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完全腹膜外法与经耻骨肌孔修补术治疗腹股沟疝的比较:一项随机临床试验的系统评价和 meta 分析及试验序贯分析。

The totally extraperitoneal method versus Lichtenstein's technique for inguinal hernia repair: a systematic review with meta-analyses and trial sequential analyses of randomized clinical trials.

机构信息

Department of Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.

出版信息

PLoS One. 2013;8(1):e52599. doi: 10.1371/journal.pone.0052599. Epub 2013 Jan 11.

Abstract

BACKGROUND

Lichtenstein's technique is considered the reference technique for inguinal hernia repair. Recent trials suggest that the totally extraperitoneal (TEP) technique may lead to reduced proportions of chronic pain. A systematic review evaluating the benefits and harms of the TEP compared with Lichtenstein's technique is needed.

METHODOLOGY/PRINCIPAL FINDINGS: The review was performed according to the 'Cochrane Handbook for Systematic Reviews'. Searches were conducted until January 2012. Patients with primary uni- or bilateral inguinal hernias were included. Only trials randomising patients to TEP and Lichtenstein were included. Bias evaluation and trial sequential analysis (TSA) were performed. The error matrix was constructed to minimise the risk of systematic and random errors. Thirteen trials randomized 5404 patients. There was no significant effect of the TEP compared with the Lichtenstein on the number of patients with chronic pain in a random-effects model risk ratio (RR 0.80; 95% confidence interval (CI) 0.61 to 1.04; p = 0.09). There was also no significant effect on number of patients with recurrences in a random-effects model (RR 1.41; 95% CI 0.72 to 2.78; p = 0.32) and the TEP technique may or may not be associated with less severe adverse events (random-effects model RR 0.91; 95% CI 0.73 to 1.12; p = 0.37). TSA showed that the required information size was far from being reached for patient important outcomes.

CONCLUSIONS/SIGNIFICANCE: TEP versus Lichtenstein for inguinal hernia repair has been evaluated by 13 trials with high risk of bias. The review with meta-analyses, TSA and error matrix approach shows no conclusive evidence of a difference between TEP and Lichtenstein on the primary outcomes chronic pain, recurrences, and severe adverse events.

摘要

背景

Lichtenstein 技术被认为是腹股沟疝修补的参考技术。最近的试验表明,完全腹膜外(TEP)技术可能会导致慢性疼痛的比例降低。需要进行系统评价,评估 TEP 与 Lichtenstein 技术相比的益处和危害。

方法/主要发现:该综述按照“Cochrane 系统评价手册”进行。检索截止到 2012 年 1 月。纳入患有原发性单侧或双侧腹股沟疝的患者。仅纳入将患者随机分配至 TEP 和 Lichtenstein 的试验。进行了偏倚评估和试验序贯分析(TSA)。构建误差矩阵以尽量减少系统和随机误差的风险。13 项试验随机分配了 5404 名患者。在随机效应模型中,TEP 与 Lichtenstein 相比,慢性疼痛患者的数量没有显著影响(风险比 0.80;95%置信区间 0.61 至 1.04;p=0.09)。在随机效应模型中,复发患者的数量也没有显著影响(风险比 1.41;95%置信区间 0.72 至 2.78;p=0.32),并且 TEP 技术可能与不太严重的不良事件相关,也可能不相关(随机效应模型风险比 0.91;95%置信区间 0.73 至 1.12;p=0.37)。TSA 显示,对于患者重要结局,所需信息的数量还远远没有达到。

结论/意义:13 项高偏倚风险试验评估了 TEP 与 Lichtenstein 治疗腹股沟疝的效果。这项综述采用荟萃分析、TSA 和误差矩阵方法,没有确凿证据表明 TEP 与 Lichtenstein 在主要结局慢性疼痛、复发和严重不良事件方面存在差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d687/3543416/cbb1e1c37c84/pone.0052599.g001.jpg

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