Marsman M S, Wetterslev J, Keus F, van Aalst D, van Rooij F G, Heyligers J M M, Moll F L, Jahrome A Kh, Vriens P W H E, Koning G G
Department of Vascular Surgery, Rijnstate Hospital, Arnhem, the Netherlands.
Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.
Int J Surg Protoc. 2020 Jan 17;19:1-7. doi: 10.1016/j.isjp.2019.12.002. eCollection 2020.
Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of plexus anesthesia or general anesthesia in traditional carotid endarterectomy is, to date, not unequivocally proven to be superior to one other. A systematic review is needed for evaluation of benefits and harms to determine which technique, plexus anesthesia or general anesthesia is more effective for traditional carotid endarterectomy in patients with symptomatic carotid stenosis.
The review will be conducted according to this protocol following the recommendations of the 'Cochrane Handbook for Systematic Reviews' and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomized Clinical Trials comparing plexus anesthesia versus general anesthesia in traditional carotid endarterectomy will be included. Primary outcomes will be postoperative death and/ or stroke (<30 days) and serious adverse events. Secondary outcomes will be non-serious adverse events.We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. We will use Trial Sequential Analysis to assist the evaluation of imprecision in Grading of Recommendations Assessment, Development and Evaluation. However, if pooled point-estimates of all trials are similar to pooled point-estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the Trial Sequential Analysis adjusted confidence interval precision of the estimate achieved in all trials as the result of our meta-analyses.
The proposed systematic review will collect and analyze secondary data from already performed studies therefore ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.
传统颈动脉内膜切除术被认为是预防有症状颈动脉狭窄患者发生新的中风的标准技术。迄今为止，在传统颈动脉内膜切除术中使用神经丛麻醉或全身麻醉，尚未明确证明哪一种优于另一种。需要进行系统评价以评估其益处和危害，以确定神经丛麻醉或全身麻醉这两种技术中哪一种对有症状颈动脉狭窄患者进行传统颈动脉内膜切除术更有效。
本评价将按照本方案，遵循《Cochrane系统评价手册》的建议进行，并根据系统评价和Meta分析的首选报告项目进行报告。将纳入比较传统颈动脉内膜切除术中神经丛麻醉与全身麻醉的随机临床试验。主要结局将是术后死亡和/或中风（<30天）以及严重不良事件。次要结局将是非严重不良事件。我们将主要基于对总体偏倚风险较低的试验进行Meta分析得出结论。我们将使用试验序贯分析来辅助评估推荐分级评估、制定与评价中的不精确性。然而，如果所有试验的合并点估计与总体偏倚风险较低的试验的合并点估计相似，并且总体偏倚风险较高的试验与总体偏倚风险较低的试验的估计之间缺乏统计学显著交互作用，我们将把所有试验中获得的估计的试验序贯分析调整置信区间精度视为我们Meta分析的结果。
拟进行的系统评价将收集和分析已开展研究的二手数据，因此无需伦理批准。系统评价的结果将通过在同行评审期刊上发表进行传播，并提交在相关会议上展示。
