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基于 1000 个植入后补片的分析对疝修补用外科补片进行改良分类。

Modified classification of surgical meshes for hernia repair based on the analyses of 1,000 explanted meshes.

机构信息

Surgical Department, University Hospital of the RWTH Aachen, Pauwelsstraße 30, 52074, Aachen, Germany.

出版信息

Hernia. 2012 Jun;16(3):251-8. doi: 10.1007/s10029-012-0913-6. Epub 2012 May 5.

Abstract

BACKGROUND

It is an undisputable fact that meshes have become standard for repair of abdominal wall hernias. Whereas in the late eighties there were only a couple of different devices available, today we have to choose among some hundreds, with lots of minor and major variations in polymer and structure. As most of the minor variations may not lead to significant change in clinical outcome and may be regarded as less relevant, we should focus on major differences. Eventually, this is used to structure the world of mesh by forming groups of textile devices with distinct biological response. Many experimental and some clinical studies have underlined the outstanding importance of porosity, which fortunately, in contrast to other biomechanical quanlities, is widely unaffected by the anisotropy of meshes.

METHODS

In accordance with the major manufacturers of meshes, a classification of meshes was derived from a huge pool of textile data based briefly on the following: (1) large pores, (2) small pores, (3) additional features, (4) no pores, (5) 3D structure and (6) biological origin. At 1,000 explanted meshes the value of this classification was evaluated by group-specific assessment of inflammatory and connective tissue reaction.

RESULTS

Application of this classification to common products has proved feasable, and each of the six different classes includes devices that in clinical trials failed to show relevant differences in patients' outcome when comparing products within the same group. Furthermore, histological analysis confirmed significant differences in tissue reactions between but not within the different classes.

CONCLUSIONS

Classifying implants according to a similar response enables grouping patients into comparable cohorts despite implantation of different devices. Furthermore, it enables the examination of the impact of mesh classes for the various indications even from heterogenous data of registries. Finally and not the least, any grouping supports the surgeon to select the best device to meet the individual need and to tailor patients therapy.

摘要

背景

毫无疑问,网片已成为腹壁疝修补的标准方法。虽然在 80 年代后期只有几种不同的设备可用,但今天我们必须在数百种设备中进行选择,这些设备在聚合物和结构上存在许多细微和重大的差异。由于大多数细微差异可能不会导致临床结果的显著变化,可以认为不太相关,因此我们应该关注主要差异。最终,这用于通过形成具有明显生物反应的纺织设备组来构建网片的世界。许多实验和一些临床研究强调了多孔性的突出重要性,幸运的是,与其他生物力学质量相比,多孔性广泛不受网片各向异性的影响。

方法

根据网片的主要制造商,根据以下几点从大量纺织数据中得出了网片的分类:(1)大孔,(2)小孔,(3)附加特征,(4)无孔,(5)3D 结构和(6)生物来源。在 1000 个植入的网片中,通过特定于组的炎症和结缔组织反应评估来评估这种分类的价值。

结果

将这种分类应用于常见产品是可行的,并且在临床试验中,在同一组内比较产品时,六个不同类别中的每一个类别都包括在患者结果中没有显示出相关差异的设备。此外,组织学分析证实了不同类别之间的组织反应存在显著差异,但在同一类别内没有差异。

结论

根据相似的反应对植入物进行分类,可以将患者分组到可比队列中,尽管植入了不同的设备。此外,即使从登记处的异质数据中,它也可以检查网片类别对各种适应证的影响。最后但并非最不重要的一点是,任何分组都支持外科医生选择满足个人需求并为患者定制治疗的最佳设备。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d83/3360857/facac96c83a5/10029_2012_913_Fig1_HTML.jpg

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