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  • The primary end point was closed or absent GSV with reflux, and secondary end points were return to normal activity, treatment-related complications, and scores for VVCSS, AVVSS, and SF-36. Data are presented as mean �� standard deviation. Continuous variables were analyzed with t test and categoric variables using the ��2 test. A value of P < .05 was considered statistically significant. Sample size calculations by a biostatistician before the start of the trial revealed that a group size of 100 limbs in each group had a statistical power of 80%, with the confidence interval set at 96%, to detect a difference in the primary study end point between EVLT and HL/S of ��0.05. During the enrollment phase, 425 limbs selleck screening library were assessed for eligibility, 204 limbs were randomized, and 4 limbs were excluded in the EVLT group, leaving 100 limbs in each group for analysis. All limbs were examined on postoperative day 12. At 1 year after treatment, 1 limb was lost to follow-up in the EVLT group, leaving 99 limbs for evaluation. At the 2-year follow-up, another 4 limbs in the EVLT group (3 limbs operated on and 1 limb lost to follow-up) and 1 limb in the HL/S group were lost to follow-up, thus allowing 2-year analysis of 95 and 99 limbs, respectively (Fig 1). There was no significant difference between the groups regarding treatment time (31.4 �� 7.8 minutes [HL/S] and 32.0 �� 7.4 minutes [EVLT], respectively). Non-specific serine/threonine protein kinase In the HL/S group, there were no perioperative complications, whereas Selleckchem IWR1 one patient sustained a small accidental skin burn at the fiber insertion site. Pretreatment varicose vein symptoms and severity classifications (CEAP, VVCSS and AVVSS) are reported in Table III and revealed no group differences. The HL/S group had a higher incidence of dermatitis compared with the EVLT group, whereas there were no significant differences between the groups regarding severity classifications (Table III). The postoperative DUS examination 6 hours and at 12 days revealed absence or abolishment of the GSV in all treated legs in both groups. One limb in the EVLT group showed reflux at the level of the thigh. Time to return to normal activity was 6.6 days for HL/S vs 6.9 days for EVLT (Table IV). Pain scores were without significant group differences throughout the first 12 postoperative days, with an average pain score of 4.6 for HL/S and 4.3 for EVLT on day 1, 2.9 vs 2.2 on day 3, and 1.8 vs 1.7 on day 12. There was no group difference in the mean use of analgesics during the initial 12 postoperative days. Few complications occurred after treatment (Table IV). All patients were specifically asked about any neurologic symptoms at each follow-up visit.

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