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内镜腹股沟疝修补术中的网片固定:基于随机临床试验的系统评价对方法学的评估。

Mesh fixation in endoscopic inguinal hernia repair: evaluation of methodology based on a systematic review of randomised clinical trials.

机构信息

Department of General Surgery, Torsby Hospital, Värmland County Council, Box 502, 68529, Torsby, Sweden.

Department of Clinical Sciences, Intervention and Technology (CLINTEC), Karolinska Institutet, and Center for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden.

出版信息

Surg Endosc. 2017 Nov;31(11):4370-4381. doi: 10.1007/s00464-017-5509-x. Epub 2017 Apr 14.

DOI:10.1007/s00464-017-5509-x
PMID:28411342
Abstract

BACKGROUND

The issue of mesh fixation in endoscopic inguinal hernia repair is frequently debated and still no conclusive data exist on differences between methods regarding long-term outcome and postoperative complications. The quantity of trials and the simultaneous lack of high-quality evidence raise the question how future trials should be planned.

METHODS

PubMed, EMBASE and the Cochrane Library were searched, using the filters "randomised clinical trials" and "humans". Trials that compared one method of mesh fixation with another fixation method or with non-fixation in endoscopic inguinal hernia repair were eligible. To be included, the trial was required to have assessed at least one of the following primary outcome parameters: recurrence; surgical site infection; chronic pain; or quality-of-life.

RESULTS

Fourteen trials assessing 2161 patients and 2562 hernia repairs were included. Only two trials were rated as low risk for bias. Eight trials evaluated recurrence or surgical site infection; none of these could show significant differences between methods of fixation. Two of 11 trials assessing chronic pain described significant differences between methods of fixation. One of two trials evaluating quality-of-life showed significant differences between fixation methods in certain functions.

CONCLUSION

High-quality evidence for differences between the assessed mesh fixation techniques is still lacking. From a socioeconomic and ethical point of view, it is necessary that future trials will be properly designed. As small- and medium-sized single-centre trials have proven unable to find answers, register studies or multi-centre studies with an evident focus on methodology and study design are needed in order to answer questions about mesh fixation in inguinal hernia repair.

摘要

背景

内镜腹股沟疝修补术中的网片固定问题经常引起争议,关于不同方法在长期结果和术后并发症方面的差异,仍然没有确凿的数据。试验的数量和同时缺乏高质量的证据提出了一个问题,即未来的试验应该如何计划。

方法

使用“随机临床试验”和“人类”过滤器,在 PubMed、EMBASE 和 Cochrane Library 中进行了搜索。纳入比较一种网片固定方法与另一种固定方法或内镜腹股沟疝修补中非固定方法的试验。为了纳入,试验必须评估至少以下一个主要结局参数之一:复发;手术部位感染;慢性疼痛;或生活质量。

结果

纳入了 14 项评估 2161 例患者和 2562 例疝修补术的试验。只有两项试验被评为低偏倚风险。八项试验评估了复发或手术部位感染;这些试验均未能显示固定方法之间的显著差异。在评估慢性疼痛的 11 项试验中,有两项描述了固定方法之间的显著差异。在评估生活质量的两项试验中,有一项显示了固定方法在某些功能方面的显著差异。

结论

对于评估的网片固定技术之间的差异,仍然缺乏高质量的证据。从社会经济和伦理的角度来看,未来的试验必须得到妥善设计。由于小样本和中等规模的单中心试验未能找到答案,因此需要进行登记研究或多中心研究,这些研究明显侧重于方法学和研究设计,以回答关于腹股沟疝修补术中网片固定的问题。

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