Hernia (2014) 18:671–680

DOI 10.1007/s10029-013-1140-5

ORIGINAL ARTICLE

Single centre observational study to evaluate the safety

and efficacy of the ProceedTM Ventral Patch to repair small
ventral hernias
J. Bontinck • I. Kyle-Leinhase • P. Pletinckx •

V. Vergucht • R. Beckers • F. Muysoms

Received: 12 April 2013 / Accepted: 14 July 2013 / Published online: 24 July 2013
Ó Springer-Verlag France 2013

Abstract others reported no problems in the questionnaire. The

Background There is evidence that mesh repair for pri- additional ultrasound performed did not reveal recurrences
mary umbilical hernias results in less recurrences and that were not already diagnosed by clinical examination. In
similar wound complication rates compared to tissue five patients a reoperation for repair of the recurrence was
repair. In recent years, several mesh devices for the repair performed (reoperation rate 5/98 = 5.1 %). Hernia defect
of small ventral hernias have been developed, but some size (p = 0.032) and type of hernia (p = 0.029) were
reports have been published on serious complications and found to be a significant risk factors for development of a
adverse effects encountered with those mesh devices. recurrent hernia (Fisher’s exact test). Hernia size was a
Methods The ProceedTM Ventral Patch (PVPTM) is a significant risk factor both in a univariate (p = 0.005) and
partially absorbable lightweight polypropylene mesh. We in a multivariate Cox model (p = 0.017). Incisional hernia
introduced PVPTM in our department in April 2009 and was of borderline significance in a univariate (p = 0.047)
collected patient data and outcome in an observational and in a multivariate Cox model (p = 0.08).
study of 101 consecutive patients until December 2011 Conclusion Intensive clinical follow-up yields a high per-
(Clinical.Trials.gov: NCT01307696). In addition to the centage (12.0 %) of clinically proven, but often asymptomatic
routine control 3 weeks postoperative, prospective follow- recurrences after repair of small ventral hernias with the
up included a questionnaire, clinical investigation and PVPTM. Reoperation rate for recurrence was 5.1 %. Hernia
ultrasound after 12 months. defect size is a significant risk factor for recurrence. Therefore,
Results The study included 91 primary (76 umbilical/15 we recommend using the PVPTM only for primary ventral
epigastric) and 10 incisional ventral hernias (including 6 hernias smaller than 2 cm. For larger or incisional hernias other
trocar hernias). In all patients a PVPTM with a diameter of techniques allowing the use of larger meshes is advocated.
6.4 cm was used. Wound problems were the most frequent
complication (n = 18). Follow-up of at least 12 months Keywords Umbilical hernias
Epigastric hernias

was achieved in 98 patients (97 %) and the mean follow-up Ventral hernias
Mesh devices
Complications

time was 15.9 months. Follow-up by clinical examination Recurrences
diagnosed a recurrence in 11/92 patients (12.0 %). Only
four patients were aware of their recurrent hernia, the seven
Introduction

J. Bontinck
I. Kyle-Leinhase
P. Pletinckx
V. Vergucht

Background
F. Muysoms (&)
Department of Surgery, AZ Maria Middelares,
Kortrijksesteenweg 1026, Ghent 9000, Belgium Although some studies report favorable outcome after a
e-mail: [email protected] non-mesh repair of umbilical hernias smaller than 2 cm [1,
2], there is evidence that mesh repair for primary umbilical
R. Beckers
Department of Radiology, AZ Maria Middelares, hernias results in reduced recurrence and similar wound
Kortrijksesteenweg 1026, Ghent 9000, Belgium complication rates compared to tissue repair [3, 4]. The

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672 Hernia (2014) 18:671–680

largest population based study on the treatment of ventral indication. The patients were enrolled after the operation
hernias is from the Danish Ventral Hernia database [5]. The and were prospectively evaluated after a minimum follow-
cumulative risk for reoperation after repair of small up of 12 months. Demographic and indication data, and
(\2 cm) primary umbilical and epigastric hernias was short-term complications were documented in the medical
found to be significantly lower for mesh repair compared to charts and operative reports. All patients were invited for a
suture repair (Kaplan–Meier analysis; 2.2 vs. 5.6 %; clinical follow-up at 12 months after surgery. During the
p = 0.001) [6]. In another study the authors showed that control visit patients were first questioned on the presence
the cumulative reoperation rate underestimated the clinical of chronic pain, foreign body feeling, wound problems and
recurrence rate by a fourfold (Kaplan–Meier analysis; 4 vs. other complications. Subsequently, a clinical examination
15 %; p \ 0.001) [7]. Moreover, a high readmission rate was performed with the patient standing and performing
for wound complications was seen after elective primary Valsalva maneuver. Then patients were invited to undergo
ventral hernia repair [8] and many patients complained an ultrasound by a radiologist, who was unaware of the
about pain and discomfort after 3 years [9]. This illustrates findings during the clinical examination. Patients that had
that although umbilical hernia repair is considered a minor not shown up for their 12 months control visit were con-
surgical procedure, its outcome is often not satisfactory. tacted by phone between November 2012 and January
In recent years, several mesh devices for the repair of 2013. Those not willing to come for a clinical control were
small ventral hernias have been developed, including the interviewed by phone on the occurrence of reoperation,
ProceedTM Ventral Patch (PVPTM, Ethicon Inc, Johnson & chronic pain or other complications. Patients seen at our
Johnson, Sommerville, NJ, USA) [10–18]. The technique department after their 12 months visit and before January
proved user friendly and initial patient satisfaction was 31st 2013 for another reason were also included in the
high. Nevertheless, published patient series on PVPTM follow-up data if a clinical examination of the hernia repair
report only small cohorts and short follow-up periods [12, site was performed.
18]. Previously, we published a word of caution after
encountering some serious complications and adverse Setting and participants
effects with those mesh devices [15]. Berrevoet et al. [16]
performed a systematic laparoscopic control and found that The study was conducted at the surgical department of the
the intra-peritoneal deployment of the mesh device was AZ Maria Middelares Hospital in Ghent, Belgium. Patients
often unsatisfactory, and that the recurrence rate was higher were operated by one of three abdominal surgeons. Post-
than open retro-muscular mesh repair in hernias smaller operative ultrasound at 12 months was performed at the
than 3 cm [17]. department of radiology. Prior to the start of the study a
surgeon made the radiologists acquainted with the PVPTM
Objectives mesh and the placement technique during a lecture.
The first patient of the cohort was the first patient
In line with the conclusions of our previous publication receiving a PVPTM in our department. The study cohort
[15] we started a registry of all patients treated in our was operated between April 2009 and December 2011. All
department for small ventral hernias with the PVPTM. In consecutive patients receiving a PVPTM repair were
this observational study we wanted to investigate its safety, included in the cohort. The ethical committee of the hos-
by monitoring serious adverse events, and efficacy at pital approved the study protocol and the trial was regis-
12 months follow-up. Primary endpoint of the study was tered at ClinicalTrials.gov (NCT01307696). The patients
freedom of recurrence proven by clinical examination at a gave their informed consent during the postoperative con-
minimum follow-up of 12 months. trol visit.

Surgical technique
Methods
Surgery was planned either as an outpatient procedure or
This study was written in accordance with the STROBE with a 24 h hospitalization, depending on the general
statement: Strengthening the reporting of observational condition or age of the patient and on the patients’ pref-
studies in epidemiology [19]. erence. Operations were performed under general anes-
thesia. A single dose of antibiotic prophylaxis (CefacidalÒ,
Study design 2 g) was administered at the induction of anesthesia. For
umbilical and epigastric hernias in the vicinity of the
All patients treated with a PVPTM in our surgical depart- umbilicus, a curvilinear incision was made in the umbilicus
ment were included in the cohort, regardless of the either caudally or cranially. The hernia sac and herniated

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Hernia (2014) 18:671–680 673

omentum were dissected and separated from the skin. The Outcome data at postoperative follow-up after at least
hernia sac was either reduced through the hernia defect or 12 months were type of follow-up (telephone questioning,
resected if the sac was too voluminous. Through the hernia clinical examination w/wo ultrasound), abdominal wall
defect the pre-peritoneal plane was widely developed pain at the operation site (classified according to Cunn-
around the defect. In case the hernia defect was too small to ingham et al. [21]), foreign body feeling, symptoms of
allow a finger, it was slightly enlarged. Cranially, the plane small bowel obstruction, reoperation for recurrent hernia
between the round ligament of the liver and the abdominal and repair technique, subsequent unrelated abdominal
wall was developed. Caudally, the plane between the operations, cosmetic result as perceived by the patient
umbilical fold and the abdominal wall was developed. Care (very good, good, acceptable or bad), clinically proven
was taken to achieve a good hemostasis. If a hole in the recurrent hernia, recurrence seen with ultrasound and date
peritoneum was made and this was easily accessible, it was of recurrence diagnosis.
closed. If not it was accepted and left open. Only if the
development of the pre-peritoneal plane was not at all Bias
possible the mesh was positioned intraperitoneally.
A PVPÒ medium size mesh (diameter 6.4 cm) was used in The cohort consisted of consecutive operations using a
all cases and the mesh was inserted through the hernia PVPTM mesh, thus eligibility depended on the decision of
defect. The mesh was deployed, centered round the defect the surgeon to use this device, allowing some inclusion
and well extended without wrinkles. Care was taken not to bias. In contaminated or clean-contaminated operations
have pre-peritoneal fat between the mesh and the posterior the use of a mesh is avoided and for hernias larger than
rectus fascia, which was checked with the index finger. The 3 cm we generally use an open retro-muscular mesh
mesh was fixed to the edge of the hernia defect with two repair or a laparoscopic technique. No other mesh devices
U-stitches through its central leaflets cranially and cau- were used during the inclusion period of the trial. For our
dally. The leaflets were cut at the level of the fascia. The primary endpoint we tried to diminish the investigator
hernia defect was closed above the mesh with 2 to 4 sutures bias to diagnose a recurrence by proposing an ultrasound
2/0, either slowly absorbable or non-absorbable, with the investigation. In 18 patients no ultrasound was performed
‘‘vest over pants’’ technique. The skin was closed with because no radiologist was available at the timing of the
separate stitches 4/0. Postoperative wound care consisted control visit or the patient refused because of lack of
of daily dry dressings and the general practitioner removed time. At the beginning of our experience the hernia defect
the skin stitches after 10 days. Patients were advised to was closed above the mesh with non-absorbable sutures.
have unrestricted activity except for heavy weight lifting or We changed to slowly absorbable sutures because in
intense exercise during 3 weeks. some skinny patients the knots of the non-absorbable
sutures remained palpable and caused irritation of the
Variables skin.

Primary endpoint of the study was recurrent ventral hernia. Study size
This was defined as a protruding bulge felt by palpation of
the hernia repair site during straining at clinical examina- In the study protocol a sample size of 100 patients was
tion or if the radiologist found a recurrent hernia defect. empirically chosen as a population large enough to
The secondary endpoint, wound infection, was defined investigate our objectives of safety and efficiency of the
as the need for antibiotic treatment or drainage of pus. new mesh, and small enough to complete the study in a
Infection was classified as superficial when confined to the reasonable time-frame. By the end of 2011, the study
skin and/or subcutaneous tissue, and as deep when fascia or size was reached and a total of 101 patients had been
mesh was involved. included.
Descriptive data at baseline included age, gender, body
mass index, ASA-score, presence of diabetes or other Quantitative variables
comorbidities, history of abdominal wall or groin hernia
operation, type of hernia (primary umbilical, epigastric, Patients were grouped in five age categories. Body Mass
incisional), emergency operation, recurrent hernia, size of Index was grouped in three categories (\25/25 to 30/
the hernia (cm), mesh positioning (pre-peritoneal, intra- C30 kg/m2). Hernias were grouped according to their size
peritoneal, retro-muscular), closure of the hernia defect, using cut-off values at 1 and 2 cm. Size measurements
intra-operative complications, early postoperative compli- performed intraoperatively were used. If intra-operative
cations (graded according to the Clavien-Dindo classifica- measurement was missing, the preoperative measurement
tion [20]) and hospital stay. was used.

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674 Hernia (2014) 18:671–680

Statistical methods Descriptive data

Statistical significance was assumed at p \ 0.05. The Patient data at baseline are described in Table 1. Indication
association between baseline characteristics and the and operative data are described in Table 2. The PVPTM
recurrence of clinically proven hernia was statistically was placed in the pre-peritoneal position in all but seven
evaluated according to Fisher’s exact test. Estimation of patients. It was placed intraperitoneal if the pre-peritoneal
recurrence-free survival curves was done according to the plane could not be developed, most often in incisional
Kaplan–Meier method. Time-to-event curves according to hernias. A retro-muscular placement between the muscle
hernia size were compared using the log-rank test. Uni- layers was done in one patient with a trocar hernia in the
variate and multivariate Cox proportional hazard modeling flank and one patient with a primary umbilical hernia in
was used to study risk factors for hernia recurrence. The whom a catheter for peritoneal dialysis was placed during
model assumption of proportionality of hazards was the same operation.
checked by plotting log [–log(S(t))] against time in the
different subgroups, where S(t) represents the Kaplan– Outcome data
Meier survival estimate. P values were obtained through
Wald Chi square statistics. All statistical analyses were Early postoperative data are listed in Table 3. In 33
performed using SAS software (version 6.12) (The SAS patients a postoperative complication occurred (32.7 %),
system, Cary, NC, USA: SAS Institute Inc). mostly minor complications. We saw one case of deep
wound infection. This patient was operated for an
incarcerated umbilical hernia. At the operation the small
Results bowel seemed viable. This proved to be wrong at the
second postoperative day, when a bowel perforation was
Participants diagnosed. We performed a laparotomy with small bowel
resection and removal of the mesh. The wound infec-
A total of 101 eligible patients were included in the study tion was treated with topical negative pressure ther-
and analyzed for the descriptive and early outcome data. A apy (VACTM) and the patient was discharged after
flow diagram of the study cohort is shown in Fig. 1. Three 25 days.
patients were lost to follow-up: two had died, one could not
be contacted. Follow-up data were obtained in 98 patients. Main results
Six patients could only be interviewed by phone. Clinical
follow-up was thus obtained in 92 patients and an addi- The results of 98 patients for whom follow-up of at least
tional ultrasound was performed in 74 patients. 12 months was available are listed in Table 4. Reoperation

Fig. 1 Study flow chart of 101

patients treated with a
ProceedTM Ventral Patch for a
primary umbilical hernia or
another abdominal wall hernia
and aged over 18 years

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Hernia (2014) 18:671–680 675

Table 1 Patient data at baseline of 101 patients treated with a Table 2 Indication and operative data at baseline of 101 patients
ProceedTM Ventral Patch for a primary umbilical hernia or another treated with a ProceedTM Ventral Patch for a primary umbilical hernia
abdominal wall hernia or another abdominal wall hernia
Patient data % (n/N)a or Mean Indication and operative data % (n/N)a or Mean (SD)b
(SD)b
Type of the hernia
Age (at the time of surgery) Primary Umbilical 75.3 % (76/101)
\40 years 13.9 % (14/101) Primary Epigastric 14.9 % (15/101)
40–49 years 20.8 % (21/101) Incisionalc 9.9 % (10/101)
50–59 years 33.7 % (34/101) Midline–Umbilical 6.9 % (7/101)
60–69 years 16.8 % (17/101) Midline–Infraumbilical 1.0 % (1/101)
C70 years 14.9 % (15/101) Lateral–Flank 2.0 % (2/101)
Mean (SD)b 54.0 years (13.3) Emergency repair 6.9 % (7/101)
% Women 32.7 % (33/101) Recurrent hernia 3.0 % (3/101)
Body Mass Index Size of the hernia
\25 kg/m2 25.7 % (26/101) B1 cm 27.6 % (24/87)
25–30 kg/m2 34.7 % (35/101) 1.1–2.0 cm 52.9 % (46/87)
C30 kg/m2 39.6 % (40/101) [2 cm 19.5 % (17/87)
Mean (SD)b 28.5 kg/m2 (5.0) Mean (SD)b 1.66 cm (0.67)
ASA-score Placement of mesh
Normal health 58.4 % (59/101) Preperitoneal 93.1 % (94/101)
Mild to moderate systemic disease 28.7 % (29/101) Intraperitoneal 5.0 % (5/101)
Serious systemic disease 12.9 % (13/101) Retromuscular 2.0 % (2/101)
Life threatening systemic disease 0 % (0/101) Closure of hernia defect above the mesh 98.0 % (99/101)
Diabetes 9.9 % (10/101) Type of sutures
Type I 2.0 % (2/101) Absorbable 48.5 % (48/99)
Type II 7.9 % (8/101) Non-absorbable 51.5 % (51/99)
History of previous abdominal wall or groin 18.8 % (19/101) a
hernia operation % (n/N) n number of patients/N total number of patients
b
a
Mean (SD) mean value of variable (standard deviation)
% (n/N) n number of patients/N total number of patients c
b
Trocar hernias N = 6
Mean (SD) mean value of variable (standard deviation)

rate for recurrent hernia was 5.1 % (5/98) with a mean

observation period in event free patients of 15.9 months are diagnosed also beyond 12 months indicating longer
(SD 4.4; median 14.3; range 9.8–24.0). Chronic pain at the follow-up studies are needed to determine the real long-
operation site was reported by 11.4 % of patients. This pain term efficiency.
was moderate or severe in three of them (3.1 %). Cosmetic Ultrasound was performed as a control of the clinical
result of the operation was perceived as ‘‘very good’’ or examination in 74 patients. The radiologist was able to
‘‘good’’ by 92.0 % of the patients. Foreign body feeling visualize the mesh in 63.5 % (47/74) of cases. In ten of
was absent in 88.4 %. those patients the radiologist noticed contraction of the
Clinically proven recurrent hernia was diagnosed in mesh. No additional recurrences that were not diagnosed
12.0 % (11/92) of patients with a mean observation period by clinical examination were found.
in event free patients of 15.8 months (SD 4.4; median In five patients the recurrent hernia was repaired, which
14.2; range 9.8–24.0). The clinically proven recurrence was performed by laparoscopy in three patients and by
rate was 9.3 per 100 person-years. Only four patients were open retro-muscular mesh repair in two. The mesh was
aware of their recurrent hernia. In the seven others, removed during the operation in four patients and impor-
recurrence was asymptomatic and not noticed previously tant centripetal contraction of the mesh, diminishing the
by the patients. The estimated recurrence-free survival surface area, was observed in all cases. In the fifth patient
curve (Kaplan–Meier) of clinically proven recurrent her- the mesh had already been removed during an early reop-
nia is shown in Fig. 2. This graph shows that recurrences eration, mentioned previously.

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676 Hernia (2014) 18:671–680

Table 3 Early complications data of 101 patients treated with a Table 4 Follow-up data (C12 months postoperative) of an observa-
ProceedTM Ventral Patch for a primary umbilical hernia or another tional cohort study on 101 patients treated with a ProceedTM Ventral
abdominal wall hernia Patch for a primary umbilical hernia or another abdominal wall hernia
Early postoperative data % (n/N)a Follow-up data (C12 months postoperative) % (n/N)a

Early postoperative complicationsb Questionnaire (N = 98)

No complications 67.3 % (68/101) Reoperation for recurrent hernia 5.1 % (5/98)
Grade I 24.8 % (25/101) Chronic pain at the operation siteb
Grade II 6.9 % (7/101) No pain 88.5 % (85/96)
Grade IIIa 0.0 % (0/101) Mild pain 8.3 % (8/96)
Grade IIIb 1.0 % (1/101) Moderate pain 2.1 % (2/96)
Grade IV 0.0 % (0/101) Severe pain 1.0 % (1/96)
Grade V 0.0 % (0/101) Cosmetic result as perceived by the patient
Type of complication Very good 62.1 % (54/87)
Wound complications 17.8 % (18/101) Good 29.9 % (26/87)
Superficial wound infection 11.8 % (12/101) Acceptable 6.9 % (6/87)
Deep wound infection 1.0 % (1/101) Bad 1.1 % (1/87)
Seroma 3.0 % (3/101) Foreign body feeling at the operation site
Hematoma 2.0 % (2/101) No foreign body feeling 88.4 % (84/95)
Prolonged postoperative pain needing 15.8 % (16/101) Sporadic (once a month) 9.5 % (9/95)
pain medication ([ 3 weeks) Frequent (once a week) 0.0 % (0/95)
Miscellaneous Constant (almost daily) 1.1 % (1/95)
Urinary retention 1.0 % (1/101) Clinical examination (N = 92)
Urinary tract infection 1.0 % (1/101) Clinical recurrence 12.0 % (11/92)
Postoperative hoarseness 1.0 % (1/101) Known by the patient 4.4 % (4/92)
Hospital stay Asymptomatic and not noticed by the patient 7.6 % (7/92)
Ambulatory surgery 31.7 % (32/101) Ultrasound investigation (N = 74)
24 h admission 53.5 % (54/101) Mesh could be visualized 63.5 % (47/74)
2 days 7.9 % (8/101) Contraction of the mesh mentioned by radiologist 21.3 % (10/47)
[2 days 6.9 % (7/101) Additional recurrences found with ultrasound 0.0 % (0/74)
a
% (n/N) n number of patients/N total number of patients a
% (n/N) n number of patients/N total number of patients
b
Using the Clavien-Dindo classification for postoperative compli- b
Using the Cunningham classification for chronic pain [21]
cations [20]

Other analyses

Among those variables where sufficient data were present,

no significant risk factors for wound complication at
3 weeks could be found. Table 5 shows the analysis of risk
factors for clinically proven recurrent hernia. The type of
hernia was a significant risk factor, with more recurrences
for primary epigastric hernias and incisional hernias com-
pared to primary umbilical hernias (p = 0.029). Size of the
hernia defect was also a significant risk factor, with larger
diameters leading to more recurrences (p = 0.032). The
estimated recurrence-free survival curve according to the
size of the hernia defect is shown in Fig. 3. An additional
proportional hazard modeling was performed for risk fac- Fig. 2 Estimated recurrence-free survival curve (Kaplan–Meier) of
101 patients treated with a ProceedTM Ventral Patch for a primary
tors of hernia recurrence with a univariate and a multi- umbilical hernia or another abdominal wall hernia
variate Cox model. These results are shown in Table 6.
Using the univariate Cox proportional hazards model, lar- same model, incisional hernia proved to be a significant
ger hernia size was found to be associated with an risk factor for recurrence, albeit with borderline signifi-
increased risk of hernia recurrence (p = 0.005). In the cance (p = 0.047). Using the multivariate Cox model,

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Hernia (2014) 18:671–680 677

Table 5 Analysis of risk factors for recurrence in 92 patients that hernia size remained a significant risk factor (p = 0.017),
were clinically evaluated at least 12 months after implantation of a but hernia type did not (p = 0.08).
ProceedTM Ventral Patch for a primary umbilical hernia or another
abdominal wall hernia
Risk factors for (clinically proven) recurrent hernias Discussion
% Recurrent hernia (n/N)* Significance**
Key results
Age p = 0.72
\50 years 15.6 % (5/32)
Of 101 eligible patients, 92 were examined clinically at
50–59 years 9.1 % (3/33)
least 1 year after operation with a recurrence rate of 12 %
C60 years 11.1 % (3/27) and a reoperation rate of 5 %. Seventy-four patients had an
Gender p = 0.81 additional ultrasound of the abdominal wall. This exami-
Men 12.5 % (8/64) nation showed shrinkage of the mesh in ten cases, but could
Women 10.7 % (3/28) not detect additional recurrences. Size of the hernia defect
Body Mass Index p = 0.39 and incisional hernia (versus primary ventral hernia)
\25 kg/m2 8.3 % (2/24) proved to be significant risk factors for recurrence.
25–30 kg/m2 6.9 % (2/29)
C30 kg/m2 17.9 % (7/39) Limitations
ASA-score p = 0.44
ASA I 8.9 % (5/56) Although data at 12 months follow-up were gathered pro-
ASA II 15.4 % (4/26) spectively, data at baseline and follow-up at 3 weeks were
ASA III 20.0 % (2/10) gathered retrospectively. Consequently, the recording of
Diabetes p = 0.59 patient characteristics—especially comorbidities, smoking
No 13.1 % (11/84) and occupation—was incomplete in a significant part of
Yes 0.0 % (0/8) our cohort. Besides inferior accuracy of retrospectively
History of abdominal wall or groin hernia operation p = 0.42 collected data, this also reduces power when analyzing
No 10.7 % (8/75) these variables for risk factors. Most recurrences after
Yes 17.6 % (3/17) ventral hernia repair occur within 2 years after the opera-
Type of the hernia p = 0.029 tion [22]. Since our study had a mean follow-up of
Primary Umbilical 8.3 % (6/72) 16 months, it is likely that a longer follow-up would yield a
Primary Epigastric 16.7 % (2/12) higher recurrence rate. All small ventral hernias of our
Incisional 37.5 % (3/8) department during the study period were repaired with the
Emergency repair p = 0.84 PVPTM and therefore the inclusion bias mentioned above
No 11.8 % (10/85) seems to be of limited magnitude. Investigator bias was
Yes 14.3 % (1/7) reduced by the ultrasound investigation, performed by the
Size of the hernia p = 0.032 radiologist.
B1 cm 0 % (0/24)
1.1–2.0 cm 15.0 % (6/40) Interpretation
[2 cm 25.0 % (4/16)
Placement of mesh p = 0.40
Recurrence is the most frequent long-term complication in
Pre-peritoneal 11.4 % (10/88)
ventral hernia repair. We know from the Danish Ventral
Hernia Database that even for small ventral hernias the
Intra-peritoneal 33.3 % (1/3)
reoperation rate for recurrence is high (4 %) and clinically
Retro-muscular 0.0 % (0/1)
proven recurrence rate is even higher (15 %) [7]. Our
Type of sutures p = 0.84
study, with a high follow-up percentage of 97 %, shows
Absorbable 11.4 % (5/44)
very similar rates. Other series on the use of mesh for
Non-absorbable 12.8 % (6/47)
repair of small ventral hernias, ranging from 28 to 152
Bold values indicate statistical significant (p \ 0.05) patients, report very variable recurrence rates between 0
* % (n/N) n number of patients/N total number of patients and 14.8 % [10–18, 23]. In studies without prospective
** According to Fisher’s exact test follow-up data [10, 11, 18, 23] recurrence rates reported are

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678 Hernia (2014) 18:671–680

gathered prospectively. The majority of the patients with a

recurrent hernia had no symptoms and were not aware they
had a recurrent hernia (7/11). It took a physical exam to
detect their recurrence. The fact that ultrasound has no
added value in detecting recurrent hernias, confirms the
importance of a thorough clinical examination. Any fol-
low-up based on less than a clinical examination of the
patient will result in an important underestimation of the
true recurrence rate. Moreover, recurrence rate should be
calculated based only on those patients that were followed.
Because no information is available on the lost to follow-
up patients, they should not be used in the equation to
calculate the recurrence rate.
Our study found that hernia defect size and the type of
Fig. 3 Estimated recurrence-free survival curve (Kaplan–Meier) of hernia are significant risk factors for hernia recurrence.
101 patients, according to the size of the hernia defect, treated with a
ProceedTM Ventral Patch for a primary umbilical hernia or another Venclauskas has stated that for umbilical hernias with a size
abdominal wall hernia [2 cm and higher BMI can be considered risk factors for
recurrence [24]. Our study supports this conclusion for
0 to 1.7 %. We consider these data irrelevant because too hernia size but not for BMI. It appears that with the PVPTM
many patients were not evaluated. In one study a recur- good results are achieved only in hernias smaller than
rence rate of 2.6 % was reported after follow-up with a 2 cm. This finding indicates the importance of the amount
questionnaire by mail and selective clinical investigation of overlap of mesh around the hernia defect. Polypropylene
[13]. In studies with a better follow-up, both in method- meshes, like the PVPTM, have demonstrated an in vivo
ology and percentage of follow-up, systematically higher centripetal shrinkage percentage of up to 77 % in some
recurrence rates are reported [12, 16, 17]. Our data show patients [15]. This finding of mesh contraction was con-
the importance of correct evaluation and reporting the firmed in those patients that were reoperated for recurrence
recurrences. Follow-up consisted of a standardized sche- and in 21 % of the patients where the radiologist was able
dule, with all interviews and clinical examinations con- to visualize the mesh. The overlap obtained with a mesh of
ducted by the same surgeon (FM). These data were 6.4 cm in diameter is insufficient with hernias larger than

Table 6 Analysis with Cox

Risk factors for recurrent hernia: Cox Proportional Hazards modeling
proportional hazards modeling
of risk factors for recurrence in b (SE)* Wald v2 Significance
92 patients that were clinically
evaluated at least 12 months Univariate Cox model
after implantation of a Age (per year) ?0.016 (0.024) 0.42 p = 0.51
ProceedTM Ventral Patch for a
primary umbilical hernia or Gender (Female vs. Male) -0.222 (0.678) 0.11 p = 0.74
2
another abdominal wall hernia Body Mass Index (per kg/m ) ?0.031 (0.056) 0.31 p = 0.58
ASA-score (vs. normal health)
Mild to moderate systemic disease ?0.612 (0.672) 0.83 p = 0.36
Serious systemic disease ?0.877 (0.840) 1.09 p = 0.30
History of a.w. or g.h. operation (yes vs. no)** ?0.504 (0.679) 0.55 p = 0.46
Type of the hernia (vs. Primary Umbilical)
Primary Epigastric ?0.548 (0.819) 0.45 p = 0.50
Incisional ?1.409 (0.711) 3.93 p = 0.047
Emergency repair (vs. elective) ?0.656 (1.066) 0.38 p = 0.54
Size of the hernia (per cm) ?1.403 (0.499) 7.89 p = 0.005
Bold values indicate statistical Type of sutures (non-absorbable vs absorbable) ?0.204 (0.608) 0.11 p = 0.74
significant (p \ 0.05) Multivariate Cox model
* Estimated regression Type of the hernia (vs. Primary Umbilical)
coefficient (standard error) in Primary Epigastric ?0.604 (0.859) 0.49 p = 0.48
Cox PH model
Incisional ?1.354 (0.778) 3.03 p = 0.08
** History of abdominal wall or
Size of the hernia (per cm) ?1.194 (0.499) 5.72 p = 0.017
groin hernia operation

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Hernia (2014) 18:671–680 679

2 cm. Therefore, we recommend not to use PVPTM in in its composition and structure and differs substantially
hernias of 2 cm or more. In these patients, another tech- from other existing mesh devices for small ventral hernias.
nique allowing the use of a larger mesh should be pre- Therefore, we cannot extrapolate our findings concerning
ferred. Berrevoet et al. [16] observed a recurrence rate of the safety and efficacy to other mesh devices.
14.8 % with the VentralexTM patch and stated that, to
achieve an adequate overlap, a patch of 8 cm diameter is Conclusion
necessary for almost all ventral hernias. They conclude that
a retro-muscular repair is still the gold standard mesh repair Intensive clinical follow-up yields a high number of
for umbilical hernias and all new devices should be eval- asymptomatic recurrences after repair of small ventral
uated against this. hernias with the PVPTM. Reoperation rate for recurrence
Although PVPTM and similar mesh devices are devel- was 5.1 %. Hernia defect size is a significant risk factor for
oped with an anti-adhesive barrier to allow intraperitoneal recurrence. Therefore, we recommend using the PVPTM
placement of the mesh we prefer to place the mesh in a pre- only for primary ventral hernias smaller than 2 cm. For
peritoneal position. Exposure of the VentralexTM patch to larger or incisional hernias other techniques allowing the
the bowel has resulted in some patients in serious com- use of larger meshes is advocated.
plications like bowel erosions [15]. Therefore, we like to
keep the peritoneum intact and place the mesh directly Acknowledgments The Committee for Innovation of the AZ Maria
Middelares Hospital funded a consultancy fee for the statistical
underneath the fascia. Sometimes small peritoneal tears are analysis. The statistical analysis was performed by Prof. Dr. Dirk De
unavoidable during the dissection which still gives a ben- Bacquer, Department of Public Health, Ghent University, Belgium.
efit to the anti-adhesive barrier, although strictly spoken No other funding was requested for this study.
this would not be necessary in a peritoneal position.
Conflict of interest The authors report no conflict of interest in
Our study shows that the repair of small ventral hernias relation to this study.
with a PVPTM mesh device is a safe procedure. One patient
had a serious complication (Grade IIIb) not directly related
to the use of the device, but leading to removal of the mesh
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