0304 Studio.docx

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0304Studio

UniversitàdegliStudidiPalermo

AziendaOspedalieraUniversitariaPoliclinicoP.Giaccone

DipartimentodiChirurgiaGenerale,d’UrgenzaedeiTrapiantid’Organo（GENURTO）

UnitàOperativaComplessadiChirurgiaGeneraleed’Urgenza（Direttore:

Prof.G.Gulotta）

ViadelVespro,129–90127PALERMO

Earlyapplicationsofanewtissuesealingsysteminthyroidsurgery

GregorioScerrino,NunziaCinziaPaladino,GiudittaMorfino,ValentinaDiPaola,GiuseppeSalamone,GaspareGulotta

ThispaperwaspresentedattheIIIbiennalCongressofEuropeanSocietyofEndocrineSurgeons,Barcelona,April24–26,2008

CorrespondingAuthor:

GregorioScerrino

ViaA.DeGasperi,53–90146PALERMO（Italy）

Tel.00390916552807/6552814/515892

Mobilephone:

00393288105607

Fax:

00390916552831/6552814

ieronimus141160@yahoo.it

gregorio.scerrino@tiscali.it

Summary

BackgroundandAims:

.Werecentlyperformedmanythyroidectomiesusingadevicethatsimultaneouslyusesheatandpressureforweldingandcuttingtissue.Weevaluatepreliminaryresultsusingthistoolinthyroidsurgery.

Patients/Methods:

Aperspectiverandomizedstudywasconductedon68patientssubjectedtototalthyroidectomyforbenignnodularnontoxicgoiter:

34patients（groupA）usingthermocautery,34withclamp-and-tietechnique.Thetwogroupswerecomparabletoaverageage,sex,thyroidalvolume（25-50ml）,incision（<35mm）.Weevaluatedsurgicaltime,complications,postoperativeserumcalciumlevels,drainage,complications.ThecomparisonhasbeendonebytStudenttest.

Results:

Theaverageoperativetimewas52.85minutesinGroupAand60.26minutesinGroupB（p<0.0001）.Thedifferenceamongcalciumlevelswassignificantly（p=0.02）.Nocomplicationwasfoundinthetwogroups.Theaverageamountofdrainagewas60.9cc.（GroupA）and63.8cc（GroupB）.

Conclusions:

Thermocauteryhasprovedsafeandeffectivetoreduceoperativetimeandtheincidenceofpostoperativehypocalcaemiaminimizingnecrosisandthermaldiffusion.Maniples‘costforeverypatientisalsooffsetbyreduceduseofligatures.TheapplicationinMIVATispossible.Furtherinvestigationsarerequiredtoconfirmasafehemostasisandthereducedheatspread.

Keywords:

electrosurgery;thermalspread;hemostasis;thyroidectomy;thermocautery

Introduction

Todaythyroidsurgery,whichstartedoutbetweentheendoftheXIXandthefirstdecadeoftheXXcentury,isbeingdiscussedespeciallyasfarastheextentoftheresectionisconcerned（lobectomy,sub-totalortotalthyroidectomy）andtheindicationtomini-invasivetechniques.

Nevertheless,thereisawideconfrontationaboutthenewtechnologiestoincreasesurgery’ssafetyand,atthesametime,toreduceitsimplementationprocedures.

Amongthetechnologieswhichhaveprobablyinfluencedthyroidsurgeryresultsbothonthereductionofrisksandthecomplicationsderivingfromthereductionofsurgeryduration,theremustbeincludedthesocalled“energybasedsurgicalinstruments”（ESI）.Theyaredifferentequipments,whichtransformelectricenergyintootherformsofenergy（ultrasounds,radio-frequencies,etc.）whicharethentransformedintoheat（1-2）.Generally,weesteemthattheESIavailableatthemomentwasteenergyinthesurroundingtissuesinanextremelylimitedwayand,inanycase,remarkablyinferiortotheelectro-surgerytraditionalinstruments（3）.

Theuseofheatwiththeaimtodetermineasafehaemostasisisacontroversialpoint,whichconcernsespeciallytwotopics:

thetrueefficacyofthedeviceinuse,whichideallyshouldproduceahealingofthevesselsinordertoresisttopressurevaluesmuchhigherthanthoseattainabledirectly“invivo”（1-4）,andtheriskthata“thermalspread”excessivelyextendedbeyondthelimitsofitsapplicationmaycauseamoreorlessreversibledamagetoparathyroidglandsandlaryngealnerves（4-5-6-7）.

Ourexperiencewithsuchkindofsurgeryinstrumentsisextendedtoallthemainvarietiesavailableonthemarket.

Inthelastperiod,atourunitwehavebeenusinganinstrumentbasedontheexclusiveanddirectheatproduction,StarionTissueWeldingSystem®,endowedwithahandtoolTLS2140mmlong,producedbyStarionInstruments（Sunnyvale,California）.Theheatissuppliedbyadistributorequippedwithaknobforthepowerregulation,anditisconcentratedonthetopofthetoolhavingtheshapeofforceps,withahandleconstitutedofatworingholder,astem,andlittlethinjawscontainingtheactivepart,astainlesssteelfilament,responsiblefortheheatproduction.

Thissystemenablesustousetwodifferentpowers,whichcanbechosenthroughadifferentpressureappliedonaspeciallyprovidedbuttoninsertedintheholder:

theinferiorpower,onthefirstrelease,canberegulatedbyhand,whilstthehighestpowerproductiontakesplaceonthesecondbuttonrelease.

Thecharacteristicsdeclaredontheinstrumentare:

*thecapacitytodeterminehaemostasisandtodissecttissues;

*theabsenceofapassageofelectricitythroughtissues;

*thelowestthermalspread;

*thelowestwatervapourandsmokeproduction.

Thecapacitytodeterminehaemostasisanddissectionsimultaneously,determinesundoubtedlyapracticaladvantage,especiallyifcomparedwithotherenergybasedinstrumentswhich,thoughproducinganextremelysafeandsuccessfultissuesynthesis,needasubsequent“cutting”,whichcanbedoneormanuallydirectlybythesurgeon,oralthoughthroughthesameinstrument,byanadditionalmechanictool.

Theelectricspreadmightberesponsibleforcarbonizationphenomena,producingaminorhaemostasisefficacy,especiallyfortheformationofaneschar,exposedtoadetachmentandconsequentreopeningofthehaemorrhagichotbedaccompaniedbypainproduction.

Thepossibledamagederivingfromthermalspreadevenafteralongspanoftime,hasalreadybeenmentioned.

Smokereductionrendersresortingtofurthermini-invasivetechniquessafer.

Theavailabilityofthisequipmenthasledustocheckitscharacteristics,qualitiesandflawsdirectlyintheatre.

Materialsandmethods

Applicationofthermaltechnology,firstofallisbasedonverifyingoftheoreticassumptions,bothonitssecurityanditsactualuse.

Measurementsconcerningtheelectricspreadofthesystemhavebeenmadeatourcentreafteranappropriatetrainingonhowtousethenewtechnology.Besidessomehistologicalcompoundshavebeenmadetoshowthechangesthatthisapplicationmaycauseonthevessels.Intheendwehavecarriedoutarandomizedperspectivestudy,on68patients,alloffemalesex,sufferingfromnon-toxicmultinodulargoitre,forwhomatotalthyroidectomyhasbeenplanned.

Thefinalcriteriawere:

-presurgicaldiagnosisofamultinodulardisease,showingnosignofmalignancy;

-thyroidsizeincludedbetween25and50ml.;

-nocoagulationalteration;

-notherapyinterferingonhaemostasis;

-nopreviousanti-thyroiddrugs;

-noanti-thyroidantibodies;

-nomalignancysuspicionafterFNAB.

Inthe12-18hoursbeforethesurgicaloperationcalcitriolhasbeengiveninaone50mcgdose.

Allthepatientshavebeensubjectedto“traditional”totalthyroidectomy,withanincisioninferiorto35mm.Attheendofthesurgeryasinglesmallsize（10Ch.）suctiondrainagetubehasbeenapplied,incorrespondencewiththethyroidcavity,where,ahaemostaticpatch（Collagen-Thrombin）hadpreviouslybeenapplied.

Thepatientsrecruitedforthisstudyhavebeendividedintotwogroupsof34people,A（inwhichthyroidectomyhasbeenwhollyconductedwiththermocautery）andB（inwhichthesurgeryhasbeenconductedwhollythroughthe“clampandtie”classicaltechnique）comparablewitheachotheraccordingtotheirage（groupA:

average=47,2,range27-61;groupB:

average=51,09,range24-60）andthesizeoftheirthyroid（groupA:

average=32,45ml,range25-47;groupB:

average=30,72ml,range25-50）measuredinthepre-operativetimeaccordingtotheultrasoundcriteria:

dlXdtXsX0,5,where:

dlisthelongitudinaldiameterofthelobe,dtisthetransversaldiameter,sisthelobethickness;0.5isacorrectionfactorusedtoassimilatetheobtainedamount（onavirtuallevel,thatofaparallelepiped）intheellipsoid.Thecalculationofthelobesizehasbeenmadeseparatelyandthevalueshavebeenaddeduplater.

IngroupAthermocauteryhasbeenusedstartingfromtheseparationofthepre-thyroidalmusclesalongthe“lineaalba”.Thesectionoftheupperpedicleshasbeenexecutedsystematicallythroughthedeviceandthehigherthecalibreofthevesselstreatedwas,thelessthepowerusedwas（generally,inthisphaseaquitelowpowerlevelwasused,whichrenderedthesynthesisphaselonger,keepinghowever,gratersecuritylevels）（fig.1）.Besidesthedissectionofthemediumandofthesubistmicveinshasbeencarriedoutatamediumpower.Thedissectionbetweenmusclesandthyroidtogetherwiththemedianligamenthasbeengenerallyperformedathighpower.Somebindings（2-3foreachlobe）wereappliedonlywhenthedistanceoftherecurrentnervevisiblewasnotguaranteedabsolutelybyathermalspread.

TheBgrouppatientsweretreatedthroughtheclassicaltechnique:

themusclesectionalongthe“lineaalba”hasbeenmadewithaunipolarelectrosurgicalknife,whilstinpractiseallthedissectionoperations,startingfromthepreparationoftheupperpedicles,totherecurrentlaryngealnervedissectionphaseandtothedetachmentoftheglandfromitssite,hasbeenmadewithoutheating,ifnecessarywiththeapplicationofbindings.Theupperpedicleshavebeentreatedwithadoubleresorptionbinding.

Allthepatientshaveundergoneafibreopticlaryngoscopeduringthe24hoursafterthesurgicalprocedure,andtheyhavebeendischar