Great Saphenous Vein Electrocoagulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Disease Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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GSV Electrocoagulation

GSV Electrocoagulation Source: Electrosurgical Generator(FX-Valley Lab; USA) Energy: 60 Watts x 10 seconds

Group Type ACTIVE_COMPARATOR

GSV Electrocoagulation

Intervention Type DEVICE

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.

GSV Radiofrequency

GSV Radiofrequency Source: Closure FAST(Covidien, USA) Energy: 60 Joules / cm

Group Type ACTIVE_COMPARATOR

GSV Radiofrequency

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes