Great Saphenous Vein Electrocoagulation
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|ClinicalTrials.gov Identifier: NCT02139085|
Recruitment Status : Unknown
Verified August 2014 by Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia.
Recruitment status was: Recruiting
First Posted : May 15, 2014
Last Update Posted : August 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Venous Disease Varicose Veins||Device: GSV Electrocoagulation Device: GSV Radiofrequency||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 Start Date :||August 2014|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||July 2016|
Active Comparator: GSV Electrocoagulation
GSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds
Device: GSV Electrocoagulation
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.
Active Comparator: GSV Radiofrequency
GSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm
Device: GSV Radiofrequency
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.
- GSV occlusion [ Time Frame: 3 months ]GSV occlusion verified by blinded DS operator
- GSV occlusion [ Time Frame: 6 months ]GSV occlusion verified by blinded DS operator
- Pain VAS [ Time Frame: 1 week ]Pain VAS by blinded Outcomes Assessor
- Post operative bruising [ Time Frame: 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.
- Post operative sensory abnormality [ Time Frame: 1 week ]
Overall incidence of postoperative sensory abnormality: Numbness or decreased sensation, paresthesia and dysesthesia.
Assessment by blinded Outcomes Assessor
- Venous Clinical Severity Score (VCSS) [ Time Frame: 6 months ]Difference from baseline. Assessment by blinded Outcomes Assessor.
- Aberdeen Varicose Vein Questionnaire (AVVQ) [ Time Frame: 6 months ]Difference from baseline. Assessment by blinded Outcomes Assessor.
- Deep Venous Thrombosis (DVT) [ Time Frame: 1 week ]Presence of DVT verified by blinded DS operator
- Clinical Etiology Anatomy Pathophysiology (CEAP) [ Time Frame: 6 months ]Difference from baseline. Assessment by blinded Outcomes Assessor.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139085
|Contact: Fabio H Rossi, PHDemail@example.com|
|Contact: Nilo M Izukawa, PHD||551150856000 ext firstname.lastname@example.org|
|Instituto Dante Pazzanese de Cardilogia||Recruiting|
|São Paulo, SP, Brazil, 04012-909|
|Contact: Fabio H Rossi, PHD 551150856000 ext 4120 email@example.com|
|Principal Investigator: Fabio H Rossi, HD|
|Principal Investigator:||Fabio H Rossi, PHD||Dante Pazzanese|