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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 Keywords Inguinal hernia repair . Quality assessment .


Purpose The Core Outcome Measure Index (COMI) is a brief Quality of life . Core Outcome Measure Index . Patient
and multidimensional, patient-orientated outcome question- satisfaction
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 Introduction
of time in a single large cohort of patients.
Methods Two hundred and twenty-eight male patients with Worldwide, approximately 20 million groin hernia repairs
inguinal hernia repair were included in the present study. are performed annually [1]. Since the routine use of mesh
Patients were recruited prospectively with an average in inguinal hernia repair, there is an increasing focus on
follow-up of 3 years. the occurrence of impaired quality of life and long-term
Results COMI-hernia total and the COMI-hernia pain scores postoperative pain after inguinal hernia repair [2].
were significantly lower following surgery and remained un- Incidence rates of long-term postoperative pain varying
changed over time. Young patients’ age (p = 0.043), high from 1 to 32% are reported in literature [3–6]. Severe
preoperative COMI-hernia total score (p = 0.018), and bilat- chronic pain is reported with an incidence of 2 to 9%
eral hernias (p = 0.035) were identified as independent risk [7]; this reflects a major socioeconomic burden consider-
factors for adverse outcome after groin hernia repair. Both ing the amount of repairs performed [1]. The International
COMI-hernia total and the COMI-hernia pain scores signifi- Association for the Study of Pain defined chronic postop-
cantly (p < 2.2*10−16 and p < 1.638*10−11) correlated with erative pain as pain lasting for more than 3 months after
patient’s satisfaction. an operation [8]. Because of the huge number of opera-
Conclusions The COMI score reflects a reliable tool to assess tions performed worldwide, a significant number of pa-
the outcome following groin hernia repair. 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
* Ralph Fabian Staerkle in the literature to assess the outcome after inguinal hernia
ralph.staerkle@ksw.ch repair. Unfortunately, most of these studies are done retrospec-
tively and hence there are no preoperative baseline values
1
Department of Visceral and Thoracic Surgery, Cantonal Hospital available [12–14]. Currently, there is no standardization of
Winterthur, Brauerstrasse 15, 8401 Winterthur, Switzerland outcome assessment after inguinal hernia repair. This fact
2
Department of Surgery, Cantonal Hospital Graubuenden, Loëstrasse makes it almost impossible to compare outcome data between
170, 7000 Chur, Switzerland different studies [15].
3
Mathematic Faculty, Cantonal School of Wil, Hubstrasse 75, In 2011, we published a simple questionnaire to assess
9501 Wil, Switzerland the outcome following inguinal hernia repair [16]. This
936 Langenbecks Arch Surg (2017) 402:935–947

questionnaire was a short, multidimensional, patient- nurse was responsible for the questionnaire return. The
orientated outcome instrument (Core Outcome Measure questionnaires were available in German and Italian.
Index; COMI). The COMI-hernia is a reliable, sensitive
and valid tool to assess multidimensional outcome in pa- Questionnaires
tients undergoing inguinal hernia repair [16].
In 2009, the European Hernia Society (EHS) published The development of the COMI-hernia questionnaire was pub-
their guidelines on the treatment of inguinal hernias [17]. lished previously [16]. In brief, it is a multidimensional instru-
The following causes and risk factors for chronic pain ment, originally developed for patients with lower back pain,
were identified with a level of recommendation between with a single item for each of the following domains: pain
1B and 2B [18]: non-mesh repair, open repair, younger (graphic rating scale ranging from 0 to 10), function,
age, preoperative pain, early postoperative pain and fe- symptom-specific well-being, general quality of life, as well
male gender. The EHS recently published an update of as social and work disability (each on a 5-point adjectival
their guidelines with level 1 studies [19]. In this update, scale). A lower score means a better quality of life and less
they concluded with a 1B level of recommendation that pain.
preoperative pain and early postoperative pain are inde- Additionally, questions about demographics, pain severity,
pendent risk factors for the development of chronic post- intake of pain medication and main symptoms were used.
operative pain. Patient satisfaction was measured on a 5-point adjectival
The primary aim of this prospective study was to as- scale. Additional questions were modified from Mannion
sess chronic postoperative pain and quality of life using and colleagues [20].
the COMI-hernia score in the long-term follow-up. The During the hospital stay, patients’ data concerning the op-
secondary aim was to identify risk factors for an adverse eration and the postoperative course were recorded.
outcome in a single large cohort of male patients. Finally,
the COMI hernia score was correlated to patient’s
satisfaction. Operative technique

Patients were operated on using different standard proce-


Material and methods dures including open (Lichtenstein repair, Stoppa opera-
tion and Shouldice repair) and minimal invasive
The present study was approved by the local ethics com- (transabdominal preperitoneal (TAPP) inguinal hernia re-
mittee, and informed consent was obtained from all par- pair, total extraperitoneal (TEP) inguinal hernia repair)
ticipants. The study was performed in accordance with the techniques. The surgeon determined the operative tech-
ethical standards as laid down in the 1964 Declaration of nique. Only large pore, lightweight meshes were used.
Helsinki and its later amendments or comparable ethical All procedures were performed by a board certified sur-
standards. Patients were recruited from six different hos- geon or under his or her direct supervision. In order to
pitals located in Switzerland (Cantonal Hospital address this putative bias, surgeon’s experience and type
Graubuenden, Cantonal Hospital Glarus, Maennedorf of surgery (open vs. minimal invasive) were assessed as
Hospital, Ilanz Hospital, Scoul Hospital and Grabs putative risk factors for worse outcome following hernia
Hospital). repair in a multivariate analysis.
Inclusion criteria were at least 18 years of age, male
gender, clinical diagnosis of groin hernia (primary or re- Statistics
current hernia), a signed informed consent and fluency in
German or Italian. Exclusion criteria were female gender, Results were given as mean ± standard deviations (SD).
hernia incarceration, emergency hernia repair and/or con- Statistical tests included: Friedman rank sum test with post
dition after groin radiation. hoc Wilcoxon signed-rank tests (COMI-hernia total/COMI-
After inclusion in the study, participants received the hernia pain over time).
pre-operative questionnaire to complete at home and re- Linear regression analysis was performed to assess risk
turn by post before surgery. Follow-up questionnaires factors for high postoperative COMI-hernia total and pain
were sent to patients 3, 6, 12, 24 und 36 months after scores. It should be noted that patient’s satisfaction was con-
surgery. All patients received their questionnaires at the sidered as metric data.
designated time. If the questionnaire was not returned Changes were rated as significant at p values <0.05.
within the determined time limit, a written reminder was Descriptive and analytical statistics were executed using R;
sent to patients. If there was no response to the written an open-source language and environment for statistical com-
reminder, patients were contacted by phone. A study 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 COMI-hernia total scores were lower after surgery (means
study. The length of follow-up was 3 years on the average with ranging from 0.82 after 3 months to 0.50 after 3 years)
a follow-up rate of 82.9%. The experience of the surgeon was when compared to preoperative values (mean 3.13) (pre-
more than 50 previous hernia repairs in 126 (55%) patients. operative COMI-hernia total score versus COMI-hernia
Laparoscopic surgeries (transabdominal pre-peritoneal (TAPP) total score after 3 months: p < 2.2*10 −16 ) (Fig. 1,
and total extraperitoneal (TEP) repairs) were performed in 92 Table 2). No differences among post-operative COMI-her-
cases (40%), whereas 136 patients (60%) were operated on using nia total scores were observed when comparing the fol-
open (Lichtenstein repair, Shouldice repair, Stoppa procedure) lowing time points: 3 versus 6 months, 6 versus
procedures. Bilateral hernias were operated on in 70 patients 12 months, 12 versus 24 months and 24 versus 36 months.
(31%) and unilateral hernias in 158 patients (69%). Mean oper- Due to the lack of significant differences between the
ation time was 73.5 min, ranging from 26 to 265 min. General postoperative COMI-hernia scores at 3, 6, 12, 24 and
anaesthesia was applied in 149 patients (65%). One hundred and 36 months, statistical tests were applied for the 12-
ninety-six patients (86%) had a primary hernia (Table 1). 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 hernia pain score (2.62), the mean postoperative score
scores ≥2 after 3 months postoperatively was 0.85 after 12 months, 0.65 after 24 months and 0.61
after 36 months (Fig. 3, Table 2). When comparing the
COMI-hernia total scores for patients with a pain score of following time points: 3 versus 6 months (p = 0.51), 6
2 or more, 3 months after surgery, were significantly de- versus 12 months (p = 0.051) and 24 versus 36 months
creased over time, when comparing the following time (p = 0.45), no differences in COMI-hernia pain scores
points: preoperative score versus 6 months (p = 0.0001), were seen. COMI-hernia pain scores decreased after
12 months (p = 0.002), 24 months (p = 0.0007) and 12 months (when compared to values after 24 months;
36 months (p = 5.433e-05), respectively, and 3 months p = 0.032).
versus 6 months (p = 0.020), 24 months (p = 0.016) and
36 months (p = 0.004), respectively. No significant de- COMI-hernia pain scores over time for patients with pain
creases were seen when comparing the preoperative score scores ≥2 after 3 months postoperatively
versus 3 months score and 3 months score versus
12 months score. Furthermore, no significant changes in COMI-hernia pain scores for patients with a pain score of
COMI-hernia total scores were seen after 6 months ≥2 at 3 months after surgery were significantly decreased
(Fig. 2, Table 3). over time, when comparing the following time points:
preoperative score versus 6 months (p = 0.005), 12 months
COMI-hernia pain scores over time (p = 0.011), 24 months (p = 0.012) and 36 months
(p = 0.003), respectively, and 3 versus 6 months
COMI-hernia pain scores were significantly lower follow- (p = 0.0005), 12 months (p = 0.002), 24 months
ing surgery. Compared to the mean preoperative COMI- (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- COMI-hernia total score. Hereby, the following risk factors
erative score versus 3 months score. Furthermore, no sig- were identified: high preoperative COMI-hernia total score
nificant changes in COMI-hernia pain scores were seen (p = 0.018), patients’ age (p = 0.043), and bilateral disease
after 6 months (Fig. 4, Table 3). (p = 0.035) (Table 4). Regression analyses showed that pa-
tients’ age was inversely correlated with COMI-hernia total
Risk factors for high postoperative COMI-hernia total scores (after 12 months) (R2 = 0.0131, p = 0.09979, coeff:
scores (after 12 months) −0.009955). Patients’ satisfaction directly correlated with
COMI-hernia total scores (after 12 months) (Fig. 5)
The following 10 variables were tested as putative risk factors (R2 = 0.3657, p < 2.2*10−16, coeff = 0.38240).
for high postoperative COMI-hernia total scores (12 months
postoperative): body mass index (BMI), age, surgeon’s expe- Risk factors for high postoperative COMI-hernia pain
rience, American Society of Anesthesiologists (ASA) score, scores (after 12 months)
type of anaesthesia (i.e. local versus general versus spinal),
type of surgery (i.e. open versus laparoscopic), location of The same 10 variables were tested as putative risk factors
the hernia (i.e. unilateral versus bilateral disease), operation for high postoperative COMI-hernia pain scores
time, relapse (i.e. no relapse versus relapse), and preoperative (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) COMI-hernia pain score (p = 0.016), and patients’ age
ASA score, type of anaesthesia (i.e. general versus spinal (p = 0.008) (Table 5). Similarly, as for COMI-hernia total
versus local), type of surgery (i.e. laparoscopic versus scores, regression analyses showed that patients’ age was
open), location of the hernia (i.e. unilateral versus bilater- inversely correlated with COMI-hernia pain scores (after
al disease), operation time, relapse (i.e. relapse versus 12 months) (R 2 = 0.02644, p = 0.01923, coeff:
primary hernia), and preoperative COMI-hernia total −0.016745). Patients’ satisfaction directly correlated with
score. Again, as for COMI-hernia total score, the follow- COMI-hernia pain scores (after 12 months) (Fig. 6)
ing two risk factors were identified: high preoperative (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


a tendency to decrease over time without being signifi-
Our data show that the COMI-hernia is a useful outcome cantly different. In patients with adverse outcome (i.e.
tool in inguinal hernia surgery to assess postoperative patients with pain scores of 2 or more after 3 months
chronic pain and quality of life. As assessed in the pres- postoperatively) postoperative COMI-hernia pain and
ent study, the COMI-hernia total and the COMI-hernia COMI-hernia total scores decrease over the first postop-
pain scores were significantly lower following surgery as erative 6 months, but stay unchanged thereafter. This
compared to the preoperative scores. Postoperative 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 Langenbecks Arch Surg (2017) 402:935–947

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 focuses mainly on pain. The IPQ consists of 18 questions
diminishes over time [19]. and is therefore longer than the COMI-hernia. Compared to
Multivariate analysis identified high preoperative COMI- the COMI-hernia, the IPQ is only made for postoperative as-
hernia pain score and younger age as independent risk factors sessment. In our opinion, this is a major disadvantage of the
for an adverse outcome after inguinal hernia repair in respect IPQ questionnaire. By enquiring retrospectively about symp-
of quality of life and long-term postoperative pain. These toms and recovery, with some questions using a reference time
findings are in accordance with the conclusion in the EHS frame of up to 2 years after surgery, answers may be unreliable
guidelines [17, 19]. In our study, bilateral repair was an inde- and therefore significantly biased[23]. As mentioned earlier,
pendent risk factor for a high postoperative COMI-hernia total the COMI-hernia not only focuses on pain but also on func-
score but not for a high postoperative COMI-pain score. In the tion, symptom-specific well-being, general quality of life, as
literature, bilateral hernia repair is not described as a risk factor well as social and work disability. These combined factors
for an adverse outcome. Since multiple (10) variables were make the COMI-hernia a more comprehensive assessment
analysed and the p value was 0.035, bilateral hernias might tool for patients after groin hernia repair compared to the IPQ.
reflect a false positive risk factor for high postoperative The European Registry for Abdominal Wall hernias recent-
COMI-hernia score. Especially, since bilateral hernia repair ly published the EuraHS-QoL instrument [14]. The EuraHS-
did not correlate with high postoperative pain score. QoL consists of nine questions and is quantitatively compara-
Age inversely correlated with the COMI-hernia total and ble to the COMI-hernia. The questionnaire covers three do-
pain score. Again, this underlines that younger age is an inde- mains: pain, restriction of activities and cosmetic discomfort.
pendent risk factor for an adverse outcome after inguinal her- The main difference to the COMI-hernia is the cosmetic as-
nia repair. Patient’s satisfaction correlated with the COMI- pect. This issue is not covered by the COMI-hernia at all. On
hernia total and pain score. This emphasize that a low the other hand, aspects like general well-being and quality of
COMI-hernia score reflects high patient satisfaction. life are not covered by the EuraHS-QoL. To our opinion, these
One strength of this study is a compliance rate of over 90% aspects in particular are decisive for outcome assessment. The
after 1 year and over 80% after 3 years. This high compliance EuraHS-QoL may be used pre- and postoperatively, like the
rate confirms the acceptance and the patient-friendly design of COMI-hernia, which is a huge advantage compared to the
the questionnaire. The diversity of different operative proce- IPQ. The European Registry publication emphasizes the ut-
dures represents a limiting factor of the present study, but most importance of patient reported outcome measurement.
reflects the daily practice in public teaching hospitals. We fully agree with this statement. This questionnaire can be
Despite the diversity of different operation techniques and used in groin and ventral hernia patients. However, in our
multiple surgeons, we identified the same main risk factors opinion, it would be difficult to use the same questionnaire
for an adverse outcome after inguinal hernia repair as men- in groin and ventral hernia patients. We advocate an inguinal
tioned by the EHS updated guidelines [19]. This underlines hernia-specific questionnaire.
again the strength of the COMI-hernia in daily practice. There is a paucity of different studies published on
Franneby published in 2008 the Inguinal Pain chronic pain and quality of life after inguinal hernia re-
Questionnaire (IPQ) for assessment of chronic pain after groin pair. Unfortunately, in many of these studies different and
hernia repair [12]. As stated in the title, this questionnaire sometimes invalidated outcome tools were used [15]. As a
Langenbecks Arch Surg (2017) 402:935–947 943

result, outcome data among these studies were not by patients, which is represented by a follow-up rate of
comparable. over 80% after 3 years.
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- Conclusions
reported outcomes. They used the COMI-hernia in a co-
hort of 120 patients undergoing total extraperitoneal her- We are convinced that the COMI-hernia is a useful tool to
nia repair. The authors concluded that the COMI-hernia assess quality of life after inguinal hernia repair. In this
scale provides reasonable insight into the patients’ expe- study, this questionnaire showed a high patient acceptance
rience. However, they criticise that the scores are difficult with a low dropout rate. The significant difference in the
to interpret for patients and physicians. Here, we would pre- and postoperative COMI-hernia scores underlines
argue that this is based on the lack of experience with the that this questionnaire may detect changes in quality of
COMI-hernia. The questionnaire has been used for the life and pain between the pre- and postoperative period.
first time in a prospective trial. In other areas of medicine This confirms the results of our first study, where we
such short questionnaires are the standard for outcome found that the COMI-hernia is a reliable, sensitive and
assessment and work very well [22]. valid tool to assess multidimensional outcome in inguinal
Outcome assessment with questionnaires is demanding. hernia surgery [16]. No significant changes were detected
First of all, patient compliance to completely fill in ques- in the postoperative COMI-scores over time. Furthermore,
tionnaires within the allotted time is challenging. patients with adverse outcomes showed no significant dif-
Furthermore, there is always a risk of response bias. ference in COMI-hernia pain and COMI-hernia total
Several studies show that mainly patients with an adverse scores after 6 months postoperatively. By using the
outcome do not respond to questionnaires [24, 25]. This COMI-hernia, we were able to detect risk factors for an
false favourable outcome could be reflected in the study. adverse outcome. The identified risk factors are in line
Therefore, it is of utmost importance that a dedicated per- with risk factors known from literature, excluding bilater-
son, such as a study nurse, be responsible for the follow- al repair [28–35].
up. If the questionnaires are not returned, this person For the future, the only way that outcome data follow-
should contact the patients proactively in order to mini- ing hernia repair can be reliably interpreted by different
mize response bias. authors, will be to use a standardized and validated ques-
The patient’s compliance can be improved by the use tionnaire. Based on our data, we would recommend the
of short questionnaires. Deyo and colleagues addressed COMI-hernia questionnaire as the official instrument to
this problem in patients with lower back pain [26]. They measure the outcome after inguinal hernia repair in males.
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 Acknowledgements The authors thank Angela Munson for language
outcome instrument in the European Spine Surgery editing of the manuscript.
Registry, Spine Tango [22]. As shown previously, the pre-
Authors’ contributions RFS conceptualised and designed the study,
senting authors took this questionnaire and adapted it to acquired the data and drafted the manuscript. RNV helped to draft the
groin hernia patients [16]. manuscript and analyse and interpret the data. LF contributed in analysis
Postoperative quality of life has become one of the main and interpretation of data. CS helped to draft the manuscript and critically
revise the manuscript. PV helped to critically revise the manuscript.
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 Compliance with ethical standards
Clavien-Dindo score [27].
To summarize, the COMI-hernia is a powerful instru- Conflicts of interest The authors declare that they have no conflict of
ment with high internal and external validity. In our opin- interest.
ion, short and simple validated instruments for measuring
pain, functioning, symptom-specific well-being, general Ethical approval All procedures performed in studies involving hu-
quality of life, as well as social and work disability should man participants were in accordance with the ethical standards of the
institutional and/or national research committee and with the 1964
be used for monitoring the long-term outcome of groin Helsinki declaration and its later amendments or comparable ethical
hernia repair. The COMI-hernia does fulfil all these standards.
criteria. As previously mentioned, the COMI-hernia has
some clear advantages over the IPQ and the EuroHS- Informed consent Informed consent was obtained from all individual
QoL. Last but not least, the COMI-hernia is well accepted 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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