Hernia (2019) 23:461–472

https://doi.org/10.1007/s10029-019-01989-7

REVIEW

Open versus laparoscopic mesh repair of primary unilateral

uncomplicated inguinal hernia: a systematic review
with meta‑analysis and trial sequential analysis
N. L. Bullen1   · L. H. Massey1 · S. A. Antoniou2,3 · N. J. Smart1 · R. H. Fortelny4,5

Received: 17 May 2019 / Accepted: 20 May 2019 / Published online: 3 June 2019
© Springer-Verlag France SAS, part of Springer Nature 2019

Abstract
Background  One standard repair technique for groin hernias does not exist. The objective of this study is to perform an update
meta-analysis and trial sequential analysis to investigate if there is a difference in terms of recurrence between laparoscopic
and open primary unilateral uncomplicated inguinal hernia repair.
Methods  The reporting methodology conforms to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-
Analyses) guidelines. Randomised controlled trials only were included. The intervention was laparoscopic mesh repair
(transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP)). The control group was Lichtenstein repair. The
primary outcome was recurrence rate and secondary outcomes were acute and chronic post-operative pain, morbidity and
quality of life.
Results  This study included 12 randomised controlled trials with 3966 patients randomised to Lichtenstein repair (n = 1926)
or laparoscopic repair (n = 2040). There were no significant differences in recurrence rates between the laparoscopic and
open groups (odds ratio (OR) 1.14, 95% CI 0.51–2.55, p = 0.76). Laparoscopic repair was associated with reduced rate of
acute pain compared to open repair (mean difference 1.19, CI − 1.86, − 0.51, p ≤ 0.0006) and reduced odds of chronic pain
compared to open (OR 0.41, CI 0.30–0.56, p ≤ 0.00001). The included trials were, however, of variable methodological
quality. Trial sequential analysis reported that further studies are unlikely to demonstrate a statistically significant difference
between the two techniques.
Conclusion  This meta-analysis and trial sequential analysis report no difference in recurrence rates between laparoscopic
and open primary unilateral inguinal hernia repairs. Rates of acute and chronic pain are significantly less in the laparoscopic
group.

Keywords  Inguinal hernia · Lichtenstein · TAPP · TEP

Introduction

The article is part of the Topical Collection “Forum on primary

monolateral uncomplicated inguinal hernia”.
Electronic supplementary material  The online version of this
article (https​://doi.org/10.1007/s1002​9-019-01989​-7) contains
supplementary material, which is available to authorized users.
Lifetime occurrence of groin hernia is 27–43% in men and
3–6% in women [1]. One standard repair technique for all
groin hernias does not exist. Mesh repair is recommended
as first choice either by an open procedure or laparoscopic

3
* N. L. Bullen European University Cyprus, Nicosia, Cyprus
n.bullen@nhs.net 4
Department of General, Visceral and Oncological Surgery,
1 Wilhelminenspital, 1160 Vienna, Austria
Department of Colorectal Surgery, Royal Devon and Exeter
5
NHS Foundation Trust, Royal Devon and Exeter Hospital, Medical Faculty, Sigmund Freud University, Freudplatz 3,
Barrack Road, Exeter EX2 5DW, UK 1020 Vienna, Austria
2
Surgical Department, St Loukas Hospital, Thessaloniki,
Greece

13
Vol.:(0123456789)

462
technique providing the surgeon is sufficiently experienced
in the specific procedure [2]. The Lichtenstein technique is
considered the reference standard for open inguinal hernia
repair [3]. Recurrence rates are reported to be less than 1%
[3, 4]. Morbidity is mainly related to chronic pain which
can occur in up to 63% of patients and affects quality of life
in 5–10% [5]. The increase in laparoscopic inguinal hernia
repairs has largely aimed at reducing rates of chronic pain
without compromising recurrence rates.
Evidence from previous meta-analyses is contradictory.
Laparoscopic repair with both transabdominal preperitoneal
(TAPP) and totally extraperitoneal (TEP) has significantly
reduced rates of chronic pain [6–10] and has improved
patient satisfaction [9]. However, TEP has been shown to
be associated with an increased risk of recurrence com-
pared to open surgery [6], specifically when follow-up data
exceeded 3 years [7]. TAPP is linked to an increased risk
of perioperative complications compared to open surgery
[6]. More recent studies have shown equivalent recurrence
rates [8, 10].
Some of the previous analyses had methodological short-
comings such as small numbers of randomized controlled
trials [8] and inclusion of trials of short follow-up duration
[9] and since the 2014 meta-analysis, three further rand-
omized controlled trials have become available.
The objective of this study is to perform an update meta-
analysis to investigate if there is a difference in terms of
recurrence and post-operative pain between laparoscopic and
open primary inguinal hernia repair, furthermore, to per-
form a trial sequential analysis and investigate whether the
required information size has been reached and evidence is
conclusive, or alternatively compute the number of patients
required to be enrolled in further trials.
Methods
The protocol for this systematic review was established
prior to initiation of the study and was registered under the
number CRD42019125335 in the International Prospective
Register of Systematic Reviews (PROSPERO) database
[11]. The reporting methodology conforms to the PRISMA
(Preferred Reporting Items for Systematic reviews and Meta-
Analyses) guidelines (Online Appendix 4) [12].
Eligibility criteria, study selection and search
strategy
Randomised controlled trials only were included compar-
ing laparoscopic versus open mesh repair for primary ingui-
nal hernia. No other study design was considered. Studies
enrolling patients aged over 16 years with primary unilateral
inguinal hernias were included. Studies were excluded if
13
Hernia (2019) 23:461–472
follow-up duration was less than 12 months and if hernias
were recurrent or bilateral. As some studies included small
amounts of data on these patients and might introduce heter-
ogeneity into analyses, it was decided to exclude those where
the proportion of recurrent or bilateral hernias was more
than 10% of the total. The intervention was any technique
of laparoscopic mesh repair, including both transabdominal
preperitoneal (TAPP) and totally extraperitoneal (TEP). The
control group was open mesh repair with the Lichtenstein
technique.
The electronic databases of Embase, Medline through
PubMed, the Cochrane Central Register of Controlled Tri-
als (CENTRAL, provider Wiley Online Library) and Open-
Grey were searched from their inception until April 2019.
A combination of the following MeSH terms (Medical Sub-
ject Headings) were used: “Inguinal”, “Groin”, “Hernia”,
“Herniorrhaphy”, “Mesh”, “Prosthetic material”, “Lichten-
stein”, “Laparoscopic”, “Endoscopic”, “Transabdominal
Preperitoneal” (TAPP), and “Totally Extraperitoneal” (TEP)
(Online Appendix 1). Randomised trials were searched for
using the Cochrane highly sensitive strategies for identify-
ing randomised trials [13]. No language restrictions were
applied. Eligibility assessment was performed independently
in an unblinded standardised manner by two reviewers. Disa-
greements were resolved by consensus.
Data collection
Two independent reviewers were involved in the study selec-
tion (NB, LM). Reviewers were blinded to studies selected
for inclusion by the other reviewer. Discrepancies were
resolved by a third party (NJS). Bibliographic references
of published studies and reviews were also interrogated.
Data were extracted using a standardised data collection
form. One reviewer extracted the data (NB) and the second
reviewer checked the extracted data (LM).
The primary outcome measure was hernia recurrence.
Data related to the primary outcome measure were collected
from the abstract, main text, tables or graphs. The method
for diagnosis recurrence was documented (clinical or radio-
logical) and the duration of follow-up.
The secondary outcome measures were short- and long-
term post-operative pain, re-operation rate, surgical site
infection, surgical site occurrence (haematoma/seroma) and
quality of life. The time intervals for short-term assessment
of post-operative pain were defined as up to 30 days. Longer-
term follow-up for chronic pain was greater than 6 months.
The ICD-11 (International Classification of Diseases) defi-
nition of chronic pain is pain lasting longer than 3 months
[14]. However, as the usage of synthetic materials for hernia
repair may lengthen the inflammatory response, chronic pain
is defined as pain lasting more than 6 months [15]. Most
studies were expected to assess post-operative pain using the
Hernia (2019) 23:461–472 463

Fig. 1  PRISMA flow chart of

search history and study selec-

Idenficaon
tion Records identified through Additional records identified
database searching through other sources
(n = 146) (n = 3)

Records after duplicates removed

(n = 83)

Screening
Records screened Records excluded
(n = 83) (n = 45)

Full-text articles assessed Full-text articles excluded,

for eligibility with reasons
Eligibility

(n = 38) (n = 18)
14 = included too many
recurrent/bilateral hernia
3 = F/u too short
Studies included in 1 = not relevant
qualitative synthesis
(n = 20)
Included

Unique studies included in

quantitative synthesis
(meta-analysis)
(n = 12)

mean visual analogue scale (VAS) from 0 to 10. VAS scores
ranging from 0 to 100 were converted to an 11-scale climax.
Descriptive data on soft tissue collection/seroma/haematoma
(such as method of diagnosis) were documented.
Synthesis of results
The presence of heterogeneity was evaluated by assess-
ing the consistency of study population, intervention,
perioperative care characteristics and method of outcome
assessment, by inspecting the forest plots, and by com-
puting the I2 values. A random effects model according
to DerSimonian and Laird was applied to synthesise data
irrespective of statistical heterogeneity as we considered
pooling preperitoneal with transperitoneal techniques
and various duration of follow-up to introduce concep-
tual heterogeneity. Difference in means (MD) with 95%
confidence intervals (CIs) was calculated to assess the
size of the effect of the use of laparoscopic or open mesh
repair on continuous variables. The standard error and
standard deviation were obtained from CIs by using the
formula suggested by the Cochrane Collaboration [16].
Pooled odds ratios (ORs) with 95% CIs were calculated to
measure the effect of each type of procedure on dichoto-
mous variables. Publication bias was assessed visually
evaluating the symmetry of funnel plots if at least ten tri-
als were included in the meta-analysis. Statistical analysis
was performed using RevMan 5.3 (Review Manger 5.3,
The Nordic Cochrane Centre, Copenhagen, Denmark).
Sensitivity analyses calculating the risk difference were
performed if one or more studies reported zero events in
both arms. Subgroup analyses of studies comparing open
mesh repair versus TAPP or TEP were performed.
Trial sequential analysis was performed to assess the
possibility of type I error and to compute the information
size. The Lan and DeMets method was used to construct
monitoring boundaries and set adjusted thresholds for sta-
tistical significance [17]. The information size was calcu-
lated at α = 0.05, β = 0.2, relative risk reduction of 50%
and a cumulative incidence of chronic post-operative pain
of 5.2% based on trials at low risk of bias, defined as out-
come assessment by a blinded investigator. The Z-value
curve was constructed based on consecutive Z-values
calculated upon two-sided significant testing. Trial
sequential monitoring boundaries were constructed using

13

464
Fig. 2  a Risk of bias graph. b
Risk of bias summary
conventional testing and applying the O’Brien-Fleming
α-spending function [18]. Futility testing was performed
and the respective futility boundaries were constructed to
assess whether the two interventions differ more than the
anticipated intervention effect. Trial sequential analysis
was performed using The Trial Sequential Analysis soft-
ware 0.9.5.10 Beta (Copenhagen Trial Unit, Copenhagen,
Denmark).
Methodological assessment
Risk of bias of the included studies was assessed using
Cochrane Collaboration’s tool [19]. This tool considers ran-
dom sequence generation, allocation concealment, blinding
of participants, personnel and outcome assessors; incom-
plete outcome data, selective outcome reporting and other
potential threats to validity.
Results
Study selection and quality assessment
The searches of the electronic databases retrieved 146
records. After the exclusion of duplicates, 83 titles and
abstracts remained for screening. From these, 38 articles
13
Hernia (2019) 23:461–472
were selected for full-text review. There was satisfactory
agreement between the reviewers (NB & LM) with eight
articles causing conflict, which were resolved by a third
reviewer (NJS) and one of these was subsequently included.
A total of 20 articles reporting on randomised controlled tri-
als (RCTs) fulfilled the eligibility criteria and were included
in the qualitative analysis. Five trials reported short- and
long-term follow-up across several papers (between two
and four separate papers); overall, 12 unique studies were
included in the quantitative analysis. The literature search
processes are summarised in Fig. 1. Search strategies can
be found in Online Appendix 1. The risk of bias assess-
ment of articles that were judged to be of acceptable or high
quality is illustrated in Fig. 2a, b. None of the trials were
patient-blinded.
Study characteristics
The twelve included RCTs were published between 1997 and
2019 and all were written in the English language. A total
of 3966 patients were included, randomised to Lichtenstein
repair (n = 1926) or laparoscopic repair (n = 2040). (Lapa-
roscopic repair included TAPP n = 387 and TEP n = 1653.)
Study characteristics are summarised in Table 1. Half of the
trials included only male patients and of the others report-
ing sex of patients: 93% were male. Duration of follow-up
 Table 1  Characteristics of included studies
Authors Year Country Num- Surgeon Male/ Proportion Number Number Type of Follow-up Patients Primary Definition of
(refer- ber of experience female recurrent/ of patients of patients mesh (months) lost to Outcome primary out-
ences) centres ratio bilateral Lichten- laparo- follow-up come
hernia stein scopic (%)
technique
Hernia (2019) 23:461–472

Sevi̇nç 2019 Turkey 1 > 100 TEP 273:29 0 160 160 TEP Polypro- Mean 5.6 Chronic Pain
[20] pylene 40.95 ± 17.9 groin for > 3 months
pain
Koju [21] 2017 Nepal 1 NR NR 7.8% 51 51 TAPP NR 12 NR Post- Pain at 24 h
operative
pain
Westin/ 2016/2013 Sweden 2 NR All male 0 191 193 TEP Polypro- 12 2.3 Chronic Any pain at
Dahl- pylene groin 1 year
strand heavy- pain
[22, 23] weight
Wang [24] 2013 China 1 > 20 TEP/ 210:42 NR 84 TAPP 84 Polypro- Mean 16 3.6 Primary NR
TAP TEP 84 pylene (3–32) outcome
light- not
weight stated
Eker/Lan- 2012/2010 Nether- 6 > 30 TEP 649:11 8.1% 317 323 TEP Polypro- Median 60 24.7 Post- Pain up to
geveld lands pylene (27–69) operative 2 weeks post
[25, 26] pain surgery
Eklund 2010/2009/2006 Sweden 11 > 25 TEP All male 0 705 665 TEP Polypro- Median 61 7 Recur- Expansile cough
[27–29] pylene (53–109) rence impulse
Pokorny 2008 Austria 12 > 30 TEP 185:13 0 69 TAPP 93, Polypro- 36 7 Recur- NR
[30] and TEP 36 pylene rence
TAPP
Butters/ 2007/2004 Germany 1 > 100 All male 0 93 94 TAPP NR Median 52 16 Recur- NR
Köninger TAPP (46–60) rence
[31, 32]
Lau [33] 2006 China 1 > 200 TEP All male 0 100 100 TEP Polypro- 12 13 Recur- Reducible ingui-
pylene rence, nal swelling.
light- post- Pain: NR
weight operative
pain,
chronic
pain
Heikkinen 2014/1998/1997 Finland 2 NR 120:3 3.3% 61 TAPP 40, Polypro- Mean 72 1.6 Cost and Cost analysis
[34–37] TEP 22 pylene short- detailed
light- term out-
weight comes

13
465

466 Hernia (2019) 23:461–472

ranged from 12 months to 5 years. All trials reported only

Overall hospi-

bulge in groin
the use of polypropylene mesh for both laparoscopic and

Operative Pain 12/24 h.

Definition of
primary out-

Recurrence:
open repairs.

tal cost
Hernia recurrence was measured as a primary outcome
come

measure in four trials [27, 30, 31, 33]: two reported primar-
ily chronic pain [20, 22], two post-operative pain [21, 25],

term out-

outcome
Outcome

one operative time [38] and one cost [34]. Most of the trials

comes,
Primary

Primary
short-

stated
time,

cost
only included patients with primary unilateral inguinal her-

not
nia except for three trials where the proportion of bilateral
or recurrent hernias was less than 10% of the total patients
follow-up
Patients

[21, 25, 34].

lost to

12.1
Two studies were multi-arm trials with Pokorny et al. [30]
(%)

NR

reporting a three-arm trial (Lichtenstein, TAPP and Shoul-

dice repair) and Butters et al. [31] reporting a five-arm trial
Median 18
Mean 13.5
Follow-up

(Lichtenstein, Bassini, Shouldice, TAPP and TEP). Both

(months)

(8–28)

these trials clearly reported data for the separate groups,

and hence for the purpose of this meta-analysis, the patients
receiving Shouldice and Bassini repairs were excluded.
Polypro-

Polypro-

weight
pylene

pylene
Type of

Additional details on the individual trials methodology is

light-
mesh

reported in Table 2 (Online Appendix 2).

of patients

technique

25 TAPP
Number

70 TEP
laparo-

Data synthesis
scopic

Recurrence
of patients
Lichten-
Number

stein

25

70

Recurrence rates were reported in all 12 trials over a range

from 1 to 5 years. Recurrence was specifically defined by
Proportion
recurrent/

two trials as a reducible swelling in the groin and one as

bilateral
hernia

the presence of an expansile cough impulse. The rest of the

trials did not define recurrence. Most trials assessed hernia
0

recurrence by clinical examination with ultrasonography if

All male

All male

inconclusive. A total of 3623 patients were analysed and

experience female
Male/

ratio

there were no significant differences in effects (OR 1.14, CI

0.51–2.55, p = 0.76) (Fig. 3). There was some evidence of
between-study heterogeneity (I2 = 58%). The funnel plot did
Surgeon

not suggest the presence of publication bias (Fig. 4).

NR

NR

Sensitivity analysis for recurrence rates was performed

and found similar results (risk difference 0.0, CI − 0.01,
centres

0.02, p = 0.74). This has allowed the inclusion of studies

ber of
Num-

that reported a zero recurrence rate hence providing a more

accurate analysis (Fig. 5).
Country

To account for zero events in the subgroup analysis com-

Turkey

Turkey

paring TAPP versus TEP, we performed sensitivity analysis

calculating the risk difference. The test for subgroup dif-
ferences suggested no statistically significant difference
in effects of TAPP versus TEP with regard to recurrence
(χ2 = 0.91, p = 0.34, I2 = 0%) (Fig. 6).
Table 1  (continued)

2004

2003
Year

NR Not recorded

Post‑operative pain
Authors

Anadol

Gokalp

Acute post-operative pain was reported in ten trials with

ences)
(refer-

[38]

[39]

mean VAS scores reported at 24 h in five trials. However,

13
Hernia (2019) 23:461–472 467

Fig. 3  Forest plot of odds ratio for recurrence between laparoscopic and standard mesh for open inguinal hernia. M-H Mantel–Haenszel, CI con-
fidence interval

pain was 3445. Laparoscopic repair was associated with

reduced odds of chronic pain compared to open repair (OR
0.41, 95% CI 0.30–0.56, p ≤ 0.00001) (Fig. 8). There was
moderate between-study heterogeneity (I2 = 33%). Visual
inspection of the funnel plot did not suggest the presence of
publication bias (Fig. 9).
VAS scores for chronic pain were reported by two trials
but specifically mean VAS score was only reported by one
trial.

Other results

Results for wound complications and re-operation rates are

displayed in Online Appendix 3. Quality of life was not
Fig. 4  Funnel plot of treatment effect estimates against the standard
error of the treatment effect for recurrence reported using the same validated questionnaires so could
not be analysed.

only four reported the standard deviations and so could be

Trial sequential analysis
included in the analysis. The number of patients followed up
for acute pain in the analysis was 672. Laparoscopic repair
The Z-curve crosses the futility boundaries; further studies
was associated with reduced rate of acute pain compared to
are thus highly unlikely to demonstrate a statistically signifi-
open repair (MD 1.19, 95% CI − 1.86, − 0.51, p ≤ 0.0006)
cant effect between the two techniques (Fig. 10).
(Fig. 7). There was evidence of substantial between-study
heterogeneity (I2 = 96%).

Chronic pain Discussion

Chronic pain was reported in 12 trials. The definition of This meta-analysis of randomised controlled trials provides
chronic pain was variable and most studies did not provide up-to-date evidence on the comparative effect of laparo-
a definition. Rates of chronic pain were analysed between 1 scopic and open mesh repair of primary unilateral ingui-
and 5 years. The number of patients followed up for chronic nal hernia. It included 12 studies and 3966 patients and

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468 Hernia (2019) 23:461–472

Fig. 5  Forest plot of the sensitivity analysis of recurrence rates between the laparoscopic and open repairs. M-H Mantel–Haenszel, CI confidence
interval

Fig. 6  Forest plot of the sensitivity analysis of recurrence rates between TAPP and TEP and open repairs. M-H Mantel–Haenszel, CI confidence
interval

demonstrated no difference with respect to recurrence rates.
However, rates of chronic pain were significantly less within
the laparoscopic groups.
These findings are important when the surgical commu-
nity reflects on current guidelines [2] and their adoption into
practice. It is noteworthy that in the UK, only approximately
20% of primary unilateral inguinal hernias are repaired
laparoscopically with wide variations between hospitals
[40]. The findings of this review regarding recurrence and
chronic pain are concordant with those from registry studies
on primary unilateral inguinal hernia [10], which suggests a
degree of external validity.
In contrast to previous meta-analyses published on this
topic, this study focused on primary unilateral inguinal her-
nia. Studies with greater than 10% rate of bilateral or recur-
rent hernias were excluded from analysis. This is important
as recurrence rates for primary recurrent hernia have been
quoted at 15% [2]. In addition, this analysis has grouped TEP
and TAPP for synthesis. This is because evidence shows
they have similar complication risks, post-operative acute

13
Hernia (2019) 23:461–472 469

Fig. 7  Forest plot of the mean difference for visual analogue scale (VAS) for acute pain between laparoscopic and open mesh repair for inguinal
hernia. CI confidence interval

Fig. 8  Forest plot of odds ratio for chronic pain between laparoscopic and standard mesh for open inguinal hernia. M-H Mantel–Haenszel, CI
confidence interval

and chronic pain incidence and recurrence rates [2]. Sub-

group analysis was in line with this finding, as it does not
suggest significant difference between the two techniques
with regard to recurrence. Other strengths of this review
include prior registration with the PROSPERO database
prior to commencement, hence minimising reporting bias.
There were no deviations from the protocol and a formal
assessment of publication bias has been performed by way
of funnel plots.
The results of this systematic review and meta-analy-
sis are limited by the methodological inadequacies of the
included randomised studies relating to their design, conduct
and statistical analysis that are covered in the “other bias”
Fig. 9  Funnel plot of treatment effect estimates against the standard
section of the Cochrane risk of bias assessment (Fig. 2a, b).
error of the treatment effect for chronic pain

13

470
Fig. 10  Trial sequential analysis
This necessitates some caution when interpreting the find-
ings of the review.
Randomised trials exist on a continuum from those that
are explanatory to those that are pragmatic [41]. In surgery
and other complex interventions, pragmatic studies are to be
favoured as they investigate effectiveness (i.e. what happens
to the average patient in the hands of the average surgeon)
and reflect quotidian practice. Studies that are confined to a
low number of centres lack generalisability and cannot reli-
ably investigate effectiveness due to inherent systemic biases
within the health care unit (usually hospital) and the limited
number of surgeons involved. Only three studies could truly
be considered multicentre [25, 27, 30]. The minimum sur-
geon skill level mandated for participation in each of the
included trials also varies considerably. Laparoscopic ingui-
nal hernia repair is a challenging operation for the surgeon
and there is evidence that it is associated with a steep learn-
ing curve during which recurrence rates increase [42]. The
European Hernia Society states that 100 laparoscopic cases
are required to achieve outcomes comparable with open
mesh repair [2]. In addition, complication rates decrease
by 50% after 50 cases. In this review, only three studies
required surgeons of experience in laparoscopic hernia to
be more than 100 [20, 31, 33]. The other studies either did
not report surgeon experience or included surgeons still on
the learning curve. Furthermore, surgeon volume and opera-
tive quality, although linked, are not synonymous and there
is no evidence of objective operative quality assessment in
either arm (c.f. the ROMIO study [43]) and no evidence
provided that the appropriate quality standard for minimally
13
Hernia (2019) 23:461–472
invasive (TAPP or TEP) inguinal hernia repair has been met
[44]. One study used expertise randomisation (i.e. differ-
ent surgeons performed the laparoscopic and open surgery).
Although this study design has its positive features, failure
to account for surgeon effects in the analysis is an inherent
source of bias and is evidenced by the fact that one surgeon
accounted for approximately one-third of the recurrences
[27].
The conduct of RCTs is of fundamental importance
when interpreting their applicability to one’s own practice.
The risk of bias assessment highlights a number of areas
of concern, particularly with regard to blinding of sur-
geons, participants and assessors. Furthermore, the lack of
standardised definitions for the outcomes and a widespread
failure to use appropriately validated assessment tools for
recurrence, complications (e.g. Clavien Dindo [45]), pain
and quality of life are of great concern. Bhangu et al. [46]
have presented data showing that outcome reporting from
RCTs concerning inguinal hernia repair is inconsistent and
poorly defined, which has limited meta-analyses. A core
outcome dataset would standardise reporting and conse-
quently improve quality of RCTs on inguinal hernias, but
as yet one does not exist.
The role of clinical trials units (CTU) in the success
of RCTs remains hotly debated, but their role in develop-
ing robust designs with appropriate statistical analysis is
widely acknowledged [47]. In this review, the lack of CTU
input is highlighted by the failure to provide a sample size
calculation in half of the studies [24, 30, 31, 34, 38, 39].
Of those that did provide a sample size calculation, only
Hernia (2019) 23:461–472 471
four accounted for loss to follow-up [20, 22, 25, 27]. Clear
statements of the use of intention to treat analysis and of
intended study design (superiority or non-inferiority etc.)
were similarly sparse. Only one study [25] could truly be
considered high quality, and while a specific CTU was not
used in this study, the REPAIR group from Rotterdam has
extensive expertise in RCTs.
The trial sequential analysis utilising all 12 RCTs has
suggested that further studies are highly unlikely to dem-
onstrate a statistically significant effect between the two
techniques in terms of recurrence for primary simple uni-
lateral inguinal hernia. However, the methodological qual-
ity of the RCTs is such that we cannot state this with any
certainty regarding other outcomes, particularly those that
matter to patients such as chronic pain and quality of life.
In conclusion, this meta-analysis and trial sequential
analysis reports no difference in recurrence rates between
laparoscopic and open primary unilateral inguinal hernia
repair. Laparoscopic groin hernia repair is associated with
less acute pain and reduced odds for chronic pain.
Funding  There were no sources of funding associated with this review.
Compliance with ethical standards  explanation and elaboration. PLoS Med 6(7):e1000100
Conflict of interest  NLB, LHM, SAA, NJS and RHF declare no con-
flict of interest.
Ethical approval  Approval from the institutional review board was not
required for this study.
Human and animal rights  This article is a systematic review and meta-
analysis and it contains data collected through literature review. It does
not include research directly involving human or animal participation.
Informed consent  For this literature review, formal consent is not
required.
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