Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      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).
    

Detailed 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.
    

Intervention name(s): Conventional Surgery; Radiofrequency Ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Cranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein; Catheter-based ablation of the great saphenous vein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radiofrequency Catheter Ablation; Operative Surgical Procedure; Saphenous Vein