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一项随机、多中心、前瞻性、观察者和患者盲法研究,旨在评估在切口疝修补术中使用不可吸收聚丙烯网片与部分可吸收网片的效果。

A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair.

机构信息

Department of Surgery, University Medical Centre Mannheim, Mannheim, Germany.

出版信息

Langenbecks Arch Surg. 2012 Dec;397(8):1225-34. doi: 10.1007/s00423-012-1009-6. Epub 2012 Oct 3.

DOI:10.1007/s00423-012-1009-6
PMID:23053458
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3510400/
Abstract

BACKGROUND

The implantation of a polymer mesh is considered as the standard treatment for incisional hernia. It leads to lower recurrence rates compared to suture techniques without mesh implantation; however, there are also some drawbacks to mesh repair. The operation is more complex and peri-operative infectious complications are increased. Yet it is not clear to what extent a mesh implantation influences quality of life or leads to chronic pain or discomfort. The influence of the material, textile structure and size of the mesh remain unclear. The aim of this study was to evaluate if a non-absorbable, large pore-sized, lightweight polypropylene (PP) mesh leads to a better health outcome compared to a partly absorbable mesh.

METHODS/DESIGN: In this randomised, double-blinded study, 80 patients with incisional hernia after a median laparotomy received in sublay technique either a non-absorbable mesh (Optilene® Mesh Elastic) or a partly absorbable mesh (Ultrapro® Mesh). Primary endpoint was the physical health score from the SF-36 questionnaire 21 days post-operatively. Secondary variables were patients' daily activity score, pain score, wound assessment and post-surgical complications until 6 months post-operatively.

RESULTS

SF-36, daily activity and pain scores were similar in both groups after 21 days and 6 months, respectively. No hernia recurrence was observed during the observation period. Post-operative complication rates also showed no difference between the groups.

CONCLUSION

The implantation of a non-absorbable, large pore-sized, lightweight PP mesh for incisional hernia leads to similar patient-related outcome parameters, recurrence and complication rates as a partly absorbable mesh.

摘要

背景

聚合物网片的植入被认为是切口疝的标准治疗方法。与不使用网片植入的缝合技术相比,它可降低复发率;然而,网片修复也有一些缺点。手术更复杂,围手术期感染并发症增加。然而,目前尚不清楚网片植入在多大程度上影响生活质量或导致慢性疼痛或不适。网片的材料、纺织结构和尺寸的影响仍不清楚。本研究旨在评估非吸收性、大孔径、轻量级聚丙烯(PP)网片是否比部分可吸收网片带来更好的健康结果。

方法/设计:在这项随机、双盲研究中,80 例接受过中位剖腹术的切口疝患者在网片下技术中分别接受非吸收性网片(Optilene® Mesh Elastic)或部分可吸收网片(Ultrapro® Mesh)治疗。主要终点是术后 21 天 SF-36 问卷的身体健康评分。次要变量包括患者术后 21 天和 6 个月的日常活动评分、疼痛评分、伤口评估和术后并发症。

结果

术后 21 天和 6 个月,两组的 SF-36、日常活动和疼痛评分相似。在观察期内未观察到疝复发。术后并发症发生率在两组之间也无差异。

结论

对于切口疝,植入非吸收性、大孔径、轻量级 PP 网片与部分可吸收网片相比,患者相关的结果参数、复发率和并发症发生率相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/1626c61aa66d/423_2012_1009_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/dff7315d6cd9/423_2012_1009_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/a758596e8c88/423_2012_1009_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/299caa29712b/423_2012_1009_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/c44247beb068/423_2012_1009_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/5087324c86dc/423_2012_1009_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/1626c61aa66d/423_2012_1009_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/dff7315d6cd9/423_2012_1009_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/a758596e8c88/423_2012_1009_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/299caa29712b/423_2012_1009_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/c44247beb068/423_2012_1009_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/5087324c86dc/423_2012_1009_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5070/3510400/1626c61aa66d/423_2012_1009_Fig6_HTML.jpg

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