Laparoscopic ventral/incisional hernia repair - Springer Link

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Surg Endosc (2015) 29:2463–2484 DOI 10.1007/s00464-015-4293-8

and Other Interventional Techniques

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 Background The Executive board of the Italian Society for Endoscopic Surgery (SICE) promoted an update of the first evidence-based Italian Consensus Conference Guidelines 2010 because a large amount of literature has been published in the last 4 years about the topics examined and new relevant issues. Methods The scientific committee selected the topics to be addressed: indications to surgical treatment including special conditions (obesity, cirrhosis, diastasis recti abdominis, acute presentation); safety and outcome of intraperitoneal meshes (synthetic and biologic); fixing devices (absorbable/non-absorbable); abdominal border

Gianfranco Silecchia and Fabio Cesare Campanile contributed equally to the preparation and writing of the article. & Fabio Cesare Campanile [email protected] 1

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Division of General Surgery and Bariatric Centre of Excellence, Department of Medico-Surgical Sciences and Biotechnology, Sapienza University of Rome, Via Faggiana 1668, 04100 Latina, LT, Italy Division of General Surgery, Ospedale San Giovanni Decollato Andosilla, ASL VT, Via Ferretti 169, 01033 Civita Castellana, VT, Italy Division of Oncologic Surgery, Department of Oncology, Azienda Ospedaliero-Universitaria Careggi, Largo Brambilla 3, 50134 Florence, Italy

and parastomal hernia; intraoperative and perioperative complications; and recurrent ventral/incisional hernia. All the recommendations are the result of a careful and complete literature review examined with autonomous judgment by the entire panel. The process was supervised by experts in methodology and epidemiology from the most qualified Italian institution. Two external reviewers were designed by the EAES and EHS to guarantee the most objective, transparent, and reliable work. The Oxford hierarchy (OCEBM Levels of Evidence Working Group*. ‘‘The Oxford 2011 Levels of Evidence’’) was used by the panel to grade clinical outcomes according to levels of evidence. The recommendations were based on the grading system suggested by the GRADE working group. Results and Conclusions The availability of recent level 1 evidence (a meta-analysis of 10 RCTs) allowed to 7

Division of General and Oncologic Surgery, Advanced Laparoscopy Center, Policlinico San Marco, Zingonia, BG, Italy

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Division of General, Oncologic and Mini-Invasive Surgery, A.O. Ospedale Niguarda Ca` Granda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy

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Division of General, Laparoscopic and Robotic Surgery, AORN dei Colli Ospedale Monaldi, Naples, Italy

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Division of General Surgery, Santa Maria della Misericordia Hospital, P.zale Menghini 1, 06129 Perugia, Italy

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Department of General Surgery, ULSS19 del Veneto, Via Etruschi 9, 45011 Adria, RO, Italy

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Division of General Surgery, Ospedale di Spoleto, Via Loreto 3, 06049 Spoleto, PG, Italy

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Laparoscopic Surgical Unit, M.Mellini Hospital, Viale Giuseppe Mazzini 4, 25032 Chiari, BS, Italy

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Department of Surgery, Catholic University of Rome, Largo A. Gemelli 8, 00168 Rome, Italy

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Division of General Surgery I, Papa Giovanni XXIII Hospital, Piazza OMS 1, 24127 Bergamo, Italy

Department of Surgery, NOCSAE (Nuovo Ospedale Civile Sant’Agostino Estense), Via Giardini 1355, 41126 Baggiovara, Modena, Italy

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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 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 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 adhesions, 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 precondition 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 % published in the last 4 years. In January 2010, the first evidence-based Italian Consensus 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, complications, their prevention and management, and recurrence after laparoscopic repair. The results were published on the 2013 issue of ‘‘Hernia’’ [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.

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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 Anesthesiology (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) (b) (c)

proven expertise in laparoscopic ventral hernia repair authorship in peer-reviewed journal on laparoscopic ventral hernia repair 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 Farmacologiche 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

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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 commentary 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 outweigh the undesirable effects. Weak recommendation The panel concludes that the desirable effects of adherence to a recommendation probably 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 decisions 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 literature 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, comparison, outcome) system was applied for the MeSH (Medical

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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 intervention, 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/incisional hernia repair, involving 880 patients, demonstrated

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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 aforementioned 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 hernias 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].

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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 indication 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 recommended 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

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in terms of recurrence nor increases the risk of complications [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].

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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 %)

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/incisional hernia and leads to higher recurrence rates and perioperative related complications. The enhanced incidence 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 laparoscopic 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 suggests deferring the hernia repair. In addition, resolution of metabolic comorbidities, (i.e., diabetes) could guarantee better outcomes [65]. However, symptomatic ventral hernias 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

Cirrhosis Umbilical and incisional hernias are more common in the cirrhotic patients than in the general population. Abdominal distension caused by ascites, consequent high intraabdominal 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 management. 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 possible and safe after liver transplantation too [69, 72]. STATEMENT 2.3 Compensated Child A-B cirrhosis is not a contraindication to elective laparoscopic ventral/incisional hernia repair. WEAK 100 %)

RECOMMENDATION

(Panel

Consensus

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 discomfort. Laparoscopic repair was described as safe and effective in small case series [80, 81]. In 2011, a systematic

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review underlined the scarceness of literature on laparoscopic repair of diastasis recti, but the authors suggest a lower complication rate in the minimally invasive compared with the open approach. [82]. Preoperative imaging evaluation for determining the position of the recti abdominis 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 surgery 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 situations, such as entero-cutaneous fistulas [89]. Absence of hemodynamic instability and severe comorbid 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 contraindication to laparoscopic approach and may be performed in selected cases. WEAK 100 %)

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RECOMMENDATION

(Panel

Consensus

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), adequately formed or composed with different adhesion barriers, 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-analysis 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 intraperitoneal 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].

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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 intraperitoneal 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].

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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 % shrinkage 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 relationship 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 laparoscopic 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

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particular) are controversial. Many biological prostheses (BP) are currently available (Table 1). They are obtained from human (homografts) or mammalian tissues (xenografts) [120]. The latter derives from uniform animal population with similar age and life history; therefore, implants are more consistent than homografts [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 susceptible 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 (crosslinked) 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 differences 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 mechanical 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 abdominal 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 contrary, 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 laparoscopic placement of a biological mesh. The LAPSIS study was a multicentre European RCT comparing open retromuscular (mesh augmentation technique) versus laparoscopic repair (mesh bridging technique) 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 compared 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

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 XenMatrix

KCI/LifeCell Brennan Medical

Porcine Porcine

Acellular dermis Acellular dermis

No No

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

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resulted in a higher early recurrence rate in each of the study arms: 19 % (10 of 53) versus 5 % (3 of 63) after laparoscopic repair, and 11 %(7 of 65) versus 3 % (2 of 76) after open repair. No differences between the study groups in the other study endpoints (infection or reoperation) have been identified [104]. In a prospective observational study, Franklin et al. [97] presented their 5-year experience with placement of Surgisis mesh in potentially or grossly contaminated fields. The study included 116 patients with 133 laparoscopic procedures for abdominal hernia. Two techniques were adopted: intraperitoneal onlay mesh (IPOM) and two-layered ‘‘sandwich’’ repair (laparoscopic and open exploration with reinforcement with Surgisis anteriorly and posteriorly by laparoscopy); the adequate fixation to the abdominal wall was obtained with transfascial sutures or staples, allowing uniform adherence to the closed defect. Among the 57 (42.8 %) procedures for incisional hernias, there were two recurrences (3.5 %). The mean follow-up was 52 ± 20.9 months. It has to be stressed, however, that the quality this single-center observational study has been questioned due to several methodological issues [128] In the prospective database of Italian Register of BP, analyzed by Coccolini et al. [129], in 2 years (January 2009–December 2010), 110 ventral/incisional hernia repaired with BP were included. Thirty-one of them (28 %) were repaired with laparoscopic underlay technique. Unfortunately no others details are available for this group of patients. Despite the lack of high-grade evidence (only LE 3–4 studies are available), BP are generally implanted in contaminated fields, where they allow for a one-stage repair with no or little subsequent mesh removal. BP may play a valuable role in ventral hernia repair in contaminated fields: in these situations, it is generally not accepted to implant a synthetic mesh, and the recurrence rate after BP implant, although high, seems to compare favorably to a direct repair. However, elective repair of non-complicated ventral/incisional hernia with BP continues to be afflicted by higher recurrence rate and wound complications. Furthermore, significant additional cost of BP should be thoughtfully considered when utilizing these materials. Although it has been shown to be feasible, very scarce data are related to the laparoscopic implant. It is imperative that the surgical community and funding agencies undertake prospective randomized trials to properly direct the use of these meshes and evaluate their ultimate value, especially in the laparoscopic field. STATEMENT Different biologic prosthesis are available, and further studies are necessary to determine the cost-effectiveness of their use. Nowadays, even if their laparoscopic

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implant is feasible, the use of biologic prosthesis should be restricted to contaminated field in open surgery. Their laparoscopic use is recommended in controlled trials. WEAK RECOMMENDATION (Panel Consensus 100 %)

Topic 5: Absorbable and non-absorbable fixing devices and positioning technique Stefano Olmi, Giovanni Cesana Non-absorbable fixing devices In a meta-analysis of more than 200 patients [130], the recurrence rate between tack and suture mesh fixations was comparable, but it is emphasized that the use of spiral tacks reduces the operative time and the postoperative pain. Other studies [14, 31, 131–133] report recurrences rate with the use of tacks, from 0.89 to 3.5 % [132] with a follow-up superior to 2 years. An important series of more than 1000 patients compares various fastening systems and concludes that there is not a significant difference in recurrence between spiral tacks alone or with sutures (3.9 vs 2.6 % respectively) [107]. Conflicting data emerge regarding a higher incidence of postoperative and chronic pain. A randomized clinical trial [110] compares three groups: spiral tacks alone, spiral tacks plus absorbable sutures, and spiral tacks plus non-absorbable sutures. There were no significant differences in terms of postoperative pain, return to work, and recurrences, with a follow-up limited to 3 months after surgery. The authors stressed the differences in operative time: the use of sutures appears to lengthen the operating time without any real improvement in outcome. Other studies confirmed the same findings [134, 135]. Postoperative pain and chronic pain are analyzed in four RCTs [110, 115, 131, 136]. Tacks are associated with an equivalent [110] or lesser [115, 131, 136] postoperative pain than sutures. The latest paper [136] demonstrates an equivalent recurrence rate at 24 months. One study [115] reports an increased risk of shrinkage in large hernia defects when tacks are used. A large case series [106] compares more than one thousand patients with four different fixation techniques (Protack, EndoAnchor, EMS, and transabdominal sutures ? Protack); chronic pain is found to exceed 10 % in all groups (with a peak of 16.4 % in transabdominal sutures ? Protack group), but the recurrence rate was lower in two Protack groups (2.6 % Protacks and sutures and 3.9 % Protacks alone), and was higher in the EMS group. No statistically significant difference was noted.

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STATEMENT

STATEMENT

Mesh fixation with non-absorbable spiral tacks should be considered the standard method of fixation in laparoscopic 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.

The use of biological glues alone as fixing device is possible in small hernia when a macropore lightweight mesh is used.

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-absorbable 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 discomfort, 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].

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Consensus

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 prosthesis 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 technique 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 possibility of future trocar hernia. No significant differences compared with the laparoscopic procedure in the perioperative 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

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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 together 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 adequate experience is available [1]. Lumbar incisional hernias Previous surgery usually produces abdominal wall musculature 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-absorbable 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 technique [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 falciform ligament up to the hepatic veins providing a generous

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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 currently 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 experienced hands with overall morbidity of 19 % and recurrence 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 concern 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 described 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 compared 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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adequate approximation of the edges prior to mesh deployment [175]. Suprapubic incisional hernias Since the first report in 2001 [176], experience with laparoscopic treatment of such hernias is limited and longterm follow-up between 2.6 months [177] and 4.8 years [178] in the four largest series. Authors agree that laparoscopy allows complete assessment of both the hernia defect and prior scar with reduced chance of ‘‘missed’’ defects [177, 178]. No comparative studies with the open technique were found, and only one article was published on this specific topic since 2009; this retrospective study of 72 patients over a period of 10 years is the largest series of laparoscopic repair of suprapubic hernias to date [179]. All the authors underline the importance of preperitoneal surgical dissection by developing a peritoneal flap with direct visualization of the pubic bone, Cooper’s ligaments, and the inferior epigastric and iliac vessels to obtain sufficient mesh overlap in an area with limited space [177–180]. Most of the authors advocate the elevation of the peritoneum flap with the bladder at the end of the procedure to cover Cooper’s ligaments and the inferior mesh edge, repositioning the bladder to its normal anatomic position [176–179]. The meshes are most frequently fixated to the periosteum of the posterior pubis and Cooper’s ligaments bilaterally [180, 181] and then to the aponeurosis in a double-crown fashion. The inferior margin of the mesh should extend below the pubic arch by at least 2 cm to enable secure fixation to Cooper’s ligaments bilaterally [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 recurrence rate [54], estimated 6 % on average [177, 178, 180]. The largest series support the additional use of transabdominal (TA) sutures to reduce the recurrence rate [177, 179]. Different ways of combining TA and tacks are described without any significant difference in terms of outcomes: TA sutures followed by circumferential tacks every 1 cm and additional TA sutures every 3 cm [177], spiral tacks every 1 cm, and TA sutures every 4–5 cm [179] or intracorporeal sutures [180] every 4–5 cm were alternatively proposed to circumferentially fix the mesh to the abdominal wall. TA sutures through the periosteum of the pubis [181] may cause pain and lead to the risk of osteitis [178]. A retrospective study reported the usefulness of intracorporeal polypropylene sutures in a running fashion to completely suture the hernial defect, thus restoring the abdominal domain and preventing the postoperative ‘‘bulge’’ in the anterior abdominal wall, potentially reducing the size of the mesh required to reinforce the repair [180]. Overall complication rate after laparoscopic

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repair is reported between 16.6 and 38 %. Morbidity has been specifically investigated in a review of 47 patients in 4 years, and the occurrence of complications was found to be related to larger defect size, history of previous hernia repair, greater number of previous surgeries, and higher BMI, although these correlations were not statistically significant [177]. STATEMENT PARASTOMAL INCISIONAL HERNIAS 6. 1. Laparoscopic parastomal hernia repair is a safe and feasible procedure and is at least as effective as open prosthetic repair with respect to recurrence, morbidity and mortality. STRONG RECOMMENDATION (Panel consensus 100 %) 6.2. When performing laparoscopic repair, the Sugarbaker technique should be preferred to the keyhole technique because of a significantly lower recurrence rate. WEAK RECOMMENDATION (Panel Consensus 87.5 %) STATEMENT INCISIONAL HERNIAS LOCATED ON THE ABDOMINAL BORDERS: 6.3 Laparoscopic repair is a safe and effective procedure in the management of incisional hernia of the abdominal borders with potentially better short -terms results and less recurrence rate than open repair in selected cases. 6.4 Careful standardization of mesh fixation technique is mandatory and must be tailored for each specific hernia site. WEAK RECOMMENDATION (Panel Consensus 100 %) Topic 7: Management of intraoperative and perioperative complications Diego Cuccurullo Intraoperative complications Enterotomies occur during adhesiolysis or are caused by traction maneuvers for the reduction in the hernia content. If unrecognized, they are diagnosed in the immediate postoperative period (peritonitis) [182]. A review of the literature [183] reported an incidence of 1.78 % in laparoscopic repair, higher than in laparotomic repair, without reaching statistical significance. Usually, it involved the small bowel and large bowel injury represented only 8.35 %. They are recognized and repaired intraoperatively in the 82 % of the cases. The prosthetic ventral hernia repair was completed laparoscopically in 57, and 43 % were converted to open. The mortality rate after

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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 perform 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 recognized 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 procedure with prosthetic repair [1, 183]. For a colon perforation, 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 previous 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 perforation), and also the type of mesh previously used (microporous 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 undertaken when a postoperative peritonitis is suspected. if the diagnosis is confirmed, the mesh removal is advisable. WEAK 75 %)

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(Panel

Consensus

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

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 surgical 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 conservative 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 puncturing 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 laparoscopic 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, emergency 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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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 filament, 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 subgroup, 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 100 %)

RECOMMENDATION

(Panel

Consensus

(adhesions, previously identified painful tacks or sutures) is advisable WEAK 100 %)

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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/incisional hernia repair. A critical issue is the mixture of primary ventral, incisional, 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 recommended 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 reapproximated, adhesiolysis, and grade of adhesion severity by Mueller’s scale [199]. The following data should be collected in order to guarantee the comparison of the results: • • • •

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

(Panel

Topic: 8 laparoscopic ventral/incisional hernia repair: how to structure a follow-up

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].

RECOMMENDATION



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

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• • • • • • • •

Perioperative complications (30 days)(Clavien– Dindo classification) [54]. Local seroma or hematoma (Morales-Conde classification) [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 postoperative day for clinical evaluation and replacement of postoperative 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, SF36, and McGill Pain Questionnaire in the long term. In absence of relevant event, a structured telephone interview 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 metaanalysis 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 inadequate 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].

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The recurrence, following either laparotomy or laparoscopy, can be treated successfully by laparoscopy with a low recurrence rate [43]. In two recent systematic reviews including approximately 8000 patients, recurrence was treated by laparoscopy 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 primary repair [55]. Symptomatic mesh bulge, though strictly not a recurrence [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 stretching 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 organized in January 2010. Its results were published in 2013 [1].

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The executive board of the Italian Society for Endoscopic 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 recommendations 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 conclusions 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

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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 independently supervised by experts in methodology and epidemiology 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 particularly 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 ‘‘Methodology of Systematic Revision and Guideline Production’’), epidemiologists, 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 consensus. The consensus conference was endorsed by: SICE, ITALIAN CHAPTER EUROPEAN HERNIA SOCIETY, SIC, ACOI, EAES, EHS, SIAARTI Disclosures Authors Gianfranco Silecchia, Fabio Cesare Campanile, 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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