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经 RCT 分析的 TAPP 腹股沟疝修补术中不固定补片的安全性:一项更新的荟萃分析。

Meta-analysis of RCTs on the safety of non-fixation of mesh in TAPP inguinal hernia repair: an updated meta-analysis.

机构信息

Department of General Surgery, Zigong Fourth People's Hospital, Zigong, Sichuan, 643000, China.

Department of Trauma Center, Zigong Fourth People's Hospital, Zigong, Sichuan, 643000, China.

出版信息

BMC Surg. 2024 Oct 17;24(1):317. doi: 10.1186/s12893-024-02628-4.

Abstract

OBJECTIVE

This meta-analysis aims to compare the clinical efficacy of mesh non-fixation and fixation in laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair, systematically evaluating the application value of the mesh non-fixation technique in clinical settings.

METHODS

A computerized search of PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov databases was conducted to identify randomized controlled trials (RCTs) comparing mesh non-fixation and fixation in TAPP inguinal hernia repair. Meta-analysis was performed using RevMan 5.3 software, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence grading system was employed for outcome quality assessment. Publication bias analysis was performed using Begg's test. A trial sequential analysis (TSA) was performed using TSA 0.9.5.10 Beta software.

RESULTS

A total of nine RCTs involving 1,879 inguinal hernia patients were included. Meta-analysis results demonstrated that, compared to the fixation group, the non-fixation group exhibited significantly lower seroma occurrence rate [RR = 0.43, 95% CI (0.20, 0.89), P = 0.02, heterogeneity P = 0.28, I²=22%], Visual Analog Scale (VAS) pain score at 6 months postoperatively [MD=-0.21, 95% CI (-0.29, -0.12), P < 0.00001, heterogeneity P = 0.34, I²=0%], and cost [MD=-3.23 thousand yuan, 95% CI (-4.26, -2.19), P < 0.00001, heterogeneity P = 0.0003, I²=92%]. There were no statistically significant differences in overall complication rate [RR = 0.88, 95% CI (0.62, 1.23), P = 0.45, heterogeneity P = 0.11, I²=44%], overall infection event rate [RR = 0.96, 95% CI (0.36, 2.56), P = 0.93, heterogeneity P = 0.62, I²=0%] and recurrence rate [RR = 0.75, 95% CI (0.28, 1.99), P = 0.56, heterogeneity P = 0.44, I²=0%] between the two groups. The results of the TSA indicated that the observed lower seroma occurrence rate in the non-fixation group compared to the fixation group requires further validation through the inclusion of additional RCTs.

CONCLUSION

Mesh non-fixation in TAPP inguinal hernia repair is deemed safe and does not elevate the risk of hernia recurrence. However, given certain limitations in this study, future comprehensive and reliable validation will require further multicenter, high-quality, large-sample double-blind RCTs.

摘要

目的

本荟萃分析旨在比较腹腔镜经腹腹膜前(TAPP)腹股沟疝修补术中网片非固定与固定的临床疗效,系统评估网片非固定技术在临床应用中的价值。

方法

计算机检索 PubMed、Embase、Cochrane 图书馆、Web of Science 和 ClinicalTrials.gov 数据库,查找 TAPP 腹股沟疝修补术中网片非固定与固定的随机对照试验(RCT)。使用 RevMan 5.3 软件进行荟萃分析,并采用推荐评估、制定与评价(GRADE)证据分级系统对结局质量进行评估。使用贝叶斯检验进行发表偏倚分析。使用 TSA 0.9.5.10 Beta 软件进行试验序贯分析(TSA)。

结果

共纳入 9 项 RCT,涉及 1879 例腹股沟疝患者。荟萃分析结果显示,与固定组相比,非固定组的血清肿发生率显著降低[RR=0.43,95%CI(0.20,0.89),P=0.02,异质性 P=0.28,I²=22%],术后 6 个月视觉模拟评分(VAS)疼痛评分[MD=-0.21,95%CI(-0.29,-0.12),P<0.00001,异质性 P=0.34,I²=0%]和成本[MD=-3.23 千元,95%CI(-4.26,-2.19),P<0.00001,异质性 P=0.0003,I²=92%]更低。两组的总并发症发生率[RR=0.88,95%CI(0.62,1.23),P=0.45,异质性 P=0.11,I²=44%]、总感染发生率[RR=0.96,95%CI(0.36,2.56),P=0.93,异质性 P=0.62,I²=0%]和复发率[RR=0.75,95%CI(0.28,1.99),P=0.56,异质性 P=0.44,I²=0%]差异均无统计学意义。TSA 结果表明,非固定组的血清肿发生率低于固定组,但需要进一步纳入更多 RCT 加以验证。

结论

TAPP 腹股沟疝修补术中网片非固定是安全的,不会增加疝复发的风险。但鉴于本研究存在一定局限性,未来还需要进行更加全面和可靠的验证,需要进一步开展多中心、高质量、大样本、双盲 RCT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/02b1/11484319/0244be42836b/12893_2024_2628_Fig1_HTML.jpg

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