Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency

Study Overview
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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).

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 Then the catheter was gradually withdrawn according to the device manufacturer's recommendations.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.

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

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Procedure: Conventional Surgery
* Procedure: Radiofrequency Ablation


Participation Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 33 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intensity of hyper pigmentation using a scale of 0 to 10 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency Catheter Ablation, Operative Surgical Procedure, Saphenous Vein