con il patrocinio di:: Consensus Development Conference on Laparoscopic Repair of Incisional and Ventral Hernias (update of 2010 Consensus Conference) Coordinatori: Fabio Cesare Campanile Gianfranco Silecchia Comitato tecnico scientifico: Ferdinando Agresta Micaela Piccoli Nereo Vettoretto Marina Davoli

Pros & cons

“…As doctor and surgeons our mission is to treat patients to the best of our knowledge and expertise. The exponential knowledge eruption and the nearly daily skill-related technology advances in minimal invasive surgery make it more than ever mandatory that we, surgeons and doctors, humbly examine, analyze and objectively audit our own practice…we have to recognise and discard our acquired biases, and base our diagnostic procedures and surgical therapy on “hard” evidence…” Fingerhut A. Do we need consensus conferences? Surg Endosc 2002; 16:

con il patrocinio di:: Consensus Development Conference on Laparoscopic Repair of Incisional and Ventral Hernias (update of 2010 Consensus Conference) Coordinatori: Fabio Cesare Campanile Gianfranco Silecchia Comitato tecnico scientifico: Ferdinando Agresta Micaela Piccoli Nereo Vettoretto Marina Davoli

Costituzione del panel -8 esperti – Pubblicazioni – Partecipazione registro SICE e casistica – Coinvolgimento Consensus Napoli anestesista Revisori esterni -EAES: Davide Lomanto -EHS: Salvador Morales Conde -Istituto M. Negri: S.Garattini Panel di esperti L. Sanchez G. Ceccarelli A. Antinori L. Ansaloni S. Olmi (Italian chapter EHS) D. Cuccurullo (Italian chapter EHS) P. Baccari A. Corcione (SIAARTI)

con il patrocinio di:: METODOLOGIA Comitato tecnico scientifico:  Metodo Delphi  Organizzazione tempistica  Individuazione e assegnazione “topics”  Scelta schema livelli di evidenza (Oxford 2011) e raccomandazione  Ricerca letteratura ed evidenze  Scelta lingua inglese per tutta la documentazione Panel di esperti  Completamento ricerca letteratura  Preparazione degli “evidence reports”  Analisi/discussione di tutti gli “evidence reports” e “statements”

con il patrocinio di:: (our) CATEGORIES OF RECOMMENDATIONS “Strong recommendation” if high LoE (LoE 1) “Moderate recommendation” if medium LoE (LoE 2) “Weak recommendation” if low LoE (LoE 3-5) The Consensus Conference has the “duty” to write the Grade of Recommendations The Expert/panel duty is to translate the clinical evidence in a Statement and to associate it with a GoR which will be discussed, modified and/or ratified during the Consensus

con il patrocinio di:: Utilizzo del forum per interazione blind tra gli esperti e il comitato scientifico Riunione full immersion Giugno 2013 Congresso Sice Napoli 19/09/2013 Presentazione degli evidence reports e degli statements

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi )

con il patrocinio di:: STATEMENT 1 LAPAROSCOPIC REPAIR OF VENTRAL HERNIA IS SAFE AND EFFECTIVE WITH LOWER RISK OF WOUND INFECTION AND SHORTER HOSPITAL STAY COMPARED TO OPEN REPAIR Strong recommendation (EL 1) Consensus 100% The only presence of a ventral hernia does not represent an indication to surgery by itself (Pubmed search : 13 Case Series, 1 meta analysis, 4 RCT General considerations

con il patrocinio di:: STATEMENT 2 OLDER AGE IS NOT A CONTRAINDICATION FOR LAPAROSCOPIC TREATMENT OF VENTRAL/INCISIONAL HERNIA Moderate recommendation Consensus 100% Age Pubmed search: 5 retrospective study (EL 3-4) 2 case series (EL 4)

con il patrocinio di:: STATEMENT 3 LAPAROSCOPIC REPAIR IS ACCEPTED FOR HERNIA DEFECT LARGER THAN 3 CM. THERE IS NO CONSENSUS ON THE SUITABLE UPPER LIMIT Strong recommendation Consensus 100% Pubmed search: 16 retrospective study/case series (EL 3-4) DEFECT SIZE

con il patrocinio di:: STATEMENT 4 Pubmed search: 2 comparative studies (LE 2b) and 2 case series (LE 5) PREOPERATIVE ASSESSMENT BY IMAGING TECHNIQUES IS RECOMMENDED IN SELECTED PATIENTS (OBESE, LARGE DEFECTS, MULTIPLE PREVIOUS SURGERY, BORDER DEFECT, COMPLEX CASES, EMERGENCY SURGERY). Moderate recommendation Consensus 100% PREOPERATIVE DIAGNOSIS

con il patrocinio di:: STATEMENT 5 PREVIOUS REPAIR OR FAILED ATTEMPTS (WITH OR WITHOUT MESHES) ARE NOT CONTRAINDICATIONS FOR FURTHER LAPAROSCOPIC REPAIR Moderate recommendation Consensus 100% Previous surgery Pubmed search: 1 prospective study (LE 3), 2 prospective studies (LE 3), 3 case series (LE 4)

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI(new),URGENZE 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI(new),URGENZE

con il patrocinio di:: Laparoscopic approach to ventral/incisional hernia repair in obese patients show lower infection rate* compared with open procedure. (EL 2-3) (1) Lesser overall complication rate, lesser hospital stay and lower overall cost of care EL 3 (2) A lower recurrence rate is reported in umbilical hernias repair EL 4 ) (3) Laparoscopy in obese paients allows: to identify additional hernia defects (4) to choose the right mesh-overlap (4 ) LAPAROSCOPIC REPAIR IS RECOMMENDED IN OBESE PATIENTS WITH VENTRAL/INCISIONAL HERNIA. Strong Recommendation ( Consensus 100%) OBESE PATIENTS 1)Mavros Shabanzadeh Colon MJ Colavita PD 2013 Tsereteli Z Sauerland Rogmark )Lee J (JAMA) )Shabanzadeh Colon MJ 2013 Moreno Egea )Rao R )Ching Eid GM 2013 – Praveen P 2012

con il patrocinio di:: Compensated Child A-B cirrhosis is not a contraindication to elective laparoscopic ventral/incisional hernia repair.. Weak Recommendation ( Consensus 100%) 1)Cobb WS 2005– Belli 2006 – Kurmann A )Hiremath BV )Choi SB 2011 – Eker )Cho SW 2012 (case-control study) 5)Kurmann A 2010 – Dokmak 2012 Laparoscopy avoids interruption of large colateral veins: non- exposure of viscera and restricts electrolytic and protein losses, improves absorption of ascites; provides lower perioperative blood loss LE 3-4 (1)

con il patrocinio di:: Incisional hernia in emergency is not a contraindication to laparoscopic approach and may be performed in selected cases. Weak Recommendation ( Consensus 100%) EMERGENCY 1)Agresta F Cuccurullo D )McDonald E )Abdel-Baki NA – Bessa SS )Landau O López-Tomassetti Fernández EM Shah RH 2008 Laparoscopic repair of incarcerated ventral hernia (primary or incisional) is feasible and safe. Anyway laparoscopy may be useful to confirm the diagnosis. (EL 4) (1) The presence of non-viable intestine is not a contraindication for laparoscopic prosthetic repair. (EL 4) (3)

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 3. SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW

con il patrocinio di:: Search strategy 78 papers reviewed 18 papers selected as main references intraperitoneal mesh implant during LVHR mesh implant during open repair = Safety and outcome of intraperitoneal meshes The intraperitoneal placement of a prosthesis specifically produced for laparoscopic ventral hernia repair, is safe. Strong Recommendation ( Consensus 100%) STATEMENT

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW

con il patrocinio di:: 1 prospective observational study (Franklin ME et al. Surg Endosc 2008 EL 4) 1 report of a prospective national register (Coccolini F et al. Eur Surg Res EL 4) 1 short report about preliminary results of a RCT (Miserez M et al. Br J Surg 2010 EL 3b) FEASIBILITY INDICATION 3 systematic reviews of observational studies (Slater NJ et al. Am J Surg 2013,Beale EW et al.. Am J Surg 2012,Kissane NA, Itani KM. Plast Reconstr Surg 2012 EL 4) 1 costs analysis article (Reynolds D, Davenport DL, Korosec RL, Roth JS. J Gastrointest Surg EL 4) QUESTION: WHICH ROLE COULD PLAY BIOLOGIC MESHES FOR LAPAROSCOPIC INCISIONAL HERNIA REPAIR? SINCE THE BIOLOGIC PROSTHESIS (BP) ARE DIFFERENT FURTHER STUDIES ARE NECESSARY TO DETERMINE THE COST-EFFECTIVENESS OF THEIR USE.NOWDAYS,EVEN IF ITS LAPAROSCOPIC IMPLANT IS FEASIBLE, THE USE OF BP SHOULD BE RESTRICTED IN CONTAMINATED FIELD IN OPEN SURGERY. LAPAROSCOPIC USE IS RECOMMENDED IN CONTROLLED TRIAL. Weak Recommendation ( Consensus 100%) STATEMENT

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI NEW

con il patrocinio di:: Search strategy 1 metanalysis EL 1; 2 RCT EL 2; 1 systematic review; 2 comparative/prospective study EL 3; 11 retrospective study EL 4 Mesh fixation with metal tacks should be considered the standard method in laparoscopic incisional/ventral 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 ( Consensus 100%) STATEMENT ABSORBABLE AND NON-ABSORBABLE FIXING DEVICES AND POSITIONING TECHNIQUE The use of biological glues alone as fixing device is feasable in small hernia when a macropore lightweight mesh is used. Weak recommendation (Consensus 100%)

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 6. LAPAROCELI DI CONFINE E PERISTOMALI NEW

con il patrocinio di:: LUMBAR INCISIONAL HERNIAS (L4) 7 articles reviewed EL 4 SUPRAPUBIC INCISIONAL HERNIAS (M5) 7 articles reviewed EL 4 SUB-XIPHOID & SUB-COSTAL INCISIONAL HERNIAS (M1, L1) 7 articles reviewed EL 4 PARASTOMAL INCISIONAL HERNIAS (L3) 12 articles reviewed (1 systematic review) EL 3 PARASTOMAL INCISIONAL HERNIAS 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 ( Consensus 100%) 2.When performing laparoscopic repair the Sugarbaker technique should be preferred to the keyhole technique because of a significantly lower recurrence rate (Consensus 87,5%) Moderate recommendation HERNIAS LOCATED ON THE ABDOMINAL BORDERS - 1.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 casesConsensus 100%) 2.Careful standardization of mesh fixation technique is mandatory and must be tailored for each specific hernia site Consensus 100%) Weak recommendation STATEMENT Search strategy LAPAROSCOPIC TREATMENT OF PARA-STOMAL AND ABDOMINAL BORDER HERNIA

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE

con il patrocinio di:: Management of intraoperative and perioperative complications Search strategy 41 publications: 1 metanalysis (2011); 1 comparative study (2010) AN INTRAOPERATIVE PERFORATION SHOULD BE REPAIRED IMMEDIATELY, LAPAROSCOPICALLY OR NOT, ACCORDINGLY TO THE EXPERTISE OF THE SURGICAL TEAM. PROSTETIC REPAIR CAN BE ACCOMPLISHED IN ABSENCE OF A SIGNIFICANT CONTAMINATION. MODERATE RECOMMENDATION CONSENSUS 100% STATEMENT Intraoperative complications

con il patrocinio di:: Peri-operative complications-1 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. MODERATE RECOMMENDATION CONSENSUS 87.5% WHEN A MECHANICAL OBSTRUCTION IS CONFIRMED A LAPAROSCOPY, IF FEASABLE,IS RECOMMENDED TO ASSESS AND TREAT PROMPTLY A MESH RELATED COMPLICATIONS. MODERATE RECOMMENDATION CONSENSUS 100% THE SEROMA SHOULD NOT BE CONSIDERED A COMPLICATION UNLESS IT BECOME SYMPTOMATIC AT LEAST AFTER 3 MONTHS. THOSE CASES COULD BE TREATED WITH ASPIRATION. MODERATE RECOMMENDATION CONSENSUS 100% STATEMENT

con il patrocinio di:: Peri-operative complications-2 A CONSERVATIVE TREATMENT OF AN INFECTED MESH MAY BE ATTEMPTED. IN CASE OF FAILURE, A MESH REMOVAL IS THE ALTERNATIVE WEAK RECOMMENDATION CONSENSUS 100% A ROUTINE ANTIBIOTIC PROPHILAXIS IS RECOMMENDED MODERATE RECOMMENDATION CONSENSUS 100% IN CASE OF CHRONIC PAIN NON RESPONSIVE TO MEDICAL THERAPY AND/OR ANAESTHETIC LOCAL INJECTION, A LAPAROSCOPIC RE-EXPLORATION TO IDENTIFY AND REMOVE THE CAUSE OF PAIN (ADHESIONS, PREVIOUSLY IDENTIFIED PAINFUL TACKS OR SUTURES) IS ADVISABLE WEAK RECOMMENDATION CONSENSUS 100% STATEMENT

con il patrocinio di:: 1.UP TO DATE SULLE INDICAZIONI AL TRATTAMENTO ELETTIVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi ) 2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI, DIASTASI (new),URGENZE 3.SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEALI NEW 4. INDICAZIONI ALL’USO DELLE PROTESI BIOLOGICHE NEW 5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI (new) 6. LAPAROCELI DI CONFINE E PERISTOMALI 7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORIE 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE TOPICS 8. STRUTTURAZIONE DEL FOLLOW-UP (new) E TRATTAMENTO DELLE RECIDIVE

con il patrocinio di:: Literature focalized on follow-up schedule after repair of incisional or ventral hernia either by laparoscopic or open approach is lacking The Panel encourage open label study using a structured flow-chart.

con il patrocinio di:: TREATMENT OF RECURRENT INCISIONAL/VENTRAL HERNIAERN RECURRENCE Search strategy: Two meta-analysis of RCTs (2011,2012) EL 1, one RCT (2013) EL 2, 20 non-comparative studies LE 4 Rate of recurrence after lap repair is less than 5% at long-term follow-up, the same as for open repair (EL 1) Predictor of recurrence are: size of the defect (EL 2, EL 4), obesity, recurrent hernia, surgical site infection, inadequate mesh overlap of the defect, inadequate fixation or unrecognized abdominal wall defects (LE 4) WHEN HERNIA RECURRENCE IS SUSPECTED, IMAGING TECHNIQUES ARE RECOMMENDED TO CONFIRM THE DIAGNOSIS AND PLAN SURGICAL REVISION. strong RECOMMENDATION CONSENSUS 87.5% INCISIONAL HERNIA RECURRENCE SHOULD BE TREATED BY LAPAROSCOPY EITHER AFTER OPEN OR LAPAROSCOPIC PRIMARY SURGERY WITHOUT NEED OF MESH REMOVAL. MODERATE RECOMMENDATION CONSENSUS 100% PATIENTS WITH BULGING IN WHOM US AND CT SCAN EXCLUDED INCISIONAL HERNIA RECURRENCE, MIGHT BE TREATED BY LAPAROSCOPY STRETHCING A NEW LARGER MESH TIGHTLY. WEAK RECOMMENDATION CONSENSUS 87.5% STATEMENT

BIOLOGICAL

con il patrocinio di::

Grazie!