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NCT Number: NCT02588911

Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency

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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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Vascular Diseases

Age range

33 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional surgery

Procedure

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

Radiofrequency ablation

Procedure

Catheter-based ablation of the great saphenous vein

Primary outcomes

  1. Change in intensity of hyper pigmentation using a scale of 0 to 10

    Time frame: One week, one month and six months after surgery

    Patients and physicians were oriented to indicate their subjective perception of intensity of hyperpigmentation on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).

  2. Change in extension of hematoma using a scale of 0 to 10

    Time frame: One week, one month and six months after surgery

    Patients and physicians were oriented to indicate their subjective perception of extension of hematoma on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).

  3. Change in aesthetic results using a scale of 0 to 10

    Time frame: One week, one month and six months after surgery

    Patients and physicians were oriented to indicate their subjective perception of aesthetic results on a scale of 0 (unaesthetic) to 10 (excellent results).

  4. Change in pain levels using a scale of 0 to 10

    Time frame: One week, one month and six months after surgery

    Patients were asked to indicate pain levels on a scale of 0 (no pain) to 10 (worst imaginable pain).

  5. Change in intensity of skin burns using a scale of 0 to 10

    Time frame: One week, one month and six months after surgery

    Physicians were asked to inform intensity of skin burns on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).

  6. Change in presence of sensitivity alteration

    Time frame: One week, one month and six months after surgery

    Patients were asked to indicate the presence or absence of sensitivity alteration.

  7. Change in presence of thrombophlebitis

    Time frame: One week, one month and six months after surgery

    Physicians were asked to inform the presence or absence of thrombophlebitis.

  8. Change in presence of resection or occlusion of the great saphenous vein

    Time frame: One month, six months and 12 months after surgery

    Duplex ultrasound scan was used to evaluate the presence or absence of resection or occlusion (success rate) of the great saphenous vein.

  9. Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein

    Time frame: One month, six months and 12 months after surgery

    Duplex ultrasound scan was used to evaluate the presence or absence of reflux in the sapheno-femoral junction and in the great saphenous vein

  10. Change in presence of complications

    Time frame: One month, six months and 12 months after surgery

    Duplex ultrasound scan was used to evaluate the presence or absence of complications such as deep vein thrombosis (DVT) and lymphocele.

Sponsors and collaborators

Lead sponsor

Nelson Wolosker

Other

Registry information

Official study title

Randomised Trial of Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency: if You Don't Tell, They Won't Know

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 28, 2015
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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