Great Saphenous Vein Electrocoagulation
A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 8, 2014
August 1, 2014
10 months
May 12, 2014
August 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
GSV occlusion
GSV occlusion verified by blinded DS operator
3 months
GSV occlusion
GSV occlusion verified by blinded DS operator
6 months
Secondary Outcomes (7)
Pain VAS
1 week
Post operative bruising
1 week
Post operative sensory abnormality
1 week
Venous Clinical Severity Score (VCSS)
6 months
Aberdeen Varicose Vein Questionnaire (AVVQ)
6 months
- +2 more secondary outcomes
Study Arms (2)
GSV Electrocoagulation
ACTIVE COMPARATORGSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds
GSV Radiofrequency
ACTIVE COMPARATORGSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Symptomatic varicose veins of the lower limbs and partial or total failure (venous reflux) of the GSV
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Dante Pazzanese de Cardilogia
São Paulo, São Paulo, 04012-909, Brazil
Related Publications (2)
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.
BACKGROUNDRossi FH, Izukawa NM, Silva DG, Chen J, Prakasan AK, Zamorano MM, Silva LM. Effects of electrocautery to provoke endovascular thermal injury. Acta Cir Bras. 2011 Oct;26(5):329-32. doi: 10.1590/s0102-86502011000500001.
PMID: 21952653BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio H Rossi, PHD
Dante Pazzanese
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vascular surgeon PhD
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 15, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2015
Study Completion
July 1, 2016
Last Updated
August 8, 2014
Record last verified: 2014-08