Accepted Manuscript

A prospective randomized study comparing laparoscopic transabdominal

preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias

Benedetto Ielpo, Hipolito Duran, Eduardo Diaz, Isabel Fabra, Riccardo Caruso,
Luis Malavé, Valentina Ferri, Sara Lazzaro, Denis Kalivaci, Yolanda Quijano, Emilio
Vicente
PII: S0002-9610(17)30662-1
DOI: 10.1016/j.amjsurg.2017.07.016
Reference: AJS 12451

To appear in: The American Journal of Surgery

Received Date: 3 April 2017

Revised Date: 28 June 2017
Accepted Date: 14 July 2017

Please cite this article as: Ielpo B, Duran H, Diaz E, Fabra I, Caruso R, Malavé L, Ferri V, Lazzaro
S, Kalivaci D, Quijano Y, Vicente E, A prospective randomized study comparing laparoscopic
transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias, The
American Journal of Surgery (2017), doi: 10.1016/j.amjsurg.2017.07.016.

This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to
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 ACCEPTED MANUSCRIPT
Abstract

Background

In literature, only a few studies have prospectively compared the results of laparoscopic with open
inguinal hernia repair yet none have compared bilateral inguinal hernia repair.
The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic trans-

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abdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia.

Methods

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Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters

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included hospital stay, operation time, postoperative complications, immediate postoperative pain and
chronic pain, recurrence and quality of life.

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Results AN
Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-
operative pain up to 7 days from surgery (p=0.003), a shorter length of hospital stay (p=0.001), less
postoperative complications (p=0.012) and less chronic pain (0.04) when compared with the OLR
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approach.
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Conclusions
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TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay
and postoperative complications.
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 ACCEPTED MANUSCRIPT

Title page

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP)

versus Lichtenstein repair for bilateral inguinal hernias.

Benedetto Ielpo MD, PhD, FACS, Hipolito Duran MD, PhD Eduardo Diaz MD, Isabel Fabra MD,

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Riccardo Caruso MD, Luis Malavé MD, Valentina Ferri MD, Sara Lazzaro MD, Denis Kalivaci MD,
Yolanda Quijano MD, PhD Emilio Vicente MD, PhD, FACS.

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General Surgery Department, Sanchinarro Hospital, San Pablo University of Madrid.

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Corresponding Author:
Benedetto Ielpo
ielpo.b@gmail.com

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Sanchinarro University Hospital, Calle Oña 10, 28050, Madrid
Tel: 0034 917567800
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Fax: 0034 917500133

Running head: TAPP Vs Lichtenstein for bilateral inguinal hernia repair

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The authors declare no conflict of interest

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 ACCEPTED MANUSCRIPT
Abstract

Background

In literature, only a few studies have prospectively compared the results of laparoscopic with open
inguinal hernia repair yet none have compared bilateral inguinal hernia repair.
The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic trans-

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abdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia.

Methods

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Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters

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included hospital stay, operation time, postoperative complications, immediate postoperative pain and
chronic pain, recurrence and quality of life.

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Results AN
Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-
operative pain up to 7 days from surgery (p=0.003), a shorter length of hospital stay (p=0.001), less
postoperative complications (p=0.012) and less chronic pain (0.04) when compared with the OLR
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approach.
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Conclusions
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TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay
and postoperative complications.
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Keywords: TAPP; Lichtenstein; Inguinal hernia

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Introduction

Inguinal hernia repair is one of the most widely performed surgical procedure [1]. Amongst the
techniques used, the open Lichtenstein repair (OLR) is still the most widely performed. However, in the
last decade there has been an increased interest in the laparoscopic approach for inguinal hernia repair,
mainly represented as the trans-abdominal pre-peritoneal (TAPP) technique [2-4].

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As described in recent studies, TAPP approach entails the benefits of minimally invasive surgery, such as
less pain and early recovery [1]. We expect that these benefits would be more apparent in the treatment of
bilateral inguinal hernias given the fact that both hernias are repaired through a single unified access.
However, there are not enough studies in literature to support the potential benefits of the TAPP approach
[4] in bilateral inguinal hernias and none address its impact on the quality of life compared with OLR.
The aim of this study is to confirm the hypothesis that TAPP procedure has superior outcome that OLR
by comparing the results and the quality of life of patients who underwent TAPP versus OLR for the

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treatment of bilateral inguinal hernias.

Methods

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We prospectively included patients from the General Surgery Department at Sanchinarro University

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Hospital from 2013 to 2015. Inclusion criteria were patients older then 18 years of age, diagnosis of
primary bilateral inguinal hernia assessed by ultrasound and in which any associated surgical procedure
had not been performed. Mean follow up was 1 year.

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The main demographic preoperative data recorded were: age, gender, BMI, ASA score and size of hernia
according to the EHS classification (Grade I: 1.5 cm, Grade II: 1.5–3 cm, Grade III: >3 cm) [5].
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Exclusion criteria were contraindications for general anaesthesia or laparoscopy, obstructed or
strangulated inguinal hernias, hernia recurrences.
Cases were randomized using a simple randomization with a computer program. All patients underwent
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the same anaesthesia and post-operative analgesia protocol. A single dose of first generation
cephalosporin was given at the induction of the anaesthesia.
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Operative time was recorded at the end of each single procedure.

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Surgical technique

Both TAPP and OLR procedures were performed by senior consultant surgeons with a minimum of 2
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years’ experience in both TAPP and OLR in a standardized manner as follows:

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TAPP approach
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This procedure is performed under general anaesthesia.

The abdomen is insufflated with CO2 using a Veress needle in the left hypochondrium. Three trocars are
placed in total. The 0-grade optic is placed through a 10-millimeter diameter periumbilical incision. A 10-
millimeter diameter trocar is placed in the right hypochondrium and finally, a 5-millimiter diameter trocar
is placed symmetrically in the left hypochondrium (Fig. 1).
The peritoneum is incised at the level of the trocar and extended medially in the direction of the superior
margin of the internal inguinal ring up to the residue of the umbilical artery. The Cooper ligament is then
exposed through a careful dissection of the preperitoneal parapubic adipose tissue. The hernia sac is than
isolated and reduced freeing the spermatic cord. Finally, a polypropylene mesh (Prim) of almost 15x10

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cm is placed bilaterally in the preperitoneal space as shown in the video 1 and it is partially cut for the
spermatic cord. A metal staple is used to secure the mesh to the Cooper ligament (CapSureTM, Bard). The
peritoneal flap is than closed using 3 or 4 metal staples for each side.

OLR approach

This procedure is performed using epidural anesthesia with the same antibiotic prophylaxis of the TAAP

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approach.
OLR is performed by all surgeons according to the standard Lichtenstein open tension-free technique as
described recently by Amid where ilioinguinal and iliohypogastric nerves are usually preserved [6]. No

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local anesthetic was infiltrated.

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Management after surgery
All patients stay overnight. A standard analgesia regime was used equally for all patients postoperatively
up to 7 days which includes paracetamol (1 gr) and metamizole (1 gr) every 8h up to 24 h from surgery

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and then oral paracetamol (500 mgr) every 12h. After discharge, patients are visited in the outpatient
clinic at 7 days after surgery and then after 1, 2, 6 and 12 months from surgery.
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Chronic pain is defined if it is lasting no less then 3 months after the hernia repair. Patients are allowed to
resume their full activities after 10 days from surgery, expect for physical exercise which we recommend
wait almost 30 days from surgery.
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Time of surgery has been recorded.

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Length of post-operative stay as well as postoperative complications occurring up to 1 year after surgery
have been prospectively recorded. Seroma is defined when it is symptomatic (pain, discomfort, etc..) and
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that tends to persist for long periods from surgery (> 1 month) and which often requires an interventional
therapeutic approach (needle aspiration).
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SF-36 quality of life

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Quality of life was assessed with the medical outcomes study SF-36 questionnaire (Spanish form)
preoperatively and at 2, 6 and 12 months after surgery.
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The scales include the physical functioning (PF), role-physical (RP), bodily pain (BP), general health
(GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). These scales
are divided into two main branches which measure physical component (PC) and mental component
(MC).
For each patient, the questionnaire was sent by mail. Data was elaborated and scored [7].

Pain

Postoperative pain was determinated at first and 7th day after surgery and at 2, 6 and 12 months, using the

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standardized 0-10 visual analgesic scale (VAS). After the discharge it is gathered in outpatient clinic.

Ethics

The study was approved by the institutional ethical committee of Sanchinarro University Hospital and all
patients included were informed about the treatment and a written informed consent was obtained. All
patients who met the criteria were offered for entry into the study.

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Statistics

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Data has been recorded in a SPSS Statistics Version 20.0 database.
To compare the means of the quantitative variables when the variables followed a normal distribution, a

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variance analysis and a Student’s t-test were used. For the rest of the variables, both Mann–Whitney and
Kruskal–Wallis tests were performed. Statistical significance was defined as having a P value of <0.05.
Data herein reported are for patients which reach a minimum of one year of follow up.

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Results

Patient characteristics
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The median duration of follow up was 18.6 months (range: 12-41 months).
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TAPP was performed in 61 cases and ORL in 73 cases. Clinical and perioperative data comparison of
both groups are summarized in Table 1.
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Short term postoperative outcome

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The mean operative time was 100.3 minutes (range: 60-130 minutes) for the TAAP group Vs 97.1
minutes (range: 60-120 minutes) for the OLR group and no statistical difference was recorded (Table 2).
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The mean hospital stay was significantly shorter for the TAAP group (1.03 days; range: 1-2 days)
compared with the OLR group (1.41 days; range: 1-5 days) (p=0.001) (Table 2).
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Long term postoperative outcome

Post-operative complications are depicted in table 2 and occurred in 5 patients in the TAAP group (8%)
and in 19 patients in the OLR group (26%) (p= 0.012).
Number of patients with BMI ≥ 25 were equally distributed among the two groups (32% in TAPP Vs
34% in OLR; p= 0.6)) (Table 1). In the ORL group, a statistically higher number of patients which
suffered from complications (79%; 15/19) were with a BMI ≥ 25 (p=0.001) (Table 2).
In the TAPP group, 40% of patients which suffered from complications were with a BMI ≥ 25 (p=0.7).

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Chronic pain was reported by 1 patients in the TAPP group (1.64%) and by 9 patients in the OLR group
(12.3%) (p=0.04). Hernia recurrence was recorded in 6.6% and 5.5% of the cases for the TAPP and OLR
group, respectively (p=0.7) (Table 2).

Postoperative pain

Preoperative pain was assessed by VAS and was similar between the 2 groups (Fig 2).

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Early postoperative pain assessed on the first and seventh postoperative day was significantly lower for
the TAPP group: 2.6 (range: 1-5) Vs 4.6 (range: 1-6) for the OLR group (p=0.001) on the first
postoperative day and 1.8 (range: 1-4) in the TAPP group Vs 3.2 (range: 1-5) in the OLR group (p=0.03)

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on the seventh postoperative day. At 2, 6 and 12 months after surgery no difference was recorded in
postoperative pain as showed in figure 2.

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Quality of life

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No statistical differences were recorded in terms of preoperative quality of life between groups according
to the SF36 questionnaire [6] (75.3, range: 65-87; and 74.8, range 66-86 for TAPP and OLR, respectively;
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p=0.8). In both groups, the mean scores increased constantly during the follow-up period (Figure 3).
At 2 months from surgery there is a slight higher score in the TAPP procedure (95.7 Vs 90.8; p= 0.06).
Regarding the PC subscale, only at 2 months from surgery, we found a significative higher score in the
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TAPP group (mean: 84.1) compared with the ORL (mean: 81.3; p= 0.04) (Fig 4).
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Discussion

TAPP approach in inguinal hernia repair has been shown to be a valid alternative to traditional OLR [3,8].
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Furthermore, the laparoscopic approach showed less post-operative pain and a shorter length of hospital
stay [1,9]. These advantages are expected to be more evident for bilateral inguinal hernias. However, only
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few reports address the difference among TAPP and OLR in bilateral inguinal hernia repair [10] and, to the
best of our knowledge, none of them provide quantitative information about the difference in the quality
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of life. The aim of this paper is to study which are the differences between the TAPP and the OLR
approach for bilateral inguinal hernia.
We found that the mean operative time was only slightly higher in the TAPP compared with the OLR
approach (110.3 vs 97.1 min; p=0.23)
This study confirmed that the minimally invasive approach is associated with less early post-operative
pain compared with the OLR. The difference between the mean VAS on the first and seventh post-
operative day in bilateral inguinal hernias is higher compared with other studies which includes only
monolateral hernias. This data supports that the major benefit of laparoscopic approach is when it is used
for bilateral inguinal hernias. In fact, in the TAPP approach, through the same access, it is possible to

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repair both sides, whereas the traditional OLR technique needs a double inguinal incision, increasing pain
and discomfort in the early post-operative period. According to our study, during the early post-operative
period up to 7 days from surgery, pain was significantly lower in the TAPP group compared with the
ORL group (Fig 2). In the late post-operative time, VAS is similar in both groups; however, as reported in
figure 2, there still exists a slight trend towards less pain in the TAPP group.
Postoperative pain and complications are closely related. One of the reasons for less postoperative pain in
the TAPP procedure lies mainly in the lower rate of complications that occurred in this approach [11-14].

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As shown in table 2, only in 8% of cases a complication occurred in the TAPP group and 26% in the
OLR group (p=0.012). Again, this difference is more significative then other studies because we only
include bilateral hernias [15-17]. Even if all these complications were minors, this data further backs up the

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hypothesis that the laparoscopic approach entails more advantages in the case of bilateral hernias. Most of
the complications that occurred in the OLR technique are specifically related to the inguinal incision

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(seroma, hematoma, infection). They are more likely to occur in the inguinal area rather than in different
abdominal areas, such as those occurring in laparoscopic approach [8,14].
Most of these complications occurred mainly in obese patients in the ORL group. In fact, the 79% of

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patients which suffered complications had a BMI higher than 25, compared with 40% of the TAPP group
(Table 2). Therefore, obesity should be a strong indication for inguinal hernia repair through a
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laparoscopic approach.
Reported recurrence rates after laparoscopic inguinal hernia repair are 0-4%. However, its incidence in
bilateral hernias is not well known as only little data has been reported. In most of these series, the
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population is not homogeneous and usually contralateral hernia repair is only because of an intraoperative
finding [11,12,15]. We only included patients with clinical and radiological evidence of bilateral hernia in
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our study. Our data suggests that recurrence rate is similar between both groups, despite there being a
slightly higher incidence rate in the TAPP group (6.6% vs 5.5%; p=0.7). In some studies, in the first
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period of time, the laparoscopic inguinal hernia repair was associated with an increased risk of recurrence
compared with the traditional open approach. The main reason for this was the inclusion of data from
surgeons with less experience in this approach. As for all surgeries, the learning curve is paramount in
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order to achieve good results [8,16]. For laparoscopic hernia repair, the EHS group stated that a learning
curve is necessary, but the number of procedures required to pass it is still a question of debate. The
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surgeons who participated in this study had performed a minimum of 10 TAPP procedures before the
study started. Furthermore, in all procedures there was always a more experienced surgical assistant. This
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is the reason why our recurrence rate is low and similar to the OLR [16-18].
Chronic postoperative pain syndrome still remains a problem for traditional open approach [2]. In fact,
several studies indicate that up to 30% of patients report pain at 1 year following inguinal hernia repair [2].
In our experience, as described in other studies, chronic pain has been found to be significantly higher in
the OLR group (TAPP: 1.64%; OLR: 12.3%; p=0.04) [1,10,18]. The main reason for lower chronic pain in
the TAPP procedure might be the different space placement of the mesh compared with the traditional
open approach. However, this issue merit to be better addressed. Post-operative complications like
seroma and hematoma are considered as risk factors for chronic pain after inguinal hernia repair [14-16]. As
expected, they are higher in the OLR group, justifying the higher incidence of chronic pain in this group.

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Our results also suggest that length of hospitalization of the TAPP group was significantly lower
compared with the OLR group. The higher post-operative pain and complication rate in the OLR group
might contribute to the increased length of hospital stay in this group (1.03 vs 1.41; p=0.001).
In terms of quality of life, the differences between the two groups of SF-36 were not significant.
However, our finding regarding the PC shows that there is a better perception of it in the TAPP group at 2
months from surgery (p=0.04).
We consider that it might be useful to report a case of a patient whom MC score showed a low quality of

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life after an uneventful TAPP procedure. We interviewed the patient and transpired that the reason for
such a low score was due to the location of the three laparoscopic incisions in the abdomen. The patient
was a body builder with particular interest in the care of his abdomen. In retrospect, this patient might

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have preferred an open traditional inguinal repair for his hernias due to a better cosmetic result with an
absence of abdominal incisions. Cosmesis results are difficult to evaluate as its importance might be

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different for each patient. Do we have to perform minimally invasive approach in all hernia repairs? Each
case must be evaluated with the patients.
This study has the limitation that we did not include a comparison of the cost effectiveness of both

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procedures in our analysis. We purposefully chose to not report it, because on the one hand it is easy to
record the cost of the surgery (surgical materials, hospital stay, dressing, etc …), on the other hand, it is
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difficult to measure the cost of the post-operative complications (work leave, medications, etc…).
Therefore, cost comparison might be not proper. A confounder factor might be the different type of
anesthesia used for the two approaches (epidural for OLR and general anesthesia for TAPP). However,
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OLR is worldwide performed by epidural anesthesia which, in our opinion, best represents the standard
technique to compare with TAPP.
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The unicentric nature of this study guarantees the homogeneity of the surgical procedures. In fact, most of
the studies which compare laparoscopic vs open techniques include several centers with different surgical
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procedures (different type and size of mesh, different type of peritoneal flap close, etc …) that may
invalidate some results.
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Conclusions
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The present study showed that TAPP approach for bilateral inguinal hernia repair is safe and reduces
early post-operative pain. Furthermore, it is related to less complications and shorter hospital stay when
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compared with OLR. A slight better quality of life perception has been found in the TAPP compared with
the OLR approach.

Figures legends:
Fig 1: Trocars placement
Fig 2: Visual Analgesic Scale (VAS) score (at 1 day p=0.001; at 7 days p=0.003; at 2 months and 1 year
p>0.5
Fig 3: SF-36 scores (at 2 months p=0.06)
Fig 4: SF-36 scores physical component subscale (at 2 months p=0.04)

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Tables legends:
Table 1: Patients baseline characteristics
Table 2: Intra and post-operative outcome

Video:
TAPP procedure

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Acknowledgment

The authors thanks Isabel de Salas, Pablo Ruiz and Beatriz Sanchez for their important contribution.

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Financial disclosures

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All the authors (Benedetto Ielpo, Hipolito Duran, Eduardo Diaz, Isabel Fabra, Riccardo Caruso, Luis
Malavé, Valentina Ferri, Sara Lazzaro, Denis Kalivaci, Yolanda Quijano, Emilio Vicente) declare any
relevant financial activities related to this study.

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TAPP (n= 61) OLR (n= 73) p
Mean age (range) years 52 (31-70) 54.7 (27-70) 0.19
Mean BMI (Kg/m2) 24.9 25.5 0.4
BMI ≥ 25 (n, %) 20 (32%) 25 (34%) 0.6
Male/Female 48/2 68/5 0.2
ASA (n) 0.4
I 15 12
II 41 57
III 5 4

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EHS (n) 0.4
I 29 41
II 22 20
III 10 12

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Mean hernia size (cm) 2.3 1.9

Table 1: Patients baseline characteristics

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TAPP (n=61) OLR (n=73) p
Mean operative time 100.3 (60-130) 97.1 (60-120) 0.23
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(range) min
Mean hospital stay (range) 1.03 (1-2) 1.41 (1-5) 0.001
days
Overall postoperative
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complications (n; %)
Total 5 (8%) 19 (26%) 0.012
Wound hematoma 4 5
Wound seroma 0 10
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Wound infection 0 2
Urinary retention 0 2
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Orchitis 1 0
Complications occurred in 2/5 (40%) p>0.5 15/19 (79%) p=0.001 0.001
patients with BMI > 25
n/total (%) p
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Recurrence (n; %) 4 (6.6%) 4 (5.5%) 0.7

Chronic pain (n; %) 1 (1.64%) 9 (12.3%) 0.04

Table 2: Intra and post-operative outcome

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U SC
AN
M
D
TE
EP
C
AC
 ACCEPTED MANUSCRIPT

PT
RI
U SC
AN
M
D
TE
EP
C
AC
 ACCEPTED MANUSCRIPT

PT
RI
U SC
AN
M
D
TE
EP
C
AC