Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency

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

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-10-31

Brief Summary

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The current study was a double blind randomised controlled trial that compared radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls and who had intact great saphenous veins (GSVs).

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Detailed Description

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Individuals with symptomatic varicose veins and bilateral GSV insufficiency confirmed by duplex ultrasound examination who were candidates for conventional vein stripping were eligible for inclusion in the study. A total of 18 patients entered the trial. As per protocol, each patient was treated with RFA in one leg and CS on the contralateral limb. Randomisation was performed preoperatively using a randomisation table. Patients were not advised of the treatment allocation in order to ensure that this trial was carried out in a blinded fashion. All operations were performed under regional anaesthesia by the same surgical team, skilled in the management of venous disease with extensive expertise in both techniques. Phlebectomy of varicosities was not concomitantly performed.

The independent observer physician not involved in the original operation, the patient, and the duplex ultrasonographer were not aware of the treatment performed in each case and the surgeon was not involved in outcome assessment.

CS. Patients underwent standard procedure of cranial ligation of the GSV and branches of the sapheno-femoral junction (SFJ) using a groin crease incision and stripping of the GSV from SFJ to ankle level, using a vein stripper that was brought out through a small incision near the medial malleolus.

RFA. The procedure was performed under ultrasound guidance. The GSV proximal to the medial malleolus was cannulated with a 7F sheath using surgical cutdown. The tip of the radiofrequency catheter was placed at least 2 cm distal to the SFJ or just distal to the superficial epigastric vein orifice. Patients received tumescent infiltration with cold normal saline (0.9%) circumferentially around the GSV within its enveloping fascia and along the entire length of the treated vein. This was to prevent nerve injury and thermal injury to the skin. Then the catheter was gradually withdrawn according to the device manufacturer's recommendations. The technique consisted of controlled segmental heating of the GSV, using a catheter with a 7-cm heating element (Closure™ system, VNUS Medical Technologies, Inc., San Jose, California, USA). The temperature was maintained at 120° C per segment using a standard time. The thermoablation continued until the catheter tip reached just below the knee. Immediately following treatment with RFA, intraoperative ultrasound imaging was used to confirm shrinkage of the vein.

For limbs operated with the radiofrequency technique, a groin crease incision was made similar to the contralateral side, but with no manipulation of the SFJ. The incision proximal to the medial malleolus was used for sheath insertion. To ensure that the independent observer physician not involved in the original operation, the patient, and the duplex ultrasonographer were not made aware of the treatment done, both incisions were performed on both legs.

Conditions

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Venous Insufficiency

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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Conventional Surgery

Limb with GSV insufficiency in the same patient, randomised to conventional surgery

Group Type ACTIVE_COMPARATOR

Conventional Surgery

Intervention Type PROCEDURE

Cranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein

Radiofrequency Ablation

Limb with GSV insufficiency in the same patient, randomised to radiofrequency ablation

Group Type ACTIVE_COMPARATOR

Radiofrequency Ablation

Intervention Type PROCEDURE

Catheter-based ablation of the great saphenous vein

Interventions

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Conventional Surgery

Cranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein

Intervention Type PROCEDURE

Radiofrequency Ablation

Catheter-based ablation of the great saphenous vein

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 60 years
* Clinical, etiologic, anatomic, pathophysiologic (CEAP): clinical grades 2 to 5 (C2-5), primary (Ep), superficial (As) and reflux only (Pr)
* Duplex scan confirmed primary bilateral GSV insufficiency requiring surgery (insufficiency with reverse venous flow was regarded significant if persisting more than 0.5 seconds in a standing position)

Exclusion Criteria

* Patients able to give informed consent

* Varicose veins without GSV insufficiency on duplex scan
* Previous varicose vein surgery
* Associated small saphenous vein reflux, duplication of the GSV at the SFJ, deep venous insufficiency or previous DVT on duplex scan
* GSV diameter \<3 mm or \>12 mm in the supine position
* Thrombus in the GSV
* Patients with a pacemaker or internal defibrillator
* Concomitant peripheral arterial disease (ankle-brachial pressure index of \<0.9)
* Patients on oral anticoagulants
* Patients with high blood pressure not controlled by medication
* Patients with known thrombophilia, cancer or lupus
* Pregnancy

Minimum Eligible Age

33 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No