Venous Disease | Great Saphenous Vein Electrocoagulation
Venous Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Symptomatic varicose veins of the lower limbs and partial or total failure (venous reflux) of the GSV Exclusion Criteria: - Previous varicose vein surgery with removal of the GSV - Pregnant women - Patients in use of anticoagulants - Known thrombophilia - Presence of saphenous vein tortuosity and/or depth less then 7 mm from the skin - GSV diameter < 5mm and > 12 mm - Previous deep vein thrombosis - Peripheral arterial disease.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:GSV ElectrocoagulationThe energy source will be the Electrosurgical Generator (FX-Valley Lab; USA) and the GSV thermo ablation will be performed with 60 Watts per 10 seconds. The catheter and electrocoagulation device head will be pulled back in increments of 2 cm also to overlap the treatment sites.
Device:GSV RadiofrequencyThe second generation RF device (Closure FAST; Covidien, USA) will be used. The treatment component of the device is 7 cm in length and works with a segmental pullback protocol. Once the catheter is in position, activation of the generator delivers 20- seconds cycles of energy to the catheter tip, which heats the vein wall to 120 o C.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
GSV ElectrocoagulationGSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds
GSV RadiofrequencyGSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm
Start Date: August 2014
Completed Date: July 2016
Phase: Phase 2
Primary Outcome: GSV occlusion
Secondary Outcome: Pain VAS
Study sponsors, principal investigator, and references
Principal Investigator: Fabio H Rossi, PHD
Lead Sponsor: Instituto Dante Pazzanese de Cardiologia
Rossi FH, Beteli CB, Zamorano MB, Silva LM. Immediate effects of endovascular electrocauterization in lower limb varicose veins. J Vasc Bras 11(3): 305-309, 2012.