ORIGINAL ARTICLE
Laparoscopic ventral hernia repair using a novel intraperitoneallightweight mesh coated with hyaluronic acid: 1-year follow-upfrom a case–control study using the Hernia-Club registry
J.-F. Gillion1• G. Fromont2
• M. Lepere3• N. Letoux4
• A. Dabrowski5 •
C. Zaranis6• C. Barrat7
• The Hernia-Club Members8
Received: 13 June 2015 / Accepted: 9 May 2016 / Published online: 9 June 2016
� Springer-Verlag France 2016
Abstract
Purpose A case–control study was performed to compare
laparoscopic ventral hernia repair (LVHR) using the Ven-
tralight STTM lightweight surgical mesh with LVHR using
other types of mesh.
Methods Adult patients undergoing intraperitoneal
implantation of Ventralight STTM during LVHR (Ventra-
light STTM group; VG) over a 2-year period (2011–2013)
were identified from the prospective French Hernia-Club
registry. Patients undergoing elective LVHR using other
types of intraperitoneal mesh in the first semester of 2013
formed the control group (CG). Patient, hernia and surgical
characteristics, and postoperative outcomes after 8 days,
1 month, and 1 year were compared between the two
groups.
Results The VG comprised 90 LVHRs in 85 patients, and
the CG 86 LVHRs in 81 patients. Patient, hernia and sur-
gical characteristics were similar between the two groups,
apart from the method of mesh fixation and the number of
procedures involving fascial closure. A low rate of minor
complications was observed in both groups at 1 month
[4.4 % (VG) and 2.3 % (CG)], and the level of postoper-
ative pain was similar in the two groups at Day 8 and
1 month. After 1 year, no complications, recurrences or
cases of chronic pain had occurred in either group, and
Quality-of-Life outcomes were similar. Patients rated their
procedure as excellent or good in 96 % (VG) and 92 %
(CG) of cases.
Conclusions Ventralight STTM mesh is effective and well
tolerated in LVHR, producing very low complication and
recurrence rates in the short and medium term. The results
are comparable to those achieved with other types of mesh.
Keyword Ventral hernia repair � Laparoscopic hernia
repair � Intraperitoneal mesh repair � Lightweight mesh �Case–control study � Registry
Introduction
The use of a surgical mesh is currently considered the gold
standard for ventral hernia repair [1]. The prosthesis can be
implanted in various positions, including the onlay, retro-
muscular or intraperitoneal positions, and many different
techniques for mesh implantation have been described. In
addition, the prosthesis can be implanted either laparoscopi-
cally [2] or through classic open procedures [1]. Each tech-
nique is associated with advantages and disadvantages [3].
Laparoscopic ventral hernia repair (LVHR) requires a
prosthesis specifically designed for intraperitoneal place-
ment [4]. This prosthesis must remain strong over time,
minimise the risk of adhesions and help to reduce the
impact of the hernia repair on patient quality-of-life (QoL).
Members of The Hernia-Club Group are listed in the Appendix.
& J.-F. Gillion
1 Unite de Chirurgie Viscerale et Digestive, Hopital Prive
d’Antony, 1, Rue Velpeau, 9210 Antony, France
2 Clinique de Bois Bernard, Bois Bernard, France
3 Clinique Saint Charles, La Roche-sur-Yon, France
4 Clinique Jeanne d’Arc, Paris, France
5 Clinique de Saint Omer, Saint Omer, France
6 Clinique de la Rochelle, La Rochelle, France
7 Hopital Universitaire Jean Verdier, Bondy, France
8 Hernia Club, 70 rue Carves, 92120 Montrouge, France
123
Hernia (2016) 20:711–722
DOI 10.1007/s10029-016-1501-y
Such prostheses have improved significantly since the first
intraperitoneal mesh implantations were performed, with
the introduction of bi-layer and lightweight meshes. It has
been suggested that the use of lightweight meshes should
improve patient QoL in the long term since a significant
amount of the mesh is absorbed over time. This could be at
the cost of an increased hernia recurrence rate [5]. This
requires further investigation.
Ventralight STTM (Davol Inc., Subsidiary of C.R. Bard
Inc., Warwick, Rhode Island, USA) is a novel lightweight
intraperitoneal onlay (IPOM) mesh coated with hyaluronic
acid. It has a polypropylene anterior layer, which allows
rapid tissue ingrowth and a posterior intraperitoneal layer
composed of SeprafilmTM (Davol Inc., Subsidiary of C.R.
Bard Inc., Warwick, Rhode Island, USA), which minimises
the attachment of peritoneal tissue (adhesions) to the
prosthesis, as well as visceral erosion. The efficacy of
SeprafilmTM in preventing the formation of adhesions has
been widely proven, in both experimental [6–8] and clin-
ical [9–11] studies. Indeed, a Cochrane review published in
2009 [12] concluded that: ‘‘There is evidence that the use
of hyaluronic acid/carbomethyl cellulose (HA/CMC)
membrane reduces incidence, extent and severity of
adhesions in the abdomen.’’
Preliminary clinical results with Ventralight STTM are
promising [13, 14], but require confirmation in larger
clinical trials and comparison with the results from other
prostheses. The only comparative study published to date is
an experimental research paper in a porcine model [15], in
which the results favoured Ventralight STTM. However, no
comparative clinical study has yet been reported. We,
therefore, conducted a case–control study comparing the
results from LVHR using the Ventralight STTM mesh with
those achieved using other types of prostheses using data
from the prospective French Hernia-Club registry.
Methods
Study design
This is a case–control study conducted using a prospec-
tively collected database from the French Hernia-Club
registry with the aim of comparing results from patients
undergoing intraperitoneal implantation of Ventralight
STTM for LVHR (Ventralight STTM group; VG) with those
from an unmatched control group of patients (control
group; CG). Adult patients (C18 years of age) undergoing
LVHR using the Ventralight STTM IPOM mesh (VG)
between September 1, 2011 and August 31, 2013 were
identified from the Hernia-Club registry starting on
September 1, 2014, so that all patients had at least 1 year of
follow-up.
Patients who underwent LVHR after the cut-off date
(August 31, 2013) were excluded from the study. The
unmatched control group comprised patients from the same
Hernia-Club registry who underwent elective LVHR using
other types of meshes, and were registered between Jan-
uary 1 and June 30, 2013. Patients registered over this time
period were chosen for the CG because they had 1-year
follow-up data (rather than the usual 2-year follow-up data
from the registry) due to participation in an international
cooperative study.
Follow-up
Clinical visits were scheduled at the end of the first post-
operative month and at the end of the third postoperative
month if patients were still symptomatic at the 1-month
visit. In the Hernia-Club registry, all patients are followed-
up via a telephone call at 2 and 5 years post surgery. An
additional telephone call may also be scheduled after
1 year. All patients included in this study participated in a
telephone interview at 1-year post surgery. A clinical
research assistant (CRA) who was blinded to the type of
mesh implanted conducted this interview using a ques-
tionnaire. Answers to the questionnaire were registered
without any medical adjustment. If patients reported any
problems at the 1-year follow-up interview, they were
strongly recommended to attend a clinical visit. Patients
were considered lost to follow-up after five attempts to
contact them on different dates had failed. Patients who
declined to participate in the telephone interview were also
considered lost to follow-up.
Hernia-Club registry
The Hernia-Club registry is a collaborative, prospective,
anonymised online database of all the parietal procedures
performed by 42 French surgeons with a specific interest in
abdominal wall surgery. Each participant must accept and
sign the Charter of Quality, which states that: ‘‘all input
must be registered in a consecutive, unselected and
exhaustive manner, and in real time’’. Participants consent
to random peer review of original medical charts. One
hundred and sixty-four parameters are collected in a
prospective manner from screening, pre-, peri- and post-
operative periods. In addition, data on patient QoL, which
is assessed throughout the ongoing follow-up period, are
collected and compared to preoperative QoL. All parame-
ters are collected by a CRA, independent of the individual
participants. Most of the parameters collected in this
database are fully compatible with the European Hernia
Society (EHS) classification of primary and incisional
abdominal wall hernias [16] and the EuraHS international
online platform [17] to facilitate further cooperative
712 Hernia (2016) 20:711–722
123
studies. The Hernia-Club online platform is mainly dedi-
cated to conducting observational cohort studies and case–
control studies, although it is also able to host randomised
controlled trials (RCTs).
Data extraction and study endpoints
Data extracted from the registry included patient age and
gender, and other patient characteristics (e.g., body mass
index, previous history of hernias, comorbidities); hernia
and cutaneous characteristics; operative characteristics;
peri- and post-operative complications; and other post-op-
erative (after 8 days and 1 month) and long-term (1-year)
outcomes. Postoperative complications were graded using
the Clavien Dindo grading system [18]. Post-operative pain
was assessed using a 10 cm visual analogue scale (VAS).
The primary endpoints of the study were the incidence of
chronic pain (defined as pain requiring analgesia lasting for
longer than 3 months), the recurrence rate and QoL out-
comes after 1-year follow-up. QoL was assessed using a
previously validated telephone questionnaire [19, 20]. Peri-
operative and 1-year follow-up results were compared
between the two groups of patients. This study aimed to
follow STROBE recommendations for the reporting of
observational studies [21, 22].
Statistical analysis
The percentage of patients for each variable was calculated
based on the number of patients with known data for that
variable (i.e., missing data were excluded from analyses).
Differences between the two groups of patients were
analysed using the Chi-square test for proportions and
Student’s t test for quantitative data. Odds ratios (ORs)
with 95 % confidence intervals (CIs) were calculated for
2 9 2 tables. The level of significance was taken as
p B 0.05.
Results
Between September 1, 2011 and August 31, 2014, 2760
ventral hernia repairs were registered in the Hernia-Club
registry, of which 159 involved LVHR using the Ventra-
light STTM mesh. Of these, 90 were performed before
August 31, 2013 and, therefore, potentially had at least
1-year follow-up data available as of September 1, 2014.
Thus, the VG comprised 90 hernia repairs in 85 patients.
Similarly, the CG comprised 86 non-Ventralight STTM
LVHRs in 81 patients. Eleven patients (12 hernias) were
lost to follow-up in the VG (9 lost to follow-up, 2 died due
to unrelated causes), and 13 were lost to follow-up in the
Elig
ible
Incl
uded
VHR2,760
Ventralight STTM
VHR168
Ventralight STTM
LVHR159
Operated on before31/08/14
Operated on before31/08/13
Hernia-Club registry01/09/11–31/08/14
Ventralight STTM
open repair9
Ventralight STTM
LVHR1-yr Fu (potential)
90
Control groupLVHR
1-yr Fu (potential) 86
Ventralight STTM
LVHR1-yr Fu78
Control groupLVHR1-yr Fu 73
Lost to 1-year follow-upLost to Fu
VG: 12; CG: 13
VHR (no Ventralight
ST™) 2,592
Follow-up <1 year69
Start date of the study31/08/14
LVHR (no Ventralight ST™) 701
Fig. 1 Prisma flow chart for the number of herniated sites. CG control group, Fu follow-up, LVHR laparoscopic ventral hernia repair, VG
Ventralight STTM group, VHR ventral hernia repair, yr year
Hernia (2016) 20:711–722 713
123
CG (12 lost to follow-up, 1 declined to participate in the
telephone interview), providing long-term (1 year) follow-
up data from 78 hernias (in 73 patients) in the VG and 73
hernias (in 68 patients) in the CG (Fig. 1).
Patient and hernia characteristics
Patient, hernia and cutaneous characteristics were similar
between the VG and CG (Tables 1, 2).
Surgical procedure
Significant differences between the VG and CG were found
for some of the operative parameters (Table 3). Absorbable
spiral tacks were more likely to be used for fixing the mesh
in the VG than in the CG, whereas absorbable U shaped
tacks were more likely to be used in the CG (p\ 0.001).
The OR for the use of absorbable spiral tacks versus the use
of absorbable U shaped tacks was 5.88 (95 % CI: 2.4,
14.3). In addition, operative procedures in which the fascial
gap was closed were significantly more common in the VG
than in the CG (p\ 0.001). Transparietal sutures were
more likely (p = 0.03) to be used in the CG. No significant
differences between the two groups were found for other
surgical parameters, including the mean surface area of the
prosthesis, the amount of overlap between the lateral edge
of the mesh and the sutured (or not) defect, and the mean
operative time (skin to skin), which was around 90 min in
both groups (Table 3).
Short-term postoperative outcomes
In both groups, no serious complications (Clavien Dindo
grade[ I) occurred in the first postoperative month and no
Table 1 Patient characteristics
Characteristic VG CG p value* ORb (95 % CI)
Number of patients (number of herniated sites)a 85 (90) 81 (86)
Mean age (±SD), years 59.0 (12.5) 59.2 (15.2) 0.94
Males 48 (56.5 %) 52 (64.2 %) 0.31 0.72 (0.39, 1.35)c
Females 37 (43.5 %) 29 (35.8 %)
Mean BMI (±SD) 31 (12.5) 29 (5.2) 0.13
ASA score 1 34 (40.0 %) 39 (48.1 %) 0.20
ASA score 2 25 (29.4 %) 27 (33.3 %)
ASA score 3 26 (30.6 %) 15 (18.5 %)
Tobacco consumption
Never 51 (60.0 %) 48 (60.0 %) 0.29
Stopped at least 1 year ago 11 (12.9 %) 17 (21.2 %)
Occasional 4 (4.7 %) 1 (1.2 %)
Heavy work 10 (11.8 %) 11 (13.6 %) 0.57 0.77 (0.30, 1.90)d
Sports activity[ once/week 6 (7.2 %) 6 (7.4 %) 0.91 0.98 (0.30, 3.20)e
History of hernias 17 (20.5 %) 13 (16.0 %) 0.46 1.35 (0.61, 3.0)f
History of intra-peritoneal surgery 43 (47.8 %) 29 (33.7 %) 0.06
Diabetes mellitus 9 (10.6 %) 7 (8.6 %)
Steroid therapy 5 (5.9 %) 0
Chemotherapy 2 (2.4 %) 1 (1.2 %)
Anticoagulant therapy 11 (12.9 %) 8 (9.9 %)
Results are presented as the number of patients with the percentage in parentheses, unless otherwise indicated
ASA American Society of Anaesthesiology, BMI body mass index, CG control group, CI confidence interval, OR odds ratio, SD standard
deviation, VG Ventralight STTM group
* For Chi square testa Herniated site: one median and/or one lateral per patient, regardless how many defects were treated in each site (no more than two herniated
sites per patient)b For VG versus CGc Versus femalesd Versus non-heavy worke Versus sports B once/weekf Versus no previous history
714 Hernia (2016) 20:711–722
123
Table 2 Hernia and cutaneous
characteristicsCharacteristic VG CG p value* ORb (95 % CI)
Number of repaired herniated sitesa 90 86
Previous intraperitoneal surgery 43 (47.8 %) 29 (33.7 %)
One site repaired (medial or lateral) 80 (88.8 %) 80 (93 %) 0.95 (0.39, 2.32)c
Bi-repair (medial and lateral) 10 (11.1 %)d 6 (7.0 %)e
Primary hernia 40 (44.5 %) 50 (58.1 %) 0.13 0.59 (0.27, 1.27)f
EHS small (diameter\2 cm) 17 (42.5 %) 28 (57.1 %) 0.17 1.80 (0.77, 4.20)g
EHS medium (diameter 2–4 cm) 20 (50.0 %) 20 (40.8 %)
EHS large (diameter[4 cm) 3 (7.5 %) 1 (2.0 %)
Medial (M) hernia 40 (100 %) 48 (96.0 %)
Lateral (L) hernia 0 2 (4.0 %)
Missing data 1 0
Incisional hernia 49 (54.5 %) 36 (41.9 %)
EHS W1 (width\5 cm) 23 (46.9 %) 16 (44.4 %) 0.82 0.90 (0.38, 2.15)h
EHS W2 (width 5–10 cm) 26 (53.1 %) 20 (55.6 %)
EHS W3 (width[10 cm) 0 0
EHS M 38 (77.6 %) 28 (77.8 %)
EHS M1 (infra-xiphoide) 0 2
EHS M2 (epigastric) 14 11
EHS M3 (umbilicus area) 22 18
EHS M4 (infra-umbilicus) 5 5
EHS M5 (supra-pubicum) 0 1
Combined Mi 3 9
EHS L 11 (22.5 %) 8 (22.2 %)
EHS L1 (subcostal) 0 5
EHS L2 (flank) 4 0
EHS L3 (iliac fossa) 6 3
EHS L4 (lumbar) 1 0
First incisional repair 39 (79.6 %) 31 (86.1 %) 0.61 1.60 (0.49, 5.13)j
Second incisional repair 10 (20.4 %) 2 (86.1 %)
Third incisional repair 0 3 (8.3 %)
Cutaneous characteristics
Normal skin 73 (84.9 %) 66 (76.7 %) 0.17 1.70 (0.78, 3.70)k
Thin without trophic changes 12 (14.0 %) 18 (20.9 %)
Local trophic changes 0 2 (2.3 %)
Cutaneous erosions 1 (1.2 %) 0
Contaminated skin 0 0
Not specified 4 (4.7 %) 0
Results are presented as the number of repaired medial or lateral herniated sites with the percentage in
parentheses, unless otherwise indicated
CG control group, CI confidence interval, EHS European Hernia Society, L lateral, M medial, OR odds
ratio, VG Ventralight STTM group, W width
* For Chi square testa Herniated site: one median and/or one lateral per patient, regardless how many defects were treated in
each site (no more than two herniated sites per patient)b For VG versus CGc Versus bi-repaird In 5 patientse In 3 patientsf Versus incisional herniag Versus medium ? large herniah Versus width C 5 cmi In some patients, more than one medial defect was repaired during surgeryj Versus second repairk Versus other skin conditions
Hernia (2016) 20:711–722 715
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hernias required reoperation (Table 4). There were two
cases of wound seroma in each group. The mean length of
hospital stay was significantly longer in the VG [2.4 ± 1.4
(SD) days] than in the CG (1.7 ± 2.0 days; p = 0.007),
and the VAS pain score at baseline and Day 1 was also
significantly higher in the VG (p = 0.025 and 0.046,
respectively). There were no significant differences
between the VG and the CG in the levels of postoperative
pain at Day 8 or 1 month: at Day 8, the mean VAS pain
score was less than 3 in both groups. By 1 month, the VAS
pain score was zero in 88 % of patients in the VG and
75 % of patients in the CG (difference not significant), and
only one patient in the CG had a VAS pain score of more
than 2. A low rate of minor complications was observed in
both groups at this time point (4.4 % in the VG, 2.3 % in
the CG).
One-year follow-up
One-year follow-up data were available from 78 LVHRs in
the VG and 73 LVHRs in the CG (Table 5). There were
two suspected (but not confirmed) recurrences (one in each
Table 3 Peri-operative characteristics
Characteristic VG CG p value* ORa (95 % CI)
Number of herniated sites 90 86
Emergency procedure 3 (3.4 %) 1 (1.2 %) 0.33 2.97 (0.30, 29.4)b
Conversion to open procedure 0 2 (2.3 %)
Length of operation, minutes (mean ± SD) 89 (15.5) 86 (20.5) 0.26
Closure of the fascial gap 60 (66.7 %) 30 (34.9 %) \0.001
Implanted prosthesis
Ventralight STTM 90 (100 %) 0
PhysiomeshTM 0 34 (39.5 %)
Covidien PCOTM 0 34 (39.5 %)
Other prosthesis 0 18 (20.9 %)
Surface area of prosthesis, cm2 (mean ± SD) 241 (84.8) 246 (99.7) 0.72
Overlap between prosthesis and sutured (or not) defect
\3 cm 1 (1.1 %) 0
3–5 cm 5 (5.7 %) 4 (4.7 %)
[5 cm 82 (93.2 %) 82 (95.3 %)
Not specified 2 (2.2 %) 0
Method of fixation
Non absorbable tacks 2 (2.2 %) 0
Absorbable spiral tacks 31 (34.5 %) 7 (8.2 %) \0.001 5.88 (2.40, 14.3)c
Absorbable U shaped tacks 54 (60 %) 74 (86.0 %)
Missing data … 3 (3.3 %) 5 (5.8 %)
Transparietal sutures 1 (1.1 %) 7 (8.2 %) 0.03
Double-crown stapling 3 (3.3 %) 9 (10.5 %) 0.06
Wound infection
Altemeier classification of risk of wound infection: clean 90 (100 %) 86 (100 %)
Antibiotic prophylaxisd 81 (90.0 %) 71 (82.6 %) 0.31 1.66 (0.64, 4.30)e
No antibiotics 8 (8.9 %) 12 (14.0 %)
Prolonged antibiotics 1 (1.1 %) 3 (3.5 %)
Results are presented as the number of herniated sites with the percentage in parentheses, unless otherwise indicated
CG control group, CI confidence interval, OR odds ratio, SD standard deviation, VG Ventralight STTM group
* For Chi square testa For VG versus CGb Yes versus noc Spiral versus U shapedd One dosee Yes versus no
716 Hernia (2016) 20:711–722
123
group). Additionally, one reoperation for a hernia at a
different site (therefore not a recurrence) was required in
the VG. There were no reports of chronic pain, obstruction,
visceral erosion, late sepsis or mesh explantation in either
group.
QoL parameters were not statistically different between
the two groups (Table 6). One patient from the VG
assessed his abdominal wall as not being firm (Q1). He
reported a recurrence, but did not want to undergo a re-
operation and did not attend the recommended surgical
visit. Seven patients (8 herniated sites) reported feeling a
lump in the scar area (n = 7) or elsewhere (n = 1) (Q2).
All of these patients had previously reported a firm
abdominal wall in response to Q1, including one patient
from the CG who had a probable recurrence (as evidenced
on ultrasound examination) that had not yet been confirmed
at a surgical visit. Of the eight treated herniated sites with a
further reported lump, three had undergone closure of the
hernia defect and five had not. Postoperative discomfort, if
present, was in all cases less bothersome than the original
hernia, apart from one case of greater discomfort after
surgery in the CG (Q8). The result of surgery was assessed
by patients as being excellent or good in 96 % of cases in
the VG and in 92 % of cases in the CG (Q10).
Table 4 Short- and medium-
term postoperative outcomesOutcome VG CG p value
Na Value Na Value
Reoperation required 90 0 86 0
1-Day surgery 87 11 (12.6 %) 79 27 (34.1 %)
Length of hospital stay, days (mean ± SD) 87 2.4 (1.4) 79 1.7 (2.0) 0.007
Median pain VAS score (range)
Day 0 43 5 (0–8) 34 4 (1–8) 0.025
Day 1 43 4 (0–8) 35 3 (0–8) 0.046
Day 8 41 2 (0–6) 27 2 (0–7) 0.374
Clinical visit at 1 month 70 77.8 % 51 59.3 %
Postoperative complications at 1 month 90 86
Medical complication 1 (1.1 %)b 0
Wound complication 2 (2.2 %)c 2 (2.3 %)c
Surgical complication 1 (1.1 %)d 0
Clavien Dindo grade Ie 4 (4.4 %) 2 (2.3 %)
Clavien Dindo grade[I 0 0
Pain VAS score at 1 month (mean ± SD) 40 0.18 (0.5) 24 0.46 (1.0) 0.130
Missing data 50 62
Pain VAS score at 1 month 40 24
0 35 (87.5 %) 18 (75.0 %) 0.200f
1 3 (7.5 %) 3 (12.5 %)
2 2 (5.0 %) 2 (8.3 %)
3 0 0 (0 %)
4 0 1 (4.2 %)
Length of absence from work, days (mean ± SD) 39 19.9 (15.9) 38 18.6 (17.4) 0.719
Not specified or unemployed 51 48
Results are presented as the number of herniated sites with the percentage in parentheses, unless otherwise
indicated
CG control group, SD standard deviation, VAS visual analogue scale, VG Ventralight STTM groupa N = number of hernia sites repaired with known data for each variable. Percentages are calculated based
on these numbersb Bronchitisc Seromad Hematomae Grade I = any deviation from the normal postoperative course without the need for pharmacological
treatment or surgical, endoscopic and radiological interventions [18]f For pain score of 0 versus other pain scores
Hernia (2016) 20:711–722 717
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Discussion
The results of this case–control study show that the new
Ventralight STTM surgical mesh is effective and well tol-
erated in LVHR, producing very low complication and
recurrence rates in the short, medium and long term. Over a
1-year period, no complications related to intraperitoneal
placement of the mesh were observed (e.g., bowel
obstruction, visceral erosion, intraperitoneal sepsis, intra-
abdominal pain). The few cases of mild pain (11.5 %) or
discomfort (5.1 %) after 1 year were less bothersome than
the original hernia, and 96 % of patients rated the proce-
dure as good or excellent. The results achieved with the
Ventralight STTM mesh in this study were also similar to
those achieved using other prostheses in terms of post-
operative complications, recurrence rates and QoL
outcomes.
Some differences were observed between the VG and
CG in surgical parameters, such as an increased likelihood
of using absorbable spiral tacks for fixing the mesh in the
VG and the use of ‘U’ shaped tacks in the CG, and more
frequent achievement of closure of the hernia defect in the
VG than in the CG. However, these differences did not
affect the early postoperative course in terms of postoper-
ative pain or the incidence of seroma. Findings from the
questionnaire suggest that more frequent closure of the
hernia defect in the VG may have reduced the likelihood of
feeling a lump in the scar area (Table 6). In medium or
large hernia defects, closure of the fascial gap can reduce
the risk of seroma, bulging, pseudo or true recurrences and
discomfort, and also helps to restore core physiology and
QoL [23–27]. The significantly longer length of hospital
stay in the VG than in the CG was due to one surgeon
retaining patients in hospital for 1 day longer in the VG
than the CG because of a peculiarity in the French reim-
bursement system at that time.
In both patient groups, post-operative complications
were rare and mild (Clavien Dindo grade I), and were
mainly comprised of seromas. These healed without the
need for pharmacologic treatment or surgical, endoscopic
or radiological interventions. The number of complications
observed was too small for statistical comparisons to be
performed.
Less than half of the patients in both groups rated the
surgery as excellent. This may be explained by the fact that
it is culturally difficult for French people to rate something
as excellent. By contrast, they are quick to point out bad or
mediocre results. Therefore, we considered ratings of
excellent and good to be equivalent.
The results achieved with Ventralight STTM in this study
confirm the positive findings from two previous studies, in
which 17 [13] and 61 patients [14] were followed up for a
period of 1 year. In both studies, only minor complications
were observed and there were no recurrences. The low
complication rates associated with Ventralight STTM have
been attributed to the hydrogel layer covering the visceral
side of the mesh. This layer is composed of SeprameshTM,
which has proved to be effective in preventing the forma-
tion of adhesions and visceral erosion in both experimental
[6–8] and clinical [9–11] studies.
In addition to the presence of the hydrogel layer, the
good results achieved with Ventralight STTM in this study
may be explained by a number of other factors: all the
procedures were performed on clean skin at low risk of
infection (Altemeier class I) and the rates of primary her-
nia, small defects (diameter\2 cm for primary hernias and
width \5 cm for incisional hernias) and overlap between
the mesh and sutured (or not) defect [5 cm, were high.
Furthermore, surgeons specialising in LVHR performed all
the procedures. Such direct correlation between excellence
of surgical outcome and specific surgeon’s skills has been
clearly demonstrated in other studies [28, 29].
The design of the current study (unmatched case–con-
trol) offers an advantage over a matched case–control
study, in that the latter may lead to the introduction of
uncontrolled bias. As a result, some experts have suggested
that unmatched controls are preferable to matched ones
[21]. In addition, the cases used in our study were unse-
lected and registered in real time from many different
centres. Hence, the CG provided a more accurate repre-
sentation of patients presenting for LVHR in a ‘real-world’
setting.
Table 5 One-year outcomes
Outcome VG CG
Lost to follow-up 9 (10.0 %) 12 (13.9 %)
Declined telephone interview 0 1 (1.1 %)
Died from unrelated cause 3 (3.3 %) 0
1-Year follow-up data available 78 (86.7 %) 73 (84.9 %)
Suspected recurrencea 1 1
Confirmed recurrence 0 0
Chronic painb 0 0
Obstruction 0 0
Visceral erosion 0 0
Late sepsis 0 0
Mesh explantation 0 0
Reoperation required 1 (1.3 %)c 0
Results are presented as the number of herniated sites with the per-
centage in parentheses
CG control group, VG Ventralight STTM groupa See Table 6, Q1 and Q2b Defined as pain requiring treatment with analgesics, even
occasionallyc Not recurrence since it involved surgery for a new hernia at a
different site
718 Hernia (2016) 20:711–722
123
Table 6 Quality of life
outcomes at 1 yearQuestion VG CG p value
Number of LVHRs 78 73
Q1: Does your abdominal wall seem firm?
Yes 76 (97.4 %) 72 (98.6 %) 0.6
No 1 (1.3 %)a 0
Do not know 1 (1.3 %)b 1 (1.4 %)c
Q2: Do you feel a lump?
No 77 (98.7 %) 66 (90.4 %) 0.056*
Operated area 1 (1.3 %)d 6 (8.2 %)e
Elsewhere 0 1 (1.4 %)f
Q3: Do you feel any pain or discomfort?
No 65 (83.3 %) 59 (80.8 %) 0.69
Discomfort 4 (5.1 %) 8 (11.0 %)
‘Pins and needles’ 0 1 (1.4 %)
Moderate pain (no analgesia required) 9 (11.5 %) 5 (6.8 %)
Severe pain (analgesia required) 0 0
Q4: Where are these symptoms located?
Operated area 6 (7.7 %) 2 (2.7 %) 0.07
Midline 7 (9.0 %) 11 (15.1 %)
Elsewhere 0 1 (1.4 %)
Q5: When do you feel these symptoms?
During lifting, coughing 1 (1.3 %) 0
During other types of effort 3 (3.8 %) 0
At the end of the day 1 (1.3 %) 7 (9.6 %)
At any time 8 (10.3 %) 7 (9.6 %) 0.55
Q6: How often do you feel these symptoms?
Rarely 4 (5.1 %) 4 (5.5 %) 0.9
Several times a week 8 (10.3 %) 8 (11.0 %)
Several times a day 1 (1.3 %) 2 (2.7 %)
Q7: The symptoms
Do not hinder your activities 9 (11.5 %) 10 (13.7 %)h 0.66
Allow you to pursue activities at a slower pace 4 (5.1 %) 3 (4.1 %)
Cause temporary interruption of your activities 0 0
Prevent certain activities 0 0
Q8: Nuisance of pain/discomfort
Discomfort\hernia 13 (16.7 %) 12 (16.4 %)h 0.99*
Discomfort[hernia 0 1 (1.4 %)
Q9: Reoperation needed
No 77 (98.7 %) 73 (100 %) 0.99*
Yes 1 (1.3 %)g 0
Q10: Personal assessment of procedure
Excellent 38 (48.7 %) 29 (39.7 %) 0.27**
Good 37 (47.4 %) 38 (52.1 %)
Hernia (2016) 20:711–722 719
123
A further advantage of using the Hernia-Club registry is
that the data are registered according to rigorous method-
ology. For example, input is exhaustive, cases being reg-
istered without any pre-selection, online, in real time,
before the outcome is known. In addition, input is retro-
controlled by the CRA during the telephone interview. In
cases of disagreement between the patient and information
registered by the surgeon, the web-master is informed and
the original medical chart is checked. No such disagree-
ment has occurred to date. This rigorous type of method-
ology is normally difficult to achieve in a registry
[17, 30, 31].
RCTs are currently considered the gold standard for
comparing two treatment options. However, they do have
limitations, especially when comparing different surgical
techniques and different surgical prostheses: (1) Operative
teams are rarely able to perform one technique as well as
another, especially if one technique is still on its ‘learning-
curve’. This introduces significant bias towards the better-
known technique. (2) It is unrealistic to design a robust
unbiased double-blinded clinical study when comparing
different surgical techniques, especially if the comparison
is between open and laparoscopic procedures. (3) Ventral
hernias are more than ten times less common than inguinal
hernias and tend to be heterogeneous in nature, especially
incisional hernias. Thus, it is difficult to accumulate suffi-
cient numbers of cases in each arm quickly enough to
identify any significant differences, even if they do exist.
(4) Many new prostheses are introduced each year and it
would be almost impossible to perform a comparative
study for every prosthesis on the market due to time con-
straints, lack of funding and insufficient numbers of cases.
Because of the time needed to organise, perform, analyse
and publish a RCT, the results are often obsolete by the
time they are finally published as the prosthesis investi-
gated might have already been replaced on the market by
another one. (5) The long delay between surgery and the
development of complications or recurrence, and the fact
that it is impossible to control for all relevant parameters,
can hinder proof of any significant effect, particularly when
studying slight modifications in techniques or materials
[17]. (6) Finally, RCTs are not designed to enable long-
term follow-up of the implanted prosthesis and may,
therefore, miss complications that might occur many years
after surgery has been performed.
Data from registries can, therefore, complement the data
from RCTs and can be used as a substitute when certain
comparisons, such as different techniques and prostheses,
are not easily feasible in a controlled trial.
Limitations of the current study include the potential for
bias in the selection of controls, the potential for con-
founding factors due to the case–control design, and the
fact that the 1-year follow-up data relied on a telephone
conversation with the patients, who are unlikely to be as
accurate as surgeons in diagnosing a recurrence. Potential
bias in the selection of controls was minimised using an
unmatched control group of patients. Patients in the CG
were registered between January 1, 2013 and June 30,
2013, while patients in the VG were registered between
September 1, 2011 and August 31, 2013, leading to
potential bias due to the different study time periods.
However, follow-up was exactly the same in each group
(1 year), regardless of when surgery was performed. The
low statistical power of the study also limits the
Table 6 continuedQuestion VG CG p value
Moderate 3 (3.8 %) 5 (6.8 %)
Poor 0 1 (1.4 %)
Results are presented as the number of herniated sites with the percentage in parentheses
CG control group, LVHR laparoscopic ventral hernia repair, VG Ventralight STTM group, GP general
practioner
* Continuity correction, **excellent or good versus moderate or poor. Statistical analysis revealed no
significant differences between the two groups for any parametera Suspected recurrence (ultrasound prescribed by the GP but not already validated by the operative team)b Cannot sayc Declined telephone interviewd Patient assessed his result as excellent; his defect has been closede Six sites in five patients. The defect has been closed in one of sixf The defect has been closed in this patient, considered as a suspected recurrenceg For a new hernia at a different siteh Data missing in one cased,e,f Assessed their abdominal wall as firm (Q1)a–f Patients did not attend yet the recommended surgical visit
720 Hernia (2016) 20:711–722
123
conclusions that can be drawn. For example, the rate of
postoperative complications in the VG was almost twice
that in the CG, but no statistical comparison could be
performed because of the small number of these compli-
cations. A final limitation is the fact that 1 year is a rela-
tively short follow-up period for the accurate assessment of
recurrences. However, in addition to evaluating the recur-
rence rate, we evaluated the incidence of chronic pain
(defined as pain requiring analgesia lasting for longer than
3 months) and QoL outcomes, for which a 1-year follow-
up period is sufficient.
Conclusions
This case–control study has shown that the Ventralight
STTM surgical mesh is effective and well tolerated when
implanted intraperitoneally for LVHR. Complication rates
and the level of pain in the first post-operative month were
very low and there were no complications, recurrences or
cases of chronic pain during 1-year of follow-up. Most
patients rated the procedure as good or excellent. The
results achieved with Ventralight STTM were comparable
to those observed with other currently available surgical
prostheses for LVHR.
Acknowledgments The authors would like to acknowledge Marie
Chantal Bourdel for statistical analysis; Ignis Vitae Ltd. for medical
writing assistance, funded by the Hernia-Club; and C Berney, a
member of the Hernia-Club, for his critical appraisal of the
manuscript.
Compliance with ethical standards
Conflicts of interest GF, ML, NL, AD, CZ, CB declare no conflicts
of interest. JFG declares a conflict of interest not directly related to
the submitted work: as president of the Hernia-Club and organiser of
the Mesh Congress, JFG has financial partnerships with a number of
companies. However, he received no personal funding for this study.
The Hernia-Club is an independent scientific institution whose
objective is to assess the use of different procedures and prostheses
for hernia repair. It, therefore, has relationships with a number of
companies with an interest in independent evaluation of their
products.
Ethical approval All procedures performed in this study involving
human participants where in accordance with the ethical standards of
the national research committee and with the 1964 Helsinki decla-
ration and its later amendments or comparable ethical standards.
Informed consent For this type of observational retrospective study
formal consent is not required.
Appendix
Ain J-F: Polyclinique Val de Saone, Macon, France.
Beck M: Clinique Ambroise Pare, Thionville, France.
Berney C: Bankstown-Lidcombe Hospital, Sydney,
Australia.
Berrot J-L: Groupe Hospitalier Paris St Joseph, Paris,
France.
Binot D: MCO Cote d’Opale, Boulogne sur Mer,
France.
Blazquez D: Clinique Jeanne d’Arc, Paris, France.
Bonan A: Hopital Prive d’Antony, Antony, France.
Cas O: Centre Medico Chirurgical –Fondation WAL-
LERSTEIN, Ares, France.
Champault-Fezais A: Groupe Hospitalier Paris St
Joseph, Paris, France.
Chastan P: Bordeaux, France.
Cardin J-L: Polyclinique du Maine, Laval, France.
Chollet J-M: Hopital Prive d’Antony, Antony, France.
Cossa J-P: CMC Bizet, Paris, France.
Durou J: Clinique de Villeneuve d’Ascq, Villeneuve
d’Ascq, France.
Dugue T: Clinique de Saint Omer, Saint Omer, France.
Framery D: CMC de la Baie de Morlaix, Morlaix,
France.
Faure J-P: CHRU Poitiers, Poitiers, France.
Gainant A: CHRU Limoges, Limoges, France.
Gauduchon L: CHRU Amiens, France.
Jacquin C: CH du Prado, Marseille, France.
Jurczak F: Clinique Mutualiste, Saint Nazaire, France.
Khalil H: CHRU Rouen, Rouen, France.
Lacroix A: CH de Auch, Auch, France.
Ledaguenel P: Clinique Tivoli, Bordeaux, France.
Loriau J: Groupe Hospitalier Paris St Joseph, Paris.
Magne E: Clinique Tivoli, Bordeaux, France.
Ngo P: Hopital Americain, Neuilly, France.
Paterne D: Clinique Tivoli, Bordeaux, France.
Pavis d’Escurac X: Strasbourg, France.
Renard Y: CHRU Reims, Reims, France.
Soler M: Polyclinique Saint Jean, Cagnes-sur-Mer,
France.
Rignier P: Polyclinique des Bleuets. Reims.
Roos S: Clinique Claude Bernard, Albi, France.
Thillois J-M: Hopital Prive d’Antony, Antony, France.
Tiry P: Clinique de Saint Omer, Saint Omer, France.
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