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Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know.

ABSTRACT: This study compared radiofrequency ablation versus conventional surgery in patients who had not undergone previous treatment for bilateral great saphenous vein insufficiency, with each patient serving as his own control.This was a randomized controlled trial that included 18 patients and was carried out between November 2013 and May 2015. Each of the lower limbs of each patient was randomly assigned to undergo either radiofrequency ablation or conventional surgery. Clinical features (hyperpigmentation, hematoma, aesthetics, pain, skin burn, nerve injury, and thrombophlebitis) were evaluated at one week, one month, and six months postoperatively. Hemodynamic assessments (presence of resection or occlusion of the great saphenous vein and recurrent reflux in the sapheno-femoral junction and in the great saphenous vein) were performed at one month, six months, and 12 months postoperatively. The independent observer (a physician not involved in the original operation), patient, and duplex ultrasonographer were not made aware of the treatment done in each case. Clinicaltrials.gov: NCT02588911.Among the clinical variables analyzed, only the aesthetic evaluation by the physicians was significant, with radiofrequency ablation being considered better than conventional surgery (average, 0.91 points higher: standard deviation: 0.31; 95% confidence interval: -1.51, -0.30; p=0.003). However, in our study, we observed primary success rates of 80% for radiofrequency ablation and 100% for conventional surgery.If the physician is not required to inform the patient as to the technique being performed, the patient will not be able to identify the technique based on the signs and symptoms. Our study revealed that both techniques led to high levels of patient satisfaction, but our results favor the choice of conventional surgery over radiofrequency ablation, as patients who underwent conventional surgery had better hemodynamic assessments.

SUBMITTER: Mendes CA

PROVIDER: S-EPMC5108164 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know.

Mendes Cynthia de Almeida CA Martins Alexandre de Arruda AA Fukuda Juliana Maria JM Parente José Ben-Hur Ferraz JB Munia Marco Antonio Soares MA Fioranelli Alexandre A Teivelis Marcelo Passos MP Varella Andrea Yasbek Monteiro AY Caffaro Roberto Augusto RA Kuzniec Sergio S Wolosker Nelson N

Clinics (Sao Paulo, Brazil) 20161101 11

<h4>Objectives:</h4>This study compared radiofrequency ablation versus conventional surgery in patients who had not undergone previous treatment for bilateral great saphenous vein insufficiency, with each patient serving as his own control.<h4>Method:</h4>This was a randomized controlled trial that included 18 patients and was carried out between November 2013 and May 2015. Each of the lower limbs of each patient was randomly assigned to undergo either radiofrequency ablation or conventional sur ...[more]

PMID: 27982166

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Project description:BackgroundEndovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.Methods/designThe Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA. All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at 1 year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.DiscussionThe aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.Trial registrationClinicalTrials.gov identifier: NCT02627846 , registered 8 December 2015 EudraCT number: 2015-000730-30 REC ref: 15/YH/0207 R&D ref: R1788.

Dataset Information

Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know.

Publications

Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know.

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