The American Journal of Surgery (2014) 207, 773-781
Review
Self-gripping mesh versus sutured mesh in open inguinal hernia repair: system review and meta-analysis Zhixue Fang, M.D., Jianping Zhou, M.D., Feng Ren, M.D.*, Dongcai Liu, M.D. Department of Geriatrics Surgery, the Second Xiangya Hospital, Central South University, No. 139, Middle Renmin Road, Changsha, Hunan 410011, P.R. China
KEYWORDS: Self-gripping mesh; Sutured mesh; Open inguinal hernia repair
Abstract BACKGROUND: The objective of this article was to compare the outcomes of self-gripping mesh (GM) with sutured mesh (SM) in open inguinal hernia repair. METHODS: A systematic review and meta-analysis were taken to compare the outcomes of GM and SM in open inguinal hernia repair. RESULTS: A total of 1,353 patients in 6 randomized controlled trials and 2 observational studies were reviewed (666 patients in GM group; 687 patients in SM group). The 2 groups did not significantly differ in chronic groin pain (P 5 .23) or recurrence (P 5 .59). The operating time was significantly shorter in GM group (P , .00001). There was no significant difference in infection (P 5 .18), seromas (P 5 .35), hematomas (P 5 .87), or discomfort (P 5 .58) between the 2 groups. CONCLUSIONS: The data showed that GM was equivalent to SM in open inguinal hernia repair. However, this new mesh still needs to be confirmed in large, multi-center, well-designed randomized controlled trials. Ó 2014 Elsevier Inc. All rights reserved.
Since Lichtenstein introduced the method of tension-free hernia repair by using modern mesh prosthetics in 1986, it has become a most often used technique worldwide and dramatically reduced the incidence of hernia recurrence.1–3 However, chronic groin pain has become one of the important complications and significant impact on the patient’s quality of life.4 Some patients complain of groin pain months or even years after surgery. The incidence of this pain varies among studies, ranging between 11% and 54%, with almost 30% of these patients reporting a significant impact on daily activities.5–8 The reason is still The authors declare no conflicts of interest. * Corresponding author. Tel.: 186-073185295167; fax: 186073185295380. E-mail address: [email protected] Manuscript received July 10, 2013; revised manuscript July 29, 2013 0002-9610/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2013.08.045
unclear, but the use of sutures during surgery which may injure minor or major nerves has been viewed as one of the potential pathogenetic factors involved in chronic pain.9–11 For this reason, alternative fixation methods with a low degree of tissue trauma were developed and several fixation procedures have been investigated, such as absorbable sutures, tacks, and glue.12–14 In 2006, Chastan15 introduced a new sutureless mesh fixation method by using a novel self-gripping mesh (GM; Parietene ProGrip, Covidien, North Haven, CT). This GM is made of a lowweight isoelastic large-pore monofilament polypropylene knitted fabric that incorporates resorbable polylactic acid micro hooks, which provide tissue-gripping properties at application of the mesh and during the following 12 months.16 In recent years, a number of trials have been carried out to compare this new mesh fixation method
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Figure 1
PRISMA flow chart for the selection.
with conventional sutured mesh (SM) fixation method (Classic Lichtenstein) in open inguinal hernia repair. Some trials have shown the benefits of GM, including fewer incidences of infection, less early postoperative pain, and less chronic groin pain.17–19 However, others have not
Table 1
confirmed this observation.20–23 There is still a controversy about whether GM is more advanced than SM in open inguinal hernia repair. The object of this article is to compare the outcomes of GM with SM in open inguinal hernia repair with respect to
Basic information of the trials Age (y)
Men/Women
Type of mesh
Trial
Year
Country
GM
SM
GM
SM
Follow-up period (months)
GM
SM
Bruna Esteban et al Jorgensen et al Kapischke et al Kingsnorth et al Pierides et al Anadol et al Quyn et al
2010
Spain
60 (26–80)
49 (19–83)
41/4
38/7
3–36
ProGrip
PP
2012 2010 2012 2013 2009 2012
Denmark Germany UK Finland Turkey UK
56.8 (40.2–65.1) 64.2 6 12.97 60 (31–74) 55 (20–79) 56 (21–85) 63.8 6 7.76
59.9 (43.8–67.5) 66.8 6 11.66 60 (31–74) 53 (19–80) 56 (30–82) 61.9 6 15.74
Men only 22/2 23/3 Men only 188/10 182/14 Men only 58/5 62/7
12 6 3 12 25–46 12
ProGrip ProGrip ProGrip ProGrip ProGrip ProGrip
PP PP PP PP PP PP
GM 5 self-gripping mesh; ProGrip 5 Parietene ProGrip; PP 5 polypropylene; SM 5 sutured mesh.
Z. Fang et al. Table 2
Self-gripping mesh versus sutured mesh
775
Variables used for meta-analysis
Trial
Patients
Bruna Esteban et al GM SM Jorgensen et al GM SM Kapischke et al GM SM Kingsnorth et al GM SM Pierides et al GM SM Anadol et al* GM SM Quyn et al* GM SM
45 45 163 171
Operation time (min) 17.8 (11.8–20.7) 20.2 (12.7–20.8) 29 (22–35) 30 (25–39)
Infection
Hematomas
Seromas
Recurrence
Chronic pain
Discomfort
0 0
1 1
1 1
0 0
NG
NG
9 12
12† 18†
12† 18†
2 2
16 13
0 0
NG
0 3
NG
24 26
51 63.2 (P 5 .0078)
1 0
4 3
NG
149 153
32.4 39.1 (P , .001)
3 11
7 2
1 1
0 0
8 9
16 18
198 196
36 45 (P , .001)
1 3
1 1
NG
0 1
16 13
49 42
24 27
23.7 6 5.57 36.9 6 11.36
1 0
NG
NG
1 1
6 7
NG
63 69
NG
2 1
NG
NG
0 1
5 15
NG
GM 5 self-gripping mesh; NG 5 not given; SM 5 sutured mesh. *Prospective study. † Data were gained from the authors of a trial via E-mail.
early and chronic pain, recurrence, infection, operating time, infection, seroma, hematomas, discomfort, and cost.
Methods Search strategy Databases including the MEDLINE, EMBASE, and Cochrane library were searched through June 2013, using the terms ‘‘inguinal or groin hernia,’’ ‘‘self-griping or selffixating or self-adhesive,’’ and ‘‘mesh.’’ Reference lists and relevant articles referenced in these primary studies were also downloaded to identify any additional studies relevant to our analysis.
Table 3
Inclusion and exclusion criteria All articles yielded by our search were reviewed to include all randomized controlled trials (RCT) and observational studies comparing GM with SM in open inguinal hernia repair. Only studies published as fulllength articles in peer-reviewed journals were included. Trials were included irrespective of the language in which they were reported. Animal model trials, reviews, case reports, and duplicate publications were excluded. Studies where the hernia repair was performed by other approaches were also excluded. The end result involved 5 RCT and 2 observational studies in the meta-analysis with publication dates ranging from 2009 to 2013 and a total of 1,353 patients.
Quality assessment of the randomized controlled trials
Random sequence generation Allocation concealment Blinding of participants and personnel Blinding of outcome assessment Incomplete outcome data Selective reporting Other potential sources of bias
Bruna Esteban et al
Jorgensen et al
Kapischke et al
Kingsnorth et al
Pierides et al
Low Low Low
Low Low Low
Low Low Low
Low Low Low
Low Low Low
Unclear
Low
Low
High
Low
Low Unclear Unclear
Low Unclear Unclear
Low Unclear Unclear
Low Unclear Unclear
Low Unclear Unclear
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Figure 2 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of chronic groin pain.
Data extraction Data extraction was performed by 2 independent researchers (Z.F. and F.R.) and included author(s), publication year, country of origin, sample size, age, sex, follow-up period, mesh type, and the following outcomes: (1) chronic groin pain and recurrence; and (2) operating time, infection, seroma, hematomas, early postoperative pain, discomfort, and cost. Chronic groin pain was defined as pain lasting for 3 months after surgery. Disagreements between the 2 investigators were solved by consensus. If the standard deviation and mean were not available, then they were calculated according to the guidelines of the Cochrane Collaboration24 and methods recommended by Hozo et al.25 Variance was either estimated from the range or the P value.
Quality assessment The quality of RCT was assessed with the Cochrane Handbook for Systematic Reviews of Interventions version 5.1 from the Cochrane Collaboration guidelines.24 Assessing risk of bias: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; incomplete outcome data; selective reporting and other bias. Newcastle–Ottawa scale was used to assess the methodological quality of observational studies26 and each included study was judged on 3e broad perspectives: the selection of the study groups; the comparability of the groups; and the ascertainment of outcome of interest. The maximum score is 9 points, representing the highest methodological quality.
analysis. Mean difference with 95% confidence intervals (CIs) was calculated for continuous data and odds ratio (OR) with 95% CIs for dichotomous outcomes. Pooled estimates of outcomes were calculated using a fixed-effects model, but a randomized-effects model was used according to heterogeneity. We accessed the statistical heterogeneity between studies using the chi-square test and evaluated the extent of inconsistency using the I2 statistic. P , .05 was considered statistically significant. Publication bias was tested using the Egger’s test.27
Results The PRISMA flowchart of selection of studies is given in Fig. 1. Five RCT and 2 observational studies were found to be eligible for inclusion in the meta-analysis. A total of 1,353 patients were enrolled in these eligible trials, with 666 of those patients in the GM group and 687 of those patients in the SM group. The characteristics of the included trials are showed in Table 1. The data and variables used to achieve a combined outcome are given in Table 2. Some data were gained from the authors of a trial via E-mail.
Statistical analysis Statistical analysis to achieve a combined outcome was performed by Review Manager (RevMan Version 5.2), provided by the Cochrane Collaboration. Forest plots were used for the graphic display of the results from the meta-
Figure 3 The Egger test publication bias plot for chronic groin pain after open inguinal hernia repair.
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Figure 4 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of recurrence.
All the included RCT reported random sequence generation and allocation concealment. Blinding of outcome assessment was unclear in the study by Esteban et al. Kapischke et al used a single-blinding method (Table 3.). All the RCT were analyzed on incomplete outcomes data. Selective reporting and other bias are unclear. According to the Newcastle–Ottawa scale, both of the 2 observational studies got 9 points and were highest quality.
Outcome Chronic groin pain. Six trials contributed to the combined calculation of chronic groin pain. There was no heterogeneity (P 5 .29, I2 5 18%) among trials. In the fixed-effects model (OR 5 .79; 95% CI, .54 to 1.16; P 5 .23; Fig. 2), there was no significant difference between the 2 groups in terms of chronic groin pain after surgery. Publication bias was also tested with Egger’s test, and no publication bias was detected among the included trials (t 5 21.67; P 5 .17; 95% CI, 24.472609 to 1.113513 [includes 0]; Fig. 3). Recurrence. Six trials contributed to the combined calculation of recurrence. There was no heterogeneity (P 5 .89,
I2 5 0%) among trials. In the fixed-effects model (OR 5 .70; 95% CI, .20 to 2.52; P 5 .59; Fig. 4), there was no significant difference in terms of recurrence after surgery between the 2 groups. Operating time. Six trials contributed to the combined calculation of the operating time. There was significant heterogeneity (P , .00001, I2 5 90%) among trials. In the random-effects model (mean difference 5 25.42; 95% CI, 27.78 to 23.06; P , .00001; Fig. 5), the operating time was shorter in GM group compared with SM group in open inguinal hernia repair. Infection. All 7 trials reported infection after surgery. There was no heterogeneity (P 5 .38, I2 5 6%) among trials. In the fixed-effects model (OR 5 .66; 95% CI, .36 to 1.21; P 5 .18; Fig. 6), the risk of infection was statistically similar between the 2 groups. Seroma. Three trials reported seroma after surgery. There was no heterogeneity (P 5 .93, I2 5 0%) among trials. In the fixed-effects model (OR 5 .71; 95% CI, .35 to 1.45; P 5 .35; Fig. 7), there was no significant difference in terms of seroma after surgery between the 2 groups.
Figure 5 Forest plot of pooled mean difference with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of operating time.
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Figure 6 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of infection.
Hematomas Five trials contributed to the combined calculation of hematomas. There was no heterogeneity (P 5 .42, I2 5 0%) among trials. In the fixed-effects model (OR 5 1.05; 95% CI, .59 to 1.87; P 5 .87; Fig. 8), there was no significant difference in terms of hematomas after surgery between the 2 groups. Discomfort. Three trials contributed to the combined calculation of discomfort. There was no heterogeneity (P 5 .48, I2 5 0%) among trials. In the fixed-effects model (OR 5 1.12; 95% CI, .75 to 1.66; P 5 .58; Fig. 9), there was no significant difference in terms of discomfort after surgery between the 2 groups. Early postoperative pain. The outcome of early postoperative pain was reported in 6 studies. Kingsnorth et al19 showed that compared to baseline, the visual analog scale pain score was lower in the GM group at discharge (210%) and at 7 days (213%), while pain increased in the SM group at discharge (139%) and at 7 days (121%). The difference between the 2 groups was significant at both time points (P 5 .007 and .039, respectively). Kapischke et al18 reported that the visual analog scale score was significantly lower in the GM group than in the SM
group (mean 17.9 vs 32.3 mm, P 5 .03) at the first postoperative day. The other 3 studies17,20,22 found that the early postoperative pain in the 2 groups was statistically similar. Cost. Two studies reported the cost. Esteban et al20 stated that although the self-adhesive mesh (V178.69) costs V64.21 more than the polypropylene mesh (V111.78) and the two 3-0 monofilament sutures (V1.35 each) used for attachment, the time saved in surgery related with their use could match the overall costs of the procedures. Kapischke et al18 stated that the GM costs 2.5 times more than the comparable mesh of pure polypropylene, but from an economical point of view, these increased costs are compensated by the reduced utilization of the operating room. Subgroup analysis. We attempted a subgroup analysis of trials of RCT and observational studies, but the result was similar to what we had already seen.
Comments With the introduction of tension-free mesh hemioplasty, the recurrence rate has decreased significantly.3,28,29 Chronic groin pain has become an important outcome and
Figure 7 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of seroma.
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Figure 8 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of hematomas.
significant impact on the patient’s quality of life, but there is still not a definite definition or consistent parameters to assess this pain. The International Association for the Study of Pain described chronic groin pain as ‘‘groin pain reported by the patient at or beyond 3-month following inguinal hernia repair,’’30 which has been widely accepted.8,31,32 For the cause of chronic pain is still unclear and no treatment has been shown to be effective,33 methods to prevent it have been extensively studied. Using lightweight mesh instead of heavyweight mesh has been reported may reduce the incidence of chronic pain, but the evidence is not enough and further studies are still needed.34,35 Atraumatic mesh fixation technique was developed under the assumption that SM fixation technique is a possible cause of chronic groin pain for it may injure the inguinal nerves or result in the excessive formation of scar.36 Several studies have suggested that cyanoacrylate glues and fibrin sealants may be the possible alternatives of sutures in mesh fixation,37,38 but in a recently published meta-analysis, Ladwa et al39 showed that there was no significant difference between the 2 mesh fixation methods in chronic pain, also there was no recommendation for using glue during hernia repair.33 GM is a novel low-density, macroporous mesh with semi-resorbable self-fixing properties, and several studies suggested that the incidence of chronic pain after open inguinal hernia repair was significantly reduced by using this mesh,18,19,23 while other studies did not confirm
that.17,20–22 From the result of this analysis, there is no difference in the occurrence of chronic pain between the 2 mesh fixation methods in open inguinal hernia repair. Inguinal nerve handling is another important factor that may affect the rate of chronic pain. Alfieri et al40 stated that failure to identify the inguinal nerves may lead to a high incidence of chronic pain. Also, the international guidelines recommended that identify and preserve all three inguinal nerves during open inguinal hernia repair to reduce the risk of chronic groin pain.33 In our analysis, only 1 study did not report the inguinal nerves identification during the surgery,20 but the result was no different to what we had already seen after excluding this study. From the data of this meta-analysis, no statistical difference in overall postoperative recurrence between GM and SM was found. For the different following period, recurrence at 1 year had also been analyzed, but the result was still similar. Compared to sutures, the resorbable polylactic acid micro hooks in GM could provide comparable strength of fixation. There are conflicting data concerning early postoperative pain. For different observation time and parameters were used to assess this pain, we could not extract the data as same type and make a meta-analysis. Early postoperative pain is mainly generated by trauma to the tissue from preparation of the anterior space and handling of the hernia sac,21 so using the GM may do no effect on this pain.
Figure 9 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of discomfort.
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Six studies reported that operating time was statistically different between the 2 groups and this was confirmed by this study. Compared to SM technique, the GM technique costs less time, ranging from 1 min to 12.2 min. Kingsnorth et al19 suggested that the shorter operating time may lead to a lower rate of wound infection. But from the results of this and other studies,17,18,20–23 the incidence of infection was similar between the 2 groups. Several factors have been associated with infection after groin hernia repair, such as sex, type of hernia, surgical technique, and type of mesh,41,42 and whether using GM can reduce the rate of infection by saving operating time still needs to be confirmed. The decision regarding the choice of mesh is very much influenced by the cost. Apparently, the price of GM is higher than the polypropylene mesh, but for the reduced operating time, the costs of utilization of the operating room were decreased. Two studies suggested that the costs between the 2 methods were almost equal,18,20 but there was still no cost-effectiveness analysis to approve that. There are several limitations to this meta-analysis. First, the inclusion and exclusion criteria were different among the included trials, such as age, sex, and types of hernias. Second, the types of SMs, surgeons’ experience, and operative procedures were different among trials and that may have a significant effect on results. Third, the timing of observations and pain definitions were various in the included trials. The follow-up times also differed among trials, ranging from 3 months to 46 months, which did not provide enough time to evaluate recurrence and other complications. Finally, a cost benefit of any intervention is needed to assess the costs between the 2 meshes.
3. Amid PK, Lichtenstein IL. Long-term results and current status of the Lichtenstein open tension-free hernioplasty. Hernia 1998;2:89–94. 4. van Hanswijck de Jonge P, Lloyd A, Horsfall L, et al. The measurement of chronic pain and healthrelated quality of life following inguinal hernia repair: a review of the literature. Hernia 2008;12: 561–9. 5. Paily A, Thornton M. Chronic pain following a Lichtenstein inguinal hernia repair: a clinical and legal dilemma. ANZ J Surg 2009;79: 517–20. 6. Eklund A, Montgomery A, Bergkvist L, et al. Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair. Br J Surg 2010;97:600–8. 7. Nienhuijs S, Staal E, Strobbe L, et al. Chronic pain after mesh repair of inguinal hernia: a systematic review. Am J Surg 2007;194:394–400. 8. Poobalan AS, Bruce J, Smith WC, et al. A review of chronic pain after inguinal herniorrhaphy. Clin J Pain 2003;19:48–54. 9. Kocijan R, Sandberg S, Chan YW, et al. Anatomical changes after inguinal hernia treatment: a reason for chronic pain and recurrent hernia? Surg Endosc 2010;24:395–9. 10. Beattie GC, Kumar S, Nixon SJ. Laparoscopic total extraperitoneal hernia repair: mesh fixation is unnecessary. J Laparoendosc Adv Surg Tech A 2000;10:71–3. 11. Wassenaar EB, Raymakers JT, Rakic S. Removal of transabdominal sutures for chronic pain after laparoscopic ventral and incisional hernia repair. Surg Laparosc Endosc Percutan Tech 2007;17:514–6. 12. Paajanen H. Do absorbable mesh sutures cause less chronic pain than nonabsorbable sutures after Lichtenstein inguinal herniorrhaphy? Hernia 2002;6:26–8. 13. Nowobilski W, Dobosz M, Wojciechowicz T, et al. Lichtenstein inguinal hernioplasty using butyl-2-cyano-acrylate versus sutures. Eur Surg Res 2004;36:367–70. 14. Douglas JM, Young WN, Jones DB. Lichtenstein inguinal herniorrhaphy using sutures versus tacks. Hernia 2002;6:99–101. 15. Chastan P. Tension free open inguinal hernia repair using an innovative self gripping semi-resorbable mesh. J Minim Access Surg 2006;2: 139–43. 16. Chastan P. Tension-free open hernia repair using an innovative selfgripping semi-resorbable mesh. Hernia 2009;13:137–42. 17. Anadol AZ, Akin M, Kurukahvecioglu O, et al. A prospective comparative study of the efficacy of conventional Lichtenstein versus selfadhesive mesh repair for inguinal hernia. Surg Today 2011;41: 1498–503. 18. Kapischke M, Schulze H, Caliebe A. Self-fixating mesh for the Lichtenstein procedure–a prestudy. Langenbecks Arch Surg 2010;395: 317–22. 19. Kingsnorth A, Gingell-Littlejohn M, Nienhuijs S, et al. Randomized controlled multicenter international clinical trial of self-gripping Parietex ProGrip polyester mesh versus lightweight polypropylene mesh in open inguinal hernia repair: interim results at 3 months. Hernia 2012; 16:287–94. 20. Bruna Esteban M, Cantos Pallare´s M, Artigues Sa´nchez De Rojas E. Use of adhesive mesh in hernioplasty compared to the conventional technique. Results of a randomised prospective study. Cir Esp 2010; 88:253–8. 21. Jorgensen LN, Sommer T, Assaadzadeh S, et al. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg 2013;100:474–81. 22. Pierides G, Scheinin T, Remes V, et al. Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Br J Surg 2012;99:630–6. 23. Quyn AJ, Weatherhead KM, Daniel T. Chronic pain after open inguinal hernia surgery: suture fixation versus self-adhesive mesh repair. Langenbecks Arch Surg 2012;397:1215–8. 24. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration; 2011. 25. Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 2005;5:13.
Conclusions Based on this system review and meta-analysis, it is still uncertain whether GM has a real benefit over SM in open inguinal hernia repair. Although the operating time is shorter with GM, its price is higher. It may be a preferred technique, but large number, well-designed, and long follow-up period RCT are still needed to confirm.
Acknowledgment The authors thank Prof Lars Nannestad Jorgensen for providing further data for inclusion in this meta-analysis.
References 1. Lichtenstein IL, Shulman AG. Ambulatory outpatient hernia surgery. Including a new concept, introducing tension-free repair. Int Surg 1986;71:1–4. 2. Bringman S, Wollert S, Osterberg J, et al. Three-year results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia. Br J Surg 2006;93: 1056–9.
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26. Wells GA, Shea B, O’Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomized studies in metaanalyses. In Department of Epidemiology and Community Medicine, University of Ottawa, Room 3227A, 451 Smyth Road, Ottawa, ON K1J 8M5, Canada. Available at: http://www.ohri.ca/. Accessed January 1, 2008. 27. Egger M, Smith GD, Altman DG. Systematic Reviews in Health Care: Meta-Analysis in Context. 2nd ed. London: BMJ; 2001. 28. Zhao G, Gao P, Ma B, et al. Open mesh techniques for inguinal hernia repair: a meta-analysis of randomized controlled trials. Ann Surg 2009;250:35–42. 29. Paajanen H, Varjo R. Ten-year audit of Lichtenstein hernioplasty under local anaesthesia performed by surgical residents. BMC Surg 2010;10: 24. 30. Merskey H, Bogduk N. Task Force on Taxonomy. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. 2nd ed. Seattle, WA: IASP Press; 1994. p. 209–14. 31. Campanelli G, Bertocchi V, Cavalli M, et al. Surgical treatment of chronic pain after inguinal hernia repair. Hernia 2013;17:347–53. 32. Loos MJ, Roumen RM, Scheltinga MR. Classifying postherniorrhaphy pain syndromes following elective inguinal hernia repair. World J Surg 2007;31:1760–5. 33. Alfieri S, Amid PK, Campanelli G, et al. International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia 2011;15:239–49. 34. Li J, Ji Z, Cheng T. Lightweight versus heavyweight in inguinal hernia repair: a meta-analysis. Hernia 2012;16:529–39.
781 35. Sajid MS, Leaver C, Baig MK, et al. Systematic review and metaanalysis of the use of lightweight versus heavyweight mesh in open inguinal hernia repair. Br J Surg 2012;99:29–37. 36. Hakeem A, Shanmugam V. Inguinodynia following Lichtenstein tension-free hernia repair: a review. World J Gastroenterol 2011;17: 1791–6. 37. Shen YM, Sun WB, Chen J, et al. NBCA medical adhesive (n-butyl-2cyanoacrylate) versus suture for patch fixation in Lichtenstein inguinal herniorrhaphy: a randomized controlled trial. Surgery 2012;151: 550–5. 38. Campanelli G, Pascual MH, Hoeferlin A, et al. Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial. Ann Surg 2012;255:650–7. 39. Ladwa N, Sajid MS, Sains P, et al. Suture mesh fixation versus glue mesh fixation in open inguinal hernia repair: a systematic review and meta-analysis. Int J Surg 2013;11:128–35. 40. Alfieri S, Rotondi F, Di Giorgio A, et al. Influence of preservation versus division of ilioinguinal, iliohypogastric, and genital nerves during open mesh herniorrhaphy: prospective multicentric study of chronic pain. Ann Surg 2006;243:553–8. 41. Akyol C, Kocaay F, Orozakunov E, et al. Outcome of the patients with chronic mesh infection following open inguinal hernia repair. J Korean Surg Soc 2013;84:287–91. 42. Bendavid R. Complications of groin hernia surgery. Surg Clin North Am 1998;78:1089–103.
Review
Self-gripping mesh versus sutured mesh in open inguinal hernia repair: system review and meta-analysis Zhixue Fang, M.D., Jianping Zhou, M.D., Feng Ren, M.D.*, Dongcai Liu, M.D. Department of Geriatrics Surgery, the Second Xiangya Hospital, Central South University, No. 139, Middle Renmin Road, Changsha, Hunan 410011, P.R. China
KEYWORDS: Self-gripping mesh; Sutured mesh; Open inguinal hernia repair
Abstract BACKGROUND: The objective of this article was to compare the outcomes of self-gripping mesh (GM) with sutured mesh (SM) in open inguinal hernia repair. METHODS: A systematic review and meta-analysis were taken to compare the outcomes of GM and SM in open inguinal hernia repair. RESULTS: A total of 1,353 patients in 6 randomized controlled trials and 2 observational studies were reviewed (666 patients in GM group; 687 patients in SM group). The 2 groups did not significantly differ in chronic groin pain (P 5 .23) or recurrence (P 5 .59). The operating time was significantly shorter in GM group (P , .00001). There was no significant difference in infection (P 5 .18), seromas (P 5 .35), hematomas (P 5 .87), or discomfort (P 5 .58) between the 2 groups. CONCLUSIONS: The data showed that GM was equivalent to SM in open inguinal hernia repair. However, this new mesh still needs to be confirmed in large, multi-center, well-designed randomized controlled trials. Ó 2014 Elsevier Inc. All rights reserved.
Since Lichtenstein introduced the method of tension-free hernia repair by using modern mesh prosthetics in 1986, it has become a most often used technique worldwide and dramatically reduced the incidence of hernia recurrence.1–3 However, chronic groin pain has become one of the important complications and significant impact on the patient’s quality of life.4 Some patients complain of groin pain months or even years after surgery. The incidence of this pain varies among studies, ranging between 11% and 54%, with almost 30% of these patients reporting a significant impact on daily activities.5–8 The reason is still The authors declare no conflicts of interest. * Corresponding author. Tel.: 186-073185295167; fax: 186073185295380. E-mail address: [email protected] Manuscript received July 10, 2013; revised manuscript July 29, 2013 0002-9610/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2013.08.045
unclear, but the use of sutures during surgery which may injure minor or major nerves has been viewed as one of the potential pathogenetic factors involved in chronic pain.9–11 For this reason, alternative fixation methods with a low degree of tissue trauma were developed and several fixation procedures have been investigated, such as absorbable sutures, tacks, and glue.12–14 In 2006, Chastan15 introduced a new sutureless mesh fixation method by using a novel self-gripping mesh (GM; Parietene ProGrip, Covidien, North Haven, CT). This GM is made of a lowweight isoelastic large-pore monofilament polypropylene knitted fabric that incorporates resorbable polylactic acid micro hooks, which provide tissue-gripping properties at application of the mesh and during the following 12 months.16 In recent years, a number of trials have been carried out to compare this new mesh fixation method
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Figure 1
PRISMA flow chart for the selection.
with conventional sutured mesh (SM) fixation method (Classic Lichtenstein) in open inguinal hernia repair. Some trials have shown the benefits of GM, including fewer incidences of infection, less early postoperative pain, and less chronic groin pain.17–19 However, others have not
Table 1
confirmed this observation.20–23 There is still a controversy about whether GM is more advanced than SM in open inguinal hernia repair. The object of this article is to compare the outcomes of GM with SM in open inguinal hernia repair with respect to
Basic information of the trials Age (y)
Men/Women
Type of mesh
Trial
Year
Country
GM
SM
GM
SM
Follow-up period (months)
GM
SM
Bruna Esteban et al Jorgensen et al Kapischke et al Kingsnorth et al Pierides et al Anadol et al Quyn et al
2010
Spain
60 (26–80)
49 (19–83)
41/4
38/7
3–36
ProGrip
PP
2012 2010 2012 2013 2009 2012
Denmark Germany UK Finland Turkey UK
56.8 (40.2–65.1) 64.2 6 12.97 60 (31–74) 55 (20–79) 56 (21–85) 63.8 6 7.76
59.9 (43.8–67.5) 66.8 6 11.66 60 (31–74) 53 (19–80) 56 (30–82) 61.9 6 15.74
Men only 22/2 23/3 Men only 188/10 182/14 Men only 58/5 62/7
12 6 3 12 25–46 12
ProGrip ProGrip ProGrip ProGrip ProGrip ProGrip
PP PP PP PP PP PP
GM 5 self-gripping mesh; ProGrip 5 Parietene ProGrip; PP 5 polypropylene; SM 5 sutured mesh.
Z. Fang et al. Table 2
Self-gripping mesh versus sutured mesh
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Variables used for meta-analysis
Trial
Patients
Bruna Esteban et al GM SM Jorgensen et al GM SM Kapischke et al GM SM Kingsnorth et al GM SM Pierides et al GM SM Anadol et al* GM SM Quyn et al* GM SM
45 45 163 171
Operation time (min) 17.8 (11.8–20.7) 20.2 (12.7–20.8) 29 (22–35) 30 (25–39)
Infection
Hematomas
Seromas
Recurrence
Chronic pain
Discomfort
0 0
1 1
1 1
0 0
NG
NG
9 12
12† 18†
12† 18†
2 2
16 13
0 0
NG
0 3
NG
24 26
51 63.2 (P 5 .0078)
1 0
4 3
NG
149 153
32.4 39.1 (P , .001)
3 11
7 2
1 1
0 0
8 9
16 18
198 196
36 45 (P , .001)
1 3
1 1
NG
0 1
16 13
49 42
24 27
23.7 6 5.57 36.9 6 11.36
1 0
NG
NG
1 1
6 7
NG
63 69
NG
2 1
NG
NG
0 1
5 15
NG
GM 5 self-gripping mesh; NG 5 not given; SM 5 sutured mesh. *Prospective study. † Data were gained from the authors of a trial via E-mail.
early and chronic pain, recurrence, infection, operating time, infection, seroma, hematomas, discomfort, and cost.
Methods Search strategy Databases including the MEDLINE, EMBASE, and Cochrane library were searched through June 2013, using the terms ‘‘inguinal or groin hernia,’’ ‘‘self-griping or selffixating or self-adhesive,’’ and ‘‘mesh.’’ Reference lists and relevant articles referenced in these primary studies were also downloaded to identify any additional studies relevant to our analysis.
Table 3
Inclusion and exclusion criteria All articles yielded by our search were reviewed to include all randomized controlled trials (RCT) and observational studies comparing GM with SM in open inguinal hernia repair. Only studies published as fulllength articles in peer-reviewed journals were included. Trials were included irrespective of the language in which they were reported. Animal model trials, reviews, case reports, and duplicate publications were excluded. Studies where the hernia repair was performed by other approaches were also excluded. The end result involved 5 RCT and 2 observational studies in the meta-analysis with publication dates ranging from 2009 to 2013 and a total of 1,353 patients.
Quality assessment of the randomized controlled trials
Random sequence generation Allocation concealment Blinding of participants and personnel Blinding of outcome assessment Incomplete outcome data Selective reporting Other potential sources of bias
Bruna Esteban et al
Jorgensen et al
Kapischke et al
Kingsnorth et al
Pierides et al
Low Low Low
Low Low Low
Low Low Low
Low Low Low
Low Low Low
Unclear
Low
Low
High
Low
Low Unclear Unclear
Low Unclear Unclear
Low Unclear Unclear
Low Unclear Unclear
Low Unclear Unclear
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Figure 2 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of chronic groin pain.
Data extraction Data extraction was performed by 2 independent researchers (Z.F. and F.R.) and included author(s), publication year, country of origin, sample size, age, sex, follow-up period, mesh type, and the following outcomes: (1) chronic groin pain and recurrence; and (2) operating time, infection, seroma, hematomas, early postoperative pain, discomfort, and cost. Chronic groin pain was defined as pain lasting for 3 months after surgery. Disagreements between the 2 investigators were solved by consensus. If the standard deviation and mean were not available, then they were calculated according to the guidelines of the Cochrane Collaboration24 and methods recommended by Hozo et al.25 Variance was either estimated from the range or the P value.
Quality assessment The quality of RCT was assessed with the Cochrane Handbook for Systematic Reviews of Interventions version 5.1 from the Cochrane Collaboration guidelines.24 Assessing risk of bias: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; incomplete outcome data; selective reporting and other bias. Newcastle–Ottawa scale was used to assess the methodological quality of observational studies26 and each included study was judged on 3e broad perspectives: the selection of the study groups; the comparability of the groups; and the ascertainment of outcome of interest. The maximum score is 9 points, representing the highest methodological quality.
analysis. Mean difference with 95% confidence intervals (CIs) was calculated for continuous data and odds ratio (OR) with 95% CIs for dichotomous outcomes. Pooled estimates of outcomes were calculated using a fixed-effects model, but a randomized-effects model was used according to heterogeneity. We accessed the statistical heterogeneity between studies using the chi-square test and evaluated the extent of inconsistency using the I2 statistic. P , .05 was considered statistically significant. Publication bias was tested using the Egger’s test.27
Results The PRISMA flowchart of selection of studies is given in Fig. 1. Five RCT and 2 observational studies were found to be eligible for inclusion in the meta-analysis. A total of 1,353 patients were enrolled in these eligible trials, with 666 of those patients in the GM group and 687 of those patients in the SM group. The characteristics of the included trials are showed in Table 1. The data and variables used to achieve a combined outcome are given in Table 2. Some data were gained from the authors of a trial via E-mail.
Statistical analysis Statistical analysis to achieve a combined outcome was performed by Review Manager (RevMan Version 5.2), provided by the Cochrane Collaboration. Forest plots were used for the graphic display of the results from the meta-
Figure 3 The Egger test publication bias plot for chronic groin pain after open inguinal hernia repair.
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Figure 4 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of recurrence.
All the included RCT reported random sequence generation and allocation concealment. Blinding of outcome assessment was unclear in the study by Esteban et al. Kapischke et al used a single-blinding method (Table 3.). All the RCT were analyzed on incomplete outcomes data. Selective reporting and other bias are unclear. According to the Newcastle–Ottawa scale, both of the 2 observational studies got 9 points and were highest quality.
Outcome Chronic groin pain. Six trials contributed to the combined calculation of chronic groin pain. There was no heterogeneity (P 5 .29, I2 5 18%) among trials. In the fixed-effects model (OR 5 .79; 95% CI, .54 to 1.16; P 5 .23; Fig. 2), there was no significant difference between the 2 groups in terms of chronic groin pain after surgery. Publication bias was also tested with Egger’s test, and no publication bias was detected among the included trials (t 5 21.67; P 5 .17; 95% CI, 24.472609 to 1.113513 [includes 0]; Fig. 3). Recurrence. Six trials contributed to the combined calculation of recurrence. There was no heterogeneity (P 5 .89,
I2 5 0%) among trials. In the fixed-effects model (OR 5 .70; 95% CI, .20 to 2.52; P 5 .59; Fig. 4), there was no significant difference in terms of recurrence after surgery between the 2 groups. Operating time. Six trials contributed to the combined calculation of the operating time. There was significant heterogeneity (P , .00001, I2 5 90%) among trials. In the random-effects model (mean difference 5 25.42; 95% CI, 27.78 to 23.06; P , .00001; Fig. 5), the operating time was shorter in GM group compared with SM group in open inguinal hernia repair. Infection. All 7 trials reported infection after surgery. There was no heterogeneity (P 5 .38, I2 5 6%) among trials. In the fixed-effects model (OR 5 .66; 95% CI, .36 to 1.21; P 5 .18; Fig. 6), the risk of infection was statistically similar between the 2 groups. Seroma. Three trials reported seroma after surgery. There was no heterogeneity (P 5 .93, I2 5 0%) among trials. In the fixed-effects model (OR 5 .71; 95% CI, .35 to 1.45; P 5 .35; Fig. 7), there was no significant difference in terms of seroma after surgery between the 2 groups.
Figure 5 Forest plot of pooled mean difference with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of operating time.
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Figure 6 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of infection.
Hematomas Five trials contributed to the combined calculation of hematomas. There was no heterogeneity (P 5 .42, I2 5 0%) among trials. In the fixed-effects model (OR 5 1.05; 95% CI, .59 to 1.87; P 5 .87; Fig. 8), there was no significant difference in terms of hematomas after surgery between the 2 groups. Discomfort. Three trials contributed to the combined calculation of discomfort. There was no heterogeneity (P 5 .48, I2 5 0%) among trials. In the fixed-effects model (OR 5 1.12; 95% CI, .75 to 1.66; P 5 .58; Fig. 9), there was no significant difference in terms of discomfort after surgery between the 2 groups. Early postoperative pain. The outcome of early postoperative pain was reported in 6 studies. Kingsnorth et al19 showed that compared to baseline, the visual analog scale pain score was lower in the GM group at discharge (210%) and at 7 days (213%), while pain increased in the SM group at discharge (139%) and at 7 days (121%). The difference between the 2 groups was significant at both time points (P 5 .007 and .039, respectively). Kapischke et al18 reported that the visual analog scale score was significantly lower in the GM group than in the SM
group (mean 17.9 vs 32.3 mm, P 5 .03) at the first postoperative day. The other 3 studies17,20,22 found that the early postoperative pain in the 2 groups was statistically similar. Cost. Two studies reported the cost. Esteban et al20 stated that although the self-adhesive mesh (V178.69) costs V64.21 more than the polypropylene mesh (V111.78) and the two 3-0 monofilament sutures (V1.35 each) used for attachment, the time saved in surgery related with their use could match the overall costs of the procedures. Kapischke et al18 stated that the GM costs 2.5 times more than the comparable mesh of pure polypropylene, but from an economical point of view, these increased costs are compensated by the reduced utilization of the operating room. Subgroup analysis. We attempted a subgroup analysis of trials of RCT and observational studies, but the result was similar to what we had already seen.
Comments With the introduction of tension-free mesh hemioplasty, the recurrence rate has decreased significantly.3,28,29 Chronic groin pain has become an important outcome and
Figure 7 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of seroma.
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Figure 8 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of hematomas.
significant impact on the patient’s quality of life, but there is still not a definite definition or consistent parameters to assess this pain. The International Association for the Study of Pain described chronic groin pain as ‘‘groin pain reported by the patient at or beyond 3-month following inguinal hernia repair,’’30 which has been widely accepted.8,31,32 For the cause of chronic pain is still unclear and no treatment has been shown to be effective,33 methods to prevent it have been extensively studied. Using lightweight mesh instead of heavyweight mesh has been reported may reduce the incidence of chronic pain, but the evidence is not enough and further studies are still needed.34,35 Atraumatic mesh fixation technique was developed under the assumption that SM fixation technique is a possible cause of chronic groin pain for it may injure the inguinal nerves or result in the excessive formation of scar.36 Several studies have suggested that cyanoacrylate glues and fibrin sealants may be the possible alternatives of sutures in mesh fixation,37,38 but in a recently published meta-analysis, Ladwa et al39 showed that there was no significant difference between the 2 mesh fixation methods in chronic pain, also there was no recommendation for using glue during hernia repair.33 GM is a novel low-density, macroporous mesh with semi-resorbable self-fixing properties, and several studies suggested that the incidence of chronic pain after open inguinal hernia repair was significantly reduced by using this mesh,18,19,23 while other studies did not confirm
that.17,20–22 From the result of this analysis, there is no difference in the occurrence of chronic pain between the 2 mesh fixation methods in open inguinal hernia repair. Inguinal nerve handling is another important factor that may affect the rate of chronic pain. Alfieri et al40 stated that failure to identify the inguinal nerves may lead to a high incidence of chronic pain. Also, the international guidelines recommended that identify and preserve all three inguinal nerves during open inguinal hernia repair to reduce the risk of chronic groin pain.33 In our analysis, only 1 study did not report the inguinal nerves identification during the surgery,20 but the result was no different to what we had already seen after excluding this study. From the data of this meta-analysis, no statistical difference in overall postoperative recurrence between GM and SM was found. For the different following period, recurrence at 1 year had also been analyzed, but the result was still similar. Compared to sutures, the resorbable polylactic acid micro hooks in GM could provide comparable strength of fixation. There are conflicting data concerning early postoperative pain. For different observation time and parameters were used to assess this pain, we could not extract the data as same type and make a meta-analysis. Early postoperative pain is mainly generated by trauma to the tissue from preparation of the anterior space and handling of the hernia sac,21 so using the GM may do no effect on this pain.
Figure 9 Forest plot of pooled odds ratio with 95% CI for comparing self-gripping mesh with sutured mesh in open hernioplasty based on the assessment of discomfort.
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Six studies reported that operating time was statistically different between the 2 groups and this was confirmed by this study. Compared to SM technique, the GM technique costs less time, ranging from 1 min to 12.2 min. Kingsnorth et al19 suggested that the shorter operating time may lead to a lower rate of wound infection. But from the results of this and other studies,17,18,20–23 the incidence of infection was similar between the 2 groups. Several factors have been associated with infection after groin hernia repair, such as sex, type of hernia, surgical technique, and type of mesh,41,42 and whether using GM can reduce the rate of infection by saving operating time still needs to be confirmed. The decision regarding the choice of mesh is very much influenced by the cost. Apparently, the price of GM is higher than the polypropylene mesh, but for the reduced operating time, the costs of utilization of the operating room were decreased. Two studies suggested that the costs between the 2 methods were almost equal,18,20 but there was still no cost-effectiveness analysis to approve that. There are several limitations to this meta-analysis. First, the inclusion and exclusion criteria were different among the included trials, such as age, sex, and types of hernias. Second, the types of SMs, surgeons’ experience, and operative procedures were different among trials and that may have a significant effect on results. Third, the timing of observations and pain definitions were various in the included trials. The follow-up times also differed among trials, ranging from 3 months to 46 months, which did not provide enough time to evaluate recurrence and other complications. Finally, a cost benefit of any intervention is needed to assess the costs between the 2 meshes.
3. Amid PK, Lichtenstein IL. Long-term results and current status of the Lichtenstein open tension-free hernioplasty. Hernia 1998;2:89–94. 4. van Hanswijck de Jonge P, Lloyd A, Horsfall L, et al. The measurement of chronic pain and healthrelated quality of life following inguinal hernia repair: a review of the literature. Hernia 2008;12: 561–9. 5. Paily A, Thornton M. Chronic pain following a Lichtenstein inguinal hernia repair: a clinical and legal dilemma. ANZ J Surg 2009;79: 517–20. 6. Eklund A, Montgomery A, Bergkvist L, et al. Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair. Br J Surg 2010;97:600–8. 7. Nienhuijs S, Staal E, Strobbe L, et al. Chronic pain after mesh repair of inguinal hernia: a systematic review. Am J Surg 2007;194:394–400. 8. Poobalan AS, Bruce J, Smith WC, et al. A review of chronic pain after inguinal herniorrhaphy. Clin J Pain 2003;19:48–54. 9. Kocijan R, Sandberg S, Chan YW, et al. Anatomical changes after inguinal hernia treatment: a reason for chronic pain and recurrent hernia? Surg Endosc 2010;24:395–9. 10. Beattie GC, Kumar S, Nixon SJ. Laparoscopic total extraperitoneal hernia repair: mesh fixation is unnecessary. J Laparoendosc Adv Surg Tech A 2000;10:71–3. 11. Wassenaar EB, Raymakers JT, Rakic S. Removal of transabdominal sutures for chronic pain after laparoscopic ventral and incisional hernia repair. Surg Laparosc Endosc Percutan Tech 2007;17:514–6. 12. Paajanen H. Do absorbable mesh sutures cause less chronic pain than nonabsorbable sutures after Lichtenstein inguinal herniorrhaphy? Hernia 2002;6:26–8. 13. Nowobilski W, Dobosz M, Wojciechowicz T, et al. Lichtenstein inguinal hernioplasty using butyl-2-cyano-acrylate versus sutures. Eur Surg Res 2004;36:367–70. 14. Douglas JM, Young WN, Jones DB. Lichtenstein inguinal herniorrhaphy using sutures versus tacks. Hernia 2002;6:99–101. 15. Chastan P. Tension free open inguinal hernia repair using an innovative self gripping semi-resorbable mesh. J Minim Access Surg 2006;2: 139–43. 16. Chastan P. Tension-free open hernia repair using an innovative selfgripping semi-resorbable mesh. Hernia 2009;13:137–42. 17. Anadol AZ, Akin M, Kurukahvecioglu O, et al. A prospective comparative study of the efficacy of conventional Lichtenstein versus selfadhesive mesh repair for inguinal hernia. Surg Today 2011;41: 1498–503. 18. Kapischke M, Schulze H, Caliebe A. Self-fixating mesh for the Lichtenstein procedure–a prestudy. Langenbecks Arch Surg 2010;395: 317–22. 19. Kingsnorth A, Gingell-Littlejohn M, Nienhuijs S, et al. Randomized controlled multicenter international clinical trial of self-gripping Parietex ProGrip polyester mesh versus lightweight polypropylene mesh in open inguinal hernia repair: interim results at 3 months. Hernia 2012; 16:287–94. 20. Bruna Esteban M, Cantos Pallare´s M, Artigues Sa´nchez De Rojas E. Use of adhesive mesh in hernioplasty compared to the conventional technique. Results of a randomised prospective study. Cir Esp 2010; 88:253–8. 21. Jorgensen LN, Sommer T, Assaadzadeh S, et al. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg 2013;100:474–81. 22. Pierides G, Scheinin T, Remes V, et al. Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Br J Surg 2012;99:630–6. 23. Quyn AJ, Weatherhead KM, Daniel T. Chronic pain after open inguinal hernia surgery: suture fixation versus self-adhesive mesh repair. Langenbecks Arch Surg 2012;397:1215–8. 24. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration; 2011. 25. Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 2005;5:13.
Conclusions Based on this system review and meta-analysis, it is still uncertain whether GM has a real benefit over SM in open inguinal hernia repair. Although the operating time is shorter with GM, its price is higher. It may be a preferred technique, but large number, well-designed, and long follow-up period RCT are still needed to confirm.
Acknowledgment The authors thank Prof Lars Nannestad Jorgensen for providing further data for inclusion in this meta-analysis.
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26. Wells GA, Shea B, O’Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomized studies in metaanalyses. In Department of Epidemiology and Community Medicine, University of Ottawa, Room 3227A, 451 Smyth Road, Ottawa, ON K1J 8M5, Canada. Available at: http://www.ohri.ca/. Accessed January 1, 2008. 27. Egger M, Smith GD, Altman DG. Systematic Reviews in Health Care: Meta-Analysis in Context. 2nd ed. London: BMJ; 2001. 28. Zhao G, Gao P, Ma B, et al. Open mesh techniques for inguinal hernia repair: a meta-analysis of randomized controlled trials. Ann Surg 2009;250:35–42. 29. Paajanen H, Varjo R. Ten-year audit of Lichtenstein hernioplasty under local anaesthesia performed by surgical residents. BMC Surg 2010;10: 24. 30. Merskey H, Bogduk N. Task Force on Taxonomy. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. 2nd ed. Seattle, WA: IASP Press; 1994. p. 209–14. 31. Campanelli G, Bertocchi V, Cavalli M, et al. Surgical treatment of chronic pain after inguinal hernia repair. Hernia 2013;17:347–53. 32. Loos MJ, Roumen RM, Scheltinga MR. Classifying postherniorrhaphy pain syndromes following elective inguinal hernia repair. World J Surg 2007;31:1760–5. 33. Alfieri S, Amid PK, Campanelli G, et al. International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia 2011;15:239–49. 34. Li J, Ji Z, Cheng T. Lightweight versus heavyweight in inguinal hernia repair: a meta-analysis. Hernia 2012;16:529–39.
781 35. Sajid MS, Leaver C, Baig MK, et al. Systematic review and metaanalysis of the use of lightweight versus heavyweight mesh in open inguinal hernia repair. Br J Surg 2012;99:29–37. 36. Hakeem A, Shanmugam V. Inguinodynia following Lichtenstein tension-free hernia repair: a review. World J Gastroenterol 2011;17: 1791–6. 37. Shen YM, Sun WB, Chen J, et al. NBCA medical adhesive (n-butyl-2cyanoacrylate) versus suture for patch fixation in Lichtenstein inguinal herniorrhaphy: a randomized controlled trial. Surgery 2012;151: 550–5. 38. Campanelli G, Pascual MH, Hoeferlin A, et al. Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial. Ann Surg 2012;255:650–7. 39. Ladwa N, Sajid MS, Sains P, et al. Suture mesh fixation versus glue mesh fixation in open inguinal hernia repair: a systematic review and meta-analysis. Int J Surg 2013;11:128–35. 40. Alfieri S, Rotondi F, Di Giorgio A, et al. Influence of preservation versus division of ilioinguinal, iliohypogastric, and genital nerves during open mesh herniorrhaphy: prospective multicentric study of chronic pain. Ann Surg 2006;243:553–8. 41. Akyol C, Kocaay F, Orozakunov E, et al. Outcome of the patients with chronic mesh infection following open inguinal hernia repair. J Korean Surg Soc 2013;84:287–91. 42. Bendavid R. Complications of groin hernia surgery. Surg Clin North Am 1998;78:1089–103.
