Division of Vascular and Endovascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University Hospital, Pathum Thani, Thailand.
Center of Excellence in Applied Epidemiology, Faculty of Medicine, Thammasat University Hospital, Pathum Thani, Thailand.
BMJ Open. 2019 Jan 30;9(1):e024813. doi: 10.1136/bmjopen-2018-024813.
Endovenous ablations are the new standard procedures for treatment of great saphenous vein reflux including endovenous laser ablation (EVLA), radio frequency ablation (RFA), endovenous steam ablation (EVSA), mechanochemical ablation (MOCA), cyanoacrylate injection and ultrasound-guided foam sclerotherapy (UGFS). EVLA and RFA have demonstrated similar anatomical success for short-term outcome, but results are controversial for longer term (≥5 years). Additional evidences from randomised controlled trials have been published. This study is, therefore, conducted to, directly and indirectly, compare outcomes among all procedures stratifying by short-term and long-term follow-up.
Medline and Scopus will be searched from 2000 to September 2018 with predefined search strategy. Interventions of interest are open surgery (ie, saphenofemoral or high ligation (HL) with stripping) and endovenous ablations (ie, EVLA, RFA, EVSA, MOCA, cyanoacrylate injection and UGFS). The primary outcome is anatomical success. Two independent reviewers will select studies, extract data and assess risk of bias. Disagreement will be adjudicated by the third party. Outcomes will be directly pooled if there are at least three studies in that comparison. A fixed-effect model will be used unless heterogeneity is present, in which case a random-effect model will be applied. Sources of heterogeneity will be explored using meta-regression analysis, and sub-group analysis will be done accordingly. Publication bias will be assessed using Egger's test and funnel plot. A network meta-analysis will be applied to indirect compare all interventions including RFA, EVLA, EVLA with HL, UGFS, UGFS with HL and HL with stripping. Probability of being best intervention will be estimated and ranked. Inconsistency assumption will be checked using a design-by-treatment interaction model.
Ethical approval is not required for systematic review and network meta-analysis. The study will be published in a peer-reviewed journal.
CRD42018096794.
静脉内消融术是治疗大隐静脉反流的新标准程序,包括静脉内激光消融术(EVLA)、射频消融术(RFA)、静脉内蒸汽消融术(EVSA)、机械化学消融术(MOCA)、氰基丙烯酸酯注射和超声引导泡沫硬化疗法(UGFS)。EVLA 和 RFA 在短期结果方面显示出相似的解剖成功率,但长期(≥5 年)结果存在争议。已经发表了来自随机对照试验的额外证据。因此,本研究旨在通过短期和长期随访分层,直接和间接比较所有程序的结果。
将从 2000 年到 2018 年 9 月在 Medline 和 Scopus 上进行搜索,并采用预设的搜索策略。感兴趣的干预措施包括开放手术(即大隐静脉-股静脉或高位结扎(HL)伴剥脱术)和静脉内消融术(即 EVLA、RFA、EVSA、MOCA、氰基丙烯酸酯注射和 UGFS)。主要结局是解剖成功率。两名独立审查员将选择研究、提取数据并评估偏倚风险。意见分歧将由第三方裁决。如果在该比较中有至少三项研究,则直接汇总结果。如果存在异质性,则使用固定效应模型;否则,将应用随机效应模型。将使用 meta 回归分析探索异质性来源,并相应进行亚组分析。将使用 Egger 检验和漏斗图评估发表偏倚。将应用网络荟萃分析间接比较所有干预措施,包括 RFA、EVLA、EVLA 与 HL、UGFS、UGFS 与 HL 和 HL 与剥脱术。将估计并排名最佳干预措施的概率。将使用设计-治疗相互作用模型检查不一致性假设。
系统评价和网络荟萃分析不需要伦理批准。该研究将发表在同行评议的期刊上。
PROSPERO 注册号:CRD42018096794。