Randomised Controlled Trial Comparing Sapheno-Femoral Ligation and Stripping of the Great Saphenous Vein with Endovenous Laser Ablation (980 nm) Using Local Tumescent Anaesthesia: One Year Results

Randomised Controlled Trial Comparing Sapheno-Femoral Ligation and Stripping of the Great Saphenous Vein with Endovenous Laser Ablation (980 nm) Using Local Tumescent Anaesthesia: One Year Results
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DOI:
10.1016/j.ejvs.2010.08.007
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发表时间:
2010-11-01
影响因子:
5.7
通讯作者:
van Vlijmen-van Keulen, C. J.
van Vlijmen-van Keulen, C. J.
中科院分区:
医学1区
文献类型:
--
作者:
Pronk, P.;Gauw, S. A.;van Vlijmen-van Keulen, C. J.

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目的:使用局部肿胀麻醉,比较隐股静脉结扎剥脱术 (SFL/S) 与静脉内激光消融术 (EVLA,980 nm) 治疗大隐静脉 (GSV) 功能不全的情况。设计:随机、单中心试验。材料和方法:GSV 功能不全和静脉曲张的患者被随机分为两组 SFL/S 或 EVLA。在治疗后第 1、2、3、7、10 和 14 天,患者完成了有关疼痛和生活质量的调查问卷。通过在第 1 周、第 6 周以及第 6 个月和第 12 个月时进行的多普勒超声 (DUS) 评估复发性静脉曲张。结果:121 名患者的 130 条腿接受了 SFL/S (n = 68) 或 EVLA (n = 62) 治疗。与 EVLA 相比,EVLA 治疗后第 7、10 和 14 天的治疗后疼痛显着增加(p < 0.01;p < 0.01;p = 0.01),第 7 天(p < 0.01)和 10(p = 0.01)的活动障碍更多,第 7 天的自我护理(p = 0.03)和日常活动(p = 0.01)障碍更多SFL/S。 1 年随访 DUS 显示 EVLA 后复发率为 9%(5/56),SFL/S 后复发率为 10%(5/49)。 结论:SFL/S 和 EVLA 均采用局部肿胀麻醉,耐受性良好,短期复发率无差异。在 EVLA 后的第二周,与 SFL/S 相比,患者经历了明显更多的疼痛,导致活动能力、自我护理和日常活动受限。 (C) 2010 年欧洲血管外科学会。由爱思唯尔有限公司出版。保留所有权利。
Objectives: Comparison of sapheno-femoral ligation and stripping (SFL/S) versus endovenous laser ablation (EVLA, 980-nm) in the treatment of great saphenous vein (GSV) insufficiency, using local tumescent anaesthesia.Design: Randomised, single centre trial.Materials and methods: Patients with GSV incompetence and varicose veins were randomised to either SFL/S or EVLA. At days 1, 2, 3, 7, 10, and 14 post-treatment, patients completed questionnaires on pain and quality of life. Recurrent varicose veins were evaluated by Duplex ultrasound (DUS) performed at 1 and 6 weeks, and 6 and 12 months.Results: 130 legs in 121 patients were treated by SFL/S (n = 68) or EVLA (n = 62). Significantly more post-treatment pain was noted after EVLA at days 7, 10 and 14 (p < 0.01; p < 0.01; p = 0.01), more hindrance in mobility at days 7 (p < 0.01) and 10 (p = 0.01), and in self care (p = 0.03) and daily activities (p = 0.01) at day 7 compared to SFL/S. DUS at 1-year follow-up showed 9% recurrences (5/56) after EVLA and 10% (5/49) after SFL/S.Conclusion: Both SFL/S and EVLA, using local tumescent anaesthesia, were well tolerated, with no difference in short-term recurrence rate. In the second week after EVLA, patients experienced significantly more pain resulting in restricted mobility, self care and daily activity compared to SFL/S. (C) 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.