Langenbecks Arch Surg (2017) 402:935–947
DOI 10.1007/s00423-017-1592-7
ORIGINAL ARTICLE
Chronic pain and quality of life after inguinal hernia
repair using the COMI-hernia score
Ralph Fabian Staerkle 1,2 & Raphael Nicolas Vuille-dit-Bille 1 & Lukas Fink 3 &
Christopher Soll 1 & Peter Villiger 2
Received: 30 January 2017 / Accepted: 23 May 2017 / Published online: 13 June 2017
# Springer-Verlag Berlin Heidelberg 2017
Abstract
Purpose The Core Outcome Measure Index (COMI) is a brief
and multidimensional, patient-orientated outcome question-
naire that assesses chronic pain and quality of life after groin
hernia repair. The primary aim of this study was to prospec-
tively assess the COMI-hernia score, over an extended period
of time in a single large cohort of patients.
Methods Two hundred and twenty-eight male patients with
inguinal hernia repair were included in the present study.
Patients were recruited prospectively with an average
follow-up of 3 years.
Results COMI-hernia total and the COMI-hernia pain scores
were significantly lower following surgery and remained un-
changed over time. Young patients’ age (p = 0.043), high
preoperative COMI-hernia total score (p = 0.018), and bilat-
eral hernias (p = 0.035) were identified as independent risk
factors for adverse outcome after groin hernia repair. Both
COMI-hernia total and the COMI-hernia pain scores signifi-
cantly (p < 2.2*10−16 and p < 1.638*10−11) correlated with
patient’s satisfaction.
Conclusions The COMI score reflects a reliable tool to assess
the outcome following groin hernia repair.
* Ralph Fabian Staerkle
ralph.staerkle@ksw.ch
1
Department of Visceral and Thoracic Surgery, Cantonal Hospital
Winterthur, Brauerstrasse 15, 8401 Winterthur, Switzerland
2
Department of Surgery, Cantonal Hospital Graubuenden, Loëstrasse
170, 7000 Chur, Switzerland
3
Mathematic Faculty, Cantonal School of Wil, Hubstrasse 75,
9501 Wil, Switzerland
Keywords Inguinal hernia repair . Quality assessment .
Quality of life . Core Outcome Measure Index . Patient
satisfaction
Introduction
Worldwide, approximately 20 million groin hernia repairs
are performed annually [1]. Since the routine use of mesh
in inguinal hernia repair, there is an increasing focus on
the occurrence of impaired quality of life and long-term
postoperative pain after inguinal hernia repair [2].
Incidence rates of long-term postoperative pain varying
from 1 to 32% are reported in literature [3–6]. Severe
chronic pain is reported with an incidence of 2 to 9%
[7]; this reflects a major socioeconomic burden consider-
ing the amount of repairs performed [1]. The International
Association for the Study of Pain defined chronic postop-
erative pain as pain lasting for more than 3 months after
an operation [8]. Because of the huge number of opera-
tions performed worldwide, a significant number of pa-
tients are affected by longstanding postoperative pain
and therefore suffer from an impaired quality of life.
Patient-reported outcome measurement is of great impor-
tance in assessing quality of life and chronic pain [9, 10, 11].
However, there are a large number of outcome tools reported
in the literature to assess the outcome after inguinal hernia
repair. Unfortunately, most of these studies are done retrospec-
tively and hence there are no preoperative baseline values
available [12–14]. Currently, there is no standardization of
outcome assessment after inguinal hernia repair. This fact
makes it almost impossible to compare outcome data between
different studies [15].
In 2011, we published a simple questionnaire to assess
the outcome following inguinal hernia repair [16]. This
936
questionnaire was a short, multidimensional, patient-
orientated outcome instrument (Core Outcome Measure
Index; COMI). The COMI-hernia is a reliable, sensitive
and valid tool to assess multidimensional outcome in pa-
tients undergoing inguinal hernia repair [16].
In 2009, the European Hernia Society (EHS) published
their guidelines on the treatment of inguinal hernias [17].
The following causes and risk factors for chronic pain
were identified with a level of recommendation between
1B and 2B [18]: non-mesh repair, open repair, younger
age, preoperative pain, early postoperative pain and fe-
male gender. The EHS recently published an update of
their guidelines with level 1 studies [19]. In this update,
they concluded with a 1B level of recommendation that
preoperative pain and early postoperative pain are inde-
pendent risk factors for the development of chronic post-
operative pain.
The primary aim of this prospective study was to as-
sess chronic postoperative pain and quality of life using
the COMI-hernia score in the long-term follow-up. The
secondary aim was to identify risk factors for an adverse
outcome in a single large cohort of male patients. Finally,
the COMI hernia score was correlated to patient’s
satisfaction.
Material and methods
The present study was approved by the local ethics com-
mittee, and informed consent was obtained from all par-
ticipants. The study was performed in accordance with the
ethical standards as laid down in the 1964 Declaration of
Helsinki and its later amendments or comparable ethical
standards. Patients were recruited from six different hos-
pitals located in Switzerland (Cantonal Hospital
Graubuenden, Cantonal Hospital Glarus, Maennedorf
Hospital, Ilanz Hospital, Scoul Hospital and Grabs
Hospital).
Inclusion criteria were at least 18 years of age, male
gender, clinical diagnosis of groin hernia (primary or re-
current hernia), a signed informed consent and fluency in
German or Italian. Exclusion criteria were female gender,
hernia incarceration, emergency hernia repair and/or con-
dition after groin radiation.
After inclusion in the study, participants received the
pre-operative questionnaire to complete at home and re-
turn by post before surgery. Follow-up questionnaires
were sent to patients 3, 6, 12, 24 und 36 months after
surgery. All patients received their questionnaires at the
designated time. If the questionnaire was not returned
within the determined time limit, a written reminder was
sent to patients. If there was no response to the written
reminder, patients were contacted by phone. A study
Langenbecks Arch Surg (2017) 402:935–947
nurse was responsible for the questionnaire return. The
questionnaires were available in German and Italian.
Questionnaires
The development of the COMI-hernia questionnaire was pub-
lished previously [16]. In brief, it is a multidimensional instru-
ment, originally developed for patients with lower back pain,
with a single item for each of the following domains: pain
(graphic rating scale ranging from 0 to 10), function,
symptom-specific well-being, general quality of life, as well
as social and work disability (each on a 5-point adjectival
scale). A lower score means a better quality of life and less
pain.
Additionally, questions about demographics, pain severity,
intake of pain medication and main symptoms were used.
Patient satisfaction was measured on a 5-point adjectival
scale. Additional questions were modified from Mannion
and colleagues [20].
During the hospital stay, patients’ data concerning the op-
eration and the postoperative course were recorded.
Operative technique
Patients were operated on using different standard proce-
dures including open (Lichtenstein repair, Stoppa opera-
tion and Shouldice repair) and minimal invasive
(transabdominal preperitoneal (TAPP) inguinal hernia re-
pair, total extraperitoneal (TEP) inguinal hernia repair)
techniques. The surgeon determined the operative tech-
nique. Only large pore, lightweight meshes were used.
All procedures were performed by a board certified sur-
geon or under his or her direct supervision. In order to
address this putative bias, surgeon’s experience and type
of surgery (open vs. minimal invasive) were assessed as
putative risk factors for worse outcome following hernia
repair in a multivariate analysis.
Statistics
Results were given as mean ± standard deviations (SD).
Statistical tests included: Friedman rank sum test with post
hoc Wilcoxon signed-rank tests (COMI-hernia total/COMI-
hernia pain over time).
Linear regression analysis was performed to assess risk
factors for high postoperative COMI-hernia total and pain
scores. It should be noted that patient’s satisfaction was con-
sidered as metric data.
Changes were rated as significant at p values <0.05.
Descriptive and analytical statistics were executed using R;
an open-source language and environment for statistical com-
puting. (http://www.R-project.org/).
Langenbecks Arch Surg (2017) 402:935–947 937

Table 1 Patients’ details

Age [years] 57.7 ± 16.0

BMI [kg/m2] 24.8 ± 2.97

OP time [min] 73.5 ± 34.3
Type of anaesthesia General: 149 (65%) Spinal: 61 (27%) Local: 18 (8%)
Preoperative ASA score I: 89 (39%) II: 122 (54%) III: 17 (7%)
Open versus laparoscopic Open: 136 (60%) Laparoscopic: 92 (40%)
procedure
Unilateral versus bilateral Unilateral: 158 (69%) Bilateral: 70 (31%)
hernia
Primary hernia versus relapse Primary hernia: 196 (86%) Relapse: 32 (14%)
Surgeon’s experience 0–20: 69 (30%) 21–50: 33 (14%) 51–100: 16 (7%) >100: 110 (48%)
Follow-up (n = 228 patients 3 months: 218 6 months: 218 12 months: 208 2 years: 201 (88.2%) 3 years: 189 (82.9%)
in total) (95.6%) (95.6%) (91.2%)

Values are given as mean ± standard deviations or as absolute values plus percentages in brackets.

Results COMI-hernia total scores over time

In total, 228 male patients were included in this prospective
study. The length of follow-up was 3 years on the average with
a follow-up rate of 82.9%. The experience of the surgeon was
more than 50 previous hernia repairs in 126 (55%) patients.
Laparoscopic surgeries (transabdominal pre-peritoneal (TAPP)
and total extraperitoneal (TEP) repairs) were performed in 92
cases (40%), whereas 136 patients (60%) were operated on using
open (Lichtenstein repair, Shouldice repair, Stoppa procedure)
procedures. Bilateral hernias were operated on in 70 patients
(31%) and unilateral hernias in 158 patients (69%). Mean oper-
ation time was 73.5 min, ranging from 26 to 265 min. General
anaesthesia was applied in 149 patients (65%). One hundred and
ninety-six patients (86%) had a primary hernia (Table 1).
COMI-hernia total scores were lower after surgery (means
ranging from 0.82 after 3 months to 0.50 after 3 years)
when compared to preoperative values (mean 3.13) (pre-
operative COMI-hernia total score versus COMI-hernia
total score after 3 months: p < 2.2*10 −16 ) (Fig. 1,
Table 2). No differences among post-operative COMI-her-
nia total scores were observed when comparing the fol-
lowing time points: 3 versus 6 months, 6 versus
12 months, 12 versus 24 months and 24 versus 36 months.
Due to the lack of significant differences between the
postoperative COMI-hernia scores at 3, 6, 12, 24 and
36 months, statistical tests were applied for the 12-
month follow-up only.

Fig. 1 Boxplot of total COMI-

hernia total scores preoperatively
(preop), after 3 months (m3),
6 months (m6), 12 months (m36),
24 months (m24) and after
36 months (m36) (solid line me-
dian, box limits 25 and 75%,
whiskers 1.5× interquartile range
(IQR), circles maximum
observations)
938 Langenbecks Arch Surg (2017) 402:935–947

Table 2 COMI-hernia scores

Time point Preoperatively 3 months 6 months 12 months 2 years 3 years

COMI-hernia total Mean 3.13 0.82 0.74 0.74 0.55 0.50

Wilcoxon signed-rank test p < 2.2*10−16 p = 0.271 p = 0.505
p = 0.146 p = 0.057
COMI-hernia pain Mean 2.62 0.79 0.85 0.85 0.65 0.61
Wilcoxon signed-rank test p < 2.2*10−16 0.051 0.454
p = 0.507 0.032

COMI-hernia total and COMI-hernia pain scores preoperatively and at 3, 6, 12, 24 and 36 months postoperatively.

COMI-hernia total scores over time for patients with pain
scores ≥2 after 3 months postoperatively
COMI-hernia total scores for patients with a pain score of
2 or more, 3 months after surgery, were significantly de-
creased over time, when comparing the following time
points: preoperative score versus 6 months (p = 0.0001),
12 months (p = 0.002), 24 months (p = 0.0007) and
36 months (p = 5.433e-05), respectively, and 3 months
versus 6 months (p = 0.020), 24 months (p = 0.016) and
36 months (p = 0.004), respectively. No significant de-
creases were seen when comparing the preoperative score
versus 3 months score and 3 months score versus
12 months score. Furthermore, no significant changes in
COMI-hernia total scores were seen after 6 months
(Fig. 2, Table 3).
COMI-hernia pain scores over time
COMI-hernia pain scores were significantly lower follow-
ing surgery. Compared to the mean preoperative COMI-
hernia pain score (2.62), the mean postoperative score
was 0.85 after 12 months, 0.65 after 24 months and 0.61
after 36 months (Fig. 3, Table 2). When comparing the
following time points: 3 versus 6 months (p = 0.51), 6
versus 12 months (p = 0.051) and 24 versus 36 months
(p = 0.45), no differences in COMI-hernia pain scores
were seen. COMI-hernia pain scores decreased after
12 months (when compared to values after 24 months;
p = 0.032).
COMI-hernia pain scores over time for patients with pain
scores ≥2 after 3 months postoperatively
COMI-hernia pain scores for patients with a pain score of
≥2 at 3 months after surgery were significantly decreased
over time, when comparing the following time points:
preoperative score versus 6 months (p = 0.005), 12 months
(p = 0.011), 24 months (p = 0.012) and 36 months
(p = 0.003), respectively, and 3 versus 6 months
(p = 0.0005), 12 months (p = 0.002), 24 months
(p = 0.002) and 36 months (p = 0.003), respectively. No

Fig. 2 Boxplot of total COMI-

hernia total scores preoperatively
(preop), after 3 months (m3),
6 months (m6), 12 months (m36),
24 months (m24) and after
36 months (m36) for patients with
pain score of ≥2 after 3 months
(solid line median, box limits 25
and 75%, whiskers 1.5× inter-
quartile range (IQR), circles
maximum observations)
Langenbecks Arch Surg (2017) 402:935–947 939

Table 3 COMI-hernia scores for patients with pain scores ≥2 after 3 months postoperatively
preoperatively 3 6 12 2 years 3 years
months months months

preoperatively P= p= p= p= p=
0.025 0.0001 0.002 0.0007 5.433e-
05
3 months p= 0.771 p= p= p= p=
0.020 0.052 0.016 0.004
6 months p = 0.005 p= p= p= p=
0.0005 0.811 0.627 0.438
12 months p = 0.011 p= p= P= p=
0.002 0.827 0.463 0.344
2 years p = 0.012 p= p= p= p=
0.002 0.641 0.857 0.949
3 years p = 0.003 p= p= p= p=
0.003 0.340 0.411 0.564
p values (Wilcoxon signed-rank test) of COMI-hernia total (grey shade) and COMI-hernia pain (white shade) scores preoperatively and at 3, 6, 12, 24
and 36 months postoperatively.

significant decrease was seen when comparing the preop-
erative score versus 3 months score. Furthermore, no sig-
nificant changes in COMI-hernia pain scores were seen
after 6 months (Fig. 4, Table 3).
Risk factors for high postoperative COMI-hernia total
scores (after 12 months)
The following 10 variables were tested as putative risk factors
for high postoperative COMI-hernia total scores (12 months
postoperative): body mass index (BMI), age, surgeon’s expe-
rience, American Society of Anesthesiologists (ASA) score,
type of anaesthesia (i.e. local versus general versus spinal),
type of surgery (i.e. open versus laparoscopic), location of
the hernia (i.e. unilateral versus bilateral disease), operation
time, relapse (i.e. no relapse versus relapse), and preoperative
COMI-hernia total score. Hereby, the following risk factors
were identified: high preoperative COMI-hernia total score
(p = 0.018), patients’ age (p = 0.043), and bilateral disease
(p = 0.035) (Table 4). Regression analyses showed that pa-
tients’ age was inversely correlated with COMI-hernia total
scores (after 12 months) (R2 = 0.0131, p = 0.09979, coeff:
−0.009955). Patients’ satisfaction directly correlated with
COMI-hernia total scores (after 12 months) (Fig. 5)
(R2 = 0.3657, p < 2.2*10−16, coeff = 0.38240).
Risk factors for high postoperative COMI-hernia pain
scores (after 12 months)
The same 10 variables were tested as putative risk factors
for high postoperative COMI-hernia pain scores
(12 months postoperative): BMI, age, surgeon’s

Fig. 3 Boxplot of COMI-hernia

pain scores preoperatively
(preop), after 3 months (m3),
6 months (m6), 12 months (m36),
24 months (m24) and after
36 months (m36) (solid line me-
dian, box limits 25 and 75%,
whiskers 1.5× interquartile range
(IQR), circles maximum
observations)
940 Langenbecks Arch Surg (2017) 402:935–947

Fig. 4 Boxplot of total COMI-

hernia pain scores preoperatively
(preop), after 3 months (m3),
6 months (m6), 12 months (m36),
24 months (m24) and after
36 months (m36) for patients with
pain score of ≥2 after 3 months
(solid line median, box limits 25
and 75%, whiskers 1.5× inter-
quartile range (IQR), circles
maximum observations)

experience (i.e. number of hernia surgeries performed)
ASA score, type of anaesthesia (i.e. general versus spinal
versus local), type of surgery (i.e. laparoscopic versus
open), location of the hernia (i.e. unilateral versus bilater-
al disease), operation time, relapse (i.e. relapse versus
primary hernia), and preoperative COMI-hernia total
score. Again, as for COMI-hernia total score, the follow-
ing two risk factors were identified: high preoperative
COMI-hernia pain score (p = 0.016), and patients’ age
(p = 0.008) (Table 5). Similarly, as for COMI-hernia total
scores, regression analyses showed that patients’ age was
inversely correlated with COMI-hernia pain scores (after
12 months) (R 2 = 0.02644, p = 0.01923, coeff:
−0.016745). Patients’ satisfaction directly correlated with
COMI-hernia pain scores (after 12 months) (Fig. 6)
(R2 = 0.1989, p < 1.638*10−11, coeff = 0.22791).

Table 4 Risk factors for high

COMI-hernia total scores Variable Coefficient 95% confidence interval p value

Preoperative total COMI score 0.117 0.021–0.213 0.018

Age −0.021 −0.037–−0.0039 0.043
Unilateral 0
Bilateral 0.689 0.050–1.328 0.035
BMI −0.021 −0.085–0.042 0.506
ASA I 0 −0.130–0.821
ASA II 0.345 0.379–1.369 0.154
ASA III 0.495 0.266
Operation time −0.005 −0.011–0.002 0.163
Open surgery 0
Laparoscopic surgery −0.227 −0.866–0.412 0.489
No relapse 0
Relapse 0.195 −0.386–0.775 0.509
Experience 0–20 repairs 0
Experience 21–50 repairs −0.536 −1.148–0.077 0.086
Experience 51–100 repairs −0.526 −1.325–0.272 0.195
Experience >100 repairs −0.434 −0.941–0.073 0.093
Local anaesthesia 0
General anaesthesia −0.2286 −1.067–0.495 0.471
Spinal anaesthesia −0.364 −1.127–0.399 0.348

Linear regression analysis of putative risk factors for high total COMI-hernia scores at 12 months postoperative.
Langenbecks Arch Surg (2017) 402:935–947 941

Fig. 5 Patients’ satisfaction

versus COMI-hernia total score
(after 12 months). R2 = 0.3657,
p < 2.2*10−16, coeff = 0.38240
(regression analysis)

Discussion COMI-hernia pain and COMI-hernia total scores show

Our data show that the COMI-hernia is a useful outcome
tool in inguinal hernia surgery to assess postoperative
chronic pain and quality of life. As assessed in the pres-
ent study, the COMI-hernia total and the COMI-hernia
pain scores were significantly lower following surgery as
compared to the preoperative scores. Postoperative
a tendency to decrease over time without being signifi-
cantly different. In patients with adverse outcome (i.e.
patients with pain scores of 2 or more after 3 months
postoperatively) postoperative COMI-hernia pain and
COMI-hernia total scores decrease over the first postop-
erative 6 months, but stay unchanged thereafter. This
underlines only in part the statement from the EHS

Table 5 Risk factors for high

COMI-hernia pain scores Variable Coefficient 95% confidence interval p value

Preoperative COMI-hernia total score 0.139 0.026–0.252 0.016

Age −0.026 −0.045–−0.007 0.008
Unilateral 0
Bilateral 0.711 −0.040–1.462 0.063
BMI −0.065 −0.142–0.013 0.101
ASA I 0
ASA II 0.191 −0.371–0.753 0.503
ASA III 0.550 −0479–1.578 0.293
Operation time −0.006 −0.014–0.002 0.118
Open surgery 0
Laparoscopic surgery −0.060 −0.810–0.691 0.875
No relapse 0
Relapse 0.339 −0.343–1.021 0.328
Experience 0–20 repairs 0
Experience 21–50 repairs −0.281 −1.001–0.442 0.444
Experience 51–100 repairs −0.169 −1.111–0.773 0.724
Experience >100 repairs −0.108 −0.707–0.491 0.723
Local anaesthesia 0
General anaesthesia −0.133 −1.049–0.783 0.775
Spinal anaesthesia 0.079 −0.820–0.978 0.862

Linear regression analysis of putative risk factors for (log transformed) high COMI-hernia pain scores at
12 months postoperative.
942
Fig. 6 Patients’ satisfaction
versus COMI-hernia pain score
(after 12 months). R2 = 0.1989,
p < 1.638*10−11, coeff = 0.22791
(regression analysis)
update, which emphasizes that postoperative chronic pain
diminishes over time [19].
Multivariate analysis identified high preoperative COMI-
hernia pain score and younger age as independent risk factors
for an adverse outcome after inguinal hernia repair in respect
of quality of life and long-term postoperative pain. These
findings are in accordance with the conclusion in the EHS
guidelines [17, 19]. In our study, bilateral repair was an inde-
pendent risk factor for a high postoperative COMI-hernia total
score but not for a high postoperative COMI-pain score. In the
literature, bilateral hernia repair is not described as a risk factor
for an adverse outcome. Since multiple (10) variables were
analysed and the p value was 0.035, bilateral hernias might
reflect a false positive risk factor for high postoperative
COMI-hernia score. Especially, since bilateral hernia repair
did not correlate with high postoperative pain score.
Age inversely correlated with the COMI-hernia total and
pain score. Again, this underlines that younger age is an inde-
pendent risk factor for an adverse outcome after inguinal her-
nia repair. Patient’s satisfaction correlated with the COMI-
hernia total and pain score. This emphasize that a low
COMI-hernia score reflects high patient satisfaction.
One strength of this study is a compliance rate of over 90%
after 1 year and over 80% after 3 years. This high compliance
rate confirms the acceptance and the patient-friendly design of
the questionnaire. The diversity of different operative proce-
dures represents a limiting factor of the present study, but
reflects the daily practice in public teaching hospitals.
Despite the diversity of different operation techniques and
multiple surgeons, we identified the same main risk factors
for an adverse outcome after inguinal hernia repair as men-
tioned by the EHS updated guidelines [19]. This underlines
again the strength of the COMI-hernia in daily practice.
Franneby published in 2008 the Inguinal Pain
Questionnaire (IPQ) for assessment of chronic pain after groin
hernia repair [12]. As stated in the title, this questionnaire
Langenbecks Arch Surg (2017) 402:935–947
focuses mainly on pain. The IPQ consists of 18 questions
and is therefore longer than the COMI-hernia. Compared to
the COMI-hernia, the IPQ is only made for postoperative as-
sessment. In our opinion, this is a major disadvantage of the
IPQ questionnaire. By enquiring retrospectively about symp-
toms and recovery, with some questions using a reference time
frame of up to 2 years after surgery, answers may be unreliable
and therefore significantly biased[23]. As mentioned earlier,
the COMI-hernia not only focuses on pain but also on func-
tion, symptom-specific well-being, general quality of life, as
well as social and work disability. These combined factors
make the COMI-hernia a more comprehensive assessment
tool for patients after groin hernia repair compared to the IPQ.
The European Registry for Abdominal Wall hernias recent-
ly published the EuraHS-QoL instrument [14]. The EuraHS-
QoL consists of nine questions and is quantitatively compara-
ble to the COMI-hernia. The questionnaire covers three do-
mains: pain, restriction of activities and cosmetic discomfort.
The main difference to the COMI-hernia is the cosmetic as-
pect. This issue is not covered by the COMI-hernia at all. On
the other hand, aspects like general well-being and quality of
life are not covered by the EuraHS-QoL. To our opinion, these
aspects in particular are decisive for outcome assessment. The
EuraHS-QoL may be used pre- and postoperatively, like the
COMI-hernia, which is a huge advantage compared to the
IPQ. The European Registry publication emphasizes the ut-
most importance of patient reported outcome measurement.
We fully agree with this statement. This questionnaire can be
used in groin and ventral hernia patients. However, in our
opinion, it would be difficult to use the same questionnaire
in groin and ventral hernia patients. We advocate an inguinal
hernia-specific questionnaire.
There is a paucity of different studies published on
chronic pain and quality of life after inguinal hernia re-
pair. Unfortunately, in many of these studies different and
sometimes invalidated outcome tools were used [15]. As a
Langenbecks Arch Surg (2017) 402:935–947
result, outcome data among these studies were not
comparable.
Mommers recently published a study where the COMI-
hernia was used for the time in a prospective clinical trial
[21]. The authors underline the importance of patient-
reported outcomes. They used the COMI-hernia in a co-
hort of 120 patients undergoing total extraperitoneal her-
nia repair. The authors concluded that the COMI-hernia
scale provides reasonable insight into the patients’ expe-
rience. However, they criticise that the scores are difficult
to interpret for patients and physicians. Here, we would
argue that this is based on the lack of experience with the
COMI-hernia. The questionnaire has been used for the
first time in a prospective trial. In other areas of medicine
such short questionnaires are the standard for outcome
assessment and work very well [22].
Outcome assessment with questionnaires is demanding.
First of all, patient compliance to completely fill in ques-
tionnaires within the allotted time is challenging.
Furthermore, there is always a risk of response bias.
Several studies show that mainly patients with an adverse
outcome do not respond to questionnaires [24, 25]. This
false favourable outcome could be reflected in the study.
Therefore, it is of utmost importance that a dedicated per-
son, such as a study nurse, be responsible for the follow-
up. If the questionnaires are not returned, this person
should contact the patients proactively in order to mini-
mize response bias.
The patient’s compliance can be improved by the use
of short questionnaires. Deyo and colleagues addressed
this problem in patients with lower back pain [26]. They
proposed for the first time a set of Bcore outcome
measures^ with only one question for each domain. This
questionnaire now reflects the official patient-orientated
outcome instrument in the European Spine Surgery
Registry, Spine Tango [22]. As shown previously, the pre-
senting authors took this questionnaire and adapted it to
groin hernia patients [16].
Postoperative quality of life has become one of the main
topics in outcome assessment. From a patient’s perspective
these outcomes are probably even more important than the
classification of complications with scores such as the
Clavien-Dindo score [27].
To summarize, the COMI-hernia is a powerful instru-
ment with high internal and external validity. In our opin-
ion, short and simple validated instruments for measuring
pain, functioning, symptom-specific well-being, general
quality of life, as well as social and work disability should
be used for monitoring the long-term outcome of groin
hernia repair. The COMI-hernia does fulfil all these
criteria. As previously mentioned, the COMI-hernia has
some clear advantages over the IPQ and the EuroHS-
QoL. Last but not least, the COMI-hernia is well accepted
943
by patients, which is represented by a follow-up rate of
over 80% after 3 years.
Conclusions
We are convinced that the COMI-hernia is a useful tool to
assess quality of life after inguinal hernia repair. In this
study, this questionnaire showed a high patient acceptance
with a low dropout rate. The significant difference in the
pre- and postoperative COMI-hernia scores underlines
that this questionnaire may detect changes in quality of
life and pain between the pre- and postoperative period.
This confirms the results of our first study, where we
found that the COMI-hernia is a reliable, sensitive and
valid tool to assess multidimensional outcome in inguinal
hernia surgery [16]. No significant changes were detected
in the postoperative COMI-scores over time. Furthermore,
patients with adverse outcomes showed no significant dif-
ference in COMI-hernia pain and COMI-hernia total
scores after 6 months postoperatively. By using the
COMI-hernia, we were able to detect risk factors for an
adverse outcome. The identified risk factors are in line
with risk factors known from literature, excluding bilater-
al repair [28–35].
For the future, the only way that outcome data follow-
ing hernia repair can be reliably interpreted by different
authors, will be to use a standardized and validated ques-
tionnaire. Based on our data, we would recommend the
COMI-hernia questionnaire as the official instrument to
measure the outcome after inguinal hernia repair in males.
Acknowledgements The authors thank Angela Munson for language
editing of the manuscript.
Authors’ contributions RFS conceptualised and designed the study,
acquired the data and drafted the manuscript. RNV helped to draft the
manuscript and analyse and interpret the data. LF contributed in analysis
and interpretation of data. CS helped to draft the manuscript and critically
revise the manuscript. PV helped to critically revise the manuscript.
Compliance with ethical standards
Conflicts of interest The authors declare that they have no conflict of
interest.
Ethical approval All procedures performed in studies involving hu-
man participants were in accordance with the ethical standards of the
institutional and/or national research committee and with the 1964
Helsinki declaration and its later amendments or comparable ethical
standards.
Informed consent Informed consent was obtained from all individual
participants included in the study.
944 Langenbecks Arch Surg (2017) 402:935–947

Appendix. COMI-hernia

Pre-operative questionnaire
In the following question we would like you to indicate the severity of your pain, by marking a
cross on the line from 0 to 10 (where "0"=no pain, "10"=the worst pain you can imagine).

For example:

1. How severe was your groin pain in the last week?

2. During the past week, how much did your groin problem interfere with your normal
work (including both work outside the home and housework)?

1 not at all
2 a little bit
3 moderately
4 quite a bit
5 extremely

3. If you had to spend the rest of your life with the groin problems you have right now,
how would you feel about it?

1 very satisfied
2 somewhat satisfied
3 neither satisfied nor dissatisfied
4 somewhat dissatisfied
5 very dissatisfied

4. Please reflect on the last week. How would you rate your quality of life?

1 very good
2 good
3 moderate
4 bad
5 very bad

5. During the past 4 weeks, how many days did you cut down on the things you
usually do (work, housework, school, recreational activities) because of your groin
problem?
Langenbecks Arch Surg (2017) 402:935–947 945

1 none
2 between 1 and 7 days
3 between 8 and 14 days
4 between 15 and 21 days
5 more than 21 days

6. During the past 4 weeks, how many days did your groin problem keep you from
going to work (job, school, housework)?

1 none
2 between 1 and 7 days
3 between 8 and 14 days
4 between 15 and 21 days
5 more than 21 days

Postoperative follow-up questionnaire

1. Surgery for inguinal hernia can lead to the following problems. Which problem troubles
you the most?

a) Men:

1 groin pain (in the region operated)

2 testicular pain
3 pain during ejaculation/sexual intercourse
4 pain passing water (during urination)
5 sensory disturbances in the groin/inner thigh
6 no problems

b) Women:

1 groin pain (in the region operated)

2 pain during ovulation or during menstruation
3 pain during sexual intercourse
4 pain passing water (during urination)
5 sensory disturbances in the groin/inner thigh
6 no problems

(QUESTIONS 1-6 FROM PRE-OPERATIVE QUESTIONNAIRE REPEATED HERE)

8. Did any of the following problems arise as a consequence of your operation (more than
one answer possible)?

1 no problems
2 wound infection
3 haematoma
4 very severe groin pain
5 testicular pain
6 other: …………………………
946 Langenbecks Arch Surg (2017) 402:935–947

If you answered „no problems“ to question 8, please go straight on to question 10

9. How bothersome were these complications?

1 not at all bothersome

2 slightly bothersome
3 moderately bothersome
4 very bothersome
5 extremely bothersome

10. Have you had to undergo any further surgery for a new inguinal hernia on the same
side?

1 yes, date: ………….

2 no

11. Over the course of treatment for your inguinal hernia, how satisfied were you with your
overall medical care in our hospital?

1 very satisfied
2 somewhat satisfied
3 neither satisfied nor dissatisfied
4 somewhat dissatisfied
5 very dissatisfied

12. Overall, when you think about your groin pain and/or groin problems before surgery,
how much did the operation help?

1 helped a lot
2 helped
3 helped only little
4 didn’t help
5 made things worse

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