Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency

Nelson Wolosker

Status

Completed

Conditions

Venous Insufficiency

Treatments

Procedure: Radiofrequency Ablation

Procedure: Conventional Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02588911

RFA vs CS

Details and patient eligibility

About

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).

Full description

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.

Enrollment

18 patients

Sex

All

Ages

33 to 76 years old

Volunteers

No Healthy Volunteers

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)
Duplex scan confirmed suitability for RFA (see exclusion criteria)
Patients able to give informed consent

Exclusion criteria

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