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Laparoscopic ventral/incisional hernia repair: updated guidelines from the

EAES and EHS endorsed Consensus Development Conference

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DOI: 10.1007/s00464-015-4293-8 · Source: PubMed

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Surg Endosc (2015) 29:2463–2484 and Other Interventional Techniques

DOI 10.1007/s00464-015-4293-8

GUIDELINES

Laparoscopic ventral/incisional hernia repair: updated guidelines

from the EAES and EHS endorsed Consensus Development
Conference
Gianfranco Silecchia1 • Fabio Cesare Campanile2 • Luis Sanchez3 •
Graziano Ceccarelli4 • Armando Antinori5 • Luca Ansaloni6 • Stefano Olmi7 •
Giovanni Carlo Ferrari8 • Diego Cuccurullo9 • Paolo Baccari10 • Ferdinando Agresta11 •

Nereo Vettoretto12 • Micaela Piccoli13

Received: 29 January 2015 / Accepted: 27 April 2015 / Published online: 3 July 2015
 Springer Science+Business Media New York 2015

Abstract and parastomal hernia; intraoperative and perioperative

Background The Executive board of the Italian Society complications; and recurrent ventral/incisional hernia. All
for Endoscopic Surgery (SICE) promoted an update of the the recommendations are the result of a careful and com-
first evidence-based Italian Consensus Conference Guide- plete literature review examined with autonomous judg-
lines 2010 because a large amount of literature has been ment by the entire panel. The process was supervised by
published in the last 4 years about the topics examined and experts in methodology and epidemiology from the most
new relevant issues. qualified Italian institution. Two external reviewers were
Methods The scientific committee selected the topics to designed by the EAES and EHS to guarantee the most
be addressed: indications to surgical treatment including objective, transparent, and reliable work. The Oxford
special conditions (obesity, cirrhosis, diastasis recti abdo- hierarchy (OCEBM Levels of Evidence Working Group*.
minis, acute presentation); safety and outcome of ‘‘The Oxford 2011 Levels of Evidence’’) was used by the
intraperitoneal meshes (synthetic and biologic); fixing panel to grade clinical outcomes according to levels of
devices (absorbable/non-absorbable); abdominal border evidence. The recommendations were based on the grading
system suggested by the GRADE working group.
Results and Conclusions The availability of recent level
Gianfranco Silecchia and Fabio Cesare Campanile contributed 1 evidence (a meta-analysis of 10 RCTs) allowed to
equally to the preparation and writing of the article.
7
& Fabio Cesare Campanile Division of General and Oncologic Surgery, Advanced
campanile@surgical.net Laparoscopy Center, Policlinico San Marco, Zingonia, BG,
Italy
1
Division of General Surgery and Bariatric Centre of 8
Division of General, Oncologic and Mini-Invasive Surgery,
Excellence, Department of Medico-Surgical Sciences and
A.O. Ospedale Niguarda Cà Granda, Piazza Ospedale
Biotechnology, Sapienza University of Rome, Via Faggiana
Maggiore 3, 20162 Milan, Italy
1668, 04100 Latina, LT, Italy
9
2 Division of General, Laparoscopic and Robotic Surgery,
Division of General Surgery, Ospedale San Giovanni
AORN dei Colli Ospedale Monaldi, Naples, Italy
Decollato Andosilla, ASL VT, Via Ferretti 169,
10
01033 Civita Castellana, VT, Italy Division of General Surgery, Santa Maria della Misericordia
3 Hospital, P.zale Menghini 1, 06129 Perugia, Italy
Division of Oncologic Surgery, Department of Oncology,
11
Azienda Ospedaliero-Universitaria Careggi, Largo Brambilla Department of General Surgery, ULSS19 del Veneto, Via
3, 50134 Florence, Italy Etruschi 9, 45011 Adria, RO, Italy
4 12
Division of General Surgery, Ospedale di Spoleto, Via Loreto Laparoscopic Surgical Unit, M.Mellini Hospital, Viale
3, 06049 Spoleto, PG, Italy Giuseppe Mazzini 4, 25032 Chiari, BS, Italy
5 13
Department of Surgery, Catholic University of Rome, Largo Department of Surgery, NOCSAE (Nuovo Ospedale Civile
A. Gemelli 8, 00168 Rome, Italy Sant’Agostino Estense), Via Giardini 1355,
6 41126 Baggiovara, Modena, Italy
Division of General Surgery I, Papa Giovanni XXIII
Hospital, Piazza OMS 1, 24127 Bergamo, Italy

123
2464
recommend that not only laparoscopic repair is an
acceptable alternative to the open repair, but also it is
advantageous in terms of shorter hospital stay and wound
infection rate. This conclusion appears to be extremely
relevant in a clinical setting. Indications about specific
conditions could also be issued: laparoscopy is recom-
mended for the treatment of recurrent ventral hernias and
obese patients, while it is a potential option for com-
pensated cirrhotic and childbearing-age female patients.
Many relevant and controversial topics were thoroughly
examined by this consensus conference for the first time.
Among them are the issue of safety of the intraperitoneal
mesh placement, traditionally considered a major draw-
back of the laparoscopic technique, the role for the bio-
logic meshes, and various aspects of the laparoscopic
approach for particular locations of the defect such as the
abdominal border or parastomal hernias.
Keywords Abdominal
Bariatric
Hernia
Obesity

Ultrasonography
Clinical papers
Clinical trials
Clinical
research
Ventral hernias (primary or incisional) are common. Their
operative repair is part of the daily routine of every general
surgeon. It can be extremely invasive with a long and
painful period of illness and even leading in some cases to
a negative outcome. Surgery can be extremely complex,
especially for incisional hernias, due to the size of the
defect or sac content, the extent of intraabdominal adhe-
sions, and the length of the operation.
For a surgeon not trained in this particular area, it is
increasingly difficult to determine the best treatment
option. The goal of these guidelines is to support surgeons
in the decision-making process. The fundamental precon-
dition for a reliable guideline is the availability of quality
published studies of high ranking in the classification of the
EBM. PubMed search on this topic (‘‘ventral/incisional
hernias’’) produced more than 11,000 papers, 30 % pub-
lished in the last 4 years.
In January 2010, the first evidence-based Italian Con-
sensus Conference about laparoscopic ventral/incisional
hernia repair was organized in Naples. The panel of that
consensus focused on the indications for laparoscopic
ventral hernia repair (LVHR), surgical technique, compli-
cations, their prevention and management, and recurrence
after laparoscopic repair.
The results were published on the 2013 issue of ‘‘Her-
nia’’ [1]. The Executive board of the Italian Society for
Endoscopic Surgery (SICE) promoted an update of that
guidelines because a large amount of literature has been
published in the last 4 years about the topics examined
then, and new relevant topics.
123
Surg Endosc (2015) 29:2463–2484
Methods
Organization of the Consensus Conference
The Executive board of the Italian Society for Endoscopic
Surgery (SICE) promoted the consensus, involved the
Italian Chapter of EHS and the Italian Society of Anes-
thesiology (SIAARTI) in the Promoting Committee and
designated a scientific committee made of five members,
expert in the surgical treatment of ventral hernia, guideline
methodology, and literature search (co-authors of this
paper: FCC, GS, FA, NV, MP). Two of them had also been
members of the 2010 Consensus Conference scientific
committee (FA and MP).
In the first stage, the scientific committee selected six
experts as Topic Editors and the Italian chapter of EHS
proposed two additional experts to complete a panel of
eight Topic Editors (also co-authors of this paper: LS, GC,
AA, LA, SO, GCF, DC, PB) plus a delegate of the Italian
Society of Anesthesiology (SIAARTI). The eight Topic
Editors and the delegate of the SIAARTI constitute the
‘‘panel’’ mentioned in the present paper.
The selection criteria were:
(a) proven expertise in laparoscopic ventral hernia
repair
(b) authorship in peer-reviewed journal on laparoscopic
ventral hernia repair
(c) involvement in the society (SICE) registry of
laparoscopic ventral hernia repair
Two epidemiologists, expert in methodology, were
indicated, respectively, by Age.na.s. (Agenzia Nazionale
per i Servizi Sanitari) and Istituto di Ricerche Farmaco-
logiche Mario Negri to oversee the methodological aspects.
In the second stage, the scientific committee selected the
topics to be addressed by the panel and performed a first
literature search.
The Topic Editors were asked to review the available
literature (after having completed and integrated it) on the
topic, produce an evidence report, outlining key statements
(and their literature support) to be discussed by the entire
panel, and grade the supporting evidence according to the
Oxford hierarchy of evidence 2011 [2].The identity of the
panelists was not revealed, at this stage, to prevent the
authority, personality, or reputation of some participants
from dominating others in the process, according to the
Delphi method.
In the third stage, the society (SICE) set up a closed
online forum on the Web site http://www.siceitalia.com to
pursue a blind discussion on the evidence report produced
by each Topic Editor. The panelists and the members of the
scientific committee posted their comments during the
Surg Endosc (2015) 29:2463–2484
following 2 months. The Topic Editors were encouraged to
revise their earlier reports in light of the replies of other
members of the panel.
In the fourth stage (June 2013), the panel met in Rome,
to discuss each topic, and produced key statements with a
grade of recommendations (GoR) followed by a com-
mentary to explain the rationale and the level of evidence
behind the statement. Only at this stage the identity of the
panelists was revealed.
The recommendations were based on the grading system
suggested by the GRADE working group [3].
Strong recommendation The panel is confident that the
desirable effects of adherence to a recommendation out-
weigh the undesirable effects.
Weak recommendation The panel concludes that the
desirable effects of adherence to a recommendation prob-
ably outweigh the undesirable effects, but is not confident
about it.
All recommendation were issued as ‘‘for’’ (in favor)
recommendation, no ‘‘recommendation against’’ was
necessary.
Next those statements and the evidence reports were
updated and the ‘‘file’’ was submitted to the external
reviewers.
The statements were presented and discussed by the
audience of the Annual Congress of the SICE in Naples
(September 20, 2013). The external reviewers participated
to the conference. The audience voted each statement
acting as jury in the guideline development process.
The panel modified the statements following the deci-
sions of the Congress audience. The full revised evidence
reports remained on the Web site http://www.siceitalia.org
for 1 month. All the members of the society (SICE) were
invited to send comments, suggestions, and questions to the
scientific committee.
A further appraisal by the external reviewers was
obtained before submitting the paper for publication.
Literature search and appraisal
The results of the systematic literature review performed
for 2010 Italian Consensus Conference on Laparoscopic
Ventral Hernia Repair were entirely considered; the liter-
ature search strategy adopted has been detailed in that
paper [1].
An additional literature search was done from 2010
through June 2013 with the following limits and filters:
Humans, Clinical Trial, Meta-Analysis, Practice Guideline,
Randomized Controlled Trial Review, English, All Adult:
19? years. The PICO (population, intervention, compar-
ison, outcome) system was applied for the MeSH (Medical
2465
Subject Headings) search whenever possible. Analogous
search has covered the Cochrane Collaboration database,
Scopus, and the Google Scholar in order to gather all the
remaining evidence, synopses, and guidelines on the topic.
Database searches combined the key word laparoscopy
(or laparosc*) with ventral/incisional hernia repair and with
condition-specific keywords (e.g., complications).
Limits regarding language, age, and study type were
then removed, to identify observational, population-based
outcomes studies, case series and case reports, and any
other clinically relevant report.
Duplicates, publications with no abstract and of low
interest in the specific topics, and key questions were not
taken into consideration.
The literature search was extended back to 1990 for
those topics not taken into consideration in the 2010
Consensus Conference, to include all relevant papers.
The Oxford hierarchy (OCEBM Levels of Evidence
Working Group*. ‘‘The Oxford 2011 Levels of Evidence’’.
Oxford Centre for Evidence-Based Medicine. http://www.
cebm.net/index.aspx?o=5653) was used by the panel to
grade clinical outcomes according to levels of evidence
(LE). Studies containing severe methodological flaws were
highlighted and downgraded as necessary. For each inter-
vention, the validity and homogeneity of study results,
effect sizes, safety, and economic consequences were
considered.
Results
Topic 1: Indications to surgical treatment of ventral/
incisional hernias
Luis Sanchez, Lapo Bencini
The only presence of a ventral/incisional hernia does not
represent an indication to surgery. The goals of ‘‘elective’’
repair are relief of symptoms (pain and discomfort) and
prevention of complications (strangulation/incarceration)
[4–7]. However, the data on the natural history of the
disease are contradictory: a prospective long-term study
and a more recent review reported that 60 % of patients are
symptoms-free [8, 9], while a retrospective review of
almost 1000 patients showed 78 % symptomatic hernias
and 5 % with complications [10]. Indications for ventral/
incisional hernia repair have to take into account age, site,
size, gender, obesity, concomitant medical illness, previous
surgery, esthetic impairment, and limitations in normal
activities.
A recent meta-analysis of 10 randomized controlled
trials comparing laparoscopic versus open ventral/inci-
sional hernia repair, involving 880 patients, demonstrated
123
2466
the superiority of the laparoscopic approach in terms of
shorter hospital stay and reduced wound infection rate [11]
(LE1). Retrospective population-based studies reported
conflicting results [12–18]. Excellent results, when dealing
with primary ventral hernias, have been published [19–21].
STATEMENT
Laparoscopic repair of ventral hernia is safe and
effective with lower risk of wound infection and shorter
hospital stay compared with open repair.
STRONG RECOMMENDATION (Panel consensus
100 %)
Laparoscopic approach could play a role in reducing
perioperative morbidity and cardio-circulatory overload in
elderly patients. Nevertheless, there are only few papers
concerning the laparoscopic approach in aged patients, but
the definition of ‘‘older’’ varies from age 65 to over 80.
Five retrospective underpowered studies targeted
advanced-age patients [22–26] (LE4). The morbidity and
mortality rates of elderly patients were similar to those of
younger age. Two studies reported longer length of stay
and later return to normal activities [26, 27]. The afore-
mentioned studies have weak statistical power and short
follow-up. The Cochrane Review 2011 demonstrated a
consistent reduced risk of infection among elderly [11].
STATEMENT
Older age is not a contraindication for laparoscopic
treatment of ventral/incisional hernia.
STRONG RECOMMENDATION (Panel consensus
100 %)
Ventral hernias occur more frequently in males than in
females, although complications (i.e., strangulation and
obstruction) affect similarly both sexes [28]. Scant data are
reported in the literature about women in childbearing age.
There have been some concerns about placing a prosthesis
in childbearing-age female who will desire a pregnancy,
but few studies targeted this specific topic. Two case
reports are available on vaginal delivery after abdominal
wall laparoscopic repair with PTFE [29, 30]. In none of the
studies aimed at detecting risk factors, female sex was
found to be significant for different perioperative results or
recurrence [31–33]. No suggestion can be issued on the
basis of the current literature.
Laparoscopic repair of ventral/incisional hernias is
currently accepted when the defect size is at least of 3 cm,
because smaller defects can be safely treated with suture
repair under local anesthesia [34, 35]. Small midline her-
nias are best treated by laparoscopy. On the other hand,
large hernias are thought to be more challenging and can
lead to more morbidity and recurrence rates [36, 37].
123
Surg Endosc (2015) 29:2463–2484
However, the term ‘‘large hernia’’ is poorly defined. The
upper limit of the hernia defect suitable for laparoscopic
repair is not clearly defined. Moreover, when considering
the dimension of the hernia defect, the whole surface of the
patient’s abdomen should be taken into account such as the
need for a wider prosthesis overlap. Several groups report a
favorable outcome with laparoscopic ventral hernias repair
larger than 15 cm in diameter [33, 38–41]. Furthermore,
some authors consider large hernias to be the best indica-
tion for the laparoscopic approach in terms of perioperative
results [42–44]. The systematic search provided only one
prospective study [45] addressing this particular issue
(defect size/outcome). The authors reported that the upper
limit of 10 cm correlates with low recurrence rate.
The panel confirms the recommendation of the previous
consensus as far as defect size is concerned.
STATEMENT
Laparoscopic repair is accepted for hernia defect larger
than 3 cm. There is no consensus on the suitable upper
limit.
STRONG RECOMMENDATION (Panel consensus
100 %)
Although the cornerstone of ventral hernias diagnosis is
represented by an accurate clinical evaluation, imaging
should be utilized to rule out abdominal comorbidities and
achieve a complete definition of the hernia defect and its
content. Ultrasound or CT scan are recommended before a
scheduled operation, especially in obese patients
(BMI [ 30), in an emergency setting and in those suffering
for large defects with loss of domain, posttraumatic hernias
or recurrences. Recent literature shows that a dynamic
ultrasound can reach the same accuracy of CT scan when
performed by experienced radiologists [46, 47], while some
authors emphasize the use of MRI for recurrences [48, 49].
The panel confirms the 2010 consensus recommendation
about the use of imaging (US, CT, MRI) before LVHR
only in selected cases.
STATEMENT
Preoperative assessment by imaging techniques is rec-
ommended in selected patients (obese, large defects,
multiple previous surgery, border defect, complex cases,
emergency surgery).
STRONG RECOMMENDATION (Panel Consensus
100 %)
The presence, the numbers, or the types of prior surgical
incision, including a failed attempt of hernia correction, are
not contraindications for laparoscopic ventral/incisional
hernia repair. A prospective study showed that the number
of previous operations and repairs neither affects the results
Surg Endosc (2015) 29:2463–2484
in terms of recurrence nor increases the risk of complica-
tions [31] (LE3), while a previous study reached opposite
conclusions about recurrence [50] (LE4). Therefore,
recurrence should not be considered a contraindication to
laparoscopy, even though complications [51], conversions
[52], and additional recurrences [32, 53] may be more
frequent. However, the short-/long-term data reported in
the literature are largely not homogeneous [54, 55].
STATEMENT
Previous surgeries (with or without the use of meshes)
are not contraindications for further laparoscopic repair.
STRONG RECOMMENDATION (Panel Consensus
100 %)
Topic 2: Indications in special conditions
Graziano Ceccarelli
Obese patients
Obesity is a risk factor for the occurrence of ventral/inci-
sional hernia and leads to higher recurrence rates and
perioperative related complications. The enhanced inci-
dence of larger defects (especially [10 cm) in the obese
population carries a further increase of recurrence rate [45].
The laparoscopic approach to ventral/incisional hernia
repair in obese patients (BMI [ 30), achieves an infection
rate lower than in open procedures [56]. Similar results are
shown in other studies [54, 57–62]. A recent retrospective
cohort analysis of 47,661 obese patients undergoing ventral
hernia repair demonstrated an increased use of the laparo-
scopic approach, with better results in terms of complication
rate, hospital stay, and overall cost of care [63]. A lower
recurrence rate after the laparoscopic approach is also
described in obese patients with umbilical hernias [58].
Laparoscopy allows identifying additional hernia
defects that might have gone unrecognized, especially in
obese patients. The timing of ventral hernia repair in
patient candidate to bariatric surgery is controversial [64].
A two-stage approach (weight loss procedure followed by
laparoscopic hernia repair) may decrease the recurrence
rate and technical difficulties. Furthermore, the risk of
mesh contamination at the time of bariatric surgery sug-
gests deferring the hernia repair. In addition, resolution of
metabolic comorbidities, (i.e., diabetes) could guarantee
better outcomes [65]. However, symptomatic ventral her-
nias could be repaired before the bariatric procedure [66].
Nevertheless, a one-stage procedure is considered to have
some advantages as the risk of mesh implantation in a
potentially contaminated or clean-contaminated field in
2467
concomitant hernia repair and bariatric procedure seems to
be very low [67].
STATEMENT
2.1. Laparoscopic repair is recommended in obese
patients with ventral/incisional hernia.
STRONG RECOMMENDATIONS (Panel Consensus
100 %)
Cirrhosis
Umbilical and incisional hernias are more common in the
cirrhotic patients than in the general population. Abdomi-
nal distension caused by ascites, consequent high intraab-
dominal pressure, and loss of muscle mass secondary to
poor nutritional status are the main risk factors for ventral
hernia formation and enlargement in patients affected by
cirrhosis. Patients with both cirrhosis and ascites have
about 20 % risk of developing umbilical hernia [68, 69].
Laparoscopic hernia repair in cirrhosis (Child A) is
feasible and safe [70–72].
The high morbility rate of an emergency treatment in
this group of patients suggests that elective treatment
should not be deferred [73, 74].
The laparoscopic approach was described also in
recurrent incarcerated umbilical hernia, Child’s class B, C,
and refractory ascites patient [75, 76].
Ascites control is the mainstay of postoperative man-
agement. Good control of ascites allows similar outcomes
as in patients without cirrhosis [77, 78].
Elective repair of an umbilical hernia should be avoided for
those with adverse predictors, such as age older than 65 years,
MELD score higher than 15, and albumin level less than
3.0 g/dL [79]. Laparoscopic incisional hernia repair is pos-
sible and safe after liver transplantation too [69, 72].
STATEMENT
2.3 Compensated Child A-B cirrhosis is not a con-
traindication to elective laparoscopic ventral/incisional
hernia repair.
WEAK RECOMMENDATION (Panel Consensus
100 %)
Diastasis recti abdominis
Surgical treatment of diastasis recti abdominis (suture of
the linea alba with the use of a mesh) is indicated in
symptomatic patients who present abdominal pain or dis-
comfort. Laparoscopic repair was described as safe and
effective in small case series [80, 81]. In 2011, a systematic
123
2468
review underlined the scarceness of literature on laparo-
scopic repair of diastasis recti, but the authors suggest a
lower complication rate in the minimally invasive com-
pared with the open approach. [82]. Preoperative imaging
evaluation for determining the position of the recti abdo-
minis muscles is recommended [83]. Ventral/incisional
hernia associated with diastasis recti abdominis represents
a challenge for the surgeon. No evidence from the literature
was obtained. The panel considers the data of the literature
too scanty to draw any recommendation.
Acute presentation: emergency
No relevant scientific data about the laparoscopic approach to
incarcerated ventral/incisional hernias were published after
the Consensus Conference of the European Association of
Endoscopic Surgery (EAES) [84] and the 2010 Consensus
Conference [1]. The open approach remains the standard
treatment for incarcerated hernia, although laparoscopic sur-
gery may be considered in selected patients [1]. The incidence
of intra- and postoperative complications and recurrences in
emergency cases was the same as in elective cases.
Selection criteria are:
• Absence of marked bowel distension [85–87].
• Absence of peritonitis [88] and high-septic-risk situa-
tions, such as entero-cutaneous fistulas [89].
• Absence of hemodynamic instability and severe comor-
bid conditions, such as heart and lung diseases, which
preclude the use of pneumoperitoneum [88].
The presence of non-viable intestine is not to be considered
as a contraindication for prosthetic repair [90]. The immediate
mesh repair is deferred only in the presence of abundant
peritoneal contamination [87, 91–94]. The biologic meshes
may provide a new prospect in a contaminated surgical field
[95], also in laparoscopic emergency hernia repair, with good
results in terms of recurrence and wound infection [96, 97].
Laparoscopy is useful both to confirm the diagnosis and to
carry out therapeutic repair [98–100]. Single-port laparoscopic
repair of incarcerated ventral hernia were described [101].
Incarcerated hernia, together with mesh size, patient
age, and complex hernia are predicting factors about longer
length of stay [27].
STATEMENT
2.4 Incisional hernia in emergency is not a contraindi-
cation to laparoscopic approach and may be performed
in selected cases.
WEAK RECOMMENDATION (Panel Consensus
100 %)
123
Surg Endosc (2015) 29:2463–2484
Topic 3: Safety and outcome of intraperitoneal
meshes
Armando Antinori
Safety
The indications for laparoscopic ventral hernia repair have
been widely debated with increasing approval from the
scientific community.
Most of the abdominal hernia surgical procedures are
mesh-based, and since the first description of a mesh use
for abdominal wall repair, numerous prosthetic materials
have become available for surgeons.
The placement of a mesh into the abdominal cavity is the
fundamental theoretic assumption of every laparoscopic
ventral hernia repair. Many meshes have been specifically
manufactured to avoid adhesion formation with the
abdominal viscera, to be implanted intraperitoneally. Today,
expanded polytetrafluorethylene (ePTFE), polypropylene
(PP), polyethylene terephthalate/polyester (PET), ade-
quately formed or composed with different adhesion barri-
ers, are the main synthetic polymers used [102]. The safety of
the intraperitoneal mesh implant is supported by the results
of more than 20 years of laparoscopic surgery for the
abdominal wall hernias.
Several randomized controlled studies and meta-analy-
sis of controlled trials published in the last decade have
demonstrated that laparoscopic repair should be considered
a safe technique, and there is a sufficient follow-up to state
that most of the barrier mesh prostheses determine a very
low risk when placed intraperitoneally [11, 36, 61, 103].
A recent Cochrane review showed heterogeneity among
studies analyzed with respect to the type of the intraperi-
toneal mesh used, even within the same study. As a matter
of fact, the purpose of the studies was generally to confirm
the feasibility of laparoscopic repair and not to analyze the
immediate and long-term results of different types of mesh.
A few papers compare different types of mesh [104].
One retrospective study compared polyester composite
versus PTFE mesh with no significant association between
types of mesh used and postoperative complication rate
[105].
In order to obtain a new mesh classification, 1000
samples of various meshes explanted for recurrence, pain,
or infection after different abdominal wall hernia open
repairs were analyzed. Although the aim of the study was
not to define the risk of a particular kind of mesh, the
number of intraperitoneal mesh sample explanted was very
low [106].
Surg Endosc (2015) 29:2463–2484
A further evidence of the safety of the intraperitoneal
implant of barrier mesh prostheses could be indirectly
deduced by some prospective and retrospective studies that
reported the use of pure, un-coated polypropylene meshes
during laparoscopic repair with an acceptable rate of
complications [11, 107].
Even in challenging indication, such as parastomal
hernia repair, where the mesh is necessarily wrapped
around the bowel, the role of the laparoscopic approach has
been positively confirmed [108].
Some case reports and a case series study suggest that
laparoscopic ventral hernia repair be an acceptable and safe
therapeutic option also in fertile woman who intend to have
further pregnancies and that intraperitoneal implant of a
mesh do not cause significant problems during pregnancy
or delivery [30].
STATEMENT
3.1 The intraperitoneal placement of a prosthesis
specifically produced for laparoscopic ventral hernia
repair is safe.
STRONG RECOMMENDATION (Panel Consensus
100 %)
Outcome
The perfect mesh for laparoscopic repair should have
minimal adhesion formation, excellent tissue ingrowth, and
minimal shrinkage: the ideal mesh is not yet available.
Adhesions are relatively frequent after the intraperi-
toneal mesh placement; they may potentially cause some
complications and make re-operations challenging.
Some clinical studies have attempted to determine the
adhesion characteristics and effectiveness of the available
barrier mesh prostheses. Re-operative findings in patients
with prior laparoscopic repair have been recently analyzed
providing the most valuable information on these issues.
Some authors reported null or minimal omental adhesions
in 89 % of cases with polyester absorbable barrier mesh
implant [109]. Other authors found null or minimal
adhesions involving omentum in 82 % of cases with a
ePTFE implant and observed that adhesions occurred
mainly against exposed elements (tacks, edge of the
mesh) [110].
Only one clinical study compared the most common
barrier mesh prostheses, and the adhesion features found at
the time of laparoscopic re-exploration performed in 69
cases. Adhesions to the permanent-barrier non-composite
mesh (ePTFE) were less tenacious than in all other mesh
groups, and the adhesiolysis-related complications were
seen only with uncoated polypropylene mesh [111].
2469
Thus, most of the barrier mesh prostheses do not prevent
adhesions completely and determine some degree of
adhesion, but the cause of related complications seems to
be multifactorial.
The potential for shrinkage of intraperitoneal meshes
remains a concern. The inflammatory reaction, stimulated
by prosthetic materials, determines a certain level of
shrinkage (from 5 to 57 % for all meshes) that might favor
recurrences or pain [112]. This issue, analyzed in several
experimental studies, has been recently investigated in
human.
Two retrospective studies reported 6.7 and 7 % shrink-
age of ePTFE mesh measured by computed tomography
[113, 114]. These results were markedly lower than those
determined in animal studies.
One prospective randomized clinical study on 40
patients treated with a polypropylene composite mesh
showed that shrinkage was significantly influenced by
mesh fixation, with a lower rate (0.1 %) in the transfascial
suture group compared with the tack group (3.1 %) [115].
All data collected from the literature cannot allow to state
that shrinkage depends on the mesh type, while it seems to
be correlated with mesh fixation technique. A clear rela-
tionship between shrinkage and recurrence rate or chronic
pain cannot be demonstrated.
On the basis of the current literature, the panel cannot
state any recommendation.
STATEMENT
Adhesions formation is relatively frequent after laparo-
scopic repair, and the cause of related complications
seems to be multifactorial. Most mesh materials undergo
some degree of shrinkage after the intraperitoneal
positioning, similar to that observed after open hernia
repair. No significant differences have been shown for
adhesion and shrinkage with different mesh types
specifically designed for intraperitoneal implant.
Topic 4: Biologic mesh for incisional hernia
Luca Ansaloni
Question: which role could play biologic meshes
for laparoscopic incisional hernia repair?
Approximately one million prostheses are worldwide used
each year for abdominal wall reconstruction [116–118].
Since the use of mesh for abdominal wall reconstruction
was first described [119], plenty of new materials have
been introduced, first synthetic and later biologic. The
specific indications of the different materials (biologic in
123
2470 Surg Endosc (2015) 29:2463–2484

particular) are controversial. Many biological prostheses
(BP) are currently available (Table 1).
They are obtained from human (homografts) or mam-
malian tissues (xenografts) [120]. The latter derives from
uniform animal population with similar age and life his-
tory; therefore, implants are more consistent than homo-
grafts [120]. BP are further classified into two main groups:
cross-linked and non-cross-linked. The introduction of
cross-linking between the collagen chains strengthens the
prosthesis and reduces the effectiveness of bacterial or host
collagenase enzymes. Therefore, the implant is less sus-
ceptible to degradation in vivo [121, 122]. On the basis of
the presence or absence of the cross-linking, biological
prostheses are categorized into two subgroups: partially or
completely remodelable (over time). The former (cross-
linked) prostheses come from porcine or human dermic and
bovine pericardium collagen [120]. The completely
remodelable (not cross-linked) ones derive mainly from
swine intestinal submucosa, swine dermis, human dermis,
fetal bovine dermis, and bovine pericardium. The differ-
ences in remodeling times should be considered in the
selection of these materials for the abdominal wall repair
[120]. Each type of prosthesis allows and promotes
angiogenesis and cellular ingrowth, but different prostheses
can offer different clinical characteristics. The presence of
additional linkages grants increased resistance to mechan-
ical stress and longer duration to the partially remodeling
prostheses. Moreover, BP are credited with the lowest
potential for adhesion formation among all prosthetic
materials available for intraperitoneal use [123]. In groin
hernia repair, biological prostheses have been shown to
reduce postoperative pain and discomfort [124]. Implants
would act as a scaffold that guides the growth of the host
tissue cells and fibroblasts. They also support the abdom-
inal wall up to its recovery. The remodeling process ranges
between a few months and few years [125], and it is related
to the properties of the prosthesis and host tissues. BP
management should be completely different from the
standard synthetic meshes. The latter trigger a foreign body
response leading to intense fibrous reaction. On the con-
trary, BP activate a remodeling process guiding the host to
start a real tissue engineering process [126]. The correct
use of different BP in abdominal wall surgery, and ventral/
incisional hernia in particular, remains unclear [120, 127].
Only few studies took into consideration the laparo-
scopic placement of a biological mesh.
The LAPSIS study was a multicentre European RCT
comparing open retromuscular (mesh augmentation tech-
nique) versus laparoscopic repair (mesh bridging tech-
nique) and the use of a non-cross-linked biological mesh
(Surgisis) versus classical synthetic mesh for clean primary
ventral/incisional hernia with a diameter of 4–10 cm, in a
two-factorial design. On August 7, 2009, further inclusion
of patients into the trial was stopped because of the low rate
of patient recruitment, incompleteness of the study data,
and a higher preliminary recurrence rate in the BP com-
pared with the synthetic mesh groups. The analysis of 257
patients whose surgical approach and type of mesh could
be assessed at the stopping time (median follow-up of
1 year) was carried out. The implantation of Surgisis

Table 1 Biological prosthesis currently on the market

Name Manufacturer Tissue source Material X-linking

Alloderm LifeCell Human Acellular dermis No

AlloMax Bard Human Acellular dermis No
Flex HD Ethicon/MTF¥ Human Acellular dermis –
DermaMatrix MTF¥ Human Acellular dermis No
Permacol Covidien Porcine Acellular dermis Yes
CollaMend Davol/Bard Porcine Acellular dermis Yes
Strattice KCI/LifeCell Porcine Acellular dermis No
XenMatrix Brennan Medical Porcine Acellular dermis No
Surgisis Cook Porcine Small intestine submucosa No
Surgisis Gold Cook Porcine Small intestine submucosa No
Lyosis Cook Porcine Lyophilized small intestine submucosa No
FortaGen Organogenesis Porcine Small intestine submucosa Yes
SurgiMend TEI bioscience Bovine Fetal dermis No
Periguard Synovis Bovine Pericardium Yes
Veritas Synovis Bovine Pericardium No
Tutomesh Tutogen Bovine Pericardium No
Tutopatch Tutogen Bovine Pericardium No
MTF Musculoskeletal Transplant Foundation

123
Surg Endosc (2015) 29:2463–2484 2471

resulted in a higher early recurrence rate in each of the implant is feasible, the use of biologic prosthesis should
study arms: 19 % (10 of 53) versus 5 % (3 of 63) after be restricted to contaminated field in open surgery. Their
laparoscopic repair, and 11 %(7 of 65) versus 3 % (2 of 76) laparoscopic use is recommended in controlled trials.
after open repair. No differences between the study groups WEAK RECOMMENDATION (Panel Consensus
in the other study endpoints (infection or reoperation) have 100 %)
been identified [104].
In a prospective observational study, Franklin et al. [97]
presented their 5-year experience with placement of Sur- Topic 5: Absorbable and non-absorbable fixing
gisis mesh in potentially or grossly contaminated fields. devices and positioning technique
The study included 116 patients with 133 laparoscopic
procedures for abdominal hernia. Two techniques were Stefano Olmi, Giovanni Cesana
adopted: intraperitoneal onlay mesh (IPOM) and two-lay-
ered ‘‘sandwich’’ repair (laparoscopic and open explo-
Non-absorbable fixing devices
ration with reinforcement with Surgisis anteriorly and
posteriorly by laparoscopy); the adequate fixation to the
In a meta-analysis of more than 200 patients [130], the
abdominal wall was obtained with transfascial sutures or
recurrence rate between tack and suture mesh fixations was
staples, allowing uniform adherence to the closed defect.
comparable, but it is emphasized that the use of spiral tacks
Among the 57 (42.8 %) procedures for incisional hernias,
reduces the operative time and the postoperative pain.
there were two recurrences (3.5 %). The mean follow-up
Other studies [14, 31, 131–133] report recurrences rate
was 52 ± 20.9 months. It has to be stressed, however, that
with the use of tacks, from 0.89 to 3.5 % [132] with a
the quality this single-center observational study has been
follow-up superior to 2 years. An important series of more
questioned due to several methodological issues [128]
than 1000 patients compares various fastening systems and
In the prospective database of Italian Register of BP,
concludes that there is not a significant difference in
analyzed by Coccolini et al. [129], in 2 years (January
recurrence between spiral tacks alone or with sutures (3.9
2009–December 2010), 110 ventral/incisional hernia
vs 2.6 % respectively) [107]. Conflicting data emerge
repaired with BP were included. Thirty-one of them (28 %)
regarding a higher incidence of postoperative and chronic
were repaired with laparoscopic underlay technique.
pain.
Unfortunately no others details are available for this group
A randomized clinical trial [110] compares three groups:
of patients.
spiral tacks alone, spiral tacks plus absorbable sutures, and
Despite the lack of high-grade evidence (only LE 3–4
spiral tacks plus non-absorbable sutures. There were no
studies are available), BP are generally implanted in con-
significant differences in terms of postoperative pain, return
taminated fields, where they allow for a one-stage repair
to work, and recurrences, with a follow-up limited to
with no or little subsequent mesh removal. BP may play a
3 months after surgery. The authors stressed the differences
valuable role in ventral hernia repair in contaminated
in operative time: the use of sutures appears to lengthen the
fields: in these situations, it is generally not accepted to
operating time without any real improvement in outcome.
implant a synthetic mesh, and the recurrence rate after BP
Other studies confirmed the same findings [134, 135].
implant, although high, seems to compare favorably to a
Postoperative pain and chronic pain are analyzed in four
direct repair. However, elective repair of non-complicated
RCTs [110, 115, 131, 136].
ventral/incisional hernia with BP continues to be afflicted
Tacks are associated with an equivalent [110] or lesser
by higher recurrence rate and wound complications. Fur-
[115, 131, 136] postoperative pain than sutures. The latest
thermore, significant additional cost of BP should be
paper [136] demonstrates an equivalent recurrence rate at
thoughtfully considered when utilizing these materials.
24 months. One study [115] reports an increased risk of
Although it has been shown to be feasible, very scarce data
shrinkage in large hernia defects when tacks are used.
are related to the laparoscopic implant. It is imperative that
A large case series [106] compares more than one
the surgical community and funding agencies undertake
thousand patients with four different fixation techniques
prospective randomized trials to properly direct the use of
(Protack, EndoAnchor, EMS, and transabdominal
these meshes and evaluate their ultimate value, especially
sutures ? Protack); chronic pain is found to exceed 10 %
in the laparoscopic field.
in all groups (with a peak of 16.4 % in transabdominal
STATEMENT sutures ? Protack group), but the recurrence rate was
Different biologic prosthesis are available, and further lower in two Protack groups (2.6 % Protacks and sutures
studies are necessary to determine the cost-effectiveness and 3.9 % Protacks alone), and was higher in the EMS
of their use. Nowadays, even if their laparoscopic group. No statistically significant difference was noted.

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2472
STATEMENT
Mesh fixation with non-absorbable spiral tacks should be
considered the standard method of fixation in laparo-
scopic ventral/incisional hernia repair. The use of
transparietal sutures seems to lengthen the operating
time without difference either in postoperative pain,
recurrence, or seroma formation.
STRONG RECOMMENDATION (Panel Consensus
100 %)
Absorbable fixing devices
At present, there are no adequate clinical researches about
the use of absorbable devices, and the panel cannot make
any recommendation. Studies on animals demonstrate the
safety of the use of those fixing devices [137, 138].
Recently few cases series have been reported.
A clinical series of 29 cases by I-clip (absorbable in
1 year) showed the absence of recurrence and chronic pain
at 1-year follow-up [138].
New devices have been developed which achieve a
sufficient tensile fixation strength compared with non-ab-
sorbable tack and transfascial suture [139, 140], but data on
large series with long-term follow-up are not yet available.
There is not enough evidence to make any recommendation
in favor or against the use of the absorbable fixing devices.
Further studies are encouraged.
Glue
Ericksen [141] compared the use of fibrin glue versus spiral
tack in laboratory animals and in the clinical setting. The
study detected less acute postoperative pain during rest
(p = 0.025) and during activity (p = 0.014), less discom-
fort, and a shorter convalescence (after median 7 vs
18 days; p = 0.027), after 1 month, when glue was used.
A recent systematic review [142] examines 36 studies
with biological glue (Tisseel/Tissucol) for a total of almost
6000 patients, including both inguinal and ventral hernias.
The papers related to laparoscopic repair of primary and
incisional ventral hernias show less postoperative and
chronic pain with glue than non-absorbable devices. The
importance of the type of mesh used is emphasized,
because its characteristics influence the ability of the glue
to induce an appropriate adhesion to the abdominal wall
[143].
Although it appears promising for small abdominal wall
defects (up to 6 cm) provided that a proper mesh is used,
further studies are necessary before recommending the use
of the glue as only fixing methods [144].
123
Surg Endosc (2015) 29:2463–2484
STATEMENT
The use of biological glues alone as fixing device is
possible in small hernia when a macropore lightweight
mesh is used.
WEAK RECOMMENDATION (Panel Consensus
100 %)
Positioning technique
There are not randomized control clinical trial comparing
the different positioning of fixation devices (single vs
double crown). Some case series confirm the variability in
the positioning of fixation device but suggest the value of a
double crown, at a distance ranging from 1.5 to 3 cm, with
different recurrence rates up to 2.1 % at 38 months [89,
107, 132, 145, 146]. The panel confirms the results of the
first Italian Consensus Conference [1].
Overlap
There is no new evidence that suggests any modifications
of the conclusion reached in the in 2010 Italian Consensus
Conference [1]. All papers stress the importance of pros-
thesis overlap, with the mesh area adequately exceeding
the margins of the hernia defect, even though there is no
agreement on numeric values.
The minimum recommended overlap is 3 cm along the
entire circumference of the defect; however, the general
trend is to extend it to 5 cm. It can be stated that a 3-cm
overlap is enough for smaller defects (about 3–4 cm),
while larger defects require a 5-cm overlap [1].
SILS
Few studies were found about the use of the SILS tech-
nique in the repair of ventral hernias. In the studies
examined [147–150], a total of 104 patients was reported.
It is suggested that the single access decreases the possi-
bility of future trocar hernia. No significant differences
compared with the laparoscopic procedure in the periop-
erative course were observed. At present, it is not possible
to make any recommendation.
Topic 6: Laparoscopic treatment of parastomal
and abdominal border hernia
Giovanni Ferrari, Camillo Bertoglio
Abdominal border incisional hernias are those defects
arising close to bony structures delimiting the abdominal
Surg Endosc (2015) 29:2463–2484
wall. Median (M1 and M5) and lateral defects (L1 and L4)
according to EHS classification are described [151]. To
date, the literature research found only one article with a
retrospective evaluation of results of laparoscopic repair
for all the aforementioned sites [142]. More frequently, the
authors take into account single types of the abdominal
border hernias, or postoperative results are analyzed toge-
ther with those derived from more common incisional
hernias. The previous consensus conference failed to find
significant influences of the hernia site on postoperative
course, and no contraindication was found whether ade-
quate experience is available [1].
Lumbar incisional hernias
Previous surgery usually produces abdominal wall mus-
culature denervation causing disruption of normal anatomy
and large bulging defects that occupy most of the lumbar
region [152, 153]. The largest series of 35 laparoscopic
repairs in 13 years showed significantly better results in
terms of early postoperative course and less incidence of
recurrence when compared to open repair. The procedure
of choice should be laparoscopic except for large hernia
because the recurrence rate is higher than in open repair
[154]. Laparoscopic lumbar defect repair usually requires a
combination of both transabdominal stitches and metallic
tacks and is always described as technically challenging
[153, 154]. Recurrence after a laparoscopic procedure
seems to be significantly higher for subcostal than lumbar
defects [45]. In some case of complex incisional hernia, the
use of a double-mesh technique may be advisable [155].
The combined use of two running sutures with non-ab-
sorbable monofilament material could restore the normal
anatomy, thereby improving muscular function of the area,
at the cost of the repair not being ‘‘tension-free’’ [156].
Subxiphoid and subcostal incisional hernias
Subxiphoid and subcostal incisional hernias published in
the last 4 years report low morbidity and 5 % recurrence
rate [157]. Few isolated cases of laparoscopic repair with
suture alone for small defect size are also described [158].
A review of 113 patients treated for subxiphoid incisional
hernia, published before 2009, remains the main source of
data on this particular topic [159]. Three different authors
have described twenty-one laparoscopic procedures with
recurrence rates ranging from 10 to 33 % [160–162]. Those
results are likely related to the learning curve of the tech-
nique [162]. Avoidance of both tacks and sutures in the
most cephalad portion of the mesh is thought to contribute
to the recurrence rate higher than in other hernia sites. An
important technical point is the need to dissect the falci-
form ligament up to the hepatic veins providing a generous
2473
retroxiphoid overlap beyond the edge of the hernia defect
[162]. Endoscopic tackers can be used around the edges to
fix the prosthesis avoiding the area beyond the costal
chondral margin [161, 164]. In other series, the placement
of additional full-thickness or intraperitoneal abdominal
wall stitches allow additional strength to mesh fixation
[142, 162]. The laparoscopic repair seems to be as effective
as the open approach although long-term comparative
studies should be advocated.
Parastomal incisional hernias
The presence of a colostomy is frequently associated with
the development of a parastomal hernia [163]. A systematic
review compared 12 papers for a total of 338 laparoscopic
repairs with meshes to 13 studies for 283 ‘‘open’’ prosthetic
repair. The laparoscopic procedure had no significant
advantage over the open repair in terms of morbidity,
mortality, and recurrence rate [164]. Both the Sugarbaker
[165, 166] and the keyhole [167, 168] techniques are cur-
rently used with a slight prevalence of the latter. The use of
a mesh with a slit is related to significant higher mean
recurrence rate (34.6 vs 11.6 %) [164, 168–171], while the
risk of mesh infection and overall postoperative morbidity
did not differ significantly between surgical techniques. A
recent multicentric cohort study on 61 patients stated that a
modified Sugarbaker procedure safe and feasible in expe-
rienced hands with overall morbidity of 19 % and recur-
rence rate of 6.6 % after a mean follow-up of 26 months
[170]. In addition Sugarbaker’s repair has been found to be
technically less demanding and associated with decreased
surgical time in recent series [172]. One theoretical con-
cern with this method would be that lateralizing the bowel
could lead to severe bowel obstructing angulation even
though there has not been a reported occurrence [163]. The
combination of both techniques has been recently descri-
bed as ‘‘sandwich repair’’ with lower recurrence rate (2 %)
over a median follow-up of 20 months [173]. E-PTFE is
the most frequently used prosthetic material for the
laparoscopic approach in both techniques. Sporadic reports
with the use, in a keyhole fashion, of composite meshes
attached with intracorporeal sutures to the bowel serosa are
also available [174]; rigorous long-term follow-up is
expected to validate its use. An inert mesh material such as
polyvinylidene fluoride (PVDF) was used in the sandwich
technique in 47 patients with promising low incidence of
postoperative mesh-related infections [172] when com-
pared to 3.6 % prosthetic infection with the use of ePTFE
patches [164]. Primary laparoscopic Sugarbaker mesh
placement with transabdominal suture on either side of the
lateralized bowel was found to be effective in reducing the
recurrence rate [169]; it could be performed in selected
small parastomal hernias or some large ones to ensure
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2474 Surg Endosc (2015) 29:2463–2484

adequate approximation of the edges prior to mesh repair is reported between 16.6 and 38 %. Morbidity has
deployment [175]. been specifically investigated in a review of 47 patients in
4 years, and the occurrence of complications was found to
Suprapubic incisional hernias be related to larger defect size, history of previous hernia
repair, greater number of previous surgeries, and higher
Since the first report in 2001 [176], experience with BMI, although these correlations were not statistically
laparoscopic treatment of such hernias is limited and long- significant [177].
term follow-up between 2.6 months [177] and 4.8 years
STATEMENT PARASTOMAL INCISIONAL
[178] in the four largest series. Authors agree that laparo-
HERNIAS
scopy allows complete assessment of both the hernia defect
6. 1. Laparoscopic parastomal hernia repair is a safe and
and prior scar with reduced chance of ‘‘missed’’ defects
feasible procedure and is at least as effective as open
[177, 178]. No comparative studies with the open tech-
prosthetic repair with respect to recurrence, morbidity
nique were found, and only one article was published on
and mortality.
this specific topic since 2009; this retrospective study of 72
STRONG RECOMMENDATION (Panel consensus
patients over a period of 10 years is the largest series of
100 %)
laparoscopic repair of suprapubic hernias to date [179]. All
6.2. When performing laparoscopic repair, the Sugarbaker
the authors underline the importance of preperitoneal sur-
technique should be preferred to the keyhole technique
gical dissection by developing a peritoneal flap with direct
because of a significantly lower recurrence rate.
visualization of the pubic bone, Cooper’s ligaments, and
WEAK RECOMMENDATION (Panel Consensus
the inferior epigastric and iliac vessels to obtain sufficient
87.5 %)
mesh overlap in an area with limited space [177–180].
STATEMENT INCISIONAL HERNIAS LOCATED
Most of the authors advocate the elevation of the peri-
ON THE ABDOMINAL BORDERS:
toneum flap with the bladder at the end of the procedure to
6.3 Laparoscopic repair is a safe and effective procedure
cover Cooper’s ligaments and the inferior mesh edge,
in the management of incisional hernia of the abdominal
repositioning the bladder to its normal anatomic position
borders with potentially better short -terms results and
[176–179]. The meshes are most frequently fixated to the
less recurrence rate than open repair in selected cases.
periosteum of the posterior pubis and Cooper’s ligaments
6.4 Careful standardization of mesh fixation technique is
bilaterally [180, 181] and then to the aponeurosis in a
mandatory and must be tailored for each specific hernia
double-crown fashion. The inferior margin of the mesh
site.
should extend below the pubic arch by at least 2 cm to
WEAK RECOMMENDATION (Panel Consensus
enable secure fixation to Cooper’s ligaments bilaterally
100 %)
[177, 178, 180]. The inherent difficulties associated with
the laparoscopic repair of such hernias, including lack of
adequate overlap, are associated with a relatively high Topic 7: Management of intraoperative
recurrence rate [54], estimated 6 % on average [177, 178, and perioperative complications
180]. The largest series support the additional use of
transabdominal (TA) sutures to reduce the recurrence rate Diego Cuccurullo
[177, 179]. Different ways of combining TA and tacks are
described without any significant difference in terms of
Intraoperative complications
outcomes: TA sutures followed by circumferential tacks
every 1 cm and additional TA sutures every 3 cm [177],
Enterotomies occur during adhesiolysis or are caused by
spiral tacks every 1 cm, and TA sutures every 4–5 cm
traction maneuvers for the reduction in the hernia content.
[179] or intracorporeal sutures [180] every 4–5 cm were
If unrecognized, they are diagnosed in the immediate
alternatively proposed to circumferentially fix the mesh to
postoperative period (peritonitis) [182].
the abdominal wall. TA sutures through the periosteum of
A review of the literature [183] reported an incidence of
the pubis [181] may cause pain and lead to the risk of
1.78 % in laparoscopic repair, higher than in laparotomic
osteitis [178]. A retrospective study reported the usefulness
repair, without reaching statistical significance. Usually, it
of intracorporeal polypropylene sutures in a running fash-
involved the small bowel and large bowel injury repre-
ion to completely suture the hernial defect, thus restoring
sented only 8.35 %. They are recognized and repaired
the abdominal domain and preventing the postoperative
intraoperatively in the 82 % of the cases. The prosthetic
‘‘bulge’’ in the anterior abdominal wall, potentially
ventral hernia repair was completed laparoscopically in 57,
reducing the size of the mesh required to reinforce the
and 43 % were converted to open. The mortality rate after
repair [180]. Overall complication rate after laparoscopic

123
Surg Endosc (2015) 29:2463–2484
a recognized enterotomy was 1.7 %, but it rose to 7.7 % if
the lesion was unrecognized at the time of surgery.
To prevent these complications, it is advisable to per-
form adhesiolysis by ‘‘cold’’ dissection using electrified
instruments only at a safe distance from the viscera. Direct
tractions on the bowel are to be avoided, and a gentle
pulling of mesentery has to be preferred. [182–184].
Surgeon experience did not influence the enterotomy
rate [183]. The management of a lesion of the bowel rec-
ognized during laparoscopic ventral hernia repair depends
on the amount and type of contamination: in case of
leakage from the small bowel, most authors perform a
laparoscopic suture of the lesion and complete the proce-
dure with prosthetic repair [1, 183]. For a colon perfora-
tion, some authors report a conversion to an open
procedure to repair the visceral lesion and a direct suture of
the hernia [85, 92, 99]; others repair the lesion, delaying
the prosthetic repair within a week [183]. 18 % of bowel
injuries remains unrecognized. CT scan should be obtained
as soon as the suspicious arises, and early surgical revision
should be considered [1, 183–185]. Excision of the previ-
ous mesh is recommended in case of evident contamination
[183–185]; it is important to note the time of recognition,
the type of contamination (small bowel or colon perfora-
tion), and also the type of mesh previously used (microp-
orous or macroporous), but there are not enough data
provide an evidence-based recommendation.
STATEMENTS
7.1 An intraoperative perforation should be repaired
immediately, laparoscopically or not, accordingly to the
expertise of the surgical team. Prosthetic repair can be
accomplished in the absence of a significant
contamination.
STRONG RECOMMENDATION (Panel Consensus
100 %)
7.2 A CT scan and/or a laparoscopy should be under-
taken when a postoperative peritonitis is suspected. if the
diagnosis is confirmed, the mesh removal is advisable.
WEAK RECOMMENDATION (Panel Consensus
75 %)
Postoperative complications
Mechanical obstruction
The incidence reported after LVHR is 0.5–1.0 % [133,
186]. A mechanical obstruction can be caused by an early
recurrence through a slipped mesh (migration of the small
bowel between the prosthesis and the anterior abdominal
wall), the formation of secondary adhesions to the
2475
prosthesis or to a ‘‘protruding’’ part (tacks, especially if not
correctly placed, and the border of the mesh), or else a
strangulated hernia at a port site [133]. If an obstruction is
suspected, a CT scan is indicated before surgical revision.
The management of this complication prompts new surgi-
cal intervention (laparoscopic if there is not abnormal
distension, or laparotomic) according to the guidelines for
mechanical obstruction [1, 133, 186].
Prolonged ileus
This is a common postoperative condition in 0.5–16 % [1,
51, 187]. The possibility of a small bowel/colonic leak and/
or mechanical obstruction should be ruled out. The con-
servative treatment with mobilization, antiemetics, and
nasogastric suction is usually effective [1, 48, 187].
Seroma and Hematoma
A multicenter clinical trial showed that seroma rate is
twofold in laparoscopic repair [188]. Other large trial
reported contradictory data with higher seroma rates after
open surgery [189]. There is an agreement to avoid punc-
turing the seroma because this procedure can cause later
wound infection [40, 189]. Only for a persisting (6/
8 weeks) or symptomatic seroma is recommended a needle
aspiration [1]; no measure has been proven to prevent the
onset of seroma; postoperative compression may reduce
the size and duration of seroma [187].
The incidence of local hematoma is similar after
laparoscopic and open repair [11]
STATEMENT
7.3 The seroma should not be considered a complication
unless it becomes symptomatic at least 3 months after
surgery. In that case it could be treated with aspiration.
STRONG RECOMMENDATION (Panel Consensus
100 %)
Wound and prosthetic infection
The rate of infection is significantly lower after laparo-
scopic than after open surgery [1, 11]. Two RCTs showed
higher mesh removal rate in the open groups [189, 190].
Predisposing factors are obesity, diabetes mellitus, emer-
gency surgery, contaminated surgery, recurrent incisional
hernia, chronic obstructive pulmonary diseases, abdominal
aortic aneurysm repair, prior surgical site infection, use of
larger microporous or expanded polytetrafluoroethylene
mesh, performance of concomitant procedures via the same
incision, longer operative time, lack of tissue coverage of
the mesh, enterotomy, and entero-cutaneous fistula [191,
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2476
192]. However, those factors are identified in open surgery,
and their relevance in laparoscopic surgery is to be
demonstrated. The Boston University group advocated that
the strategy to avoid mesh infection should be based on the
best evidence and high-quality prospective trials and
observational studies. A conservative treatment is possible
in case of non-septic patients, with targeted antibiotic
therapy and local percutaneous drainage [1].
Relevant properties of the meshes are the type of fila-
ment, tensile strength, and porosity. Large-pore meshes are
also associated with a reduced risk of infection in open
surgery [193, 194]. Those results have to be cautiously
interpreted due to the much lower infection rate in the
laparoscopic repair [11]. In a small retrospective series,
mainly laparotomic, the risk of mesh infection with the use
of PTFE was found to be higher in the open-surgery sub-
group, and, to a much lesser and not statistically significant
degree, in the smaller laparoscopic group [193].
Recently, several positive and promising experiences of
salvage of infected meshes by topical negative pressure
therapy are reported, particularly when large-pore mesh is
used [195, 196]. The different properties of the meshes are
analyzed in the literature more extensively in the context of
an open than laparoscopic repair.
STATEMENT
7.4 A conservative treatment of an infected mesh may be
attempted. In case of failure, a mesh removal is the
alternative.
WEAK RECOMMENDATION (Panel Consensus
100 %)
Postoperative pain
An imaging study (ultrasound or CT scan) can help to
identify the possible cause of persisting pain (that is a
known clinical entity, which becomes critical when still
present after 6–8 weeks after surgery), such as seroma,
retracted mesh due to abnormal inflammatory reaction, or
recurrence [197]. The treatment of chronic pain with local
injection of anesthetic has been described leading to the
resolution of symptoms after one or two applications [198].
In non-responders, a laparoscopic lysis of the adhesions to
the prosthesis and the tacks or removal of the fixation
devices located in the areas of the referred pain could
provide the solution of the problem [181].
STATEMENT
7.6 In case of chronic pain non-responsive to medical
therapy and/or anesthetic local injection, a laparoscopic
re-exploration to identify and remove the cause of pain
123
Surg Endosc (2015) 29:2463–2484
(adhesions, previously identified painful tacks or
sutures) is advisable
WEAK RECOMMENDATION (Panel Consensus
100 %)
Topic: 8 laparoscopic ventral/incisional hernia
repair: how to structure a follow-up
Paolo Baccari
Proposed follow-up plan
The follow-up schedule after repair of incisional or ventral
hernia either by laparoscopic or open approach is not
clearly defined in the literature. The panel suggests a
flowchart for follow-up after laparoscopic ventral/inci-
sional hernia repair.
A critical issue is the mixture of primary ventral, inci-
sional, and spigelian hernia, as well as primary and
recurrent incisional hernia in the different studies [11, 103].
Their outcomes should be individually studied. It is rec-
ommended to separate the results in short (\1 year),
middle (1–3 years), and long-term ([3 years).
Relevant data to collect:
• Patient demographics
• Body Mass Index (kg/m2)
• Previous open repair
• Previous laparoscopic repair
• Factors related to hernia defect according to EHS
classification [151] (diameter in cm or area in cm2,
localization of the hernia, multiple defects, occult
hernias, incarcerated hernias, recurrence after previous
repair)
• Technical details on the repair: type of prosthesis, size
of the prosthesis, mesh-to-defect ratio, overlap, method
of mesh fixation, whether or not the defect was re-
approximated, adhesiolysis, and grade of adhesion
severity by Mueller’s scale [199]. The following data
should be collected in order to guarantee the compar-
ison of the results:
• Duration of surgery
• Conversion to open surgery and the reason thereof
(bowel injury, bleeding)
• Length of postoperative hospital stay
• Necessity for and duration of intensive care unit
(ICU) stay after surgery
• Acute pain (on day 1, 2, 3 after surgery) as
measured with visual analog or numerical rating
scale
Surg Endosc (2015) 29:2463–2484
• Perioperative complications (30 days)(Clavien–
Dindo classification) [54].
• Local seroma or hematoma (Morales-Conde classi-
fication) [200].
• Local infection (if possible divided into infections
with or without mesh involvement)
• Re-operation within 30 days
• Time until return to normal activities or work
• Quality of life measured by questionnaires
• Chronic pain ([6 months after surgery)
• Recurrence
Suggested follow-up schedule
The patients should be observed on the seventh postoper-
ative day for clinical evaluation and replacement of post-
operative dressing with pressure garment to wear for other
3 weeks.
A second outpatient visit is planned at 4 weeks, then
after 12 weeks; and every year for the first 3 years.
When hernia recurrence is suspected by clinical
assessment, imaging evaluation is recommended [103].
At follow-up, quality of life, or chronic pain are usually
measured by different validated questionnaires: SF-36, Mc
Gill pain questionnaire, VAS (visual analogic scale) or
NRS (numeric rating scale), CCS (Carolina comfort scale),
and GIQLI (Gastrointestinal Quality of Life Index) [14, 44,
50, 201].
The panel suggest VAS and NRS in the short-term, SF-
36, and McGill Pain Questionnaire in the long term.
In absence of relevant event, a structured telephone inter-
view can be useful to assess postoperative follow-up status.
Recurrent ventral/incisional hernia
The incidence of hernia recurrence after laparoscopic
repair is less than 5 % at long-term follow-up. A meta-
analysis suggests that the risk of recurrence be the same as
for open abdominal hernia repair [11, 103]. When a
recurrence is suspected but not clinically evident, an
ultrasonography or computed tomography (CT scan) or
both are indicated [43, 133].
The size of the defect is the most significant predictor
for recurrence [32, 36, 44, 62]. Obesity and recurrent
incisional hernia were already identified in the previous
consensus conference as negative prognostic factors [1].
Technical pitfalls as small size of the mesh with an inad-
equate overlap of the defect, inadequate fixation, or
unrecognized abdominal wall defects are the most frequent
causes of early recurrence [202]. Furthermore, the surgical
site infection has been identified as independent risk factor
for recurrence [43].
2477
The recurrence, following either laparotomy or laparo-
scopy, can be treated successfully by laparoscopy with a
low recurrence rate [43].
In two recent systematic reviews including approxi-
mately 8000 patients, recurrence was treated by laparo-
scopy after open or laparoscopic primary surgery: 27 % of
the patients treated (nearly 2000 patients) had a recurrent
hernia (range in the different studies: 10–51 %). All these
patients were treated by laparoscopic repair, but no specific
data have been reported [11, 103]. In other studies with a
lower level of evidence, all the reported recurrences were
approached by laparoscopy [18, 44, 51, 107, 133].
Non-comparative studies reported a recurrence rate,
after laparoscopic recurrent hernia mesh repair, as low as
3.5–5.7 % at 41 month follow-up, comparable with pri-
mary repair [55].
Symptomatic mesh bulge, though strictly not a recur-
rence [203], should be considered an adverse outcome of
laparoscopic incisional or ventral hernia repair. A loosely
stretched mesh can protrude into the hernia defect when the
pneumoperitoneum is released [204].
In patients with symptoms suggestive of recurrent hernia
but in whom CT or laparoscopy excluded recurrence, the
mesh bulging can be corrected by laparoscopy by stretch-
ing a new, larger mesh tightly over the past repair [133].
STATEMENTS
8.1 When hernia recurrence is suspected, imaging
techniques are recommended to confirm the diagnosis
and plan surgical revision.
STRONG RECOMMENDATION (Panel Consensus
87.5 %)
8.2 Incisional hernia recurrence can be treated by
laparoscopy either after open or after laparoscopic
primary surgery without need of mesh removal.
STRONG RECOMMENDATION (Panel Consensus
100 %)
8.3 Patients with bulging in whom US and CT scan
excluded incisional hernia recurrence, if symptomatic
can be treated by laparoscopy stretching a new larger
mesh tightly.
WEAK RECOMMENDATION (Panel Consensus
87.5 %)
Discussion
Clinical practice guidelines are required to be reviewed and
updated as necessary.
The first evidence-based Italian Consensus Conference
about laparoscopic ventral/incisional hernia repair was orga-
nized in January 2010. Its results were published in 2013 [1].
123
2478
The executive board of the Italian Society for Endo-
scopic Surgery (SICE) promoted a full review of those
results after having acknowledged that the large amount of
literature published in the last 4 years had to be analyzed
and synthesized to help clinical practitioners in their work.
As expected, some of the recommendations issued in 2010
were found to be still current and were confirmed, and
others had to be challenged after having examined the most
recent high-quality research. Besides the topics examined
then, new relevant aspects were included in the review.
Furthermore, the contents of this update differ from those
of 2010 in many ways. In fact, the scientific committee
elected to grade the strength of the clinical recommenda-
tions according to the ‘‘GRADE working group’’ grading
system. This makes the recommendations consistent with
all those delivered by GRADE methodology and allows
easier interpretation of the guideline for clinical purpose.
The level of recommendation is reflected in the very same
wording of the statements that ‘‘recommend’’ when the
grade of recommendation is strong or ‘‘suggest’’ when it is
only weak.
In fact, the entire work of the panel aimed at translating
the available literature evidence into recommendation
(when possible) easy to interpret and clear to apply in
everyday clinical practice. The grading system adopted was
instrumental in this effort, and even when the panel con-
clusions were similar to those reached in 2010, as in many
instances, the GRADE recommendation could make them
easier to be interpreted.
Several aspects could be better defined than in 2010.
The availability of recent level 1 evidence (a meta-analysis
of 10 RCTs) allowed us to agree that not only laparoscopic
repair is an acceptable alternative to the open repair (for the
indications detailed above), but also it is advantageous in
terms of shorter hospital stay and wound infection rate.
This conclusion appears to be extremely relevant in a
clinical setting.
In 2010, it was not possible to get over the uncertainty
about the outcome of different fixation methods. The most
recent literature included more than one well-conducted
RCTs comparing suture versus tack mesh fixation, and the
statements about this topic could now be better defined.
Indications about specific conditions could also be
issued: laparoscopy can be considered recommended for
the treatment of recurrent ventral hernias and obese
patients, while it is a potential option for compensated
cirrhotic and childbearing-age female patients.
Many relevant and controversial topics were thoroughly
examined by this consensus conference for the first time.
Among them are the issue of safety of the intraperitoneal
mesh placement, traditionally considered a major drawback
of the laparoscopic technique, the role for the biologic
meshes, and various aspects of the laparoscopic approach
123
Surg Endosc (2015) 29:2463–2484
for particular locations of the defect such as abdominal
border or parastomal hernias.
The panel pointed out the examined literature was not
homogeneous as far as follow-up criteria and suggested a
follow-up schedule.
All the recommendations are the result of a careful and
complete literature review examined with autonomous
judgment by the entire panel. The conclusions were inde-
pendently supervised by experts in methodology and epi-
demiology from the most qualified Italian institution. Two
external reviewers were designed by the EAES and EHS to
guarantee the most objective and reliable work. Every
issued recommendation, however, needs to be adapted to
the specific organizational and professional context.
Surgeons should use these recommendations to support
their own judgment, taking into account their clinical
scenario, their own technical experience and the specific
organizational setting.
Acknowledgments We gratefully acknowledge the contributions of
Dr Salvator Morales Conde and Davide Lomanto, as external
reviewers, designed, respectively, by the European Hernia Society
and the European Association for Endoscopic Surgery. We are par-
ticularly grateful to Dr Marina Davoli (Director of Department of
Epidemiology of SSR Lazio) and Dr. Michela Cinquini (Istituto
Ricerche Farmacologiche Mario Negri—Head of the Unit ‘‘Method-
ology of Systematic Revision and Guideline Production’’), epidemi-
ologists, who reviewed the methodological aspects and supported the
Panel during all the steps of the consensus conference. Finally, Dr
Antonio Corcione, designed by the Italian Society of Anesthesia
(SIAARTI), who reviewed the aspects related to anesthesia. Thanks
also to Dr Luigi Di Maggio, webmaster of the S.I.C.E. Web site, for
his helpfulness and professional support in adapting the S.I.C.E.
Forum to the needs of the consensus. We also express our gratitude to
all the Presidents of the Scientific Societies that endorsed the con-
sensus. The consensus conference was endorsed by: SICE, ITALIAN
CHAPTER EUROPEAN HERNIA SOCIETY, SIC, ACOI, EAES,
EHS, SIAARTI
Disclosures Authors Gianfranco Silecchia, Fabio Cesare Cam-
panile, Luis Sanchez, Graziano Ceccarelli, Armando Antinori, Luca
Ansaloni, Stefano Olmi, Giovanni Carlo Ferrari, Diego Cuccurullo,
Paolo Baccari, Ferdinando Agresta, Nereo Vettoretto, and Micaela
Piccoli declare that they have no conflict of interest to disclose.
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