Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I, et al.
Annals of surgery. Date of publication 2013 Mar 1;volume 257(3):419-26.
1. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4.
Randomized clinical trial of endovenous laser ablation versus conventional
surgery for small saphenous varicose veins.
Samuel N(1), Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I.
Author information:
(1)Academic Vascular Surgical Unit, Hull York Medical School/University of Hull,
United Kingdom. Nehemiah.samuel@hey.nhs.uk
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.).
DOI: 10.1097/SLA.0b013e318275f4e4
PMID: 23160149 [Indexed for MEDLINE]