Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins.

IF 8.6 1区医学 Q1 SURGERY British Journal of Surgery Pub Date : 2024-08-02 DOI:10.1093/bjs/znae195

Abduraheem H Mohamed, Annabel Howitt, Shivani Rae, Paris L Cai, Louise Hitchman, Tom Wallace, Sandip Nandhra, Sean Pymer, Alexander Knighton, George Smith, Ian C Chetter, Daniel Carradice

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Abstract

Background: Surgical ligation and stripping (surgery) and endothermal ablation are both effective treatments for varicose veins, improving quality of life (QoL) up to 5 years. Few data are available on long-term outcomes. The aim of this study was to evaluate the outcomes 10 years after interventions in an RCT. Previously this RCT demonstrated that endothermal ablation is associated with superior postprocedural QoL, more rapid recovery, and lower rates of early clinical recurrence. This analysis reports outcomes at 10 years.

Methods: Patients with symptomatic varicose veins owing to unilateral great saphenous vein reflux were randomized to either surgery or endovenous laser ablation (EVLA). Outcomes at 10 years included clinical recurrence and QoL.

Results: Data were obtained for 206 of 280 patients (73.6%) at 10 years. Both groups retained significant QoL improvement compared with pretreatment levels (Aberdeen Varicose Vein Questionnaire (AVVQ), Short Form 36 (SF-36®), and EQ-5D™; P < 0.001). Clinical disease progression from baseline was observed in only 10.7% of patients. The clinical recurrence rate was lower in the EVLA group (37 versus 59%; P = 0.005). The number needed to treat with EVLA to avoid one clinical recurrence within 10 years was five. This was associated with significantly higher (better) generic QoL scores with EVLA in several SF-36® domains, including bodily pain (median 84 (i.q.r. 51-100) versus 62 (41-84); P = 0.009) and general health (77 (62-87) versus 67 (52-82); P = 0.017). AVVQ scores in the EVLA group were also lower (better) (3.1 (0-7.7) versus 6.3 (0.7-13.3); P = 0.029).

Conclusion: Both surgery and endothermal ablation are effective treatments for varicose veins at 10 years, with durable improvement in QoL and a very low rate of disease progression. However, endothermal ablation was associated with superior clinical and QoL outcomes. Registration number: NCT00759434 (http://www.clinicaltrials.gov).

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大隐静脉曲张内热消融术与传统手术随机临床试验的十年疗效。

背景：外科结扎和剥脱术（手术）以及内热消融术都是治疗静脉曲张的有效方法，可改善患者长达 5 年的生活质量（QoL）。但有关长期疗效的数据却很少。本研究旨在评估一项研究性试验中干预10年后的疗效。之前的研究表明，内热消融术具有更高的术后生活质量、更快的恢复速度和更低的早期临床复发率。本分析报告的是 10 年后的结果：方法：因单侧大隐静脉回流而出现症状性静脉曲张的患者被随机分配到手术或静脉腔内激光消融术（EVLA）治疗。10年后的结果包括临床复发率和生活质量：280名患者中有206人（73.6%）获得了10年的数据。与治疗前相比，两组患者的 QoL 均有明显改善（阿伯丁静脉曲张问卷 (AVVQ)、短表 36 (SF-36®) 和 EQ-5D™; P < 0.001）。仅有 10.7% 的患者出现了临床疾病进展。EVLA组的临床复发率较低（37%对59%；P = 0.005）。在10年内避免一次临床复发所需的EVLA治疗人数为5人。这与EVLA在多个SF-36®领域的一般QoL评分明显更高（更好）有关，包括身体疼痛（中位数84（i.q.r. 51-100）对62（41-84）；P = 0.009）和一般健康（77（62-87）对67（52-82）；P = 0.017）。EVLA组的AVVQ评分也更低（更好）（3.1（0-7.7）对6.3（0.7-13.3）；P = 0.029）：结论：手术和内热消融术都是治疗静脉曲张的有效方法，可在10年内持久改善患者的生活质量，且疾病进展率极低。然而，内热消融术的临床效果和生活质量都更胜一筹。注册编号NCT00759434 (http://www.clinicaltrials.gov)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

British Journal of Surgery 医学-外科

CiteScore

12.70

自引率

7.30%

发文量

1102

审稿时长

1.5 months

期刊介绍： The British Journal of Surgery (BJS), incorporating the European Journal of Surgery, stands as Europe's leading peer-reviewed surgical journal. It serves as an invaluable platform for presenting high-quality clinical and laboratory-based research across a wide range of surgical topics. In addition to providing a comprehensive coverage of traditional surgical practices, BJS also showcases emerging areas in the field, such as minimally invasive therapy and interventional radiology. While the journal appeals to general surgeons, it also holds relevance for specialty surgeons and professionals working in closely related fields. By presenting cutting-edge research and advancements, BJS aims to revolutionize the way surgical knowledge is shared and contribute to the ongoing progress of the surgical community.