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

BMC Surgery volume 24, Article number: 317 (2024) Cite this article

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.

Peer Review reports

Introduction

Inguinal hernia, as a common surgical condition, has undergone significant evolution in its treatment approach in recent years. The transition from traditional hernia repair surgeries to laparoscopic transabdominal preperitoneal repair (TAPP) has introduced a minimally invasive therapeutic option, improving the overall patient experience [1,2,3,4]. With continuous advancements in medical technology, attention in inguinal hernia treatment has expanded beyond the surgical methods to finer details, such as the fixation technique of mesh. In the management of inguinal hernia, the choice of mesh fixation has been a focal point of discussion in the medical community. Conventionally, robust mesh fixation has been employed during surgery; however, in recent years, the debate over the use of non-fixation techniques has gained attention [5, 6]. At the core of this controversy lies the question of whether a secure fixation of the mesh is necessary during TAPP surgery and whether non-fixation of the mesh could have a significant impact on clinical outcomes, particularly in terms of recurrence [7, 8].

This study employs a meta-analysis approach to comprehensively assess the clinical efficacy of mesh non-fixation and fixation techniques in TAPP inguinal hernia repair. The primary objective is to gain a thorough understanding of the outcomes associated with different surgical approaches. Emphasis is placed not only on comparing postoperative recurrence rates but also on various aspects, including complications, postoperative pain scores, and total costs. Through a comprehensive analysis of these key indicators, we aim to uncover the advantages and disadvantages of mesh fixation methods in TAPP inguinal hernia repair, providing clinicians with more comprehensive information to make informed decisions in surgical management. Additionally, this study utilizes the GRADE evidence grading system for a comprehensive evaluation of the quality of results, striving to deliver high-quality scientific evidence and enhance the credibility of the research. This effort will contribute to a clearer understanding within the medical community of the impact of different mesh fixation techniques on TAPP inguinal hernia repair surgical outcomes, offering more reliable evidence for the future treatment of inguinal hernias.

Materials and methods

We carried out and reported the systematic review in accordance with the guidelines outlined by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols [9]. The registration code assigned to this review is INPLASY202410092.

Inclusion and exclusion criteria

Inclusion criteria

Inclusion Criteria: (1) Study Population: Adults with inguinal hernia, including primary or recurrent, unilateral or bilateral, direct or indirect hernias, aged 18 or older, and of any gender. (2) Intervention: TAPP inguinal hernia repair with mesh non-fixation or fixation, regardless of the type of mesh used. (3) Study Design: Randomized controlled trials conducted in English. (4) Outcome indicators: Seroma occurrence rate, overall complication rate (the combined rate of intraoperative complications, seroma, wound infection, urinary retention, hematoma, testicular problems, wound infections, and local numbness), overall infection event rate (including wound infection rate and mesh infection rate), VAS pain score at 6 months postoperatively, cost, and recurrence rate.

Exclusion criteria

Exclusion Criteria: (1) Non-RCTs; (2) Relevant reviews, meta-analyses, or duplicated publications; (3) Literature with inaccessible full text or unavailable data extraction; (4) Studies involving individuals aged below 18; (5) Surgical procedures involving totally extraperitoneal inguinal hernia.

Search strategy

A computerized search was conducted across multiple databases, including PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov. The search terms employed encompassed key terms such as inguinal hernia, groin hernia, TAPP, Transabdominal Preperitoneal, hernioplasty, mesh fixation, no-fixation, non-fixation, staple, tack, glue, randomized controlled trial, RCT. The search was conducted from the inception of the databases up to January 13, 2024. Additionally, a thorough examination of references in the included studies was performed to identify any relevant literature meeting our inclusion criteria.

Literature selection and data extraction

Two independent researchers conducted literature screening and data extraction, cross-verifying to ensure accuracy. In cases of disagreement, resolution was achieved through discussion or consultation with a third party. During the literature selection process, titles were initially reviewed, leading to the elimination of obviously irrelevant literature. Subsequently, abstracts and full texts were scrutinized to determine eligibility. In instances where clarification was necessary, direct communication via email or phone was initiated with the original authors to obtain crucial information vital to this study, but not clearly stated in the literature. The extracted data encompassed details such as the first author and publication year, sample size, age, mesh fixation method, mesh type, follow-up time, and outcome indicators.

Quality assessment

Two independent researchers conducted a bias risk assessment for the included studies, with cross-verification of the results. The assessment of bias risk utilized the Risk of Bias (RoB) 1 tool, as recommended by the Cochrane Handbook 5.1.0. This tool encompasses seven aspects, including random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessors, completeness of outcome data, selective reporting, and other sources of bias. Each item was judged and categorized as high risk of bias, low risk of bias, or unclear, following the criteria outlined in the Cochrane Handbook [10].

Statistical analysis

Statistical analyses were performed using RevMan 5.3 software. For continuous data, the mean difference (MD) was employed as the effect size statistic, while for binary variables, the relative risk (RR) served as the effect size statistic. All effect sizes were accompanied by their respective 95% confidence intervals (CI). Heterogeneity among the included study results was assessed using the chi-square test and quantified with the I2 statistic. If no statistical heterogeneity was observed among the studies (P ≥ 0.1, I2<50%), a fixed-effects model was employed for the analysis. In the presence of statistical heterogeneity, the sources of heterogeneity were further explored. Following the exclusion of apparent clinical heterogeneity, a random-effects model was used for meta-analysis [11]. The significance level for meta-analysis was set at α = 0.05. Substantial clinical heterogeneity was addressed through subgroup analysis, sensitivity analysis, or descriptive analysis. Publication bias analysis was performed using Begg’s test. For indicators with more than 10 included studies, funnel plots were generated to assess publication bias [12]. A trial sequential analysis of the seroma occurrence rate was performed using TSA 0.9.5.10 Beta software. The required information size (RIS) was set as the sample size, with a Type I error rate of 5% and a power of 80%. The relative risk reduction was set at 20%, and the incidence in the control arm was established at 80% based on the results of the meta-analysis.

Assessment of evidence quality

In accordance with the GRADE criteria, we employed the GRADEprofiler version 3.6 tool to assess the quality of evidence for each outcome indicator. Based on five key aspects: risk of bias, consistency, indirectness, imprecision, and publication bias, we categorized the outcome indicators into four levels: high, moderate, low, and very low quality [13].

Results

Literature search results

Initially, a total of 268 articles were retrieved from various databases, and an additional one article was obtained through manual searching. After reviewing titles and abstracts, 46 duplicate articles were excluded, along with 146 articles unrelated to the research objectives, and 54 articles comprising empirical summaries, meta-analyses, and reviews. The remaining 22 articles underwent full-text screening. Among them, six articles were excluded for utilizing the totally extraperitoneal hernia repair technique, two articles for both groups using the fixed method for the mesh, and five articles for not being RCTs. Following this hierarchical screening process, a final selection of nine articles was included [8, 14,15,16,17,18,19,20,21]. The detailed screening process is illustrated in Fig. 1, and the basic information of the selected articles is summarized in Table 1.

Fig. 1
figure 1

Study selection

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Table 1 Characteristics of the studies included in this meta-analysis
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Results of literature quality assessment

Among the nine RCTs, six studies [15,16,17,18,19,20] explicitly described the randomization methods employed. Allocation concealment was utilized in four studies [14, 16, 17, 20], while blinding of both participants and implementers was implemented in three studies [14, 17, 20]. Two studies [14, 20] employed blinding for outcome assessors. In one study [8], there was incomplete outcome data. None of the studies [8, 14,15,16,17,18,19,20,21] exhibited selective result reporting or other biases. As illustrated in Figs. 2 and 3.

Fig. 2
figure 2

Risk of bias graph for RCTs included in this study

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Fig. 3
figure 3

Summary of the risk of bias analysis for the RCTs included in this study

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Meta analysis results

Seroma occurrence rate

Seven studies [8, 14,15,16,17,18,19] (involving 1,703 patients with inguinal hernia) reported the seroma occurrence rate. The seroma occurrence rate in the non-fixation group was 9/709 (1.26%), while in the fixation group, it was 31/994 (3.11%). No statistical heterogeneity was observed among the studies (P = 0.28, I2 = 22%). Utilizing a fixed-effects model for meta-analysis, the pooled effect size indicated a lower seroma occurrence rate in the non-fixation group compared to the fixation group [RR = 0.43, 95% CI (0.20, 0.89), P = 0.02]. This difference was statistically significant, as illustrated in Fig. 4.

Fig. 4
figure 4

Forest plot of meta-analysis comparing seroma occurrence rate between the two groups

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Overall complication rate

Six studies [8, 14,15,16, 20, 21] (involving 901 patients with inguinal hernia) reported the overall complication rate. The overall complication rate in the non-fixation group was 54/442 (12.2%), while in the fixation group, it was 63/459 (13.7%). No statistical heterogeneity was observed among the studies (P = 0.11, I2 = 44%). Utilizing a fixed-effects model for meta-analysis, the pooled effect size indicated that there was no statistically significant difference between the non-fixation group and the fixation group in terms of the overall complication rate [RR = 0.88, 95% CI (0.62, 1.23), P = 0.45], as illustrated in Fig. 5.

Fig. 5
figure 5

Forest plot of meta-analysis comparing overall complication rate between the two groups

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Overall infection event rate

Seven studies [8, 15,16,17,18,19, 21] (involving 1,712 patients with inguinal hernia) reported the overall infection event rate. The overall infection event rate in the non-fixation group was 6/723 (0.83%), while in the fixation group, it was 7/989 (0.71%). No statistical heterogeneity was observed among the studies (P = 0.62, I2 = 0%). Utilizing a fixed-effects model for meta-analysis, the pooled effect size indicated that the difference in overall infection event rates between the two groups was not statistically significant [RR = 0.96, 95% CI (0.36, 2.56), P = 0.93], as illustrated in Fig. 6.

Fig. 6
figure 6

Forest plot of meta-analysis comparing overall infection event rate between the two groups

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VAS pain score at 6 months postoperatively

Two studies [19, 20] (involving 190 patients with inguinal hernia) reported the VAS pain score at 6 months postoperatively. No statistical heterogeneity was observed among the studies (P = 0.34, I2 = 0%). Utilizing a fixed-effects model for meta-analysis, the pooled effect size indicated that the VAS pain score at 6 months postoperatively in the non-fixation group was lower than in the fixation group [MD=-0.21, 95% CI (-0.29, -0.12), P < 0.00001]. This difference was statistically significant, as illustrated in Fig. 7.

Fig. 7
figure 7

Forest plot of meta-analysis comparing VAS pain score at 6 months postoperatively between the two groups

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Cost

Two studies [19, 21] (involving 176 patients with inguinal hernia) reported the cost. There was statistical heterogeneity among the studies (P = 0.0003, I2 = 92%). Utilizing a random-effects model for meta-analysis, the pooled effect size indicated that the cost in the non-fixation group was lower than in the fixation group [MD=-3.23 thousand yuan, 95% CI (-4.26, -2.19), P < 0.00001]. This difference was statistically significant, as illustrated in Fig. 8.

Fig. 8
figure 8

Forest plot of meta-analysis comparing cost between the two groups

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Recurrence rate

Nine studies [8, 14,15,16,17,18,19,20,21] (involving 1,879 patients with inguinal hernia) reported the recurrence rate. The recurrence rate in the non-fixation group was 4/797 (0.50%), while in the fixation group, it was 8/1,082 (0.74%). No statistical heterogeneity was observed among the studies (P = 0.44, I2 = 0%). Utilizing a fixed-effects model for meta-analysis, the pooled effect size indicated that the difference in recurrence rates between the non-fixation group and the fixation group was not statistically significant [RR = 0.75, 95% CI (0.28, 1.99), P = 0.56], as illustrated in Fig. 9.

Fig. 9
figure 9

Forest plot of meta-analysis comparing recurrence rate between the two groups

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Subgroup analysis

Subgroup analyses were conducted based on the method of mesh fixation for outcome indicators that included more than two studies. These were divided into the invasive mesh fixation group and the non-invasive mesh fixation group. The detailed results of the subgroup analysis are shown in Table 2.

Table 2 The results of the subgroup analysis based on different fixation methods
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Publication bias analysis

The Begg’s test results for Seroma occurrence rate, overall complication rate, overall infection event rate, VAS pain score at 6 months postoperatively, cost, and recurrence rate were P = 0.221, P = 0.452, P = 1.000, P = 1.000, P = 1.000, and P = 1.000, respectively. No publication bias detected.

Results of the TSA

The TSA results indicated that, although the Z-statistic exceeded 1.96 (P < 0.05), the Z-curve did not cross the trial sequential boundary, and the cumulative information size remained below the RIS. Consequently, additional RCTs are necessary to further validate this finding, as illustrated in Fig. 10.

Fig. 10
figure 10

Results of the TSA

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Grade evidence quality grading results

The evidence grade for seroma occurrence rate and VAS pain score at 6 months postoperatively, is moderate, while the evidence grades foroverall complication rate, overall infection event rate, cost, and recurrence rate are low, as illustrated in Table 3.

Table 3 GRADE assessment of outcome measures
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Discussion

In TAPP inguinal hernia repair, the fixation method for the mesh has always been a focal point for surgeons. Traditionally, ithas been considered a standardized surgical procedure. However, with the continuous evolution of medical technology, an increasing number of studies have explored the approach of mesh non-fixation. This has sparked a debate regarding the safety and efficacy of non-fixation compared to fixation in TAPP inguinal hernia repair [7, 8]. In this research context, we conducted a meta-analysis aiming to comprehensively assess the clinical efficacy of both non-fixation and fixation approaches in TAPP inguinal hernia repair, providing more accurate guidance for clinical practice. The evaluated parameters include seroma occurrence rate, overall complication rate, overall infection event rate, VAS pain score at 6 months postoperatively, cost, and recurrence rate. Through this study, our aim is to provide surgeons with more comprehensive and scientifically informed decision support, aiding them in selecting the most suitable mesh management approach during TAPP inguinal hernia repair, whether it be fixation or non-fixation.

In our meta-analysis, we found that in TAPP inguinal hernia repair, the use of non-fixation mesh, compared to fixation mesh is associated with lower seroma occurrence rate, which may be attributed to multiple factors. Firstly, the non-fixation mesh technique may reduce mechanical stimulation to surrounding tissues, thereby lowering the risk of vascular injury and bleeding. The use of non-fixation mesh might promote natural tissue healing, decrease the chance of seroma formation, and maintain the physiological process of normal healing. Non-fixation mesh may also reduce postoperative inflammatory reactions, further slowing down seroma development [22, 23]. However, the TSA results indicated that additional RCTs are required to further validate this finding. The non-fixation mesh approach evidently simplifies surgery, reducing the complexity of instrument use and tissue manipulation, thereby minimizing potential complications. Additionally, non-fixation mesh may decrease additional damage to surrounding tissues, aiding in lowering complications associated with instrument use and tissue manipulation [24,25,26]. However, the results of this meta-analysis indicate that there is no statistically significant difference between the non-fixation group and the fixation group in terms of overall complication rate. These findings may be influenced by factors such as study design, sample size, research quality, individual patient characteristics, and surgical team experience, and further confirmation is required through large-sample, high-quality RCTs. Compared to fixation mesh, non-fixation mesh may result in less tissue tension and discomfort, contributing to alleviating long-term pain. Additionally, the use of non-fixation mesh may reduce manipulation and stimulation of surrounding nerve structures, helping to alleviate neuropathic pain in patients during the months following surgery. Moreover, non-fixation mesh may lead to a milder postoperative inflammatory response, slowing down the progression of pain [24, 27,28,29]. Therefore, the VAS pain score at 6 months postoperatively in the non-fixation group is lower than in the fixation group. However, only two studies reported this outcome, and there is considerable heterogeneity, necessitating further validation through more RCTs in the future. The cost in the non-fixation group is lower than in the fixation group. This is attributed to the reduced need for surgical instruments and materials in the non-fixation group, as there is no requirement for additional fixation materials. This significantly decreases the consumable costs associated with the surgery [21, 26, 29, 30]. The success of inguinal hernia repair is largely contingent on the recurrence rate, and factors contributing to postoperative hernia recurrence are multifaceted, closely tied to mesh size, mesh displacement, contraction, and the type of hernia [15, 31]. In this meta-analysis, the recurrence rate in the non-fixation group was 0.50%, while in the fixation group, it was 0.74%. The absence of a statistically significant difference in recurrence rates between the two groups suggests that the non-fixation group did not increase the hernia recurrence rate and is considered safe. In the studies included in this meta-analysis, we observed that the follow-up times in some studies were relatively short, which may have an impact on the evaluation of recurrence rates. Therefore, we recommend extending follow-up times in future research to comprehensively assess surgical outcomes. Prolonged follow-up times help more accurately capture potential hernia recurrence, provide more reliable data support, and thereby gain a more comprehensive understanding of the long-term effects of non-fixation mesh in TAPP inguinal hernia repair.

This study also has certain limitations: (1) Some included studies had small sample sizes, and most studies lacked clear descriptions of randomization methods, blinding, and allocation concealment. (2) Variability in surgeon expertise, surgical procedures, mesh materials, and fixation techniques among the included studies inevitably influenced the outcome analysis. (3) Inconsistent follow-up durations across studies, with some having relatively short follow-up periods, resulted in limitations when assessing the long-term risk of hernia recurrence. (4) Due to limited data, early postoperative outcomes such as VAS pain scores and rates of chronic pain were not assessed, and subgroup analyses for different fixation methods (e.g., glue fixation, tack fixation) were not conducted. (5) In some studies, self-gripping mesh was used, which inherently possesses fixation properties, making comparisons very difficult. (6) The evidence quality for the majority of outcome indicators assessed by GRADE was rated as low.

In conclusion, the non-fixation of mesh in TAPP inguinal hernia repair is considered safe and does not increase the risk of hernia recurrence postoperatively. However, due to some limitations in this study, comprehensive and reliable validation is still required through future multi-center, high-quality, large-sample, double-blind RCTs.

Data availability

All data generated or analyzed during this study were included in this published article.

Abbreviations

CI:

Confidence Interval

F:

Female

GRADE:

Grading of Recommendations, Assessment, Development, and Evaluation

INPLASY:

International Platform of Registered Systematic Review and Meta-analysis Protocols

M:

Male

m:

Month

MD:

Mean Difference

Na:

Not available

PRISMA:

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

RCT:

Randomized Controlled Trial

RR:

Relative Risk

TAPP:

Transabdominal Preperitoneal

VAS:

Visual Analog Scale

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Acknowledgements

Not applicable.

Funding

No funding was received for this study.

Author information

Author notes

  1. Tao Jiang and Chen Zhang contributed equally to this work.

Authors and Affiliations

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

    Tao Jiang & Deng-Chao Wang

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

    Chen Zhang

  3. Department of Network Engineering, School of Computer Science and Engineering, Sichuan University of Science & Engineering, Zigong, Sichuan, 643000, China

    Xiao-Ling Wang

  4. Department of Orthopedics, People’s Hospital of Pingchang County, Pingchang, Sichuan, 636400, China

    Chen Zhang, Da-Chun Yue & Xiao-Ping Yuan

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  4. Da-Chun Yue
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  5. Xiao-Ping Yuan
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  6. Deng-Chao Wang
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Contributions

Tao Jiang: Conceived and designed the study, collected data, and contributed to the writing of the manuscript. Played a pivotal role in the interpretation of data and the critical revision of the manuscript.Chen Zhang: Assisted with the design of the study, data analysis, and interpretation. Contributed significantly to the writing and critical revision of the article. Handled correspondence and acted as the primary contact for project coordination.Xiao-Ling Wang: Led the data collection efforts, contributed to the design of the study, and assisted in the analysis of the data. Played a key role in revising the manuscript critically for important intellectual content.Da-Chun Yue: Participated in data analysis and interpretation. Contributed to writing sections of the manuscript and critically revising the content for important intellectual perspectives.Xiao-Ping Yuan: Provided critical feedback and helped shape the research, analysis, and manuscript. Contributed to the conception and design of the study.Deng-Chao Wang: Contributed to the conception and design of the study, oversaw the entire project, and ensured the accuracy of the data and analysis. Involved in providing final approval of the version to be published.

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Correspondence to Chen Zhang.

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Jiang, T., Zhang, C., Wang, XL. et al. Meta-analysis of RCTs on the safety of non-fixation of mesh in TAPP inguinal hernia repair: an updated meta-analysis. BMC Surg 24, 317 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12893-024-02628-4

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12893-024-02628-4

Keywords

BMC Surgery

ISSN: 1471-2482

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