Hernia
DOI 10.1007/s10029-014-1316-7
ORIGINAL ARTICLE
Randomised clinical trial: conventional Lichtenstein vs.
hernioplasty with self-adhesive mesh in bilateral inguinal hernia
surgery
Jose L. Porrero • Marı́a J. Castillo • Ana Pérez-Zapata • Marı́a T. Alonso •
Oscar Cano-Valderrama • Esther Quirós • Sol Villar • Beatriz Ramos •
Carlos Sánchez-Cabezudo • Oscar Bonachia • Alberto Marcos • Brı́gido Pérez
Received: 8 March 2014 / Accepted: 24 October 2014
Ó Springer-Verlag France 2014
Abstract
Purpose To compare the results of conventional Lich-
tenstein hernioplasty with polypropylene mesh (PLP) with
a lightweight self-adhesive mesh (Parietene ProgripÒ;
Covidien, Dublin, Ireland) (PPG) used in patients with
bilateral inguinal hernia.
Methods Randomised clinical trial with 89 patients with a
minimum follow-up of 1 year. Every patient had bilateral
inguinal hernia and had both prostheses implanted ran-
domly, one on each side. Early postoperative and chronic
pain was evaluated using the visual analogue scale. Also
recurrence rate and subjective evaluation of patients were
analysed.
Results Pain in the early postoperative period was infe-
rior on the side where the self-adhesive mesh had been
implanted (6.12 vs. 6.62, p=0.005 during the 1st postop-
erative day; 2.12 vs. 2.62, p=0.001 during the 7th postop-
erative day). Differences disappeared with the long-term
evaluation (0.71 vs. 0.98, p=0.148 1 year after the surgery).
The operative time was significantly shorter on the PPG
mesh side (24.37±5.1 in case of the PPG mesh and
29.66±5.6 in case of the PLP mesh, p\0,001). Recurrence
occurred in seven patients (7.8%), six of them (6.7%, CI
3.0–14.4) on the PPG mesh side and one (1.1%, CI 0.2–7.8)
J. L. Porrero
M. J. Castillo
A. Pérez-Zapata

M. T. Alonso
O. Cano-Valderrama (&)
E. Quirós
S. Villar

B. Ramos
C. Sánchez-Cabezudo
O. Bonachia
A. Marcos
Servicio de Cirugı́a General y del Aparato Digestivo, Hospital
Universitario Santa Cristina, Calle Maestro Amadeo Vives 2,
28009 Madrid, Spain
e-mail: oscarcanovalderrama@hotmail.com
B. Pérez
Servicio de Medicina Preventiva y Salud Laboral, Hospital
Universitario La Princesa, Madrid, Spain
on the PLP side. These differences were not statistically
significant (p=0.125)
Conclusions Although hernioplasty with self-adhesive
mesh reduced early postoperative pain, this reduction was
clinically irrelevant and it had no influence on chronic pain.
There was a trend towards a higher recurrence rate when
self-adhesive meshes were used, and although in this study
differences were not statistically significant they should be
confirmed in later studies using larger samples. Surgical
procedures that do not need fixing sutures are promising,
but further studies are needed before they become the gold
standard of inguinal hernia repair.
Keywords Inguinal hernia
Chronic pain
Hernia
recurrence
Self-adhesive mesh
Polypropylene mesh

Postoperative complications
Bilateral hernia
Introduction
Inguinal hernia repair is one of the most common proce-
dures in daily surgical practice, with the Lichtenstein her-
nioplasty as the gold standard of prosthetic repair
techniques [1]. Recurrence rates after anatomical repair
techniques are 4.4–17 % vs. 0.3–2.2 % after prosthetic
repair [2–4]. Because of these low recurrence rates,
inguinal chronic pain emerges as the most relevant out-
come in those techniques, with highly variable percentages
ranging 9–51 % [5–7]. These variations are mostly due to
the different terminology used in the definition of chronic
pain. If more strict definitions are used, such as an inca-
pacitating pain that interferes with normal daily activities
or work, prevalence diminishes until 0.5–6 % [8, 9].
In an attempt to standardise terminology and according
to the International Society for the Study of Pain, a group
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of experts defined chronic post-herniorrhaphy neuropathic
pain as the pain that appears as a direct consequence of a
nervous injury or disease that affects the somatosensory
system in patients that had no pre-surgery inguinal pain or
in the event that they had, it was different from the post-
operative pain. Its duration must be longer than 3 months
after surgery [10].
The cause of this pain is not well known, it is probably
related to aspects such as repair technique, nerve man-
agement, mesh type and mesh fixation. Some authors
believe that there is no evidence showing that the prosthetic
material is the cause of postoperative discomfort [11],
while others do believe that pain is related to the charac-
teristics of the prosthetic material [12, 13] and the materials
used to fix it [14, 15]. Lightweight prosthesis and self-
adhesive meshes could produce a lower morbidity because
there is no suture material and they produce less inflam-
matory reaction [16, 17]. There is also lack of consensus
regarding the management of inguinal nerves. There are
studies in favour of their resection [18] and others where
identification and preservation of nerves is supported [19,
20].
The aim of this study was to compare surgery duration,
intra- and post-operative complications, early and chronic
postoperative pain and recurrence rate when a conventional
polypropylene mesh (Bard, New Jersey, USA) was used vs.
a lightweight self-adhesive mesh (Parietene ProgripÒ;
Covidien, Dublin, Ireland) in patients with bilateral ingui-
nal hernias in which both meshes were implanted. The
reason to implant both types of meshes in the same patient
was to eliminate bias due to individual factors, not only
related to recurrence and complications, but also to the
subjective valuation of postoperative pain as it is the
patient who evaluated his/her own groins.
Methods
A randomised clinical trial comparing Parietene ProgripÒ
(Covidien, Dublin, Ireland) mesh (PPG) and Lichtenstein
traditional repair with a heavyweight polypropylene (Bard,
NJ, USA) mesh (PPL) was carried out. This clinical trial
was not registered, as it was not compulsory in Spain in
2008.
The study was done between September 2008 and
October 2010. A total of 105 consecutive patients with
primary bilateral inguinal hernias were included in the
study, of which 10 refused to participate in the study and 6
did not properly match the study protocol and follow-up
(Fig. 1).
Inclusion criteria were: patients presenting primary
bilateral inguinal hernia, older than 17 years of age and
with non-complicated hernia. Patients with other
123
Hernia
hernioplasty-concomitant surgeries, on chronic analgesic
or steroid treatment, with cognitive damage, associated
crural hernia, emergency surgery and bleeding disorders
were excluded from the study. Informed consent for sur-
gery and a specific informed consent for inclusion in the
study were obtained from all patients.
The proportion of patients with chronic inguinal pain
was settled as the primary endpoint of this study, so
sample size calculation was made using the McNemar test
(Connett approach) assuming an odds ratio of 3 and a
13 % proportion difference. The total number of pairs
(patients in this study) was 94 for a one-side test with a
power of 80 %.
Randomization was performed by a simple random
sampling based on a computer-generated list of the side
where the PPG mesh had to be used for each consecutive
patient. All patients were operated by a team of nine senior
surgeons, all of them with broad experience on abdominal
wall surgery. 60 patients were operated within our
department with the PPG mesh before the start of the trial
in order to ensure that all the surgeons had enough expe-
rience using this kind of mesh. All the patients had both
inguinal hernia repairs performed during the same proce-
dure and the same surgeon performed surgery on both
sides. The operating surgeon decided the order of the groin
reparation.
A heavyweight polypropylene mesh of 9 9 15 cm
(Bard, NJ, USA) was used on one side and a self-adhesive
mesh of 8 9 12 cm (Parietene ProgripÒ; Covidien, Dub-
lin, Ireland) was used on the other side. The PPG mesh is
made of lightweight polypropylene monofilament and
absorbable polylactic acid hooks. Once these hooks are
reabsorbed, after some months, a polypropylene 40 g/m2
mesh remains.
Lichtenstein hernioplasty was the performed technique
in those cases where PLP mesh was used [21]; fixing was
done with ProleneÒ 00 (Ethicon, Johnson and Johnson
Company, Cincinnati, OH, USA) to the inguinal ligament
and VicrylÒ 00 (Ethicon, Johnson and Johnson Company,
Cincinatti, OH, USA) to the minor oblique muscle. The
PPG mesh was placed on the contralateral groin, flaps
were placed around the cord and the mesh was orientated
to its final position. To fix the mesh to the muscular plane
it was necessary to apply pressure on the mesh, starting
on the cranial portion and descending to the pubis
medially, and then finally push it laterally over the
inguinal ligament and the internal portion of the external
oblique aponeurosis. No fixing sutures were needed, not
even to the spine of the pubis. Inguinal nerves were
identified on both inguinal areas and were tried to be
preserved whenever possible.
The Gilbert classification was used and all patients were
on antibiotic prophylaxis with cefazolin 1 g IV.
Hernia

Fig. 1 Study protocol and flow September 2008- October 2010

chart n= 105
Refuse to
participate
Recruitment n= 10
Randomization
n= 95

PGP group PLP group

n=95 n=95

Lost during the follow-up

n=6

PGP group PLP group

n=89 n=89

1st, 7th
postoperative Pain evaluation Pain evaluation
day Early complications Early complications

Pain evaluation Pain evaluation

1 Late complication Late complication
postoperative Recurrence Recurrence
year Patient subjective evaluation Patient subjective evaluation

The anaesthetic procedure of choice in our centre is Table 1 Demographic and clinical characteristics of the patients
regional anaesthesia, and it was applied to all patients in included in the study
the study. Percentage
Pain was evaluated using a visual analogue scale (VAS)
Number of patients 89
that qualifies the pain level between 0 (absence of pain) and
Gender
10 (maximum tolerable pain). Patients evaluated pain on
Male 87 97.8
the day after surgery, on the 7th postoperative day and
Female 2 2.2
1 year after surgery. In this study, we consider chronic pain
Mean age (years) ± SD 55.7 ± 12.27
as a pain more severe than or equal to four on the VAS
Ambulatory surgery 36 40.4
lasting for more than 3 months. No blinding was used Hernia classification
during this study. Gilbert II (PPG group) 33 37.1
One year after surgery patients underwent a subjective Gilbert II (PLP group) 33 37.1
evaluation. During this evaluation patients were asked Gilbert III (PPG group) 8 9
about their satisfaction with the surgery, comparing both Gilbert III (PLP group) 12 13.5
sides. The answer was based on which groin the patient felt Gilbert IV (PPG group) 46 51.7
more comfortable with. A physical examination was also Gilbert IV (PLP group) 41 46.1
performed in order to diagnose any recurrence. Gilbert V (PPG group) 2 2.2
Data related to age, gender, type of hernia, ASA clas- Gilbert V (PLP group) 3 3.4
sification, type of anaesthesia, length of hospital stay, ASA classification
surgery duration, early and late complications, subjective ASA I 31 34.8
evaluation and VAS were collected. ASA II 56 62.9
All patients had a minimum follow-up period of 1 year. ASA III 2 2.2
A statistical analysis with StataÒ 13.1 (Serial Number: Anaesthetic procedure
301306228757, StataCorp, Texas, USA) was performed Regional 89 100
using paired Student’s t test or McNemar test when appro- Mean follow-up (months) ± SD 18.2 ± 7.2
priate; p \ 0.05 was considered statistically significant.

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Table 2 Comparison of 1st and
7th postoperative day VAS,
1-year VAS, surgery duration
and recurrence rate on the PGP 1st postoperative day VAS
and PLP side (mean ± SD)
7th postoperative day VAS
(mean ± SD)
1 year VAS (mean ± SD)
Surgery duration (min)
(mean ± SD)
* Paired Student’s t test
Number of recurrences (%)
** McNemar test
Results
Eighty-nine patients with bilateral inguinal hernia were
analysed, with a total of 178 hernioplasties. The mean age
was 55.7 ± 12.27, 97.8 % were male, 62.9 % were ASA
II. Hernias were classified using the Gilbert classification,
being hernias on both sides homogeneous in size. 40.4 %
of procedures did not require hospital stay. The anaes-
thetic procedure used in all cases was regional anaesthe-
sia. The medium follow-up was 18.2 ± 7.2 months
(Table 1)
Surgery duration
Mean surgery time was 24.37 ± 5.13 min for PPG mesh
and 29.66 ± 5.60 min for PLP mesh. This difference was
statistically significant (p \ 0.001) (Table 2)
Immediate and late complications
Three patients (3.4 %) suffered a minor haematoma and
did not need treatment, two of them on the PLP mesh side
and one on the PPG mesh side. There was a wound
infection on the PLP mesh side in the early postoperative
course (1.1 %) that was solved by draining the wound and
with oral antibiotic treatment.
Seven patients suffered a recurrence (7.8 %), of which
six were on the side of the PPG mesh 6.7 % (CI 3.0–14.4)
and one on the PLP mesh side 1.1 % (CI 0.2–7.8); these
differences were not statistically significant (p = 0.125)
(Table 2). Hernia classification was Gilbert II in three of
these patients, Gilbert III in two and Gilbert IV in another
two. Three patients with a recurrence after a PPG mesh was
implanted underwent surgery again. In two cases recur-
rence was located at the internal inguinal orifice, in the
third patient recurrence was observed at the pubis spine.
Repair consisted of implanting a polypropylene plug in the
patients with a recurrence at the internal inguinal orifice
and a flat mesh for the last patient.
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Hernia
PGP side PLP side p Number of patients
(missing) (%)
6.12 ± 1.40 6.62 ± 1.30 0.005* 89 (0)
2.12 ± 1.31 2.62 ± 1.34 0.001* 89 (0)
0.71 ± 1.25 0.98 ± 1.47 0.148* 89 (0)
24.37 ± 5.13 29.66 ± 5.60 \0.001* 89 (0)
6 (6.7 %) 1 (1.1 %) 0.125** 89 (0)
Pain
Patients referred less pain on the side where the PPG mesh
was implanted on the 1st and 7th postoperative day com-
pared to the PLP mesh side (6.12 ± 1.40 vs. 6.62 ± 1.30;
2.12 ± 1.31 vs. 2.62 ± 1.34), the differences being sta-
tistically significant in both cases (p = 0.005; p = 0.001).
These differences disappeared in the VAS evaluation after
1 year of follow-up (Table 2).
We had 7 patients with chronic inguinal pain with a
VAS higher than 4 (7.8 %), 4 at the PLP mesh side and 3 at
the PPG mesh side, this difference was not statistically
significant. Three patients referred unbearable pain on the
PLP mesh side that interfered with their physical and work
activity, which needed continuous medication. Due to this,
a surgical treatment was decided with partial resection of a
bent mesh performed in one patient and neurectomy in the
other two. The postoperative evolution was optimal with
good analgesic control for all of them.
Patient-subjective evaluation
A patient-subjective evaluation of the result comparing
both groins was possible in 84 patients. Patient evaluation
was the same for both groins in 48 patients (57.1 %); 24
(28.5 %) patients rated the side with PPG mesh as best and
12 (14.2 %) patients rated the side with PLP mesh as best,
a statistically significant difference (p = 0.0241).
Discussion
The two most relevant outcomes of the hernia surgery are
recurrence and chronic pain.
This study is based on the hypothesis that self-adhesive
meshes that do not need any fixing suture, could improve
inguinal pain in the early and late postoperative stages and
reduce surgery time without raising the number of
recurrences.
The surgery time in our study showed a difference of
5 min in favour of the PPG mesh. This reduction is
Hernia
explained by the time needed to fix the mesh with a suture
on the PLP mesh side and allows us to propose the
hypothesis that raising the number of surgical procedures
would compensate for the higher price of the PPG mesh
and would make the procedure more efficient [22].
Only 40.4 % of patients were operated in an ambulatory
setting. This low percentage is explained by a conservative
approach to ensure appropriate pain control during the first
postoperative day and understanding of the study protocol.
This is clearly an area for improvement in further studies.
Pain in the 1st and 7th postoperative days was lower,
with statistical significance, when using the PPG mesh.
This finding supports the idea that the suture used to fix the
mesh may play an important role in early postoperative
pain, while eliminating the fixation to the pubis minimises
the risk of nerve entrapment. Similar data have been con-
firmed in other studies [23–25], although these differences
disappeared 1 year after surgery, which leads to an open
debate on other mechanisms for chronic pain. The pain
difference was small (0.5 points in the VAS scale) and the
clinical relevance of this finding is questionable. Never-
theless, this finding suggests that this is a good area for
improvement in order to achieve a clinically significant
reduction in postoperative pain after inguinal hernia repair.
There were seven patients with chronic inguinal pain
and VAS higher than 4 (7.8 %), three of them with pain
that interfered with their daily activities and required sur-
gery. Four of these patients referred pain on the PLP side
and three on the PGP side. These results are similar to
those found in a randomised clinical trial performed by
Jorgensen et al. [5].
Although the incidence of chronic pain after inguinal
hernia repair is highly variable between studies [5], the rate
found was lower than expected [5, 6, 26]. This low chronic
pain rate could affect the power of the study, as sample size
calculation was made for a higher rate.
In addition to the small sample size for the primary
endpoint, this study has other limitations. First, it was per-
formed without blinding. So, patients could refer a lower
pain VAS on the side where the ‘‘new mesh’’ had been
implanted. However, the authors’ impression is that most
patients did not even remember on which side the PGP mesh
had been used. Another possible limitation is pain evaluation
by the patient. The patient could mistake pubic pain on one
side as if it was caused on the other side, due to anatomic
proximity and pain spread. Nevertheless, no patient with
significant pain expressed any doubt as to which side was
causing the discomfort. Finally, the PGP mesh was not
compared with a lightweight polypropylene mesh but with a
heavyweight mesh. This choice was made in order to com-
pare PGP mesh with our standard technique, so it is
impossible to know if the differences found are due to the
lightweight or the self-adhesive property of the PGP mesh.
We consider our study as a good observational model,
that suppresses individual bias and that can measure not the
intensity of pain but the comparison between both sides by
the same individual with the same pain threshold. It is also
the patient him/herself who defines after 1 year how he or
she feels about both inguinal regions, although our data is
in favour of the PPG prosthesis (28.5 vs. 14.2 %), even
though 57.1 % evaluated their groins as equal.
Some other studies have obtained similar results in
terms of chronic inguinal pain, by using fibrin glue [27] or
resorbable sutures [28, 29].
There were seven recurrences (7.8 %) in the overall
series, six of which were with the PPG mesh, even though
there were no significant differences when both types of
meshes were compared. The greater number of recurrences
with the PPG mesh has not been pointed out in other
studies [23–26]. We think that the type of preformed mesh
used may be too small for the inguinal canal of some
patients, which added to the reduction of the mesh size
over time and/or its displacement within the pubic region
may explain the recurrence near the pubic spine in one of
our patients. Concerning this event, some authors recom-
mend fixing the mesh with a resorbable material stitch in
the pubis spine [30], which means losing the benefit of not
using sutures in such a painful area.
The crossing of tails in these preformed meshes could be
an insufficient closing mechanism for the internal inguinal
orifice, as two out of three recurrences that were re-oper-
ated where observed at this level. The incorporation of the
new Parietex ProgripÒ meshes (Covidien, Dublin, Ireland)
made of polyester instead of polypropylene and with a
bigger size (14 9 9 cm) will allow less shrinkage of the
mesh, which may improve the results regarding recurrences
[24]. More studies with a larger sample size and taking into
account the previous details on the way to avoid recur-
rences should be performed to discard a higher significant
recurrence rate with the PGP mesh, as a 7.8 % recurrence
rate is not acceptable.
We think that the future of hernia surgery is leaning
towards the disappearance of the suture material in favour
of self-adhesive meshes or its adhesion with biodegradable
glue, providing these systems can guarantee recurrence
indexes similar to those obtained when using sutures. This
study suggests that early postoperative pain could be
reduced, but it is important that the high recurrence rate
and the clinical significance of pain reduction be evaluated
in further studies.
Conclusion
Although hernioplasty with self-adhesive mesh reduced
early postoperative pain, this reduction was clinically
123

irrelevant and it had no influence on chronic pain. There
was a trend towards a higher recurrence rate when self-
adhesive meshes were used, and although in this study
differences were not statistically significant they should be
confirmed in later studies using larger samples. Surgical
procedures that do not need sutures to be fixed are prom-
ising but further studies are needed before they become the
gold standard of inguinal hernia repair.
Conflict of interest JP declares no conflict of interest. MC declares
no conflict of interest. AP declares no conflict of interest. MA
declares no conflict of interest. OC declares no conflict of interest. EQ
declares no conflict of interest. SV declares no conflict of interest. BR
declares no conflict of interest. CS declares no conflict of interest. OB
declares no conflict of interest. AM declares no conflict of interest. BP
declares no conflict of interest.
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