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Randomized Clinical Trial of Endovenous Laser Ablation Versus Conventional Surgery for Small Saphenous Varicose Veins

Samuel, Nehemiah MBBS, MRCS; Carradice, Daniel MBChB, MRCS; Wallace, Tom MBBS, MRCS; Mekako, Anthony MBBS, MRCS; Hatfield, Josie RGN; Chetter, Ian MD, FRCS

Annals of Surgery:
doi: 10.1097/SLA.0b013e318275f4e4
Randomized Clinical Trials
Abstract

Introduction: No randomized clinical trial comparing treatment options for small saphenous vein (SSV) incompetence exists, and there is no clear evidence that this axis behaves the same as the great saphenous vein after treatment. This means that the existing literature base, centered on the treatment of great saphenous vein incompetence cannot simply be extrapolated to inform the management of SSV insufficiency. This trial compares the gold standard of conventional surgery and endovenous laser ablation (EVLA) in the management of SSV incompetence.

Methods: Patients with unilateral, primary saphenopopliteal junction incompetence and SSV reflux were randomized equally into parallel groups receiving either surgery or EVLA. Patients were assessed at baseline and weeks 1, 6, 12, and 52. Outcomes included successful abolition of axial reflux on duplex, visual analog pain scores, recovery time, complication rates, Venous Clinical Severity Score, and quality of life profiling.

Results: A total of 106 patients were recruited and randomized to surgery (n = 53) or EVLA (n = 53). Abolition of SSV reflux was significantly higher after EVLA (96.2%) than surgery (71.7%) (P < 0.001). Postoperative pain was significantly lower after EVLA (P < 0.05), allowing an earlier return to work and normal function (P < 0.001). Minor sensory disturbance was significantly lower in the EVLA group (7.5%) than in surgery (26.4%) (P = 0.009). Both groups demonstrated similar improvements in Venous Clinical Severity Score and quality of life.

Conclusion: EVLA produced the same clinical benefits as conventional surgery but was more effective in addressing the underlying pathophysiology and was associated with less periprocedural morbidity allowing a faster recovery. (Registration number: NCT00841178.)

In Brief

Suboptimal results and lack of consensus on the best surgical technique for small saphenous varicosities have disappointed surgeons and patients alike. This randomized clinical trial established the safety and efficacy of endovenous laser ablation and demonstrated its superior technical and clinical outcomes in comparison with surgery, thus favoring its adoption as standard treatment of small saphenous vein incompetence.

Author Information

From the Academic Vascular Surgical Unit, Hull York Medical School/University of Hull, United Kingdom.

Reprints: Nehemiah Samuel MBBS, MRCS, Academic Surgical Vascular Unit, 1st Floor, Tower Block, Hull Royal Infirmary, Anlaby Rd, Hull HU3 2JZ. E-mail: Nehemiah.samuel@hey.nhs.uk.

Presented to the Annual General Meeting of the Vascular Society of Great Britain and Ireland, Edinburgh, United Kingdom, November 2011. Winner of the Venous Forum Prize of the Royal Society of Medicine.

Disclosure: The primary funding source for this study was internal University funding. Diomed/Angiodynamics (Cambridge, United Kingdom) also provided 50% of a research nurse's salary over a 12-month period to facilitate our work but had no involvement or influence in the design, data collection/analysis, writing of the report, or in the decision to submit for publication. Diomed/Angiodynamics does not have access to any unpublished data.

© 2013 Lippincott Williams & Wilkins, Inc.