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缝线固定与自固定网片修补开放型腹股沟疝:系统评价、荟萃分析和试验序贯分析。

Suture fixation versus self-gripping mesh for open inguinal hernia repair: a systematic review with meta-analysis and trial sequential analysis.

机构信息

Department of Colorectal Surgery, Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital, Barrack Road, Exeter, EX2 5DW, UK.

Department of General Surgery, Sandwell and West, Birmingham Hospitals NHS Trust, Birmingham, UK.

出版信息

Surg Endosc. 2021 Jun;35(6):2480-2492. doi: 10.1007/s00464-020-07658-6. Epub 2020 May 22.

Abstract

INTRODUCTION

Morbidity following open inguinal hernia repair is mainly related to chronic pain. ProGrip™ is a self-gripping mesh which aims to reduce rates of chronic pain. The aim of this study is to perform an update meta-analysis to consolidate the non-superiority hypothesis in terms of postoperative pain and recurrence and perform a trial sequential analysis.

METHODS

Systematic review of randomised controlled trials performed according to PRISMA guidelines. Pooled odds ratios with 95% confidence intervals (CI) were calculated using the Mantel-Haenszel (M-H) method. The primary outcome measure was postoperative pain and secondary outcomes were recurrence, operative time, wound complications, length of stay, re-operation rate, and cost. Trial sequential analysis was performed.

RESULTS

There were 14 studies included in the quantitative analysis with 3180 patients randomised to self-gripping mesh (1585) or standard mesh (1595). At all follow-up time points, there was no significant difference in the rates of chronic pain between the self-gripping and standard mesh (risk ratio, RR 1.10, 95% confidence interval, CI 0.83-1.46). There were no significant differences in recurrence rates (RR 1.13, CI 0.84-2.04). The mean operating time was significantly shorted in the ProGrip™ mesh group (MD - 7.32 min, CI - 10.21 to - 4.44). Trial sequential analysis suggests findings are conclusive.

CONCLUSION

This meta-analysis has confirmed no benefit of a ProGrip™ mesh when compared to a standard sutured mesh for open inguinal hernia repair in terms of chronic pain or recurrence. No further trials are required to address this clinical question.

摘要

简介

开放式腹股沟疝修补术后的发病率主要与慢性疼痛有关。ProGrip™是一种自固定网片,旨在降低慢性疼痛的发生率。本研究旨在进行更新的荟萃分析,以巩固术后疼痛和复发方面的非优越性假设,并进行试验序贯分析。

方法

根据 PRISMA 指南进行系统的随机对照试验综述。使用 Mantel-Haenszel(M-H)方法计算合并的优势比和 95%置信区间(CI)。主要观察指标是术后疼痛,次要观察指标是复发、手术时间、伤口并发症、住院时间、再次手术率和成本。进行了试验序贯分析。

结果

共有 14 项研究纳入定量分析,3180 例患者随机分为自固定网片(1585 例)或标准网片(1595 例)。在所有随访时间点,自固定网片和标准网片的慢性疼痛发生率均无显著差异(风险比,RR 1.10,95%置信区间,CI 0.83-1.46)。复发率无显著差异(RR 1.13,CI 0.84-2.04)。ProGrip™网片组的平均手术时间明显缩短(MD - 7.32 分钟,CI - 10.21 至 - 4.44)。试验序贯分析表明结果具有结论性。

结论

本荟萃分析证实,与标准缝合网片相比,ProGrip™网片在开放式腹股沟疝修补术中,在慢性疼痛或复发方面没有优势。不需要进一步的试验来解决这个临床问题。

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