Great Saphenous Vein Electrocoagulation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.

Conditions
-----------------
Venous Disease, Varicose Veins

Intervention / Treatment
-----------------
* Device: GSV Electrocoagulation
* Device: GSV Radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GSV Electrocoagulation<br>GSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds | Device: GSV Electrocoagulation<br>* The 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.<br>|
| Active Comparator: GSV Radiofrequency<br>GSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm | Device: GSV Radiofrequency<br>* The 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GSV occlusion | GSV occlusion verified by blinded DS operator | 3 months | 
| GSV occlusion | GSV occlusion verified by blinded DS operator | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS | Pain VAS by blinded Outcomes Assessor | 1 week | 
| Post operative bruising | The bruised area traced manually, and the surface area estimated by placing the tracing on a square chart. Assessment by blinded Outcomes Assessor. | 1 week | 
| Post operative sensory abnormality | Overall incidence of postoperative sensory abnormality: Numbness or decreased sensation, paresthesia and dysesthesia. Assessment by blinded Outcomes Assessor | 1 week | 
| Venous Clinical Severity Score (VCSS) | Difference from baseline. Assessment by blinded Outcomes Assessor. | 6 months | 
| Aberdeen Varicose Vein Questionnaire (AVVQ) | Difference from baseline. Assessment by blinded Outcomes Assessor. | 6 months | 
| Deep Venous Thrombosis (DVT) | Presence of DVT verified by blinded DS operator | 1 week | 
| Clinical Etiology Anatomy Pathophysiology (CEAP) | Difference from baseline. Assessment by blinded Outcomes Assessor. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
varicose veins, catheter ablation, Catheter Ablation, Electrical, Catheter Ablation, Radiofrequency