Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency

October 26, 2015 updated by: Nelson Wolosker

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Hospital Israelita Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Surgery
Limb with GSV insufficiency in the same patient, randomised to conventional surgery
Procedure: Conventional Surgery
Cranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein
Active Comparator: Radiofrequency Ablation
Limb with GSV insufficiency in the same patient, randomised to radiofrequency ablation
Procedure: Radiofrequency Ablation
Catheter-based ablation of the great saphenous vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One week, one month and six months after surgery
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).
One week, one month and six months after surgery
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).
One week, one month and six months after surgery
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).
One week, one month and six months after surgery
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).
One week, one month and six months after surgery
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.
One week, one month and six months after surgery
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.
One week, one month and six months after surgery
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.
One month, six months and 12 months after surgery
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
One month, six months and 12 months after surgery
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.
One month, six months and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nelson Wolosker

Investigators

  • Principal Investigator: Nelson Wolosker, MD, PhD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFA vs CS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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