ombilicales avec Symbotex™ Composite Mesh: Résultats à 1 ... · mesh weight (HW vs LW), pore size (SP vs LP) and weave (2D vs 3D) • Large pore mesh showed beZer integraon than

Traitementdeséventra.onsetherniesombilicalesavecSymbotex™CompositeMesh:

Résultatsà1and’unregistreprospec.f

Presented by: Dr. Constantin Zaranis,MD1

1CliniqueduMail,LaRochelle,France

Zaranis– Symbotex™ Composite Mesh – MESH 2017

Disclosures–Constan.nZaranis

SymCHrostudysponsorship,funding,anddataanalysiswasprovidedby:

2Zaranis– Symbotex™ Composite Mesh – MESH 2017

•  Meshtransparencyforincreasedvisibilityduringplacement1

•  GreenorientaDonmarkingforaccurateposiDoning1,2

•  Abdominalwallside:monofilament3DpolyestertexDle•  Visceralside:hydrophiliccollagenbioabsorbablefilm•  Largeporesize:3.3mm×2.3mm

Symbotex™CompositeMesh

3Zaranis– Symbotex™ Composite Mesh – MESH 2017 1.  Covidieninternalreport0901CR252a(June2013)

2.  CovidiendesignvalidaDonreport0901CR249a(June2013)

MeshPorosityMaGers

Methodology:PreclinicalstudyofPETmeshintegraDonandshrinkagecomparingmeshweight(HWvsLW),poresize(SPvsLP)andweave(2Dvs3D)

•  LargeporemeshshowedbeZerintegraDonthansmallporemesh•  Lightweightsmallporemeshexhibitedthemostshrinkage•  3Dmeshsupportedthehighestcollagencountandexhibitedtheleastshrinkage

→Meshporosityismoreimportantthanmeshdensityfor.ssueintegra.on 4

Zaranis– Symbotex™ Composite Mesh – MESH 2017 1. Weyheetal.InternaDonalJournalofSurgery22(2015)46-53

Observational registry study: the short and long-term clinical outcomes following the use of Symbotex™ composite mesh. •  100 consecutive patients reported in the Hernia Club database •  2 Years Follow-up •  Inclusion Criteria:

ü  ≥18 years of age ü  Ventral hernia: Primary or incisional

•  Exclusion Criteria: ü None

ü  Surgical technique is left to the surgeon’s preference

Study Design


Study Endpoints

Primary Endpoints: •  Peri-operative complications •  Post-operative complications (up to 2 year follow-up)

Secondary Endpoints: •  Operative time and hospital stay •  Quality of life and patient satisfaction •  Ease of use / mesh manipulability assessment by surgeons


Pa.entFollow-Up(asofJuly2016)

Surgery(N=100)

Month1(N=82)

Month3/6(N=23)

1-Year(N=94)

MedianFollow-Up:349.5(0–579)days

On-goingstudywillassess24monthsfollow-up

8

StudyFlowChart


Pa.entDemographics&RiskFactors

Diabetes

Chemotherapy/immunosuppressive treatment

Anticoagulant treatment or bleeding disorder

0% 10% 20% 30% 40% 50% 60% 70% 80%

Prior extraperitoneal surgery

Mac Burney

Prior intraperitoneal surgery

Pa.ents(%)

3218

87

6855

167

Riskfactorsrelatedtohealing(≥1)

Riskfactorsrelatedtodissec.on(≥1)

Daily/RegularSmoker 14

10

20

30

40

50

60

BMIran

ge(k

g/m

2 )

17.8

48.1

28.7

9

40.4%ofpa.entshadaBMI≥30

MedianAge(min–max)

61.5years(30-91)

Gender(N=100)

Male 49

Female 51


HerniaCharacteris.cs

1site

≥2sites

(81%)

(19%)

Mul.-sitehernias(N=104)

Pa.ents(%)

83(79.8%)

21(20.2%)

5.2

41.6

0

10

20

30

40

50

60

70

80

90

Primary Hernia (N=39) Incisional Hernia (N=65)

Def

ect a

rea

(cm²)

HerniaDefectArea(N=104)

32

1

88

8

0 20 40 60 80 100

Incarcerated hernia (N=103)

Strangulated hernia with obstruction

Discomfort/pain or dysesthesia

Asymptomatic hernia

HerniaSymptoms(N=103)

10

39(37.1%)

66(62.9%)

HerniaType(N=105)

Incisional

Primary


0

20

40

60

80

100

Laparoscopic Open

Minutes(m

ean±SD

)

Operative time

Opera.veData

37

PRIMARYHernia

2039

INCISIONALHernia

Open(Laparotomy)

Laparoscopy

SurgicalApproach

(100%) (66%)

(34%)

02468101214161820

Laparoscopic Open

Minutes(m

ean±SD

) Mesh positioning time


SurgeonSa.sfac.on

Sa.sfied

Unsa.sfied

Unknown2

8

2

19

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

LowvisceralaGachment

MeshMemoryShape

EaseinMeshInser.on

EaseinMeshTrimming

MeshFlexibility

SurgeonResponse(%)


Pa.entComplica.ons

•  Onerecurrenceoccurred,paDentwasreoperatedon•  FewcomplicaDonsoccurred•  Nosepsisorotherseriousadverseeventswerereported

within12months

Patient Complications

Complication Symbotex™ composite mesh (N=100) Time of occurrence

Seroma1 1 Perioperative 5 Post-operative (2-4 weeks)

6 (6.0%) Total within one year

Transitory ileus2 2 Perioperative 1 Post-operative (2-4 weeks)

3 (3.0%) Total within one year Recurrence3 1 (1.0%) Total within one year

Data are represented as n (%) 1 No seroma were mesh-related; five were minor, requiring no medical treatment; one diagnosed at 1 month was punctured at 2 months post-

surgery 2 All were low-grade (Clavien 1 or 2); relation to mesh or procedure is unknown at this time 3 Asymptomatic occuring between 6 – 12 months, patient was reoperated on.


Post-Opera.vePain

P<0.0001forscoresrelaDvetobaseline,basedonWilcoxonsignedranktest(non-parametric)forpaireddata.*

0

1

2

3

4

5

6

7

8

Day 0 Day 1 Day 8 Month 1 Month 3

VAS

pain

(mea

n ±

SD)

VAS Pain Assessment

N=82 N=79 N=76 N=77 N=23

*

14At12months,pa.entsweregivenaques.onnairewithoutVASpainassessment

**

*


Patient Satisfaction

Patient Satisfaction Survey by Phone at One Year

Patient satisfaction rating Responses (N=94)

Excellent 10 (10.6%)

Good 73 (77.7%)

Medium 7 (7.4%)

Bad 4 (4.3%)


•  PrimaryandincisionalventralherniarepairwithSymbotex™compositemeshyieldedminimaladverseeventswithonlyonerecurrence

•  Highpa.entsa.sfac.onatoneyearfollow-upandhighrateofsurgeonsa.sfac.onregardingmeshhandlingreported

•  Post-opera.vepaindecreasedsignificantly•  ThesepromisingresultssupporttheuseofSymbotex™compositemeshinprimaryandincisionalventralherniarepair

Studyresultswillbeassessedagainattwoyearfollow-up

Conclusions


ombilicales avec Symbotex™ Composite Mesh: Résultats à 1 ... · mesh weight (HW vs LW), pore size (SP vs LP) and weave (2D vs 3D) • Large pore mesh showed beZer integraon than

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