Clinical trial NCT02588911: Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency
Official title: Randomised Trial of Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency: if You Don't Tell, They Won't Know
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Keywords: Radiofrequency Catheter Ablation
Operative Surgical Procedure
Saphenous Vein
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 18
Sex: ALL
Minimum age (years): 33
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in intensity of hyper pigmentation using a scale of 0 to 10
timeFrame: One week, one month and six months after surgery
measure: Change in extension of hematoma using a scale of 0 to 10
timeFrame: One week, one month and six months after surgery
measure: Change in aesthetic results using a scale of 0 to 10
timeFrame: One week, one month and six months after surgery
measure: Change in pain levels using a scale of 0 to 10
timeFrame: One week, one month and six months after surgery
measure: Change in intensity of skin burns using a scale of 0 to 10
timeFrame: One week, one month and six months after surgery
measure: Change in presence of sensitivity alteration
timeFrame: One week, one month and six months after surgery
measure: Change in presence of thrombophlebitis
timeFrame: One week, one month and six months after surgery
measure: Change in presence of resection or occlusion of the great saphenous vein
timeFrame: One month, six months and 12 months after surgery
measure: Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein
timeFrame: One month, six months and 12 months after surgery
measure: Change in presence of complications
timeFrame: One month, six months and 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Nelson Wolosker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Subramonia S, Lees T. Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial. Eur J Vasc Endovasc Surg. 2010 Jan;39(1):104-11. doi: 10.1016/j.ejvs.2009.09.012. Epub 2009 Oct 29.
citation: Mendes CA, Martins AA, Fukuda JM, Parente JB, Munia MA, Fioranelli A, Teivelis MP, Varella AY, Caffaro RA, Kuzniec S, Wolosker N. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know. Clinics (Sao Paulo). 2016 Nov 1;71(11):650-656. doi: 10.6061/clinics/2016(11)06.