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普理灵疝修补系统、利氏疝修补补片及疝环充填式无张力疝修补术治疗原发性腹股沟疝:一项前瞻性随机对照试验的3年结果。BOOP研究:双层及连接体、平片及疝环充填式平片修补腹股沟疝。

Prolene Hernia System, Lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial. The BOOP study: bi-layer and connector, on-lay, and on-lay with plug for inguinal hernia repair.

作者信息

Dalenbäck J, Andersson C, Anesten B, Björck S, Eklund S, Magnusson O, Rimbäck G, Stenquist B, Wedel N

机构信息

Department of Surgery, Frölunda Specialist Hospital, University of Gothenburg, Västra Frölunda, Box 138, 421 22 Gothenburg, Sweden.

出版信息

Hernia. 2009 Apr;13(2):121-9; discussion 231. doi: 10.1007/s10029-008-0443-4. Epub 2008 Nov 13.

DOI:10.1007/s10029-008-0443-4
PMID:19015933
Abstract

BACKGROUND

Dissection requirements differ between various methods for inguinal hernia repair, which may affect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected following three principally different techniques for primary inguinal hernia repair.

METHODS

A total of 472 men between 30 and 75 years of age with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug (P) or the Prolene Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year and 3 years.

RESULTS

The follow-up rates were 100, 99.8, 98.7 and 95.3%, respectively. The mean operation time was shorter for P (35.5 min, P < 0.001) and PHS (37.4 min, P < 0.02) versus L (40.4 min). More than 85% of the procedures were performed under local anaesthesia. There were no statistically significant differences between the groups concerning early or late complications, return to full functional ability, early pain response, analgesic consumption or the studied late-outcome parameters after 3 years of observation. Seven (1.5%) evenly distributed recurrences were registered.

CONCLUSION

All of the techniques are suitable for operation under local anaesthesia. The PHS and P techniques can be performed with shorter operation times than the L method. Early and late outcomes are, however, comparable, with no significant differences concerning complication rates, return to full functional status and/or pain response.

摘要

背景

腹股沟疝修补的不同方法对解剖的要求各异,这可能会影响手术时间、疼痛反应以及恢复时间。本研究的目的是确定在三种主要不同的原发性腹股沟疝修补技术之后,是否能检测到这些方面的任何差异。

方法

一项前瞻性对照研究纳入了472例年龄在30至75岁之间的原发性腹股沟疝男性患者,并将其随机分为Lichtenstein修补术(L)组、PerFix补片修补术(P)组或普理灵疝修补系统(PHS)组。在术后2周、3个月、1年和3年对所有患者进行检查并收集数据。

结果

随访率分别为100%、99.8%、98.7%和95.3%。与L组(40.4分钟)相比,P组(35.5分钟,P<0.001)和PHS组(37.4分钟,P<0.02)的平均手术时间更短。超过85%的手术在局部麻醉下进行。在早期或晚期并发症、恢复至完全功能能力、早期疼痛反应、镇痛药使用量或观察3年后的晚期结局参数方面,各组之间无统计学显著差异。记录到7例(1.5%)复发,分布均匀。

结论

所有这些技术都适用于局部麻醉下的手术。与L方法相比,PHS和P技术的手术时间更短。然而,早期和晚期结局具有可比性,在并发症发生率、恢复至完全功能状态和/或疼痛反应方面无显著差异。

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