Great Saphenous Vein Electrocoagulation

Phase 2

• Conditions: Venous Disease; Varicose Veins
• Interventions: Device: GSV Radiofrequency; Device: GSV Electrocoagulation

• Registration Number: NCT02139085
• Lead Sponsor: Instituto Dante Pazzanese de Cardiologia

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.

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Status Verified: 2014-08
• Study Start: 2014-08
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-08
• Primary Completion: 2015-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSV Radiofrequency	GSV Radiofrequency	GSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm
GSV Electrocoagulation	GSV Electrocoagulation	GSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds

Primary Outcome Measures

Name	Time	Method
GSV occlusion	6 months	GSV occlusion verified by blinded DS operator

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Dante Pazzanese de Cardilogia; 🇧🇷 São Paulo, SP, Brazil