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The American Journal of Surgery (2010) 200, 291297

Review

Laparoscopic versus open mesh repair for recurrent


inguinal hernia: a meta-analysis of outcomes
Georgia Dedemadi, M.D.a,*, George Sgourakis, M.D.b, Arnold Radtke, M.D.c,
Alexandros Dounavis, M.D.a, Ines Gockel, M.D.c, Ioannis Fouzas, M.D.d,
Constantine Karaliotas, M.D.b, Evangelos Anagnostou, M.D.a
a
Surgical Department of A. Fleming General Hospital, 14, 25th Martiou Str, 15127, Athens, Greece; b2nd Surgical Department
and Surgical Oncology Unit of KorgialenioBenakio, Red Cross Hospital, Athens, Greece; cDepartment of General and Abdominal
Surgery, Johannes Gutenberg University Hospital, Mainz, Germany; dOrgan Transplant Unit, Hippokration Hospital, Aristotle
University Medical School, Thessaloniki, Greece

KEYWORDS: Abstract
Meta-analysis; BACKGROUND: The objective of this study was to examine the outcomes of comparisons between
Evidence based; laparoscopic and open mesh repairs in the setting of recurrent inguinal hernia.
Publication bias; METHODS: The electronic databases MEDLINE, Embase, Pubmed, and the Cochrane Library were
Recurrent inguinal used to search for articles from 1990 to 2008. The present meta-analysis pooled the effects of outcomes
hernia; of a total of 1,542 patients enrolled into 5 randomized controlled trials and 7 comparative studies, using
Totally classic and modern meta-analytic methods.
extraperitoneal; RESULTS: Significantly fewer cases of hematoma/seroma formation were observed in the laparo-
Transabdominal scopic group in comparison with the Lichtenstein group (odds ratio, .38; .15.96; P .04). A matter
preperitoneal; of great importance is the higher relative risk of overall recurrence in the transabdominal preperitoneal
OPM; group compared with the totally extraperitoneal group (relative risk, 3.25; 1.327.9; P .01).
Open preperitoneal CONCLUSIONS: Laparoscopic versus open mesh repair for recurrent inguinal hernia was equivalent
mesh; in most of the analyzed outcomes.
Stoppa; 2010 Elsevier Inc. All rights reserved.
Giant prosthetic
reinforcement of the
visceral sac;
Lichtenstein procedure

The repair of recurrent inguinal hernia is a demanding inal wall has been established during the past decades.2 The
procedure accounting for 10% to 15% of inguinal hernia mesh can be placed either anteriorly under the external
repairs.1 The use of mesh for reinforcement of the abdom- aponeurosis (interparietal) or posteriorly (preperitoneal).3,4

Georgia Dedemadi designed the study, analyzed data, and was Anagnostou designed the study and was responsible for critical revision.
responsible for acquisition of data; George Sgourakis designed the All authors have read and approved the final version of the manuscript
study, analyzed data, and was responsible for acquisition of data; to be published. Georgia Dedemadi and George Sgourakis take respon-
Arnold Radtke analyzed data and was responsible for acquisition of sibility for the integrity of the data and the accuracy of the data analysis.
data; Alexandros Dounavis designed study and was responsible for * Corresponding author. Tel.: 30-210-6033361; fax: 30-210-
acquisition of data; Ines Gockel drafted the manuscript and was respon- 7514179.
sible for substantial review; Ioannis Fouzas was responsible for critical E-mail address: gdedemadi@yahoo.gr
review and drafting the manuscript; Constantine Karaliotas designed Manuscript received June 9, 2009; revised manuscript December 1,
the study and was responsible for critical revision; and Evangelos 2009

0002-9610/$ - see front matter 2010 Elsevier Inc. All rights reserved.
doi:10.1016/j.amjsurg.2009.12.009
292 The American Journal of Surgery, Vol 200, No 2, August 2010

Figure 1 Progress through the stages of the meta-analysis.

Issues concerning the most appropriate treatment are still keyword lists: randomized controlled trials, double-blind, re-
under consideration.57 The Lichtenstein technique com- current inguinal hernia, totally extraperitoneal, transabdominal
monly is used for the repair of primary inguinal hernia and preperitoneal,OPM, open preperitoneal mesh, Stoppa, giant
may be suitable for repairing recurrent inguinal hernia if the prosthetic reinforcement of the visceral sac, and Lichtenstein
defect is larger than 4 cm.8 However, the technical ease and procedure. Where it was applicable the earlier-mentioned
low recurrence rate of this technique has lead to its wide- terms were used in [MESH] (PubMed and the Cochrane
spread use to repair recurrent inguinal hernias of any Library), otherwise the terms were combined with AND/
size.9,10 Laparoscopic repairs are based on the same princi- OR and asterisks. In addition, the abstracts from na-
ples as preperitoneal mesh repair and therefore combine the tional and international conferences were searched using
advantages of open preperitoneal repair with those of min- online search engines corresponding to the particular
imal access surgery.11,12 There is a major body of criticism conference.
concerning laparoscopic hernia repair.1315 The main argu- The scheme for this repetitive search is shown in Figure 1.
ments address the potential long-term recurrence rate, in- After the initial screen additional criteria were imposed as
traoperative complications, and the need for general anes- follows: (1) adult population undergoing recurrent hernia
thesia.1,16 Conversely, laparoscopic procedures may be repair, (2) elective surgeries, (3) Nyhus class II to III her-
associated with less postoperative pain, simultaneous repair nias, and (4) analysis on an intention-to-treat basis.
of bilateral and other concurrent less-frequent types of in-
guinal hernia, short hospital stay, and early return to normal Data extraction
activities.13,17,18 To date, the effectiveness of the treatment
modalities, concerning short- and long-term results for re- Two authors (G.D., G.S.) independently selected stud-
current inguinal hernia, has not been compared by meta- ies for inclusion and exclusion, and reached consensus
analysis of published reports. when they did not agree on the initial assignment. The
following variables concerning studies addressing pa-
tients with recurrent hernia repair were recorded: authors,
journal and year of publication, country of origin, trial
Methods duration, participant demographics, and data concerning
complications and follow-up evaluation. Where neces-
Literature search sary, the corresponding authors were contacted to obtain
supplementary information.
All randomized control trials and comparative studies
concerning recurrent hernia repair were identified.1,19 29 Interventions and outcome definition. Definitions were
The electronic databases MEDLINE, Embase, Pubmed, and as follows: early recurrence was defined as hernia recur-
the Cochrane Library were used to search for relevant arti- rence during the first 2 months of follow-up evaluation;
cles published in English from 1990 to 2008 using the totally extraperitoneal (TEP) was defined as laparoscopic
following terms and/or combinations in their titles, abstracts, or hernia repair with extraperitoneal mesh placement; transab-
G. Dedemadi et al. Laparoscopic versus open mesh repair 293

dominal preperitoneal (TAPP) was defined as laparoscopic Results


hernia repair through the peritoneal cavity with extraperi-
toneal mesh placement; Lichtenstein procedure was defined The Maxwell test statistic was not significant (P .852),
as open tension-free mesh hernia repair; open preperitoneal indicating that the raters (assigned with study selection) did not
mesh (OPM) was defined as open preperitoneal mesh repair, disagree significantly. The generalized McNemar statistic (P
including the Stoppa technique and giant prosthetic rein- .56) indicated that the agreement was spread evenly.
forcement of the visceral sac. Seven comparative and 5 RCTs were ascertained fina-
lly.1,19 29 The literature search and study selection process
therefore yielded 12 studies with 1,542 enrolled patients.
Data analysis All studies provided a minimum follow-up period of at least
18 months. Four studies provided a mean/median follow-up
A formal systematic review (according to the guidelines period of more than 5 years 1 longer than 4 years 3 longer
of the QUOROM statement)30,31 was performed for all than 3 years, and 2 longer than 2 years.
randomized controlled trials (RCTs) and comparative stud- The foremost randomized controlled study restrictions
ies concerning laparoscopic versus open recurrent hernia were relevant as follows: (1) validation of sample size; in
repair. The primary outcomes used for this study were as only 2 of the studies1,27 was a power analysis performed
follows: (1) preoperative complications, (2) early recur- (although 1 study25 would have validated its results because
rence, and (3) overall recurrence. of the large number of patients per treatment arm), and (2)
Studies with 3 treatment arms27 were treated as being 2 disclosure of the number of drop-outs: 2 of 5 studies pro-
separate studies for outcome measures. vided complete data.23,27 Among the comparative studies 5
were retrospective and only 2 were prospective.
Missing data limited the analysis only to these outcomes
Statistical analysis about which trials granted comprehensive information. Base-
line characteristics of patients and results for various outcome
The Maxwell test statistic and the generalized McNemar measures in the included trials are summarized in Table 1.
statistic were calculated to quantify the level of agreement
between reviewers. Pooled estimates of outcomes were cal- Outcomes. By enclosing 5 RCTs and 7 comparative studies
culated using a fixed-effects model but a randomized-effects for recurrent inguinal hernia repair 14 comparisons were
model was used according to heterogeneity. For dichoto- conducted with regard to the following: (1) TEP versus
mous data, results for each trial were expressed as an odds Lichtenstein (Table 2); (2) laparoscopic versus Lichtenstein
ratio (OR), relative risk (RR), with 95% confidence inter- (Table 3); (3) laparoscopic versus OPM (Table 4); (4) lapa-
vals (CIs). Tests for heterogeneity and overall effect were roscopic versus open (Lichtenstein/OPM) (Table 4); and (5)
provided for each total or subtotal. TAPP versus TEP (Table 4). Comparisons between TAPP
The MosesShapiroLittenberg method was applied to versus Lichtenstein, TEP versus OPM, and TAPP versus
explore sources of heterogeneity by adding covariates to the OPM were not conducted because of insufficient data pro-
model. Where there was a threshold effect (suspicion for vided by the investigators.
heterogeneity), the summary of study results was performed The TEP group was equivalent to the Lichtenstein group
by a receiver operating characteristics curve. Bootstrap CIs in comparisons related to the following outcomes: wound
were used to estimate the range of uncertainty for a given infection, hematoma/seroma, urinary retention, and the RR
test statistic and to generate the lower and upper 95% of overall recurrence (Fig. 2 and Table 2).
Heterogeneity among studies in terms of hematoma/se-
confidence limits.
roma formation (P .007/I2 75.1%) was observed and
Bias was studied using sensitivity analysis by removing
this finding was analyzed further by the MosesShapiro
individual studies from the data set and analyzing the over-
Littenberg method (see paragraph analyzing heterogeneity).
all effect size and the weighted regression tests described by
Funnel plots did not detect any obvious publication bias
Egger et al.32 Results were significant if the P value was less concerning all outcomes.
than .5. The RevMan Version 4.2,33,34 the Statsdirect ver- The laparoscopic groups were comparable with the Lich-
sion 2.6.5, the Meta Disk version 1.4,35 and Meta-Win tenstein group in relation to the following outcomes: wound
version 2.136 were used for the data analysis. infection, urinary retention, testicular pain/discomfort, pain/
neuralgia, and the RR of early and overall recurrence (Fig.
Study quality assessment. According to the Cochrane 3 and Table 3). Significantly fewer cases with hematoma/
Handbook for Systematic Reviews of Interventions 4.2.6,34 seroma formation were observed in the laparoscopic group.
high-quality RCTs were designated as A, low-quality but This outcome was evaluated by the random-effects model
randomized controlled studies were designated as B, and owing to significant heterogeneity, which also was analyzed
comparative studies were designated as C, taking into further (see paragraph analyzing heterogeneity). Funnel
account the way these studies deal with allocation conceal- plots and normal quantile plots did not detect any obvious
ment information. publication bias concerning all outcomes.
294 The American Journal of Surgery, Vol 200, No 2, August 2010

Table 1 Baseline characteristics of patients included in the meta-analysis


Bilateral Wound Hematoma/ Testicular pain/ Pain/ Urinary Urinary Early Overall
Study Group N Age, y M/F recurrence infection seroma discomfort neuralgia retention infection recurrence recurrence

Feliu et al25 TEP 86 57.2 10.8 77/1 8 2 13 2 5 5 1 NR 1


OPM 121 57.8 13.2 105/5 11 0 10 1 1 0 0 NR 2
Alani et al26 TEP 45 60 42/3 7 0 5 NR NR NR NR NR 0
OPM 54 64 51/3 9 0 12 NR NR NR NR NR 0
Dedemadi TEP 26 NR 26/0 1 0 3 3 1 1 NR 0 2
et al27* Lichtenstein 32 NR 32/0 2 1 12 1 2 1 NR 2 5
Dedemadi TAPP 24 NR 24/0/ 1 0 4 0 1 1 NR 1 2
et al27* Lichtenstein 32 NR 32/0 2 1 12 1 2 1 NR 2 5
Eklund et al28 TAPP 73 52 10.4 73/0 NR 1 5 0 NR 7 1 NR 12
Lichtenstein 74 55 11.3 74//0 NR 2 17 3 NR 10 1 NR 12
Kouhia et al29 Lichtenstein 47 55.8 46/1 0 4 6 NR NR NR NR NR 3
TEP 49 57.8 47/2 2 1 13 NR NR NR NR NR 0

NR not reported.
*RCTs with 3 treatment arms and subsequently 2 comparisons.

When comparing the laparoscopic and the OPM groups, threshold effect was examined by calculating the Spearman
results in terms of hematoma/seroma formation were similar correlation coefficient. No inverse correlation was observed
(Table 4). Sensitivity analysis disclosed that the study by (.000; P 1.000), putting the presence of heterogeneity in
Alani et al26 contributed to the noncombinability of the question. The study by Richards et al24 showed a marginal
studies (P .009, I2 74%). By omitting this study the sensitivity by using resampling tests and bootstrapping to
OPM treatment arm presented fewer cases of hematoma/ generate CIs around the overall cumulative mean effect size
seroma formation (pooled OR, 2.6; 1.49 4.51; P .001). (OR, .4507; bootstrap CI, 1.2274 to .4889).
Funnel plots did not detect any obvious publication bias.
There was no significant difference in terms of urinary Laparoscopic versus Lichtenstein (hematoma/seroma). Het-
infection between the laparoscopic and open treatment arms erogeneity among studies was observed (P .001/I2
(Table 4). Neither heterogeneity nor publication bias was 64.4%), and the threshold effect was examined by calculat-
present. ing the Spearman correlation coefficient. No inverse corre-
The RR of overall recurrence was less in the TEP treat- lation was observed (.754; P .084), putting the presence
ment arm when compared with that of TAPP. Heterogeneity of heterogeneity in question. Resampling tests derived from
and publication bias were absent. 999 iterations and bootstrapping were used to generate CIs
around the overall cumulative mean effect size (OR, .6546;
Analyzing heterogeneity. bootstrap CI, 1.1005 to .0266).

TEP versus Lichtenstein (hematoma/seroma). Heterogeneity Laparoscopic versus OPM (hematoma/seroma). Significant
among studies was observed (P .007/I2 75.1%) and the heterogeneity among studies was observed (P .009/I2

Table 2 Comparisons of outcomes between TEP and Lichtenstein

Test for
overall Publication bias Study Favors
Outcome/subgroup Studies N Effect estimate (95% CI) Heterogeneity effect (indicator/P value) quality group
Wound infection 3 294 FE, OR .49 (.122.0) P .379 2 .48 Harbold-Egger: 2A None
bias .84
I2 0% P .489 P .786 1C
Hematoma/seroma 4 344 RE, OR .43 (.091.91) P .007 2 1.24 Egger: 2A None
bias 3.3
I2 75.1% P .264 P .427 2 C
Urinary retention 3 248 FE, OR .47 (.092.42) P .733 2 .3 Egger: bias .3 1 A None
I2 0% P .580 P .923 2 C
Overall recurrence 4 344 FE, RR .48 (.181.33) P .531 2 1.97 Egger: bias .16 2 A None
I2 0% P .160 P .943 2 C
The P values of comparisons are given in the column labeled Test for overall effect and the group favored is depicted in the column labeled Favors
group.
FE fixed-effects model; RE random-effects model; A high-quality studies; C comparative studies.
G. Dedemadi et al. Laparoscopic versus open mesh repair 295

Table 3 Comparisons of outcomes between laparoscopic procedures and Lichtenstein


Test for
overall Publication Bias Study
Outcome/subgroup Studies N Effect estimate (95% CI) Heterogeneity effect (indicator/P value) quality Favors group
Wound infection 5 497 FE, OR .48 (.151.43) P .74 2 1.03 Egger: bias 1.34 4 A None
I2 0% P .30 P .594 1C
Testicular pain/ 3 261 FE, OR .94 (.253.53) P .25 2 .06 Harbold-Egger: 3 A None
discomfort bias 3.75
I2 27% P .80 P .4013
Urinary retention 5 451 FE, OR .65 (.281.47) P .91 2 .69 Egger: bias .09 3 A None
I2 0% P .4 P .87 2 C
Hematoma/seroma 6 547 RE, OR .38 (.15.96) P .01 2 4.16 Egger: bias 2.28 4 A Laparoscopic
I2 64% P .04 P .451 2 C
Pain/neuralgia 3 261 FE, OR .63 (.271.47) P .99 2 .74 Harbold-Egger: 3 A None
bias 4.49E03
I2 0% P .39 P .9553
Early recurrence 4 304 FE, RR .73 (.212.51) P .77 2 .23 Egger: bias .54 2 A None
I2 0% P .62 P .874 2 C
Overall recurrence 7 706 FE, RR .72 (.451.15) P .75 2 1.97 Egger: bias .64 5 A None
I2 0% P .16 P .331 2 C
The P values of comparisons are given in the column labeled Test for overall effect and the group favored is depicted in the column labeled Favors
group.
FE fixed-effects model; RE random-effects model; A high-quality studies; C comparative studies.

74%), and this threshold effect was evaluated by calculating term laparoscopic (TAPP/TEP) or open repair (Lich-
the Spearman correlation coefficient. An inverse correlation tenstein/OPM)). Probability between studies was .287 and
was observed (.400; P .6) confirming the stated heter- within studies was .076. The total model probability was
ogeneity. A sensitivity analysis disclosed that the study by .088, justifying our comparisons.
Alani et al26 contributed to the noncombinability of the
studies. By omitting this study, the OPM treatment arm
presented fewer cases of hematoma/seroma formation.
Comments
Validating our model of comparisons. Randomization
tests were used to test the significance of our model struct- A meta-analysis of RCTs and comparative studies con-
ure (pooling the effects of different procedures under the cerning patients treated for recurrent inguinal hernia with

Table 4 Comparisons of outcomes between laparoscopic and open procedures and TAPP versus TEP

Test for overall Publication bias Study Favors


Outcome/subgroup Studies N Effect estimate (95% CI) Heterogeneity effect (indicator/P value) quality group
Laparoscopic versus
OPM
Hematoma/seroma 4 530 RE, OR 1.86 (.685.07) P .009 2 1,46 Egger: bias 1.44 1 A None
I2 74% P .226 P .8833 3C
Laparoscopic versus
open
Urinary infection 3 433 FE, OR 2.67 (.5113.9) P .716 2 .68 Harbold-Egger: 2 A None
bias 2.48
I2 0% P .40 P .608 1C
TAPP versus TEP
Overall recurrence 3 407 FE, RR 3.25 (1.327.9) P .186 2 6.58 Harbold-Egger: 1 A TEP
bias .96
I2 40.4% P .01 P .6327 2C
The P values of comparisons are given in the column labeled Test for overall effect and the group favored is depicted in the column labeled Favors
group.
FE fixed-effects model; RE random-effects model; A high-quality studies; C comparative studies.
296 The American Journal of Surgery, Vol 200, No 2, August 2010

If we confine the search to the English language litera-


ture this could represent a potential publication bias during
the review process; however, when going through the ab-
stracts, no suitable studies were found in the non-English
language literature. The HarboldEgger test was used to
maintain the power of the Egger test in reducing the false-
positive rate, which was a problem in cases of large treat-
ment effects and few events per trial.
In our effort to make an overall judgment of the external
validity of this meta-analysis the outcomes were balanced
with those of a Cochrane database systematic review (41
eligible trials involving 7,161 participants) concerning the
application of laparoscopic techniques versus open tech-
niques for primary inguinal hernia repair.37 There was no
apparent difference in recurrence between laparoscopic and
Figure 2 Meta-analysis of the RR of overall recurrence in stud- open mesh methods of hernia repair in this study either.
ies addressing TEP versus Lichtenstein. Moreover, the prominent advantage of the present meta-
analysis is the analysis of heterogeneity and the validation
of the results by randomization tests and bootstrapping.
laparoscopic procedures were comparable, in most of the There also were some limitations in this meta-analysis.
analyzed outcomes, with patients treated with open mesh Important clinical issues such as quality of life and return to
repair. Significantly fewer cases of hematoma/seroma for- normal physical activity were not evaluated because of the
mation were observed in the laparoscopic group in compar- paucity of comprehensive data among studies. It would be
ison with the Lichtenstein group. A matter of importance is more apposite should this analysis contain comparisons
the higher RR of overall recurrence in the TAPP group between each laparoscopic group separately with the open
compared with the TEP group, whereas the RR of overall approaches, nevertheless only 2 studies in each outcome
recurrence of the laparoscopic versus the Lichtenstein group provided satisfactory data, which could not guarantee the
was comparable. appropriateness of the outcome in terms of heterogeneity
Potential heterogeneity of evaluating studies collectively and publication bias.
either in the open or the laparoscopic group was assessed. The major reasons for considering collectively the pa-
Noncompatibility of the studies was present only in 3 cases, tients of the laparoscopic approaches as a single group are
all concerning the outcome of hematoma/seroma formation. that the surgical field and handling of the tissues (dissection
Sensitivity analysis disclosed the 2 studies contributing to of the cord/round ligament and clip placement) are similar
heterogeneity. In the third case the presence of heterogene- in both procedures and the anticipated postoperative com-
ity was rejected by the MosesShapiroLittenberg method. plications (testicular pain/discomfort, pain/neuralgia, hema-
Randomization tests were used to test the significance of toma/seroma, and urinary retention) are potentially analo-
this model structure (pooling the effects of different tech- gous. In support of this is the current evidence provided by
niques), showing no significant probability, which justified a Cochrane database systematic review38 in which no ob-
vious differences were observed between TAPP and TEP
our comparisons.
concerning hematoma, vascular injuries, deep mesh infec-
When considering the completeness and applicability of
evidence, the included studies provided satisfactory data to
address the issues properly including complications and
recurrence. In addition, their inclusion criteria (adult popu-
lation undergoing recurrent hernia repair, elective surgeries,
Nyhus class IIIII hernias) appeared to be almost identical,
thus ensuring comparable types of analyzed interventions
and outcomes.
Making allowances for the quality of the evidence, the 12
included studies had a total of 1,542 participants, with good
methodologic quality (5 RCT and 2 prospective studies).
Only 3 of 12 studies that were analyzed were sufficiently
powered to document their findings.1,27,28 Significant but
explicable heterogeneity was revealed in only 3 of 14 com-
parisons without the presence of publication bias. Modern
meta-analytic techniques declined heterogeneity of studies Figure 3 Meta-analysis of the RR of overall recurrence in stud-
in 2 of the 3 cases. ies addressing laparoscopic repairs versus Lichtenstein.
G. Dedemadi et al. Laparoscopic versus open mesh repair 297

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