:
A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.
Introduction: 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 has never been studied before.
Objective: The objective of this study is to compare Great Saphenous Vein electrocoagulation
and radio frequency (RF) endovascular varicose vein treatment clinical 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 endovenous treatment. The primary outcome measure
will be GSV occlusion rate at 3 and 6 months after treatment verified by Duplex Scanning
(DS). Secondary outcome measures will be pain visual analogue scale (VAS), bruising,
neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and
Clinical Etiology Anatomy and Pathophysiology (CEAP) classification ,Venous Clinical
Severity Scale (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ), obtained
preoperatively, at 3 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 level of p <0.05.
All patients included in the study will be preoperatively examined to evaluate the severity
of venous disease, using the CEAP classification, VCSS and AVVQ. They will undergo venous DS
with the aim of investigating GSV insufficiency, its caliber and depth and presence of
previous thrombophlebitis.
Patients will be randomized on the day of surgery with an electronic table of random
numbers:
Group 1:Electrocoagulation treatment. Group 2: Radiofrequency treatment.
Patients and outcomes assessor will be blinded to the group of endovenous treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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