Clinical trial NCT02139085: Great Saphenous Vein Electrocoagulation
Official title: A Prospective Double Blind Randomized Controlled Trial Of Electrocoagulation Versus Radiofrequency Treatment Of The Great Saphenous Vein In Patients With Varicose Veins.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Venous Disease
Varicose Veins
Keywords: varicose veins
catheter ablation
Catheter Ablation, Electrical
Catheter Ablation, Radiofrequency
Lead sponsor: Instituto Dante Pazzanese de Cardiologia
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: GSV occlusion
timeFrame: 3 months
measure: GSV occlusion
timeFrame: 6 months
Secondary outcomes:
measure: Pain VAS
timeFrame: 1 week
measure: Post operative bruising
timeFrame: 1 week
measure: Post operative sensory abnormality
timeFrame: 1 week
measure: Venous Clinical Severity Score (VCSS)
timeFrame: 6 months
measure: Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: 6 months
measure: Deep Venous Thrombosis (DVT)
timeFrame: 1 week
measure: Clinical Etiology Anatomy Pathophysiology (CEAP)
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardilogia
state: SP
Study officials:
affiliation: Dante Pazzanese
name: Fabio H Rossi, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rossi 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.