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LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

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Page 1: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAKS IN BARIATRIC SURGERY

Paolo GentileschiBariatric Surgery Unit

University of Rome Tor Vergata

Page 2: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAKS IN BARIATRIC SURGERY

Page 3: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

+ 142%

Page 4: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 5: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 6: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAKS

Page 7: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Mortalità < 30 giorni (precoce) : 0,28% > 30 giorni (tardiva) : 0,35%

Pazienti SuperObesi:

Mortalità Precoce: 1,25% Mortalità Tardiva: 0,81%

Pazienti con età> 65 anni

Mortalità Precoce: 0,34% Mortalità Tardiva: 0,0%

Page 8: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Postoperative Adverse Events by Bariatric Procedure in Controlled Trials.

Maggard M A et al. Ann Intern Med 2005;142:547-559

Page 9: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Local and Systemic Factors that negatively influence suture integrity

Page 10: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Leaks 0-6 %

Sleeve GastrectomySleeve Gastrectomy Sleeve GastrectomySleeve Gastrectomy

Page 11: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 12: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAK RATE BY PROCEDURELAGB 0%LSG 0-7%

LRYGB 0-7%LBPD 0-6%

Page 13: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

RCTs

Page 14: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 15: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 16: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Int’l Consensus Summits on Sleeve Gastrectomy

Page 17: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 18: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 19: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 20: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 21: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 22: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

 Comparative Use of Different Techniques Comparative Use of Different Techniques for Leaks and Bleeding prevention during for Leaks and Bleeding prevention during

Laparoscopic Sleeve GastrectomyLaparoscopic Sleeve Gastrectomy

M.AnselminoM.Anselmino, N. Basso*, P. Gentileschi°, L. Angrisani§, , N. Basso*, P. Gentileschi°, L. Angrisani§, G. Casella°, D. Benavoli°, S. D’Ugo°, P. Cutolo§, G. Casella°, D. Benavoli°, S. D’Ugo°, P. Cutolo§, C. Moretto, R. Bellini, R.D. Berta, S. FranceschiC. Moretto, R. Bellini, R.D. Berta, S. Franceschi

Bariatric & Metabolic Surgery Unit, PisaBariatric & Metabolic Surgery Unit, Pisa*VII Dept. of Surgery, Rome La Sapienza*VII Dept. of Surgery, Rome La Sapienza

§Dept. Of General Surgery, S. G. Bosco Hospital, Naples§Dept. Of General Surgery, S. G. Bosco Hospital, Naples°Bariatric Surgery Unit, Rome Tor Vergata°Bariatric Surgery Unit, Rome Tor Vergata

Page 23: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Center City Investigator

A.O.U.P. Pisa Anselmino

S. Giovanni Bosco Naples Angrisani

Tor Vergata University Rome Gentileschi

La Sapienza University Rome Basso

All cases of primary SG in 4 Italian Bariatric Centers

Page 24: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 25: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Company 

Synovis SI Covidien Gore Baxter

Product Brand Name Peri-Strips Dry withVeritas

Duet TRS SEAMGUARDBioabsorbable

FLOSEALTISSEEL

Material BovinePericardium

Synthetic polyester(Biosyn material)

Glycolide andTrimethyleneCarbonateCopolymer

Thrombine Haemostatic

matrix+

Fibrin Glue

Host TissueResponse

Remodels Reabsorbs Reabsorbs -

Tissue thickness Avg = 0.35 mm0.20 – 0.60 mm

Avg = 0.07 mm0.04 – 0.10 mm

0.25 mm -

Tensile strength(Peak load)

4.0 kg TBD 1.2 kg -

Storage Controlled room temp Ambient room temp Ambient room temp

 Preparation

One piece; requires gelapplication

Pre-loaded on stapler loads; attached with

Biosyn sutures

Two pieces; sleeves fit on stapler

arms

COMPETITIVE LANDSCAPE

Page 26: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Reinforcement TypeReinforcement TypeReinforcement TypeReinforcement Type

Page 27: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

ResultsResultsResultsResults

Page 28: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

CONCLUSIONS

No evidence at this time for minor incidence of leaks with either materials or oversewing

- Sufficient evidence of less episodes of bleeding with reinforcement with either strips

Page 29: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata
Page 30: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAKS

Page 31: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Laparoscopic Sleeve Gastrectomy

Page 32: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Laparoscopic Sleeve Gastrectomy

SERIES (Policlinico Tor Vergata Roma)March 2013

382 LSG (primary)6 LEAKS (1.5%)

Page 33: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Laparoscopic Sleeve Gastrectomy

5 healed with :2 with laparoscopic drainage and TPN

3 with endoscopic clipping and stenting

1 Mortality :Pulmonary failure and sepsis

Page 34: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

IL BY-PASS GASTRICO

Page 35: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Complicanze dopo By Pass gastrico Complicanze dopo By Pass gastrico sec. Rouxsec. Roux

Precoci (entro 30 giorni)Precoci (entro 30 giorni) TardiveTardive

Fistola 2-7% Fistola 2-7% Embolia polmonare 0,2-1%Embolia polmonare 0,2-1% Infezione ferita 8% Infezione ferita 8% Emorragia 0,8-4,4% Emorragia 0,8-4,4% Insufficienza respiratoria 1-Insufficienza respiratoria 1-

4% 4%

Ernia ferita chirurgica 12-15% Ernia ferita chirurgica 12-15% Occlusione intestinale 1-3%Occlusione intestinale 1-3% Stenosi delle anastomosi 3-7% Stenosi delle anastomosi 3-7% Anemia da carenza di Ferro Anemia da carenza di Ferro

e/o vitamimina B12 e/o acido e/o vitamimina B12 e/o acido folico 15-33%* folico 15-33%*

Osteoporosi da carenza di Osteoporosi da carenza di calcio 8-10% * calcio 8-10% *

Ulcera marginale 1-16%Ulcera marginale 1-16%

Page 36: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAKS DOPO BY-PASS GASTRICO

Serie (Policlinico Tor Vergata)Marzo 2013

464 pz1 leak anastomosi gastro-digiunale (0.2%)

Re-intervento, drenaggio, NPT1 leak anastomosi entero-entero (0.2%)

Re-intervento, riconfezionamento

Page 37: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

STENTINGSTENTING STENTINGSTENTING

Page 38: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

STENTINGSTENTING STENTINGSTENTING

Page 39: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

La II causa più comune di morte dopo La II causa più comune di morte dopo RYGBRYGB

Leak Anastomosi G-J :Leak Anastomosi G-J : Incidenza 2-5%Incidenza 2-5% - LRYGB: 5,2%- LRYGB: 5,2% - ORYGB:2,6%- ORYGB:2,6% Mortalità 1,5%Mortalità 1,5%Tempo medio per la diagnosi: 2 giorniTempo medio per la diagnosi: 2 giorni

Leak anastomosi J-JLeak anastomosi J-JMortalità: 40%Mortalità: 40%Tempo Medio per la diagnosi: 4 giorniTempo Medio per la diagnosi: 4 giorni

Diagnosi Diagnosi Leak anastomoticiLeak anastomotici

Segni e/o Sintomi:Segni e/o Sintomi: Dolori addominale Tachicardia Iperpiressia Aumentati segni di flogosi: VES,

PCR, ProCalcitonina Leucocitosi Neutrofila Distress respiratorio Studio Radiologico:Studio Radiologico: Rx digerente con Gastrografin Tc con mdc per os

Complicanze Precoci: Leak AnastomoticiComplicanze Precoci: Leak Anastomotici

Page 40: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Leak AnastomoticiLeak AnastomoticiTrattamentoTrattamento

Pz StabilePz Stabile

No segni di shock settico,No segni di ampio Leak

Trattamento ConservativoTrattamento Conservativo DigiunoDigiuno

NPTNPT Antibtioticoterapia e.v.Antibtioticoterapia e.v.

SNGSNG STENTSTENT

Presenza di Raccolta AddominalePresenza di Raccolta Addominale

Drenaggio percutaneo TC-guidatoDrenaggio percutaneo TC-guidato

Pz InstabilePz Instabile

Segni shock SetticoSegni radiologici di ampio Leack

ReinterventoReintervento

Relaparoscopia LaparotomiaRelaparoscopia Laparotomia

Lavaggio raccolte intraddominaliLavaggio raccolte intraddominaliPosizionamento di Drenaggi AspirativiPosizionamento di Drenaggi Aspirativi

Sutura diretta LeakSutura diretta Leak

Page 41: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Treated 19 patients with removable covered stents

-acute leaks (n=11)-chronic fistulas (n=2)

-strictures (n=6)

Leaks were identified endoscopically, marked radiographically,

and stents deployed under fluoroscopy.

Oral feeding could be started in 79% of the patients after

stenting. At a follow up of 3.6 months

successful healing was achieved in :

• 91% of acute leaks• 100% of gastrocutaneous

fistulas • 81% of strictures

Mean healing time of 30 days

Page 42: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

Treatment of Leaks and Other Bariatric ComplicationsTreatment of Leaks and Other Bariatric Complicationswith Endoluminal Stentswith Endoluminal Stents

Treatment of acute fistolaInfected fluid collection

Percutaneus or laparoscopic dranaige

Acute fistola

Applications of stents were extended to treat esophageal

and gastrointestinal leaks

Healed anastomotic leak after stent removal

Page 43: LEAKS IN BARIATRIC SURGERY Paolo Gentileschi Bariatric Surgery Unit University of Rome Tor Vergata

LEAKS

PREVENTIONAPPROPRIATE SURGICAL TECHNIQUE

STAPLE LINE REINFORCEMENT (?)suture

buttress materialsealants

MET BLUE TESTINGNG TUBE (?)

DIAGNOSISENDOSCOPY WITH FLUOROSCOPY

CT SCAN

TREATMENTCONSERVATIVE

DrainageTPN

STENTINGEndoscopic clipping or sealants (?)