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CE: D.C.; ANNSURG-D-18-00434; Total nos of Pages: 6;
ANNSURG-D-18-00434
Cost-effectiveness of Randomized Study of Laparoscopic
Versus Open Bilateral Inguinal Hernia Repair
Benedetto Ielpo, MD, PhD, FACS,
Javier Nun
˜ez-Alfonsel,yHipolito Duran, MD, PhD,
Eduardo Diaz, MD,
Isabel Fabra, MD,
Riccardo Caruso, MD,
Luis Malave
´, MD,
Valentina Ferri, MD,
Ernesto Barzola, MD,
Yolanda Quijano, MD, PhD,
and Emilio Vicente, MD, PhD, FACS
Objective: The aim of this study is to compare the clinical and cost-effective
outcomes of the open Lichtenstein repair (OL) and laparoscopic trans-
abdominal preperitoneal (TAPP) repair for bilateral inguinal hernias.
Summary Background Data: A cost-effective analysis of laparoscopic
versus open inguinal hernia repair is still not well addressed, especially
regarding bilateral hernia.
Methods: This is a clinical and cost-effectiveness analysis within a random-
ized prospective study conducted at Sanchinarro University Hospital.
Cases of primary, reducible bilateral inguinal hernia were included and
randomized using a simple randomization program.
The outcome parameters included surgical and postoperative costs, quality
adjusted life years (QALY), and incremental cost per QALY gained or the
incremental cost effectiveness ratio.
Results: Between March 2013 and January 2017, 165 patients were enrolled
in this study (81 of them underwent TAPP and 84 OL).
The TAPP procedure had less early postoperative pain (P¼0.037), a shorter
length of stay (P¼0.001), and fewer postoperative complications (P¼0.002)
when compared with the OL approach. The overall cost of TAPP procedure
was higher compared with the OL cost (1,683.93svs 1192.83s,P¼0.027).
The mean QALYs at 1 year for TAPP (0.8094) was higher than that associated
with OL (0.6765) (P¼0.018). At a willingness-to-pay threshold of 20,000 s
and 30,000 s, there was a 95.38% and 97.96% probability that TAPP was
more cost-effective relative to OL.
Conclusions: The TAPP procedure for bilateral inguinal hernia appears to be
more cost-effective compared with OL.
Keywords: cost-effectiveness, inguinal hernia, laparoscopic
(Ann Surg 2018;xx:xxx– xxx)
The standard tension-free open technique was introduced by
Lichtenstein in 1984 and remains the most widely performed
open procedure for inguinal repair.
1
The success and clinical advantages of laparoscopic approach
for inguinal hernia repair are well reported.
2–4
However, very few
studies report data on the laparoscopic advantages and costs of
bilateral inguinal hernia repair over the open approach, where we
expect the benefits to be even greater.
5,6
Until now, in the literature there is not any prospective study –
except for 1 American multicenter study
7
– which address quality of
life and economic data differences between elective bilateral inguinal
hernia repairs. The value of minimally invasive treatments for
inguinal hernia needs to appropriately balance quality of life and
the costs associated with the intervention. Therefore, the purpose of
this randomized study is to examine the clinical outcomes and cost-
effectiveness of laparoscopic versus open hernia repair.
METHODS
This is a clinical and cost-effectiveness analysis of a random-
ized clinical study comparing laparoscopic trans-abdominal preper-
itoneal (TAPP) technique with the open Lichtenstein technique (OL)
in bilateral inguinal hernia repair. The objective of the study was to
compare the main operative and clinical outcomes and to assess the
incremental cost-effectiveness ratios (ICERs) to compare the strate-
gies. We adhered to principles of reporting of results as suggested by
the CONSORT and CHEERS protocol extended for nonpharmaco-
logical trials. This study is registered at the ISRCTN registry and
Current Controlled Trials number is ISRCTN76445970.
Study Setting and Patients
This study was carried out in a private hospital in Madrid
(Spain) at the General Surgery Department of Sanchinarro University
Hospital recruiting patients from March 2013. Patients (aged over 18
yrs), with primary, bilateral inguinal hernias assessed by ultrasound
were included.
The patient demographic data recorded were: age, gender,
body mass index (BMI), American Society of Anaesthesiology (ASA
score), comorbidities and size of hernia according to the European
Hernia Society (EHS) classification (Grade I: 1.5 cm, Grade II: 1.5 –
3 cm, Grade III: >3 cm).
8
Exclusion criteria were contraindications for general anesthe-
sia or laparoscopy, obstructed or strangulated inguinal hernias, and
hernia recurrences.
Cases were randomized using a simple randomization with a
computer program and divided into 2 groups according to the
surgical approach elected by the computer program: TAPP or OL
group. A single dose of first generation cephalosporin was given at
the induction of the anesthesia.
Surgical Technique
The same team of surgeons (4 senior consultant surgeons with
a minimum of 2 years’ experience in both TAPP and OL techniques)
and an anesthesiology team performed the operation. All procedures
were performed using the same surgical steps as follows.
TAPP Approach
This procedure is performed under general anesthesia.
Pneumoperitoneum is established with a Veress needle in the
left subcostal space. Three trocars are placed in total.
The peritoneum is incised at the level of the trocars and
extended medially in the direction of the superior margin of the
internal inguinal ring up to the residue of the umbilical artery. The
From the
General Surgery Department, HM Sanchinarro Hospital, San Pablo
University of Madrid, Sanchinarro University Hospital, Madrid, Spain; and
yIVEC (Instituto de Validacio
´n de la Eficiencia Clı
´nica), Fundacio
´nde
Investigacio
´n HM Hospitales, Madrid, Spain.
The authors report no conflicts of interest.
Reprints: Benedetto Ielpo, MD, PhD, FACS, General Surgery Department, HM
Sanchinarro Hospital, San Pablo University of Madrid, Sanchinarro University
Hospital, Calle On
˜a 10, 28050 Madrid, Spain. E-mail: ielpo.b@gmail.com.
Copyright ß2018 Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0003-4932/16/XXXX-0001
DOI: 10.1097/SLA.0000000000002894
Annals of Surgery Volume XX, Number XX, Month 2018 www.annalsofsurgery.com | 1
ESA-RANDOMIZED CONTROLLED TRIAL
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ANNSURG-D-18-00434
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, 2 polypro-
pylene meshes (Prim) of almost 15 10 cm are rolled and introduced
into the abdominal cavity bilaterally in both preperitoneal spaces. A
unique metal staple is used to secure the mesh to each Cooper
ligament (CapSure, Bard). The peritoneal flap is than closed using 3
or 4 metal staples for each side.
OL Approach
This procedure is performed using epidural anesthesia with
the same antibiotic prophylaxis of the TAPP approach.
OL 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.
9
The same polypropylene mesh used in the TAPP pro-
cedure is placed and fixed using prolene sutures. No local anesthetic
was infiltrated.
Management After Surgery
Patients were transferred to the ward with all of them staying
overnight. A standard analgesia regime was used equally for all
patients postoperatively up to 7 days which included paracetamol (1
g) and metamizole (1 g) every 8 hours up to 24 hours from surgery
and then oral paracetamol (500 mg) every 12 hours.
Patients are allowed to resume their full activities after 10 days
from surgery, except for physical exercise which was recommended
to commence after 30 days from surgery.
Peroperative and Postoperative Data Recorded
The time of surgery has been defined from the induction of
general anesthesia until the closing of the skin. The lengths of
postoperative stay and postoperative complications have been pro-
spectively recorded. Seroma is defined when it is symptomatic
(pain, discomfort, etc.) which tends to persist for long periods from
surgery (>1 mo) and which often requires an interventional thera-
peutic approach (needle aspiration). Postoperative pain was deter-
mined on the first and seventh day after surgery and at 2, 6, and
12 months after surgery, using the standardized 0–10 visual anal-
gesic scale (VAS). After the discharge, the data was gathered in the
outpatient clinic. Chronic pain was recorded and defined if it is
lasted no less than 3 months after the hernia repair and which
required some analgesic drug. The number of outpatient surgical
visits was also recorded as well as readmission or emergency visits
without admission.
Cost Analysis
The Institute of Validation of Efficacy Clinic (IVEC) of
the HM Hospitals group is responsible for capturing costs
ascribed to each patient’s treatment. The total direct hospital
costs of care were recorded under the patient’s unique medical
record number.
Costs were further divided into operative and hospitalization
costs. Materials and medicines used during surgery were standard-
ized so that all patients underwent surgery using the same materials
according to the TAPP or OL technique. Operative costs included the
cost of the operating room in relation to the operative time, and all
required supplies (including all laparoscopic devices, sutures, and
instruments), anesthesia, laboratory, and related blood transfusion
costs when required. Hospitalization costs included the costs associ-
ated with room and board, the length of hospital stay (including
medications, blood transfusion, and radiology charge), and costs for
surgical visits (programmed and emergency). The direct costs of the
professionals involved have not been calculated as they did not
change between the 2 types of operation. All costs are presented
in euros.
Quality of Life
Quality-adjusted life years (QALYs) were used to measure
effectiveness. QALYs were estimated for 1 year following the
procedure for each patient using the medical outcomes study SF-
36 questionnaire (Spanish form)
10
administered by mail at 12 months
after surgery to each patient.
Using the Nichol method, the 8 subscales of the SF-36 were
used to calculate the Health Utilities Index 2 (HUI2) score. Data was
elaborated and scored at a minimum of 1 year postoperatively, due to
evidence that, similarly to incisional hernia, the postoperative quality
of life plateaus is at 1 year.
Cost-effectiveness
A model-based cost-utility analysis estimating mean costs and
QALYs per patient was performed.
Stochastic cost-utility analysis was undertaken, whereby the
ICER was estimated using overall costs of the TAPP and OL
procedures and QALYs derived from patient interviews, in order
to find the incremental cost per QALYs gained.
A sensitivity analysis was carried out in order to propagate the
uncertainty of the estimations to the results of the model. We use a
multivariate and stochastic sensitivity analysis performed by 5000
Monte Carlo simulations. The cost-effectiveness plane was used to
represent all pairs of solutions of the model.
We also computed a cost-effectiveness acceptability curve
which plots the probability that the TAPP was cost-effective relative
to OL over a reasonable range of levels of willingness-to-pay. A
willingness-to-pay of 20,000 sand 30,000 sper QALY was used as
a threshold to recognize which treatment was most cost-effective.
Ethics
The study was approved by the institutional ethical committee
of the HM Hospitals group. All patients included were informed
about the treatment and written informed consent was obtained.
Statistics
It was calculated that a sample size of 150 study participants
would detect postoperative outcomes between the study groups with
80% power and 5% significance level.
Data has been recorded in a SPSS Statistics Version 20.0 data-
base.
Data are expressed as median (interquartile range – IQR 25 –
75). Categorical data are presented as numbers (%). To compare the
means of the quantitative variables when the variables followed
a normal distribution, a variance analysis and a Student ttest
were used. For the rest of the variables, both Mann –Whitney and
Kruskal– Wallis tests were performed.
APvalue <.05 was considered significant. Data herein
reported are for patients who reached a minimum of 1 year of
follow-up.
RESULTS
Between March 2013 and January 2017, 165 patients under-
went elective bilateral inguinal hernia repair at the Department of
Surgery of Sanchinarro Hospital, Madrid, Spain with a median of
22.4 months of follow-up. Baseline clinical and perioperative data
comparison of both groups are summarized in Table 1. Mean
hospitalization was significantly shorter in the TAPP group than
in the OL group (see Table 2).
Postoperative complications occurred in 8.64% patients in
the TAPP group and 27.38% patients in the OL group (P¼0.002).
Ielpo et al Annals of Surgery Volume XX, Number XX, Month 2018
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Copyright © 2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
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ANNSURG-D-18-00434
Chronic pain was reported by 2.46% patients in the TAPP group and
by 11.9% in the OL group (P¼0.04).
As shown in Table 2, early postoperative pain assessed on the
first and seventh postoperative day was significantly lower for the
TAPP group.
Cost Analysis
During follow-up, there was a drop out of 6 patients (2
TAPP, 4 OL) and they have been excluded only from the cost-
effectiveness analysis. A summary of costs is presented in Table 3.
In univariate analysis, patients who underwent TAPP had greater
overall mean costs compared with the OL group (1683.93 svs
1192.83 s;P¼0.027). There was no statistically significant
difference in costs in hospitalization and outpatient surgical visit
cost (Table 3).
Among patients undergoing TAPP, materials comprised the
great majority of operation costs with a mean of 937.87 s, statisti-
cally higher compared with the OL group (430.3 s;P<0.0001) (see
Table 3).
The estimated ICER for patients was 3696.10sper QALY
gained, in favor of TAPP (Fig. 1). In Monte Carlo simulations
analysis, there was a 10.08% probability that TAPP is both less
costly and more effective. The acceptability curve (Fig. 2) shows that
the probability that TAPP is cost effective, that is, at the willingness
to pay threshold of 20,000sand 30,000sper QALY gained, was
95.38% and 97.96%, respectively (Fig. 2).
TABLE 1. Patients Baseline Characteristics
TAPP (n ¼81) OL (n ¼84)
Median age (yrs) (IR) 52 (9.5) 54.7 (12.7)
Median BMI (kg/m
2
) (IR) 24.9 (8.2) 25.5 (7)
BMI 25 (n, %) 28 (34.5%) 29 (34.5%)
<25 53 55
25– 29.9 19 21
30 9 8
Gender (male/female) 48/33 52/32
ASA (n)
I– II 63 65
III 18 19
Comorbidities (n, %) 35 (43.2) 37 (44)
Diabetes 6 5
Hypertension 19 23
Chronic obstructive
pulmonary disease
32
Oral anticoagulation therapy 4 3
Chronic ischemic heart 3 4
EHS (n)
I7270
II 54 60
III 36 38
Mean diameter hernia size cm (95% CI) 2.2 (1.2– 4.2) 1.9 (1.1 –4)
Calculated among the total amount of hernias (162 TAPP; 168 OL).
BMI indicates body mass index; CI, confidence interval; IR, interquartile range.
TABLE 2. Intra and Postoperative Outcome
TAPP (n ¼81) OL (n ¼84) P
Mean operative time min (95% CI) 102.3 (60.8– 130.6) 97.1 (61.5– 120.7) 0.23
Conversion to open surgery (n; %) 0
Mean hospital length of stay days (95% CI) 1.05 (1.1– 2.3) 1.61 (1.6– 5.4) 0.001
Overall postoperative complications (n; %) 7 (8.6%) 23 (27.4%) 0.002
Bleeding 0 2
Wound hematoma 2 7
Wound seroma 4 11
Wound infection 1 2
Urinary retention 0 1
Recurrence (n; %) 6 (7.4%) 4 (4.8%) 0.7
Chronic pain (n; %) 2 (2.5%) 10 (11.9%) 0.04
Mean VAS
Preoperative 3.15 2.87 0.67
First postoperative day 2.52 4.68 0.037
Seventh postoperative day 1.86 3.31 0.041
2 mo 0.64 0.91 0.56
6 mo 0.55 0.67 0.71
12 mo 0.14 0.16 0.80
VAS indicates Visual Analgesic Scale.
TABLE 3. Financial Data Stratified by Approach (Euro)
TAPP (n ¼81) OL (n ¼84) P
Mean costs of operation 1298.37 (1285.50– 1320.7) 749.07 (675.51– 705.13) <0.0001
Materials 937.87 (926.85–1008.48) 430.3 (445.63 –468.41) <0.0001
Operating room 360.5 (287.67–329.78) 318.77 (235.73 –262.80) 0.15
Mean costs of hospitalization 195.86 (181.30 –190.25) 218.09 (201.45 –237.03) 0.17
Mean outpatient surgical visit cost 189.7 (176.5 –197.41) 225.67 (254.10– 271.21) 0.41
Mean total costs 1683.93 (1675.08; 1692.76) 1192.83 (1183.75; 1201.90) 0.027
Mean total utility 0.8094 QALY (0.7805; 0.8133) 0.6765 QALY (0.6426; 0.6905) 0.018
(n): 95% confidence interval.
Laparoscopic disposable instruments.
Annals of Surgery Volume XX, Number XX, Month 2018 TAPP vs Open Bilateral Inguinal Hernia Repair
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DISCUSSION
Data on quality of life and cost-effectiveness of open versus
laparoscopic procedures are still limited and almost unknown on
inguinal hernia repair. With the emphasis of healthcare systems,
specifically on the cost-effectiveness of surgical procedures and
overall hospital costs, the cost comparison between the minimally
invasive and open procedures may become an important factor in
driving the selected approach, while providing the same, or possibly
better, outcomes.
When examining intraoperative outcomes of OL and TAPP
procedures we found a higher mean hospital length of stay for the
OL group, as has been reported by other authors.
6,11
The lower
early postoperative pain of the TAPP group may have contributed
to a shorter length of stay. According to our study, from the first
day up to 7 days from surgery, the VAS score was significantly
lower in the TAPP group compared with the OL group (see
Tab le 2).
In this study, we found that complications of OL repairs were
greater than those of TAPP hernia repairs (8.64% vs 27.38%; P¼
0.002). Common early complications occurring in the OL repair
include seroma, hematoma formation, and superficial surgical infec-
tion, which are likely to occur in the inguinal area rather than in
different abdominal areas, such as those occurring in the laparoscopic
approach. This data is supported by other similar series of unilateral
inguinal hernia repair.
2–4
Late main complications include recurrence, which was found
to be similar in both groups, and chronic pain, higher in the OL group
(11.9% vs 2.46%; P¼0.04). Chronic pain after the open approach is
still an issue and several studies report up to 30% of incidence. This
aspect is even more important for bilateral inguinal hernia repair,
where it may be even higher.
12
The main reason for chronic pain
needs to be better addressed; however, it may be justified by different
aspects, such as the different space placement of the mesh compared
with the laparoscopic approach and the extensive subcutaneous fat
dissection of the OL approach.
Beyond the comparisons of clinical outcomes, the analysis of
costs depicted in Table 3 shows that overall TAPP hernia repair
approach is significantly higher than for the OL approach (1683.93 s
vs 1192.83 s;P¼0.018). The reason for this higher cost is justified
by the higher surgical costs of the laparoscopic disposable instru-
ments used for the TAPP.
Our study showed that laparoscopic TAPP surgery is more
cost-effective than the open standard approach.
Our ICER calculations showed that the probability that LAP is
cost effective compared with OPEN (below 20,000sper QALY
gained) was 95.38%.
To the best of our knowledge, there are only a few studies in
the literature reporting the cost analysis of laparoscopic compared
with conventional open repair inguinal hernia, suggesting the higher
cost of laparoscopic repair.
3–7
However, all of these studies recruited
patients more than a decade ago, and may have led to a change in
costs over time.
The retrospective study by Netto et al
3
reporting hospital costs
of only few patients with bilateral inguinal hernia (9 open and 24
laparoscopic, both TAPP and TEP) and without considering opera-
tive time cost and without a cost-effective analysis found a slight
incremental value (100 $) associated with laparoscopic bilateral
hernia repairs.
FIGURE 1. Plot of 5000 bootstrap rep-
licates of the incremental cost per QALY.
Mean incremental results total costs:
s491.10 (95% CI: s478.25 s–
s503.94). Mean incremental results
total utility: 0.1329 QALY; (95% CI:
0.1273; 0.1385 QALY). Mean incremen-
tal cost–utility ratio (ICER): s3,696.10/
QALY; (95% CI: s-3219.85/QALY;
s4023.94/QALY). WTP indicates
willing-to-pay.
FIGURE 2. Cost-effectiveness acceptability curve. WTP indi-
cates willing-to-pay.
Ielpo et al Annals of Surgery Volume XX, Number XX, Month 2018
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The analysis by Vale et al reported that laparoscopicrepair is not
cost-effective compared with open repair, although there are short-
term benefits of the laparoscopic approach (TEP and TAPP).
5
How-
ever, differently from our series, this study did not include bilateral
hernias. The only systematic review analysis assessing the costs of
laparoscopic versus open hernia repair estimated only the cost per
recurrence avoided and the cost per additional day of usual activities,
reporting that laparoscopic repair is unlikely to be cost-effective.
6
In the literature, there exists only 1 American randomized trial
comparing laparoscopic versus open hernia repair, gathering patients
from 1999 to 2001, including also 108 laparoscopic and 101 open
bilateral hernia repairs.
7
Unexpectedly, it concluded that laparo-
scopic repair is a cost-effective treatment option only for patients
with unilateral (primary and recurrent) hernia, and not for bilateral
inguinal hernias. However, the results of this study must be analyzed
considering that they recorded surgical costs of operations performed
almost 17 years ago, which means that cost may have be changed
over time. They also involved 14 different institutions, which may
invalidate some results using different surgical procedures (TAPP
and TEP, different type and size of mesh, different type of peritoneal
flap close, different disposable instruments, etc.). The unicentric
nature of the present study and the small number of surgeons who
performed all procedures guarantee the homogeneity of the 2
groups analyzed.
To better understand the real cost differences between laparo-
scopic and open hernia repair, indirect and societal costs associated
with patient suffering, loss of productivity, and caregiver expense
should also be evaluated, but they are difficult to quantify.
Despite these promising data, we acknowledge some limita-
tions. The TAPP group patients underwent to general anesthesia,
while OL patients underwent epidural anesthesia, which may have
affected costs. However, because general anesthesia is more costly
than epidural anesthesia this difference would likely favor OL.
CONCLUSION
As a result of our study, TAPP for bilateral hernia represents
cost-effective procedure compared with OL repair.
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3. Netto FS, Quereshy F, Camilotti BG, et al. Hospital costs associated with
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toneal versus Lichtenstein herniorrhaphy: cost comparison at teaching hos-
pitals. Surg Laparosc Endosc Percutan Tech. 2003;13:261– 267.
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effectiveness of alternative methods of surgical repair of inguinal hernia. Int J
Technol Assess Health Care. 2004;20:192–200.
6. Vale L, Ludbrook A, Grant A. Assessing the costs and consequences of
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7. Hynes DM, Stroupe KT, Luo P, et al. Cost effectiveness of laparoscopic versus
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9. Chen DC, Amid PK. Prevention of inguinodynia: the need for continuous
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11. Ko
¨ckerling F, Stechemesser B, Hukauf M, et al. TEP versus Lichtenstein:
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DISCUSSANTS
Norbert Senninger (Mu
¨nster, Germany):
I wish to congratulate the authors for a well-designed study
with clear results and am grateful for having read the manuscript
beforehand.
In their manuscript entitled, Cost-effectiveness of randomized
study of laparoscopic versus open bilateral inguinal hernia repair,
Ielpo et al analyzed 165 patients undergoing bilateral hernia repair
between March 2013and January2017 in the context of a randomized
clinical study in a single center. The primary objective of the study was
to compare clinical outcomes and to assess the incremental cost-
effectiveness ratios, in order to compare the 2 strategies, namely
the open Lichtenstein procedure and the transabdominal preperitoneal
technique (TAPP). Despitethe fact that the TAPP procedurehad higher
overall costs than the open Lichtenstein approach, it appeared to be
more cost-effective thanthe bilateral inguinal herniarepair, paired with
less early postoperative pain, a shorter length of stay, fewer postopera-
tive complications, and higher quality adjusted life years (QALY).
The topic of the manuscript is of high interest, since inguinal
hernia repairs are a routine operation and daily business in surgical
departments. Surprisingly, only very few studies report data on the
laparoscopic costs of bilateral inguinal hernia repair and its advan-
tages over the open approach. The current study adds data to address
this question and clearly favor the laparoscopic approach with
obviously convincing results. Taken together, the single-center study
is well designed and appears to be standardized for patients’ treat-
ment pre-, peri-, and postoperatively, including standardized
operative procedures.
I have the following questions:
First, the authors suggest that all 165 patients had bilateral
hernias, as suspected by clinical examination and ultrasound.
Did intraoperative findings confirm the preoperative diagnoses in
every patient?
Second, an advantage of the TAPP procedure is the relatively
simple diagnosis of a bilateral hernia and the ability to treat both
hernias in 1 operation. For the open Lichtenstein approach, many
surgeons prefer a 2-step approach, repairing the predominant hernia
first and the second hernia after the first repair has healed. What was
the rationale for the bilateral synchronous Lichtenstein repair? Is this
simultaneous open repair a routine procedure at your hospital? How
would the cost-effectiveness differ in the case of a 2-step approach?
Third, the authors categorize hernia size as shown in Table 1.
Since the TAPP procedure was performed in 81 patients with
bilateral hernias, the size of the hernias should be given for 162
hernias and not summed up to only 81. The same information should
be given for the 168 hernias within the open repair; however, the
hernia sizes only add up to 84. Please explain these numbers.
Fourth, overall postoperative complications for the Lichten-
stein repair are 27.38%, which means that nearly a third of all patients
suffered complications. Do the authors have an explanation for this
rather high complication rate for a standardized procedure by
experienced surgeons? How were the complications diagnosed?
Were they diagnosed clinically or by ultrasound, for example, for
wound seromas?
Annals of Surgery Volume XX, Number XX, Month 2018 TAPP vs Open Bilateral Inguinal Hernia Repair
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ANNSURG-D-18-00434
Response From Benedetto Ielpo (Madrid, Spain):
Thank you very much for reading our paper and your
interesting questions.
Regarding the first question, the combination of ultrasound
and clinical examination makes it very difficult that preoperative
findings do not coincide with the intraoperative ones. In all of the
cases in our series, there were bilateral inguinal hernias.
With regard to your second question, the routine procedure at
our hospital is to perform both repairs in only 1 step, whether
laparoscopy or the open approach is used. Of course, I agree that
an important advantage of the laparoscopic approach is to repair both
sides in a 1-step procedure. On the other hand, a 2-step procedure
within the open technique would have increased the overall costs, and
therefore, it would have decreased the cost-effectiveness when
compared to the laparoscopy.
Third, regarding the overall number of procedures performed
and the related data shown, hernia size refers to the total number
of procedures.
Finally, complications are double than those reported in the
literature, but all of the cases treated underwent bilateral hernia
repair. Therefore, data is concomitant with the literature. However,
most of these complications were minor, mainly represented by
seromas, especially in the open approach. Also, most of these
complications were diagnosed clinically and by ultrasound.
Jacob F. Hamming (Leiden, The Netherlands):
Thank you very much. I would also like to compliment
your beautiful study. I have 2 questions. The first question is
about the surgeons. Did the same surgeons, who performed the
TAPP procedure, also perform the Lichtenstein procedure, or
were there 2 different groups of surgeons? You may have an
attribution bias because if those 4 surgeons favor the TAPP procedure
more than the Lichtenstein procedure, that might be a bias in
your study.
Second, why did you use the TAPP procedure, instead of the
TEP one? In the Netherlands, we now perform 95% of endoscopic
procedures via the TEP procedure. The reason for this is that it is
more easily accessible and you don’t have to worry about the fixation
of the grafts.
Response From Benedetto Ielpo (Madrid, Spain):
Thank you very much. Regarding your first question, 4
surgeons performed both the open and the laparoscopic procedures
with almost the same number of cases.
Concerning your second question, I agree that the TEP
procedure may improve results. When we started this study, we
were only performing TAPP procedures. Now, we are starting to
progressively move toward the TEP procedure. We are also changing
the closure of the peritoneum by a barbed suture and fixing the mesh
with glue.
Peter A. Lodge (Leeds, United Kingdom):
Congratulations on this very nice study. I have a very a quick
question, which doesn’t concern the surgery. One of your outcomes
was length of stay in the TAPP patients under general anesthesia. In
the open Lichtenstein, an epidural was used. I wasn’t certain, whether
this was a single epidural or an epidural paired with general
anesthesia? Either way, do you think that this influenced the length
of the hospital stay?
Response From Benedetto Ielpo (Madrid, Spain):
This is a good point. Of course, the patients within the
laparoscopic group underwent general anesthesia, while the patients
within the open group underwent epidural anesthesia, which may
have affected the length of stay. We decided to maintain this
difference because it reflects the worldwide current practice in
the hospitals.
However, if we assume that the recovery of the epidural
anesthesia is faster when compared to general anesthesia, results
would likely favor the open over the laparoscopic approach. There-
fore, the cost of the laparoscopic technique would increase
even more.
Ielpo et al Annals of Surgery Volume XX, Number XX, Month 2018
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