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

jfgillion@wanadoo.fr

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

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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

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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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