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单中心随机对照试验的中期分析:有或无合成补片固定的切口疝修补术

Interim analysis of single - centre randomised controlled trial on incisional hernia repair with vs without synthetic mesh fixation.

作者信息

Varanauskas Gintaras, Brimas Gintautas, Dulskas Audrius

机构信息

Faculty of Medicine, Vilnius University, Vilnius, Lithuania.

Centre of General Surgery, Republican Vilnius University Hospital, Vilnius, Lithuania.

出版信息

Langenbecks Arch Surg. 2025 Apr 21;410(1):134. doi: 10.1007/s00423-025-03707-7.

DOI:10.1007/s00423-025-03707-7
PMID:40257601
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12011918/
Abstract

INTRODUCTION

In a prospective randomised trial, we aimed to compare incisional hernia repair with mesh fixation versus incisional hernia repair without mesh fixation.

METHODS

The study was performed from June 2018 to August 2024 at a single centre in Vilnius, Lithuania. Fifty-seven patients with incisional abdominal wall hernia were randomly included into two groups: group one-"sublay" hernia repair with mesh fixation and the second - without mesh fixation. The duration of surgery, hospital stay, pain levels, quality of life and rate of complications were compared.

RESULTS

Of the 38 women and 19 men who were included in the study, 30 were with mesh fixation and 27 without mesh fixation. The median patient's body mass index was 31.57 ± 5.96 (19.5-49.6). The most common hernia width was W2 according to the European Hernia Society (EHS) classification. A significant difference between the groups was found in duration of surgery - 108.00 ± 47.35 (40-235) minutes in the mesh fixation group vs. 75.74 ± 30.25 (35-150)-without the mesh fixation group (p < 0.05). A higher pain level was observed on the 10th postoperative day-3.03 ± 2.54 in the mesh fixation group versus 1.67 ± 2.22 in the group without the mesh fixation group (p < 0.05). A statistically significant difference was also observed in seroma rate after 6 months (16.6% versus 0%, p < 0.05). There have been no hernia recurrences in either group so far.

CONCLUSIONS

No mesh fixation on "sublay" hernia repair does not worsen the patient's postoperative condition. It does not increase postoperative pain, worsen the quality of life, or increase the risk of postoperative complications. On the 10th postoperative day, the non-fixed mesh group had less postoperative pain, however, later the pain was equal. A lower number of seromas was also observed in this group after 6 months. However, the operative time in the group without mesh fixation was significantly shorter.

摘要

引言

在一项前瞻性随机试验中,我们旨在比较使用补片固定的切口疝修补术与不使用补片固定的切口疝修补术。

方法

该研究于2018年6月至2024年8月在立陶宛维尔纽斯的一个中心进行。57例腹壁切口疝患者被随机分为两组:第一组为使用补片固定的“腹膜前间隙”疝修补术,第二组为不使用补片固定的疝修补术。比较手术时间、住院时间、疼痛程度、生活质量和并发症发生率。

结果

纳入研究的38名女性和19名男性中,30例使用补片固定,27例未使用补片固定。患者的中位体重指数为31.57±5.96(19.5 - 49.6)。根据欧洲疝学会(EHS)分类,最常见的疝宽度为W2。两组在手术时间上存在显著差异——补片固定组为108.00±47.35(40 - 235)分钟,而未使用补片固定组为75.74±30.25(35 - 150)分钟(p<0.05)。术后第10天观察到补片固定组的疼痛程度更高——为3.03±2.54,而未使用补片固定组为1.67±2.22(p<0.05)。6个月后血清肿发生率也存在统计学显著差异(16.6%对0%,p<0.05)。到目前为止,两组均未出现疝复发。

结论

“腹膜前间隙”疝修补术中不使用补片固定不会使患者术后情况恶化。它不会增加术后疼痛、恶化生活质量或增加术后并发症风险。术后第10天,未固定补片组的术后疼痛较轻,但之后疼痛程度相当。该组6个月后血清肿数量也较少。然而,未使用补片固定组的手术时间明显更短。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/f3445a65634f/423_2025_3707_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/61cd171b0131/423_2025_3707_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/262f93e8d03b/423_2025_3707_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/4a7343c494c4/423_2025_3707_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/f3445a65634f/423_2025_3707_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/61cd171b0131/423_2025_3707_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/262f93e8d03b/423_2025_3707_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/4a7343c494c4/423_2025_3707_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c8/12011918/f3445a65634f/423_2025_3707_Fig4_HTML.jpg

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本文引用的文献

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