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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 PiccoliNereo 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; 16:1149-1450


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 PiccoliNereo Vettoretto

Marina Davoli

Costituzione del panel- 8 esperti

– Pubblicazioni– Partecipazione registro

SICE e casistica– Coinvolgimento Consensus

Napoli 2010- 1 anestesista

Revisori esterni- EAES: Davide Lomanto- EHS: Salvador Morales Conde- Istituto M. Negri: S.Garattini

Panel di espertiL. SanchezG. CeccarelliA. AntinoriL. AnsaloniS. Olmi (Italian chapter EHS)D. Cuccurullo (Italian chapter EHS)P. BaccariA. Corcione (SIAARTI)


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”


(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


Utilizzo del forum per interazione blindtra gli esperti e il comitato scientifico

Riunione full immersion Giugno 2013

Congresso Sice Napoli 19/09/2013

Presentazione degli evidence reports e degli

statements


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 ELETT IVO DELLE ERNIE VENTRALI (Età, sesso, sede, dimensioni e metodo di valutazione, interventi pregressi )


STATEMENT 1

LAPAROSCOPIC REPAIR OF VENTRAL HERNIA IS SAFE AND EFFECTIVE WITH LOWER RISK OF WOUND INFECTION AND

SHORTER HOSPITAL STAY COMPARED TO OPEN REPAIRStrong recommendation (EL 1)

Consensus 100%

The only presence of a ventral hernia does not represent an indication to surgery by itself

(Pubmed search 2009-2013: 13 Case Series, 1 meta analysis, 4 RCT

General considerations


STATEMENT 2

OLDER AGE IS NOT A CONTRAINDICATION FOR LAPAROSCOPIC TREATMENT OF VENTRAL/INCISIONAL HERNIA

Moderate recommendationConsensus 100%

Age

Pubmed search: 5 retrospective study (EL 3-4) 2 case series (EL 4)


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


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 recommendationConsensus 100%

PREOPERATIVE DIAGNOSIS


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)










TOPICS

2. INDICAZIONI IN CASI PARTICOLARI: OBESITA’,CIRROSI , DIASTASI(new),URGENZE


Laparoscopic approach to ventral/incisional hernia repa ir 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 he rnias 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 2011 - Shabanzadeh 2012 -Colon MJ 2013 - Colavita PD 2013Tsereteli Z 2008- Sauerland 2011 - Rogmark 2013

2) Lee J (JAMA) 20133) Shabanzadeh 2012 - Colon MJ 2013

Moreno Egea 20124) Rao R 2011 5) Ching 2008- Eid GM 2013 – Praveen P 2012


Compensated Child A-B cirrhosis is not acontraindication to elective laparoscopicventral/incisional hernia repair. .

Weak Recommendation

(Consensus 100%)

1) Cobb WS 2005– Belli 2006 – Kurmann A 2010

2) Hiremath BV 2012

3) Choi SB 2011 – Eker 2011

4) 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)

GS1GS2

Diapositiva 24

GS1 Gianfranco Silecchia; 13/09/2013

GS2 NON E' POSSIBILE METTERE IN DISCUSSIONE ALLA STRESSA STREGUA CHILD B, C ETC E POI CCOMUNARE NELLO STATEMENT FINALE CHILD

A-B

..CHE VUOL DIRE ASYMPTOMATIC

Gianfranco Silecchia; 13/09/2013


Incisional hernia in emergency is not a contraindication tolaparoscopic approach and may be performed in selected case s.

Weak Recommendation

(Consensus 100%)

EMERGENCY

1)Agresta F 2012 - Cuccurullo D 20132)McDonald E 20093)Abdel-Baki NA – Bessa SS 2013 4)Landau O 2004 - López-Tomassetti FernándezEM 2006 - 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)










TOPICS

3. SICUREZZA ED OUTCOME DELLE PROTESI ENDOPERITONEA LI NEW


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










TOPICS



� 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. 2013 EL 4)

� 1 short report about preliminary results of a RCT (Miserez M et al. Br J Surg 2010 EL 3b)

FEASIBILITYINDICATION

� 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. 2013 EL 4)

QUESTION: WHICH ROLE COULD PLAY BIOLOGIC MESHES FOR LAPAROSCOPIC INCISIONAL HERNIA REPAIR?

SINCE THE BIOLOGIC PROSTHESIS (BP) ARE DIFFERENT FU RTHER 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. L APAROSCOPIC USE

IS RECOMMENDED IN CONTROLLED TRIAL.Weak Recommendation

(Consensus 100%)

STATEMENT










TOPICS

5. MEZZI DI FISSAGGIO ASSORBIBILI E NON ASSORBIBILE E TECNICHE DI POSIZIONAMENTO e NUOVI APPROCCI NEW


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 transp arietal sutures seems to lengthen the operating

time without difference either in postoperative pai n, 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 macroporelightweight mesh is used.

Weak recommendation(Consensus 100%)










TOPICS

6. LAPAROCELI DI CONFINE E PERISTOMALI NEW


LUMBAR INCISIONAL HERNIAS (L4)

7 articles reviewedEL 4EL 4

SUPRAPUBIC INCISIONAL HERNIAS (M5)


SUB-XIPHOID & SUB-COSTAL INCISIONAL HERNIAS (M1, L1)


PARASTOMAL INCISIONAL HERNIAS (L3)

12 articles reviewed (1 systematic review)EL 3EL 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










TOPICS

7. GESTIONE DELLE COMPLICANZE INTRA E PERIOPERATORI E


Management of intraoperative and perioperative complications

Search strategy

41 publications: 1 metanalysis (2011); 1 comparative study (2010)

AN INTRAOPERATIVE PERFORATION SHOULD BE REPAIRED IM MEDIATELY, LAPAROSCOPICALLY OR NOT, ACCORDINGLY TO THE EXPERTI SE OF THE

SURGICAL TEAM. PROSTETIC REPAIR CAN BE ACCOMPLISHED IN ABSENCE OF A SIGNIFICANT CONTAMINATION.

MODERATE RECOMMENDATION CONSENSUS 100%

STATEMENT

Intraoperative complications


Peri-operative complications-1

A CT SCAN AND/OR A LAPAROSCOPY SHOULD BE UNDERTAKEN WHEN A POS TOPERATIVEPERITONITIS IS SUSPECTED. IF THE DIAGNOSIS IS CONFIRMED, THE MESH REMOVAL ISADVISABLE.

MODERATE RECOMMENDATIONCONSENSUS 87.5%

WHEN A MECHANICAL OBSTRUCTION IS CONFIRMED A LAPARO SCOPY, IF FEASABLE ,IS RECOMMENDED TO ASSESS AND TREAT PROMPTLY A MESH R ELATED COMPLICATIONS .

MODERATE RECOMMENDATIONCONSENSUS 100%

THE SEROMA SHOULD NOT BE CONSIDERED A COMPLICATION UNLESS IT BECOME SYMPTOMATIC AT LEAST AFTER 3 MONTHS. THOSE CASES CO ULD BE TREATED WITH ASPIRATION.


STATEMENT


Peri-operative complications-2

A CONSERVATIVE TREATMENT OF AN INFECTED MESH MAY BE ATTEMPTE D. IN CASE OFFAILURE, A MESH REMOVAL IS THE ALTERNATIVE

WEAK RECOMMENDATIONCONSENSUS 100%

A ROUTINE ANTIBIOTIC PROPHILAXIS IS RECOMMENDED


IN CASE OF CHRONIC PAIN NON RESPONSIVE TO MEDICAL T HERAPY AND/OR ANAESTHETIC LOCAL INJECTION, A LAPAROSCOPIC RE-EXPLORATION TO I DENTIFY AND REMOVE THE CAUSE OF PAIN (ADHESIONS, PREVIOUSLY IDENTIFIED PAINFUL T ACKS OR SUTURES) IS ADVISABLE

WEAK RECOMMENDATIONCONSENSUS 100%

STATEMENT










TOPICS

8. STRUTTURAZIONE DEL FOLLOW -UP (new) E TRATTAMENTO DELLE RECIDIVE


• Literature focalized on follow-up schedule after repair of incisional or

ventral hernia either by laparoscopic or open appro ach is lacking

• The Panel encourage open label study using a struct ured flow -chart

.

GS1

Diapositiva 39

GS1 FAGLIELE TU LE SLIDES NON SI CAPISCE UN CAZZO

Gianfranco Silecchia; 13/09/2013


TREATMENT OF RECURRENT INCISIONAL/VENTRAL HERNIAERN

RECURRENCESearch 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 walldefects (LE 4)

WHEN HERNIA RECURRENCE IS SUSPECTED, IMAGING TECHNIQUES AR E RECOMMENDED TOCONFIRM THE DIAGNOSIS AND PLAN SURGICAL REVISION.

strong RECOMMENDATIONCONSENSUS 87.5%

INCISIONAL HERNIA RECURRENCE SHOULD BE TREATED BY LAPAROSCOPY EITHER AFTER OPEN OR LAPAROSCOPIC PRIMARY SURGERY WITHOUT NEED OF MESH REMOVAL.


PATIENTS WITH BULGING IN WHOM US AND CT SCAN EXCLUD ED INCISIONAL HERNIA RECURRENCE, MIGHT BE TREATED BY LAPAROSCOPY STRETHC ING A NEW LARGER MESH TIGHTLY.

WEAK RECOMMENDATIONCONSENSUS 87.5%

STATEMENT

BIOLOGICAL

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