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
{"title":"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。","authors":"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","doi":"10.1093/bjs/znae195","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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).</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"111 8","pages":""},"PeriodicalIF":8.6000,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins.\",\"authors\":\"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\",\"doi\":\"10.1093/bjs/znae195\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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).</p>\",\"PeriodicalId\":136,\"journal\":{\"name\":\"British Journal of Surgery\",\"volume\":\"111 8\",\"pages\":\"\"},\"PeriodicalIF\":8.6000,\"publicationDate\":\"2024-08-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"British Journal of Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/bjs/znae195\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjs/znae195","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins.
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).
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.
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