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一项比较普理灵(Prolene)和 VyproII 补片用于双侧内镜下腹膜外疝修补术(TEP)的随机多中心试验的早期结果。

Early results of a randomized multicenter trial comparing Prolene and VyproII mesh in bilateral endoscopic extraperitoneal hernioplasty (TEP).

作者信息

Bringman S, Wollert S, Osterberg J, Heikkinen T

机构信息

Center for Surgical Sciences, Karolinska Institutet, Sodertalje Hospital, SE-15286, Sodertalje, Sweden.

出版信息

Surg Endosc. 2005 Apr;19(4):536-40. doi: 10.1007/s00464-004-9100-x. Epub 2005 Mar 11.

Abstract

BACKGROUND

The use of mesh in inguinal hernia surgery has become increasingly popular despite the potentially harmful effects that foreign material may exert on human tissue. The purpose of this study was to compare the use of a lightweight mesh vs a standard hernia mesh in bilateral endoscopic hernioplasty.

METHODS

This single-blinded multicenter trial, 140 men with bilateral inguinal hernias were randomized to undergo totally extraperitoneal endoscopic hernioplasty (TEP) with either Prolene or VyproII. The randomization and all data management were done via the Internet.

RESULTS

A total of 139 patients were operated on as allocated. The follow-up was complete in 94% of the patients. The median (range) operating times were 85 min (45-140) and 73 min (35-165) for the Prolene and VyproII groups, respectively. (p = 0.01). The difference was due to uneven distribution of the allocated patients to study groups among individual surgeons. The time to return to work was similar (11 vs 9 days, p = 0.08). The time to return to normal daily activities was 19 days (1-133) in the Prolene group and 12.5 days (0-237) in the VyproII group (p = 0.06). There were no significant differences between the groups in their scores on the Visual Analogue Scale or SF-36 Health Scores during the 8-week follow-up.

CONCLUSIONS

The use of Prolene and VyproII meshes in bilateral endoscopic repair of inguinal hernia seems to result in similar short-term outcome and quality of life. However, there was a tendency toward faster return to normal activity among VyproII patients.

摘要

背景

尽管外来材料可能对人体组织产生潜在有害影响,但补片在腹股沟疝手术中的应用越来越普遍。本研究的目的是比较轻质补片与标准疝补片在双侧内镜疝修补术中的应用。

方法

在这项单盲多中心试验中,140例双侧腹股沟疝男性患者被随机分为接受使用普理灵或VyproII进行完全腹膜外内镜疝修补术(TEP)。随机分组和所有数据管理均通过互联网进行。

结果

共有139例患者按分配方案接受手术。94%的患者完成了随访。普理灵组和VyproII组的中位(范围)手术时间分别为85分钟(45 - 140分钟)和73分钟(35 - 165分钟)。(p = 0.01)。差异是由于各外科医生分配到研究组的患者分布不均。恢复工作的时间相似(11天对9天,p = 0.08)。普理灵组恢复正常日常活动的时间为19天(1 - 133天),VyproII组为12.5天(0 - 237天)(p = 0.06)。在8周的随访期间,两组在视觉模拟评分或SF - 36健康评分上没有显著差异。

结论

在双侧内镜腹股沟疝修补术中使用普理灵和VyproII补片似乎能产生相似的短期结果和生活质量。然而,VyproII组患者恢复正常活动的趋势更快。

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