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一项双中心盲法随机对照研究,比较Lichtenstein修补片、Perfix补片和ProLoop补片在原发性腹股沟疝修补中的效果。

A two-centre blinded randomised control study comparing the Lichtenstein patch, Perfix plug and ProLoop plug in the repair of primary inguinal hernia.

作者信息

Sanders D L, Samarakoon D H, Ganshirt S W, Porter C S, Kingsnorth A N

机构信息

Department of Surgery, Derriford Hospital, Plymouth PL6 8DH, UK.

出版信息

Hernia. 2009 Oct;13(5):499-503. doi: 10.1007/s10029-009-0540-z. Epub 2009 Jul 31.

Abstract

INTRODUCTION

Mesh plug is an established and effective method for repair of inguinal hernia. The ProLoop plug (Atrium) is a recently developed mesh plug with a novel configuration, which may offer advantages over the standard Prefix plug (Bard) or the Lichtenstein repair. This two-centre double-blinded randomised control trial assessed the short- and medium-term outcomes, comparing the above three methods.

PATIENTS AND METHODS

Consecutive patients over the age of 18 years with primary unilateral inguinal hernia were randomised to receive a Lichtenstein tension free mesh repair (LTFM), Perfix plug (Bard) (PF) or ProLoop plug (Atrium) (PL) repair. Follow-up was at 2 weeks, 6 months and 12 months. Endpoints were operative time, hospital stay, bodily pain scores, return to daily activity and complications.

RESULTS

A total of 295 consecutive patients were recruited to the study. Ninety-three patients were randomised to receive PL plug repairs, 101 PF plug repairs and 101 LTFM repairs. There was no significant difference among the three groups in terms of age, sex or BMI. There was no significant difference among the groups in terms of operative time (PL vs PF P = 0.92; PL vs LTFM P = 0.52), hospital stay (PL vs PF P = 0.74; PL vs LTFM P = 0.44), bodily pain scores (at 12 months PL vs PF P = 0.84, PL vs LTFM P = 0.85, PF vs LTFM P = 0.16), complication rates or return to daily activity.

CONCLUSIONS

The ProLoop plug (Atrium) is a safe and effective method of repairing primary inguinal hernias. Its novel lightweight configuration does not increase the risk of recurrence when compared to thicker mesh plugs, and it may offer benefit in terms of long-term patient comfort. The ProLoop plug (Atrium) represents a new effective alternative to the established mesh repairs.

摘要

引言

网塞是一种成熟且有效的腹股沟疝修补方法。ProLoop网塞(Atrium公司)是一种最近研发的具有新颖结构的网塞,与标准的Prefix网塞(Bard公司)或Lichtenstein修补术相比可能具有优势。这项双中心双盲随机对照试验评估了上述三种方法的短期和中期结果。

患者与方法

连续纳入年龄超过18岁的原发性单侧腹股沟疝患者,随机接受Lichtenstein无张力网片修补术(LTFM)、Perfix网塞(Bard公司)(PF)或ProLoop网塞(Atrium公司)(PL)修补术。随访时间为2周、6个月和12个月。观察指标包括手术时间、住院时间、身体疼痛评分、恢复日常活动情况及并发症。

结果

共连续纳入295例患者进行研究。93例患者随机接受PL网塞修补术,101例接受PF网塞修补术,101例接受LTFM修补术。三组患者在年龄、性别或体重指数方面无显著差异。三组在手术时间(PL与PF比较,P = 0.92;PL与LTFM比较,P = 0.52)、住院时间(PL与PF比较,P = 0.74;PL与LTFM比较,P = 0.44)、身体疼痛评分(12个月时,PL与PF比较,P = 0.84,PL与LTFM比较,P = 0.85,PF与LTFM比较,P = 0.16)、并发症发生率或恢复日常活动情况方面均无显著差异。

结论

ProLoop网塞(Atrium公司)是一种安全有效的原发性腹股沟疝修补方法。与较厚的网塞相比,其新颖的轻质结构不会增加复发风险,且在长期患者舒适度方面可能有益。ProLoop网塞(Atrium公司)是现有网片修补术的一种新的有效替代方法。

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