Hernia (2015) 19:147153
DOI 10.1007/s10029-014-1289-6
ORIGINAL ARTICLE
Randomized Clinical Trial on the postoperative use
of an abdominal binder after laparoscopic umbilical
and epigastric hernia repair
M. W. Christoffersen B. H. Olsen
J. Rosenberg T. Bisgaard
Received: 21 March 2014 / Accepted: 12 July 2014 / Published online: 9 September 2014
Springer-Verlag France 2014
Abstract
Purpose Application of an abdominal binder is often part
of a standard postoperative regimen after ventral hernia
repair to reduce pain and seroma formation. However,
there is lack of evidence of the clinical effects. The aim of
the present study was to investigate the pain- and seroma-
reducing effect of an abdominal binder in patients under-
going laparoscopic umbilical or epigastric hernia repair.
Methods Based on power analysis, a minimum of 54
patients undergoing laparoscopic umbilical and epigastric
hernia repair were to be included. Patients were random-
ized to abdominal binders vs. no abdominal binders during
the first postoperative week. Standardized surgical tech-
nique, anaesthesia, and analgesic regimens were used and
study observers were blinded towards the intervention.
Postoperative pain (visual analogue score) on day 1 was the
primary outcome. In addition, ultrasonographic evaluation
of seroma formation and several subjective patient-related
parameters were registered. Furthermore, patients in the
abdominal binder group were asked to rate benefits or
discomforts of wearing the binder.
M. W. Christoffersen (&)
T. Bisgaard
Gastro Unit, Surgical Section, Hvidovre Hospital, University
of Copenhagen, Kettegaard Alle 30, 2650 Hvidovre, Denmark
e-mail: mette.willaume@gmail.com
B. H. Olsen
Department of Diagnostic Radiology, Hvidovre Hospital,
University of Copenhagen, Hvidovre, Denmark
J. Rosenberg
Gastro Unit, Surgical Section, Herlev Hospital, University
of Copenhagen, Hvidovre, Denmark
Results Data from 56 patients (abdominal binder,
n = 28; no binder, n = 28) were available for analysis. No
significant intergroup differences in postoperative pain or
any of the other surgical outcomes, including seroma for-
mation, were found. However, the abdominal binder group
reported subjective beneficial effect of wearing the binder
in 24 of the 28 patients (86 %). No adverse effects of the
abdominal binder were found.
Conclusions There were no effects of an abdominal
binder on pain, movement limitation, fatigue, seroma for-
mation, general well-being, or quality of life. However,
most patients claimed a subjective beneficial effect of using
their abdominal binder.
Keywords Laparoscopic ventral hernia repair

Abdominal binder
Pain
Girdle
Trusses
Introduction
Severe postoperative pain and wound-related problems
such as seroma formation are the most frequent causes of
readmission and prolonged convalescence after laparo-
scopic ventral hernia repair [1, 2]. Thus, a postoperative
abdominal binder is often recommended to prevent seroma
and decrease pain, but the presumed effects are not sup-
ported by evidence [3, 4]. Previous studies have been
conducted on the effects of abdominal binder on patients
undergoing midline laparotomy. Two out of four random-
ized controlled trials (RCT) found that an abdominal binder
helps reduce pain and discomfort without compromising
respiratory function [58].
This trial was undertaken to evaluate the pain- and
seroma-reducing effect of 1-week abdominal binder after
elective laparoscopic umbilical or epigastric hernia repair.
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148
Methods
Between October 2012 and September 2013, patients
scheduled for elective, laparoscopic hernia repair for pri-
mary or recurrent umbilical or epigastric hernias at Hvi-
dovre Hospital University of Copenhagen (with
unrestricted referral of patients) were screened for inclu-
sion criteria. Patients between 18 and 80 years old with a
hernia defect of 28 cm (largest diameter of the defect
estimated clinically at the outpatient clinic preoperatively)
were invited to participate by a nurse assisting with the
study. Patients with chronic pain syndrome (defined as
daily intake of opioids for chronic back pain, chronic
headache, or fibromyalgia), drug or alcohol abuse,
decompensated liver cirrhosis (ChildPugh BC), or
expected poor compliance (e.g. foreign language) were not
included. Patients were preoperatively screened for previ-
ous postoperative nausea and vomiting (PONV). Smoking
status, body mass index (BMI), and daily intake of pain
medication were registered.
Intervention and randomization
Patients were randomly allocated to wear an abdominal
binder or no abdominal binder for the first 7 days after their
hernia repair and allocated to intervention 1:1. Patients
were carefully instructed to use the abdominal binder
during the first 7 consecutive days and nights, and to
reposition the abdominal binder correctly when needed. At
inclusion, all patients had their waistline measured and an
abdominal binder was fitted according to a fitting table
provided by the abdominal binder production company
(ETO garments, Ejby, Denmark, standard elastic belts
with a standard height of 22 cm).
Randomization was performed by the sealed envelope
method (central block randomization in blocks of four via
randomization.com) and the randomization code was kept
separate and not known to any of the investigators until
data were analysed. A non-transparent randomization
envelope was drawn at the end of each surgical procedure
before the patient was awake. If the randomization code
indicated abdominal binder, the preoperatively fitted
abdominal binder was positioned after skin closure by an
operation nurse not participating in the study. Thus, the
primary investigator, the surgeon, and the radiologist were
blinded towards the intervention.
Surgery, anaesthesia, analgesia, and antiemetics
Two consultant surgeons with expertise in laparoscopic
ventral hernia repair ([200 and [500 procedures, respec-
tively) operated all included patients. The abdominal cavity
was insufflated to 12 mmHg by Veress needle and a
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Hernia (2015) 19:147153
12-mm trocar was placed along the left side lateral to the
mid-clavicular line under the left lower costa. Two 5-mm
trocars were placed in a vertical line downward. After
adhesiolysis the hernia gap area was cleared for fatty tissue
and the falciform ligament was partially detached from the
abdominal wall. The maximum diameter of the hernia gap
was measured from inside with 68 mmHg intraperitoneal
pressure (IPP) before fixation of the mesh. A Physiomesh
(Ethicon, NJ, USA) was fixated intraperitoneally without
closure of the hernia gap with at least 5-cm overlap. For
mesh fixation we used ProtackTM (Covidien, CN, USA)
with double-crown technique. Fixation was performed
under 68 mmHg IPP with 1.5- to 2-cm distance between
the tacks. At the end of the procedure a total of 20 ml of
bupivacaine 0.5 % was administered equally into the trocar
sites. At the 12-mm trocar site the fascia was closed with
PDS (polydioxanone suture material) long-term absorbable
suture, the skin was closed with Prolene, and the wounds
were covered with standard dressing patches. The abdom-
inal binder was applied directly at the operating table (if
randomization was for abdominal binder).
Patients received a single dose of gabapentin 600 mg
administered preoperatively. At the induction of anaes-
thesia 16 mg methylprednisolone succinate (dexametha-
sone) i.v and 1,500 mg cefuroxime i.v were injected.
Patients were anaesthetized using propofol 35 mg/kg/h
and remifentanil 1 lg/kg/h. Pain was controlled intraop-
eratively according to local hospital routine with sufentanil
0.15 lg/kg i.v and with a bolus of ketorolac 30 mg i.v.
towards the end of the operation. Isotonic saline (standard
1,000 ml) was infused during the surgical procedure
independent of patients weight or duration of surgery.
Postoperative pain was initially controlled in the pos-
tanaesthesia care unit (PACU) with morphine (0.1 mg/kg)
until visual analogue scale scores (VAS) \20. PONV was
treated with ondansetron 4 mg i.v. After discharge from
PACU the postoperative analgesic regimen included para-
cetamol 1,000 mg and ibuprofen 400 mg, four times daily
for the first 3 postoperative days. Patients were carefully
instructed to take analgesic medication in their private
homes even though they were without pain. In addition,
patients were provided with ten tablets of 10 mg morphine
for rescue medication. Patients were instructed to register
their use of rescue medication on postoperative day 13.
Study end points and assessments
The primary end point was pain during activity measured
on the first postoperative day (24 h postoperatively) with
VAS. Secondary end points were incidence of seroma and
seroma volume measured with transabdominal ultraso-
nography on day 7 (see below). Also, activity limitation,
impaired general well-being, fatigue, and impaired quality
Hernia (2015) 19:147153 149

of life (QoL) were assessed by self-registrations in a study Statistical analysis

logbook using VAS. VAS registrations were performed
preoperatively and on postoperative days 1, 2, 3, 7, and 30. Statistical sample size calculation was based on data from a
VAS scales were from 0 to 100 mm with end points previous study from our group assessing pain after lapa-
labelled no pain during activity and worst imaginable roscopic umbilical or epigastric hernia repair [12]. This
pain during activity, no activity limitation and max- study found VAS pain levels of 60 mm (mean) with a
imal activity limitation, no impaired general well-being standard deviation of 26 mm on postoperative day 1. The
and maximal impaired general well-being, no fatigue minimum relevant difference between the groups in the
and maximal fatigue, and no impaired QoL and present study was set to be 20 mm (33 % reduction) on a
maximal impaired QoL. A hernia-related quality of life VAS scale. We set the risks of type I and II statistical errors
questionnaire Carolina Comfort Scale (CCS) [9] was to 0.05 and 0.2, respectively. Accordingly, 27 patients were
completed on postoperative days 1, 7, and 30. required in each randomization arm. Due to possible
The reported defect size was the maximum diameter of dropouts we chose to randomize 2 9 30 patients (n = 60).
the defect measured intraoperatively under 68 mmHg We planned to analyse patients by the intention-to-treat
intraperitoneal pressure (IPP) and was classified according principle. Thus, patients with unexpected postoperative
to EHS classification of primary ventral hernias [10]. course and/or complications were included in the data
PONV were evaluated during the first 24 h as described analysis. We used non-parametric statistics. Outcome data
elsewhere [11]. Thus, vomiting was registered as self- on day 1 were statistically compared for intergroup dif-
reported number of vomiting episodes. Patients were asked ferences by a MannWhitney test or Chi-square test.
to rate nausea on a four-point verbal rating scale (none, Changes of VAS scores over time (within and between
mild, moderate, severe) [11]. surgical groups) were analysed by the Friedmans non-
Additionally, on day 7 patients retrospectively reported parametric analysis of variance. We used 95 % confidence
how much of the recommended time they wore the intervals (CI) when appropriate. A level of P \ 0.05 was
abdominal binder during the week (0, 25, 50, 75, or 100 % regarded to be significant.
of the time). The study was approved by The Local Ethics Committee
Seroma formation was estimated by a transabdominal of the Capital Region (H-4.2012-092) and by the Danish
ultrasonography (GE logic E9, WAU WATOSA 53226, Data Protection Agency (01805 HVH-2012-032). Further-
USA) scan performed by an expert radiologist, who was more, the study was registered at clinicaltrials.gov
blinded towards intervention (no patients wore abdom- (NCT01673568).
inal binders when entering the examination room and
they were instructed not to inform about their ran-
domization). Seroma was defined as a fluid collection in Results
relation to the previous hernia sac or in relation to the
mesh. The seroma was quantified in ml. In case of more During the period of study from October 2012 to Sep-
than one fluid collection, individual collections were tember 2013, 60 patients were randomized and 56 com-
summed. pleted the study (28 abdominal binders; 28 no abdominal
On day 7, patients registered in the study logbook if the binders) (for further details see Fig. 1) and, thus, were
abdominal binder was beneficial, or uncomfortable to wear available for analysis. All patients assigned to abdominal
if randomized to the abdominal binder (if randomized to binders reported they wore the abdominal binder during the
the no binder group, patients were asked to omit these entire week (100 %) and night (100 %). Thus, all patients
questions). Patients were asked to rate their opinion on a stayed in their allocated randomization group. Patient
verbal rating scale (1 = no benefit, 2 = little benefit, demographics and perioperative information of the 60
3 = moderate benefit, 4 = maximal benefit), or uncom- randomized patients are summarized in Table 1.
fortable feeling (1 = no discomfort, 2 = little discomfort, There were no significant intergroup differences in VAS
3 = moderate discomfort, 4 = severe discomfort). pain during activity, activity limitation, general well-being,
Answers were dichotomized (benefit = maximal/moderate fatigue, or quality of life on the first postoperative day
benefit; discomfort = severe/moderate discomfort). (Table 2), or during the postoperative study period
Intra- and postoperative (\30 days) complications and (P [ 0.05) (Fig. 2). In the abdominal binder group, 24 of
mortality were registered from patients files and the hos- the 28 patients (86 %; CI 7399) reported a subjective
pital computer system. In addition, patients were asked beneficial effect from wearing the binder, whereas 4
about complications through a structured questionnaire on patients (14 %; CI 127) claimed no beneficial effect.
postoperative day 30. Furthermore, 21 patients (75 %; CI 5991) reported no

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150 Hernia (2015) 19:147153

Assessed for eligibility, n = laparoscopic repairs, n = 87 Excluded (n = 27)

Not meeting inclusion criteria (n = 18)
Declined to participate (n = 6)
Other reasons (n = 3) (undergoing inguinal
repair simultaneously, n = 1, canceled
operation, n = 1, >2 defects, n = 1)
Randomized (n = 60)

Allocation

Allocated to abdominal binder (n = 29 ) Allocated to no abdominal binder (n = 31)

Received allocated intervention (n = 29) Received allocated intervention (n = 31)

Follow-up

Lost to follow-up (n = 1) Lost to follow-up (n = 3)

1 patient withdrew informed consent after repair 2 patients did not complete any follow-up
despite several phone calls
1 patient withdrew informed consent after
repair

Analysed

Analyzed (n = 28) Analyzed (n = 28)

Fig. 1 Participants flow diagram of 60 patients undergoing laparoscopic primary ventral hernia repair, randomized to wearing an abdominal
binder postoperatively for 7 days or wearing no binder

Table 1 Patient characteristics and perioperative data (randomized binder group (P = 0.611). The median volume of seroma
patients n = 60) was 7 ml (range 0301) in the abdominal binder group and
Abdominal No binder P value 9 ml (0164) in the no binder group (P = 0.688) (Table 2).
binder (n = 29) (n = 31) Four patients in the no binder group had an unexpected
postoperative course vs. none in the abdominal binder group
Sex (no. M:F) 23:6 24:7 0.859
(P = 0.111). Thus, one patient developed fever and abdom-
Age (years) 56 (4077) 51 (3279) 0.894
2
inal pain (readmitted, as described below) and was treated
Body mass index (kg/m ) 31 (2140) 29 (2142) 0.252
with i.v. antibiotics and fully recovered within 2 days. In
Hernia type (umbi:epi) 23:6 27:4 0.419
three patients a diagnostic laparoscopy was performed within
(no.)
the first 24 h after the hernia repair due to severe postoper-
ASA (1:2:3) 8:21:0 13:18:0 0.280
ative pain. There were no signs of bleeding or visceral lesions
Mesh size of largest 12 (716) 13 (917) 0.485
diameter (cm) and removal of single tacks corresponding to the patients
Hernia size (EHS maximum pain site was performed with good results. Their
classification) further postoperative courses were uncomplicated.
\2 cm: [24 cm: [4 cm 13:14:2 15:15:1 0.801 Four patients were readmitted (two patients in the abdominal
Duration of surgery (min) 39 (2379) 34 (20118) 0.417 binder group and two patients in the no binder group) on
Primary:recurrent hernia 7:2 25:6 0.156 postoperative day 1, 2, 4, and 12, due to intense postoperative
(no.) pain. All four patients had computerized abdominal tomogra-
Data are presented as medians with range or numbers (no.). Mann phy (CAT) scans performed but without pathology.
Witney rank sum test was used for continuous data and Chi-square or We found no adverse effects or of wearing the abdom-
Fishers exact test was used for categorical data inal binder, especially no pulmonary or trombo-embolic
adverse events were registered.
discomfort from wearing the abdominal binder, whereas 7
patients (25 %, CI 941) claimed discomfort.
No differences were found in PONV between the groups
(Table 2) and there were no significant differences in total Discussion
CCS scores between the groups on days 1, 7, or 30
(P [ 0.05) (Table 2). This randomized clinical trial found no effect on pain,
In the abdominal binder group, 27/28 patients had seroma seroma formation, movement limitation, fatigue, general
formation on day 7 compared with 26/28 patients in the no well-being, or quality of life by wearing an abdominal

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Hernia (2015) 19:147153 151

Table 2 Clinical outcome data Abdominal binder No binder P value

(analysed patients, n = 56) (n = 28) (n = 28)

Day 1 outcome
Pain activity (VAS) 50 (13100) 70 (1197) 0.210
Activity limitation 53 (12100) 68 (097) 0.207
(VAS)
Impaired general 30 (393) 51 (097) 0.342
well-being (VAS)
Fatigue (VAS) 30 (095) 38 (076) 0.844
Impaired quality of 67 (0100) 53 (093) 0.520
life (VAS)
Quality of life (total 42 (880) 50 (168) 0.103
CCS score)
PONV (no.) (entire 7 6 0.752
024 h after
surgery)
Nausea (no.) 6 5 0.737
Moderate/severe (no.) 0 0 1.000
Vomiting (no.) 1 1 1.000
Data are presented as medians Moderate/severe (no.) 0 1 0.368
with range or numbers (no.). Day 7 outcome
MannWhitney rank sum test
Seroma formation 27:1 (96 %, CI 89103) 26:2 (93 %,CI 0.611
was used for continuous data
(present:absent) 84103)
and Chi-square or Fishers exact
test was used for categorical Seroma volume (ml) 7 (0300) 9 (0164) 0.688
data. The incidence of seroma is Day 30 outcome
given as no. and percentages. Complications (no.) 0 4 0.111
Confidence intervals (CI) are
provided Readmittance to 2 2 0.127
hospital (no.)
VAS visual analogue scale

binder. However, most patients reported a subjective ben-
eficial effect from using abdominal binders.
Abdominal binders can be used after laparotomy,
abdominoplasty, or ventral hernia repair to decrease pain
and seroma formation, enhance mobilization, and prevent
incisional hernia formation [4, 5, 7, 8, 13, 14]. However,
evidence for these presumed positive effects is limited and
may even be challenged by suggested negative effects on
lung function [15] and reduction in cardiac stroke volume
with following increased venous volume in the lower
extremities, which may induce deep venous thrombosis
[16]. Moreover, abdominal binders have been criticized for
being uncomfortable to wear and to impinge the breast line
in females when sitting down (wheelchair users) [17].
No studies have previously investigated the possible
effects of an abdominal binder after ventral hernia repairs.
Four randomized controlled trials have investigated their
pain-reducing effect after laparotomy. In these studies
(n = 75, n = 54, n = 50, n = 48), the abdominal binders
were worn for 15 days postoperatively [58]. Only two
studies [6, 8] found a significant analgesic effect (on
postoperative day 5). However, as in the present study, one
of the two negative studies reported that the majority of the
patients noted a beneficial effect of wearing the abdominal
binder after laparotomy [7].
This study found no effect of the abdominal binder on
activity limitation. However, one RCT on abdominal bind-
ers after laparotomy found that the abdominal binder
patients significantly improved their walking performance
[6].
Seroma formation after ventral hernia repair is a common
postoperative complication [1, 1821]. However, postop-
erative seroma is defined and diagnosed in a heterogenic
way in the literature [1822]. Accordingly, a new definition
of seroma after ventral hernia repair has been proposed,
where only clinically detectable, bothersome, or interven-
tion-requiring seromas are regarded as a complication [19].
In the present trial, we assessed seroma volume using
transabdominal ultrasonography performed by a blinded
expert radiologist. Transabdominal ultrasonography or
computed tomography scan are believed to be more objec-
tive, since the clinical diagnosis may depend on both the
patients physical appearance (difficult to diagnose clini-
cally in obese patients) and the experience of the examining
physician [18, 20, 23]. However, in the present study it was
sometimes possible to squeeze the fluid collection/seroma

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152 Hernia (2015) 19:147153

Fig. 2 Changes in self- = abdominal binder; n = 28

reported patient-related visual = no binder; n = 28
analogue scale (VAS) scores of pain during activity (VAS) activity limitation (VAS)
pain during activity, activity 100
0.981 100 0.787
limitation, impaired general
well-being, fatigue, and 75 75
impaired quality of life in 56
randomized patients (filled 50 50
square = abdominal binder;
n = 28 or open circle = no 25 25
abdominal binder; n = 28).
P values are intergroup 0 0
preop Day 1 Day 2 Day 3 Day 7 Day 30
comparison for changes of VAS preop Day 1 Day 2 Day 3 Day 7 Day 30
(visual analogue scale) scores
during the entire study period impaired general well-being (VAS) fatigue (VAS)
100 100
0.145 0.522
75 75

50 50

25 25

0 0
preop Day 1 Day 2 Day 3 Day 7 Day 30 preop Day 1 Day 2 Day 3 Day 7 Day 30

impaired quality of life (VAS)

100
0.597
75

50

25

0
preop Day 1 Day 2 Day 3 Day 7 Day 30

into the abdominal cavity through the open hernia gab and trials on the effect of abdominal binders in patients
mesh. This may have decreased the ultrasonic accuracy of undergoing ventral hernia repair [24].
the volume estimation.
There may be several other explanations for the lack of
clinical effects of the abdominal binder in this study. These
Conclusion
may include lack of statistical power, the fact that small
umbilical or epigastric hernias imply too small a surgical
In conclusion, we found no significant effects on pain,
trauma and too small amount of seroma, or simply that
seroma formation, movement limitations, fatigue, general
abdominal binders do not affect the clinical outcome after
well-being, or quality of life on wearing an abdominal
laparoscopic umbilical or epigastric hernia repair. Fur-
binder after laparoscopic umbilical or epigastric hernia
thermore, we only monitored pain on days 13, 7, and 30,
repair. However, since the majority of patients reported
but not on day 5, where previous studies (of laparotomies)
beneficial effects on wearing an abdominal binder and
showed an analgesic effect [6, 8]. Another limitation of the
since no adverse effects were seen, a postoperative
present study was lack of a double-blind design. However,
abdominal binder could be considered after repairs for
it would for obvious reasons not be possible to blind the
small ventral hernias.
patients. The findings of the present study are considered
applicable in a clinical setting. Acknowledgments We thank the research nurse Pernille Strandfelt
Future studies should investigate the clinical effects in (BN at the Gastro Unit, Surgical Section, Hvidovre Hospital, Uni-
patients undergoing repair for incisional hernias where a versity of Copenhagen) for exquisite professional help in carrying out
larger surgical trauma and more seroma formation should the study. No compensation was received for data collection. The trial
was funded by private foundations and by the University of
be expected. Also, patient-reported outcomes focusing on Copenhagen.
hernia-related quality of life and patient satisfaction should
be used as outcome measures in randomized controlled Conflict of interest None of the authors have anything to declare.

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Hernia (2015) 19:147153
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