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www.bjorl.org

Brazilian

Journal

of

OTORHINOLARYNGOLOGY

ORIGINAL

ARTICLE

Treatment

of

large

persistent

tracheoesophageal

peristomal

fistulas

using

silicon

rings

Ibrahim

Erdim

a

,

Ali

Ahmet

Sirin

a

,

Bahadir

Baykal

a

,

Fatih

Oghan

b,∗

,

Ali

Guvey

b

,

Fatma

Tulin

Kayhan

a

aBakirkoySadiKonukEducationandResearchHospital,DepartmentofORL,Istanbul,Turkey bDumlupinarUniversity,FacultyofMedicine,DepartmentofORL,Kutahya,Turkey

Received24April2016;accepted22June2016 Availableonline21July2016

KEYWORDS

Voiceprosthesis; Siliconring; Fistula

Abstract

Introduction:Tracheoesophagealperistomalfistulaecanoftenbesolvedbyreducingthesize ofthefistulaorreplacingtheprosthesis;however,evenwithconservativetechniques,leakage aroundthefistulamaycontinueintotallaryngectomypatients.Also,severaltechniqueshave beendevelopedtoovercomethisproblem,includinginjectionsaroundthefistula,fistulaclosure withlocalflaps,myofascial flaps,orfreeflapsandfistulaclosureusingaseptalperforation siliconbutton.

Objective:Topresenttheresultsoftheapplicationofsiliconringexpandingthevoiceprosthesis inpatientswithlargeandpersistentperi-prostheticfistula.

Methods:Avoiceprosthesiswasfittedto42patientsafter totallaryngectomy.Leakage was detectedaroundtheprosthesisin18ofthese42patients.Fourpatientsdemonstrated improve-mentwithconservativemethods.Eightof18patientswhocouldn’tbecuredwithconservative methodsweretreatedbyusingprimarysutureclosureand4patientsweretreatedwithlocal flaps.Assiliconringwasappliedasaprimarytreatmentinthe2remainingpatientsandalso, appliedto2patientswhohadrecurrenceaftersuturerepairandto2patientswhohad recur-renceafterlocalflapimplementation.Siliconringswereusedinatotalof6patientsduetothe secondarytrachea-esophagealfistula.Patientsweretreatedwithprovox-1initiallyandlater withprovox-2.Atthetimeofleakagearoundthefistula,6patientshadprovox-2.

Results:Fistulaeweretreatedsuccessfullyin6patients,andeffectivespeechofpatientswas preserved.Patientsexperiencednoadaptationproblem.Prosthesischangingtimewasnot dif-ferent between silicon rings expanded andnormal prosthesis applied patients. Silicon ring combinedvoiceprosthesiswasused26times;therewasnorecurrenceinfistulacomplication during29±6monthsfollowup.

Pleasecitethisarticleas:ErdimI,SirinAA,BaykalB,OghanF,GuveyA,KayhanFT.Treatmentoflargepersistenttracheoesophageal peristomalfistulasusingsiliconrings.BrazJOtorhinolaryngol.2017;83:536---40.

Correspondingauthor.

E-mail:drfoghan@gmail.com(F.Oghan).

PeerReviewundertheresponsibilityofAssociac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial.

http://dx.doi.org/10.1016/j.bjorl.2016.06.011

(2)

Conclusion: Siliconringsformodifiedexpandedvoiceprosthesisseemstobeaneffective treat-mentforpersistentperi-prostheticleakage,forboth,fistulaclosureandpreservingthepatients speech.

© 2016 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Published by Elsevier Editora Ltda. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).

PALAVRAS-CHAVE

Prótesevocal; Aneldesilicone; Fistula

Tratamentodefístulaperiestomaltraqueoesofágicagrandeepersistentecomanéis desilicone

Resumo

Introduc¸ão: Fístulastraqueoesofágicaspersistentespodemserresolvidasatravésdareduc¸ãodo tamanhodafístulaousubstituic¸ãodaprótese;noentanto,mesmocomtécnicasconservadoras, opertuitoemtornodafístulapodecontinuarempacientescomlaringectomiatotal.Alémdisso, váriastécnicastêmsidodesenvolvidasparasuperaresseproblema,incluindoinjec¸õesaoredor dafístula,fechamentodafístulacomretalhoslocais,retalhomiofasciais,ouretalhoslivrese fechamentodafístulausandoumbotãoseptaldesilicone.

Objetivo: Apresentarosresultadosdaaplicac¸ãodeaneldesiliconeparaexpansãodaprótese vocalempacientescomgrandesfístulasperiprotéticaspersistentes.

Método: Prótesevocalfoicolocadaem42pacientesapóslaringectomiatotal,efístulafoi detec-tadaaoredordapróteseem18desses42pacientes.Quatropacientesobtiverammelhoracom métodosconservadores.Oitodos18pacientesquenãoobtiveramsucessocommétodos conser-vadoresforamtratadosusandosuturaprimáriaequatropacientesforamtratadoscomretalhos locais.Umaneldesiliconefoiaplicadoinicialmentenosdoispacientesrestantese,também, aplicadoadoispacientesquetiveramrecorrênciaapósatécnicadesuturaeadoispacientes quetiveramrecorrênciaapósautilizac¸ãoderetalholocal.Nototal,seispacientesreceberam anéisdesiliconeemdecorrênciadafístulatraqueoesofágicasecundária.Ospacienteshaviam sidotratadoscomprovox-1inicialmenteeposteriormentecomprovox-2.Nomomentodetecc¸ão dafístulaemtornodoestoma,seispacienteshaviamrecebidoprovox-2.

Resultados: Afístulafoitratadacomsucessoemseispacientes.Alémdisso,apósotratamento afalafoimantidadeformaeficaznospacientes.Nãohouveproblemadeadaptac¸ão.Otempo detrocadapróteseexpandidacomosanéisdesiliconenãofoidiferentedotempoqueseleva paraacolocac¸ãodaprótesenormal.Oaneldesiliconecombinadocomaprótesevocalfoiusado 26vezesempacientesnaépocadatrocadepróteseenãohouverecorrênciadafístuladurante os29±6mesesdeacompanhamento.

Conclusão:Os resultados sugeremque em casosde grandes fístulasperi-prostéticas persis-tentes, anéis expandidosde silicone eprótese vocalmodificada, sãoeficazes tanto para o fechamentodafístulacomoparaamanutenc¸ãodafaladopaciente.

© 2016 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Publicado por Elsevier Editora Ltda. Este ´e um artigo Open Access sob uma licenc¸a CC BY (http:// creativecommons.org/licenses/by/4.0/).

Introduction

Oneofthemostimportantproblems ofpatientswhohave

undergonetotallaryngectomyislossofspeech.Avoice

pros-thesis can solve the problem in most patients; however,

there can be numerous complications, including a

peris-tomal fistula.1---4 This frequent complication can result in

severemorbidity,includingaspirationpneumoniaand

mal-nutrition,orevenmortality.5---7

Such problems can be solved by reducing the size

of the fistula or replacing the prosthesis; however, even

with conservative techniques, leakage around the fistula

may continue. Several techniques have been developed

toovercomethisproblem,includinginjectionsaroundthe

fistula8---11; fistula closure with local flaps,12 myofascial

flaps,1,13,14 free flaps;1,5 and fistula closure using a septal

button.6,13

Theproblemscausedbysmallfistulas(5---10mm)are

eas-iertoovercomecomparedtothosecausedbylargefistulas;

indeed,itmaynotbepossibletosolvetheproblemscaused

bylargefistulas,andcomplicationssuchasspeechlossand

morbiditymayresultfromintervention.

Here, we report the application of a silicone ring

expanded voice prosthesis in patients who had a

large-sized fistula and persistent peri-prosthetic

(3)

Methods

Avoiceprosthesiswasfittedto42patientsaftertotal

laryn-gectomybetweenJanuary2005andDecember2011.Ethical

approvalwasobtainedfromethicalcommitteeasanumber

of32/2015.Leakagewasdetectedaroundtheprosthesisin

18 of the 42 patients. While fourpatients improved with

conservativemethods,eightpatientsimprovedatfirstwith

conservativemethodsbutlaterdidnotrespondtotherapy,

and six patients did not respond to conservative therapy

eveninitially.

Eightoffourteenpatientswhocouldnotbecuredwith

conservative methods were treated using primary suture

repair, andfour patients were treatedwith localflaps. A

siliconeringwasappliedinitiallytotwopatientswithwide

fistulas.Asiliconeringwasalsoappliedtotwopatientswho

hadrecurrenceaftersuturerepairandtwopatientswhohad

recurrenceafterlocalflapimplementation.Intotal,silicone

ringswerefittedtosixpatients.

FiveofthepatientswhoreceivedProvox2widenedwith

siliconeringsweremaleandonewasfemale.Themeanage

was57±11years.Fourpatientsunderwentbilateral

func-tionalneckdissection,one underwentbilateralfunctional

neckdissectionandrightsubmandibularglandexcision,and

oneunderwentrightfunctional,leftradicalneckdissection

andreconstructionwith a pectoralismajormyocutaneous

flap. Three patients received radiotherapy, one patient

receivedradiotherapyandchemotherapy,andtwopatients

receivedneither.Asecondarytracheoesophagealfistulawas

opened in all patients. The patients were treated with

Provox 1 first and followed later with Provox 2. At the

timeofleakagearoundthefistula,sixpatientshadProvox

2 (outer diameter,22.5 F; Atos Medical, Hörby,Sweden).

Theminimumandmaximumdiametersofthefistulaswere

1.5cm×1.5cmand2cm×2.5cm,respectively.

Preparationandapplicationofthesiliconering expandedvoiceprosthesis

Twosiliconeringsmadeofwingsofseptalbuttonsor

inex-pensive silicone plaques were prepared according to the

widthofthefistulaandinnerdiameterofthevoice

prosthe-sis.Theseringsengagedwiththetrachealandesophageal

flangesofthevoiceprosthesis(Fig.1a).Thesiliconerings

werefixedtothevoiceprosthesisusing3.0non-absorbable

sutures --- 2 at the posterior flange and 2 at the anterior

flange(Fig.1b).Carewastakenthatthepreparedringsdid

nothavesharppiecesontheouterside.Thewingmatched

withtheesophagusengagedwiththefistula.Thevoice

pros-thesiscombinedwiththesiliconeringswasappliedtothe

tracheoesophagealfistula.Last,theuppersideof the

tra-chealflangeofthevoiceprosthesiswassuturedtoskinon

thetracheostomausing3.0non-absorbablesutures(Fig.2a

andb).

Results

Fistulas were treated successfully in six patients. After

treatment,effectivespeechofthepatientswasmaintained.

Noadaptationproblemoccurredinthepatients.Asilicone

ring combinedwith a voice prosthesis wasused 26 times

Figure 1 (a) Schematization of expanded voice prosthesis with siliconerings.(b) Silicone ringsand preparedexpanded voiceprosthesis.

Figure 2 (a) The rings engaged with the tracheal and esophageal flangesofthevoiceprosthesis. (b) Heupperside ofthetracheal flangeofthe voiceprosthesiswas suturedto skinonthetracheostomausing3.0non-absorbablesutures.

in patients when it was time to change the prosthesis,

andtherewasnorecurrenceoffistulacomplicationsduring

29±6 months of follow-up. Prosthesis changing timewas

183.5±58.7(min---max:21---424)daysfortotal42patients,

and 171.6±74.8 (min---max: 32---384) daysfor silicon ring

(4)

time was not statistically different between these two

groups(Non-parametricMann---WhitneyUtestwasusedand

p=0.163).

Discussion

Thesizeofthefistulaandwhetherthepatienthasreceived

radiotherapy are essential factors in the closure of

tra-cheoesophagealfistulas.Thesuccessrateoffistulaclosure

is decreased inpatients whoreceivedradiotherapy,

espe-ciallywhensurgicaltechniques wereapplied.1,14 However,

septalbutton6,13,15andsiliconeringexpandedProvox,which

weused,aremoreeffectiveinpatientswhohavereceived

radiotherapy becausethese techniques have no effecton

woundhealing.

Inmost patients,theproblemcanbesolvedbyusinga

smallerprosthesis.Iftheproblempersists,spontaneous

clo-sureofthefistulacanoccurafterdetachingtheprosthesis.

However,iffistulaclosurewiththismethodfails,the

appli-cationofvarioustechniquescouldberequiredaccordingto

thesizeofthefistula.16

For small fistulas (5---10mm), local suture-repair

tech-niques are appropriate and the success rate is between

60% and 100%.14 Additionally, some studies have reported

the effectiveness of collagen,8 hyaluronate,9 calcium

hydroxyapatite,10andGM-CSF11injectionsforsmallfistulas.

Jacobs et al.17 used the ‘‘submucosal purse-string

suture’’ technique in 20 patients to constrict the fistula

and reuse the voice prosthesis. They were successful in

16 of20 patients (80%).While theyachievedsuccess in 9

of 16 patients in thefirst suture trial, repetitivesuturing

wasrequiredfortheremaining7patients.Thistechniqueis

simpleandcouldbethefirstchoicemethodfor

constrict-ingfistulas.However,itcannotbeconsideredeffectivefor

medium-orlarge-sizedfistulas.Additionally,tracheostoma

narrowness, which excluded one patient from the study,

makes the application of this technique difficult.17 Lee

et al.12 reached the fistula tract by making an incision

fromthe9to3o’clockdirectionontheupperpart ofthe

tracheostoma.Theyelongatedtheincisiontowardthe

ster-nocleidomastoid(SCM) muscle.Aftersplitting the trachea

and esophagus, theyrepaired the esophagealdefect with

absorbablesutures.Rotatingtheinferiorly-basedflap,using

the right SCM muscle, they sutured this on the repaired

esophageal site. Also, they repaired the trachea using

absorbable sutures. The patient’s fistula was closed

com-pletely, and the patient could not speak with the voice

prosthesis.Thelimitationsofthisstudyarethatthe

diame-terofthefistulawasnotstatedandthetechniquewastried

ononly onepatient.12 Additionally,Wong etal.15 usedan

SCM muscle flaptwice consecutivelyto closea

tracheoe-sophagealfistula,buttheywerenotsuccessful.Therefore,

theyclosedthefistulawithaseptalbutton.

Mobashiretal.16removedthefistula,makinganincision

fromthe9to3o’clockdirectionontheupperpart ofthe

tracheostomainmiddle-sizedfistulas(maximumfistulasize,

1.5cm×1cm).Theyputnon-absorbablesuturesonthe

tra-cheal and esophageal parts of the fistula and closed the

fistulaby tying.Inall patients,the fistulaclosed

success-fully,butthepatientscouldnotspeak.

Forlargefistulas,large-basedflapsandfreeflapscould

beused.The pectoralmajormyofascialflap(PMMF)13 and

radialforearmfree flaparemajortypes of flaps usedfor

largefistulas.Inthesesurgeries,therecanbemorbidityat

thedonorsites.RadialflapsaremoresuitablethanPMMFs

becausetheyarethinandshapedeasily.WithaPMMF,

dys-phagiaand constriction of the tracheal lumen may occur

becauseofthemasseffect.Witharadialforearmfreeflap,

microvascularanastomosisisneeded.Thisistechnically

dif-ficult, and the operation time is long. Also, the vascular

status of the patient is important.14 Despite this surgical

technique,theclosure oflarge-sizedfistulas couldnotbe

achievedinpreviousreports.5,13Inparticular,incaseswhere

thevesselinthepediclecouldnotnourishtheflap,closure

ofthefistulacouldnotbeachievedbecauseofnecrosis.

Analternativeapproachforalarge-sizedfistulaisa

sep-tal button.6,13,15 Septal buttons can be appliedeasily and

rapidlyandarewelltolerated.Theypreventaspirationand

pulmonaryinfections,andpatientscaneatanddrink

com-fortably. Salivary bypass tubes (Boston Medical Products,

Westborough, MA) can also be used for eating and

drink-ingin patientswithlarge fistulas. However,depending on

theduration of usage of the tube, large granulomasmay

developonthetipandfeedingcandeteriorate,13makingthe

patientuncomfortable.Anotheruncomfortablesituationis

therequirementforsuturerepairofthesalivarybypasstube

toneckskintostabilizeit.13 Forthesereasons,septal

but-tonusageis recommendedfor largefistulas, orforfailure

ofthe flapsusedfor fistulaclosure.6,13,15 When avoidance

ofsurgical morbidity is required and ifthereare medical

contraindications,thistechniquecouldberecommended.13

However,thedisadvantagesofaseptalbuttonarethatthe

patientcannotspeakagain,andtherecanbefungal

prolif-erationaroundthebutton.15

Hilgeretal.18demonstratedthetreatmentof

tracheoe-sophagealfistulasbyattachingasiliconeringtothetracheal

flangeoftheprosthesis.Theypreventedfistularecurrence

in29of32patientsbutfailedin3patients;subsequently,

in9patients,thefistularelapsedandadditional

interven-tions were needed. Therefore, in 20 of 32 patients they

obtainedsuccessfulresults,butin12 patients(37.5%)the

fistulacouldnotbetreatedusingthismethodalone.Inthis

study,foreithersmallorlargefistulas,thesametechnique

wasattemptedonallpatients.Inourstudy,2patientswith

alocalflapwhohadarelapse,2patientswhohadarelapse

aftersuturerepair,and2patientswhohadverylarge

fistu-las(6patientsintotal)receivedinterventionwithsilicone

rings.The differencebetween our technique and that of

Hilgeretal.18istheattachmentofthesiliconeringtoboth

thetrachealandesophagealflangesofthevoiceprosthesis

insteadofattachingthesiliconeringtoonlyoneside.Inthis

way,weaimedtopreventrecurrentaspiration.

EricBlomdesignedadjustable abi-flanged fistula

pros-thesis(Blom-Singer®)madefrommedical-gradesiliconefor

the management of hypopharyngeal fistulas. Our silicone

ringsaresimilartothisprosthesisbutourringsareusedto

preventtracheoesophagealfistulas. The prosthesisflanges

designedbyBlomaresoft,flexible,andtranslucentlikeour

rings.

With a septal button, the patient cannot speak again

despiteclosureofthetracheoesophagealfistula.Similarly,

(5)

speak. Also, there is a failure risk with flaps because of

necrosisoftheflaporopeningofthesuturesontheflaps.

However,usingourtechnique,thefistulawasclosedandthe

patientretainedtheabilitytospeak.Additionally,theneed

forsurgery wasprevented. Inpatients whohavereceived

radiotherapy,thesuccessrateoffistulaclosuredecreases1,14

witheitherlocalorothersurgicaltechniques.Inourstudy,

thesuccessratewasindependentofradiotherapy.However,

oneof the disadvantages of ourtechnique is the need to

preparesiliconeringseverytimetheprosthesisischanged.

Conclusions

Although we demonstrated our technique only in six

patients, we managed to treat resistant enlarged

tra-cheoesophageal fistula while preserving speech without

periprostheticleakage recurrence.According toourstudy

the use of expanded voice prosthesis with silicone rings

forlargetracheoesophagealfistulaswithpersistentleakage

appearstobeeffective.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

References

1.HosalSA,MyersEN.HowIdoit:closureoftracheoesophageal puncturesite.HeadNeck.2001;23:214---6.

2.OpdeCoulBM,HilgersFJ, BalmAJ,TanIB,vandenHoogen FJ,vanTinterenH.Adecadeofpostlaryngectomyvocal reha-bilitationin318patients:asingleInstitution’sexperiencewith consistent applicationofprovox indwellingvoiceprostheses. ArchOtolaryngolHeadNeckSurg.2000;126:1320---8.

3.Hutcheson KA, Lewin JS, Sturgis EM, Kapadia A, Risser J. Enlarged tracheoesophageal puncture after total laryngec-tomy: a systematic review and meta-analysis. Head Neck. 2011;33:20---30.

4.DayangkuNorsuhazenahPS,BakiMM,MohamadYunusMR,Sabir HusinAtharPP,AbdullahS.Complicationsfollowing tracheoe-sophagealpuncture:atertiaryhospitalexperience.AnnAcad MedSingapore.2010;39:565---8.

5.Wreesmann VB, Smeele LE, Hilgers FJ, Lohuis PJ. Closure of tracheoesophageal fistula with prefabricated revascular-izedbilaminarradialforearmfreeflap.HeadNeck.2009;31: 838---42.

6.Mirza S, Head M, Robson AK. Silicone septal button in the managementofalargetracheo-oesophageal fistulafollowing primary puncture ina laryngectomy. ORL JOtorhinolaryngol RelatSpec.2003;65:129---30.

7.HutchesonKA,LewinJS,SturgisEM,RisserJ.Multivariable anal-ysisofriskfactorsforenlargementofthetracheoesophageal punctureaftertotallaryngectomy.HeadNeck.2012;34:557---67. 8.Remacle M, Declaye XJ. Gax-collagen injection to correct anenlargedtracheoesophagealfistula fora vocalprosthesis. Laryngoscope.1988;98:1350---2.

9.LuffDA,IzzatS,FarringtonWT.Viscoaugmentationasa treat-ment for leakage around the Provox 2 voice rehabilitation system.JLaryngolOtol.1999;113:847---8.

10.KasbekarAV,ShermanIW.Closureofminortracheoesophageal fistulae with calcium hydroxlapatite. Auris Nasus Larynx. 2013;40:491---2.

11.MargolinG, MasucciG, Kuylenstierna R,BjörckG, Hertegård S, Karling J. Leakage around voice prosthesis in laryngec-tomees: treatment with local GM-CSF. Head Neck. 2001;23: 1006---10.

12.Lee LM,Razi A. Three-layer technique toclose a persistent tracheo-oesophagealfistula.AsianJSurg.2004;27:336---8. 13.SchmitzS,VanDammeJP, HamoirM.Asimpletechniquefor

closureofpersistenttracheoesophagealfistulaaftertotal laryn-gectomy.OtolaryngolHeadNeckSurg.2009;140:601---3. 14.KochM,ZenkJ,BirkS,AlexiouC,IroH.Surgicalclosureof

per-sistenttracheoesophagealfistulasbyesophagealsuturingand cranialtransposition ofthe trachea. Otolaryngol Head Neck Surg.2010;143:843---4.

15.WongBY,KurianM,ChidambaramA.Alternativemanagement ofleakingtracheoesophagealfistulaafterlaryngectomyusing nasalseptalbutton.ClinOtolaryngol.2011;36:97---9.

16.MobashirMK,BashaWM,MohamedAE,AnanyAM.Management ofpersistenttracheoesophagealpuncture.EurArch Otorhino-laryngol.2014;271:379---83.

17.JacobsK, DelaerePR,VanderPoorten VL.Submucosal purse-stringsutureasatreatmentofleakagearoundtheindwelling voiceprosthesis.HeadNeck.2008;30:485---91.

Imagem

Figure 1 (a) Schematization of expanded voice prosthesis with silicone rings. (b) Silicone rings and prepared expanded voice prosthesis.

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