50119thStreet,TrusteeTowers FORTSANDERSWOMEN’SSPECIALISTS 1924PinnaclePointWaySuite401,KnoxvilleTn37916 P#865-331-1122F#865-331-1976 Suite200,KnoxvilleTn37922

Dr.CurtisElam,M.D.,FACOG,AIMIS,Dr.DavidOwen,M.D.,FACOG,Dr.StevenPierceM.D. Dr.DeanTurnerM.D.,FACOG,ASCCP,Dr.F.RobertMcKeownIII,M.D.,FACOG,AIMISDr.BrookeFoulk,M.D.,FACOG,Dr.G.WaltonSmith,M.D.,FACOG,Dr.SusanRobertsonM.D.,FACOG

ROBOTICASSISTEDLAPAROSCOPICSUPRA-CERVICALHYSTERECTOMY

Pleasereadandsignthefollowingconsentformwhenyoufeelthatyoucompletelyunderstandthesurgicalprocedurethatistobeperformedandafteryouhaveaskedallofyourquestions.Ifyouhaveanyfurtherquestionsorconcerns,pleasecontact

ourofficepriortoyourproceduresothatwemayclarifyanypertinentissues.

Definition:RoboticAssistedLaparoscopicSupra-CervicalHysterectomyisanoperationtoremovetheuterus(womb)withtheaidofthedaVinciRoboticLaparoscopicsurgicalsystem.Thecervixremainsattachedtothevaginaandisnotremovedduringtheprocedure.Theuterusisremovedbyusingseveralminiaturizedwristedinstruments,insertedthroughsmallincisions,thatareguidedbyasurgeonusinga3Dcamera.Ahysterectomydoesnotrequiretheremovaloftheovaries;howevertheovariesand tubes can be removed at the time of the hysterectomy if medically necessary. Supra-cervical hysterectomy is notrecommended forpatientswhohaveprecancerouscervicalcellsorgynecologicalcancers.TheRobotdoesnotperformthesurgerybutisratheratooldesignedtoassistthesurgeonashe/shecontrolsthemovementoftheroboticarms.

Procedure: Aftersedationfromgeneralanesthesiaisachieved;thedoctorwillmakethreetofivesmallincisionsinthelowerabdomentoallowthesurgeontoinserta3Dhigh-definitioncamera/laparoscopeandtheminiaturizedwristedinstruments.ThroughthedaVincirobotic-computerconsole,thesurgeonviewsamagnified3Dimageofthesurgicalsiteinsideyourbody.ThedaVincirobotictechnologytranslatesthesurgeon’shandmovementsintoprecisemicro-movementstomanipulatethepelvicorgans.Carbondioxidegaswillbeusedtoinflatetheabdomentoallowthedoctortoinsertthelaparoscopeandvisualizetheabdomen/pelvis.Throughtheguidanceofthelaparoscopetheuteruswillbefreedfromligamentsandsurroundingbloodvessels.Thetopoftheuterusiscutfreefromthecervixandthecervixremainsinsidethebodyandattachedtothevagina.AninstrumentcalledaMorcellatorwillbeusedtodividetheuterusintosmallsectionsthatarethenremovedfromthebodythroughoneoftheabdominalincisions.Bloodvesselsarethentied,stapledorcauterized,thenecessarylayersoftheabdomenandskinaresutured,anddressingsareplacedovertheincisionsites.

Diagnosis:ThemostcommonreasonstohaveaRoboticsupra-cervicalHysterectomyare:Fibroids-noncanceroustumorsthatcausepelvicpain,heavyandabnormaluterinebleeding,painful intercourse,orother symptoms.Endometriosis- growthofuterine lining inotherpartsof theabdomenoruterinemuscle (adenomyosis) thatcausespelvicpain.Uterineprolapse-thedownwardmovementoftheuterusintothevagina.Yourphysicianwilldiscussyourdiagnosiswithyoupriortosurgeryanditwillbedocumentedinyourmedicalrecord.

ExpectationsofOutcome:ARobotic Supra-cervicalHysterectomy typically takes1-2hours.Whenyouawake fromsurgeryyouwillhaveanIVandyoumayhaveabladdercatheter.Somepatientswillgohomethesamedayassurgerywhileothersmaystayonenightinthehospitalandwillbedischargedonthedayaftersurgery.Roboticsupra-cervicalHysterectomyisamajorsurgeryandrecoverytypicallytakes2-4weeks.Followingtherecoveryfromahysterectomy,itisexpectedforwomentohave relief frompainandcorrectionofabnormaluterinebleeding.Youwillhaveapathology report todiscusswith thedoctoranddetermineifanyfurthertreatmentisnecessary.Ifuterineprolapsewasanissuepriortosurgery,thosepatientsshouldhaverelieffromvaginalpressureandpelvicpain.

PossibleComplicationsoftheProcedure:Allsurgicalprocedures,regardlessofcomplexityortime,canbeassociatedwithunforeseenproblems.Theymaybeimmediateorevenquitedelayedinpresentation.Whilewehavediscussedtheseandpossiblyothersinyourconsultation,wewouldlikeyoutohavealistofsomespecificcomplicationssothatyoumayaskquestionsifyouarestillconcerned.Asidefromanesthesiacomplications,alistofpossiblecomplications,wouldinclude,butarenotlimitedto:

•OrganInjury:Duringanypartoftheprocedure,anyorganintheabdomenorpelvis(liver,spleen,colon,intestine,bladder,stomach,ureter,etc)canbeinadvertentlyinjured.Oftentheinjuryisminorandcanbetreatedwithrelativeease;howeveriftheinjuryismajorortherepairiscomplicated,moreextensivesurgerymaybenecessary.Thismayprolongthehospitalstayandrecoveryandmightalsonecessitateadditionalsurgicalproceduresinthefuture.Whilerobotic/larparoscopichysterectomieshavealowerincidenceofcomplicationsformostinjuries;Ureteralinjuryisstatisticallyhigherinrobotic/laparscopichysterectomyvsabdominalhysterectomy.Theriskisapproximately3-4%.Ureteralinjuriesfromelectricalcauteryinstrumentsmaynotbecomeobviousfor7-21daysaftersurgery.Yoursurgeonmaylookintoyourbladderneartheendofyoursurgerytomakesurethaturineisenteringthebladderfrombothureters.ToeasevisualizationoftheurineyoumaybegivenanIVdyethatwillturnyoururineblueforseveralhours.Bylookinginthebladder,theriskofunrecognizedureteralinjuryisloweredbutnoteliminated.

•Infections:AlthoughprophylacticantibioticsaregiventhroughyourIVpriortosurgery,postoperativeinfectionscanstilloccur.Themostcommontypeofinfectionisabladderinfection(UTI).AUTIcancauseburningwithurination,increasedurinaryfrequency,bloodintheurine,pelvicorbackpain,feverandorchills.Awoundinfectioncanalsooccurintheincisionsitesontheabdomen.Ifaninfectionispresent,theincisionwillbered,warmtotouchandpossiblyoozingabrownodorousdischarge.Pneumoniaisaninfectioninvolvingthelungs.Pneumoniamayoccurfromlackofdeepbreathingaftersurgeryduetopainfromtheincisionsites.Earlyambulationanddeepbreathinghelpstoreducetheriskofpneumonia.Apelvicabscessiswhenaninfectionoccursatthetopofthevaginaortheareawheretheuteruswasremovedfrom.Fevermorethan100degrees;increasingpain,severeconstipation,andmalodorousvaginaldischargecanbesignsofthistypeofinfection.Whilerare,sepsisisanotherinfectionthatcanoccur.Sepsisiswhentheinfectionentersthebloodstreamandcanmakeyouveryill.Sepsissymptomsusuallyinclude:fever,chills,weakness,nausea,vomitingandorconfusion.Ifanyoftheabovesymptomsofinfectionoccur,callouroffice.

•VascularInjury:Anyofthevesselsinsidetheabdomenareatpotentialriskforinjuryduringahysterectomy.Inadvertentinjurytoabloodvesselcanoccurasinstrumentsareintroducedintotheabdomen,duringdissectionoftheuterusfromthesurroundingtissues,orfromelectricalinjurytothevesselwall.Anothertypeofvascularinjuryoccurswhenthesealedorsuturedvesselcomeslooseaftertheprocedurehasbeenfinished.Mostoftheseinjuriesarerecognizedandresolvedatthetimeofsurgery.Majorvesselinjuryordelayedbleedingmayrequireadditionalsurgery,prolongedhospitalstayandrecovery,readmissiontothehospital,andbloodtransfusion.

•BloodLoss/Transfusion:Thevaginalregionisvascular.Usuallythebloodlossinthisprocedureisminimaltomoderate.Insomecasesbloodlosscanbesignificantenoughtonecessitateabloodtransfusion.Ifatransfusionisnecessary,thereisasmallriskofbloodrelatedinfectionssuchasHepatitisorHIV.

*CancerSpread:IftheUteruscontainsafibroidtumorthenthechancethattheFibroidcouldrepresentacancercalledLeiomyosarcomaisapproximately.25%(.23%to.27%).Ifanunanticipatedcancer(Ovarian,Endometrial,FallopianTube,orLeiomyosarcoma)weremorcelatedbyknifeorpowerequipmentthenthecancerwouldbeupstaged.Thisincreasesthepossibletreatmentsneeded(suchasadditionalsurgery,Chemotherapy,and/orRadiation)andcanincreasetheprobabilityofcancerspread,recurrence,andcancerdeath.

•PainfulIntercourseandVaginalShortening:Supra-cervicalhysterectomyretainsthenormalanatomyatthetopofthevagina.Itisthoughttoimprovethesupportofthevaginaanddecreasethepossibilityfordiscomfortwithintercoursefollowingsurgery.However,thedepthofthevaginamaybelessenedandtheanglechanged,causingsomewomentocomplainofpainordifficultywithintercourseaftersurgery.Thispainmaybetemporaryorpermanent.Itisextremelyimportanttonotresumeintercourse(vaginalpenetration)untilreleasedtodosobyyoursurgeon.Ifyouhavesuddenonsetofwateryorbloodydischargebeyondwhatalightsanitarypadwouldtakecareof,thencallouroffice.

•Hematoma:Whenasmallbloodvesselcontinuestobleedaftertheprocedureisover,theareaofcollectedbloodisreferredtoasahematoma.Thebodynormallyre-absorbsthiscollectionoverashortperiodoftimeandsurgicaldrainagemaybenecessary,however,thisisrare.

•ChronicPain:Withanyprocedure,apatientcandevelopchronicpaininanareathathasundergonesurgery.Typically,thepaindisappearsovertime,althoughsomefeelingofnumbnessmaypersist.

•DeepVeinThrombosis(DVT)/PulmonaryEmbolus(PE):Inanyoperation(especiallylongeroperations),youcandevelopaclotinaveinofyourleg(DVT).Typically,thispresentstwotosevendayspostopaspain,swellingandtendernesstotouchinthelowerlegarea.Althoughlesslikely,thisbloodclotcanmovethroughtheveinsandblockoffpartofthelung(PE).Thispresentsasshortnessofbreathandchestpain.Ifyounoticeanyofthesesigns,callouroffice.

•LowerExtremityWeakness/Numbness:Whilethisisrare,itispossiblethatduetothepositioningofyourlegsinthelithotomyposition(legsintheair/stirrup)foralongperiodoftimeordirectinjurytonervesbysurgicalinstruments,youmaydevelopweaknessornumbnessinyourlegs.Itisusuallyself-limited,withareturntobaseline.

•ScarTissue/Hernia:Scartissuecanformwithintheabdomenand/orpelvisandcauseadhesions.Adhesionscancreatepelvicpain.RoboticandLaparoscopicproceduresalsocarrytheriskofcreatinganincisionalhernia;whereabdominaltissueprotrudesthroughthemuscleattheincisionsite.

•CervicalBleeding/PapSmears:Afterasupra-cervicalhysterectomyitispossibletohavebleedingfromthecervix.Thereisasmallamountofglandulartissuewithinthecervixandapproximately10%ofwomenwillexperiencelightbleedingorspottingonamonthlybasis.Thebleedingusuallyoccursduetothemonthlychangeinhormones,butcouldoccurduetomoreconcerningproblems.Ifcyclicspottingisunacceptabletoyouthenyoushouldhaveyourcervixremovedatthetimeofsurgery.ItisimportanttomaintainpapsmearscreeningasrecommendedbytheAmericanCancerSocietyandtheAmericanCongressofObstetricsandGynecology.

•PermanentInjury/Death:Permanentinjuriesfromsurgeryarerarebutdooccur.Permanentinjuriesmayinvolveremovaloforgansnotplannedduringtheoriginalsurgery,painthatdoesnotresolvewithtime,ordiminishedabilitytoenjoylife.DeathisextremelyrarefromGynecologicsurgerybutdoesoccur.Themostcommonreasonsaremassivebloodloss,overwhelmingsepsis,heartattack,DVT/Pulmonaryembolus,stroke,andanesthesiacomplications.

AdditionalProcedures/Consultations:Ifthereareunanticipatedfindings,difficultyduringthesurgery,orasituationwhereyourdoctordoesnotbelievethathehastheexpertisetoaccomplishallofyourcasethenanintra-operativeconsultationmaybenecessary.Intra-operativeconsultationiswhenanotherphysicianorsurgeonisaskedtogiverecommendations,assistortakeoverasurgicalcase.Thisoccursatyourdoctor’sdiscretionforyoursafetyandwithoutregardtowhethertheotherphysicianisonyourinsurancepanel.Bysigningbelowyougiveconsenttointra-operativeconsultationsifnecessary.

Photographs/Recordings:Stillphotographsanddigitalrecordingsofyoursurgerymayoccurfordocumentationofintra-operativefindingsorforeducationalpurposes.

Consent:I,Dr._________________________,havecounseled___________________________________________regardingherplannedsurgery.InmyprofessionalopinionIbelievethatthesurgeryisreasonableandmostlikelywillresultinabeneficialoutcome.Itismybeliefthatthepatienthasconsideredheroptionsandfullyweighedtherisksofsurgery.

Signed__________________________________________________Date____________________Time______________

I,____________________________________________________,believethatthesurgicalprocedurelistedaboveisthebestoptionforme.MysituationisnotanemergencyandIunderstandthatIhaveotheroptions,includingnothavingsurgery.Iunderstandthatcomplications,badoutcomes,andunanticipatedeventswilloccuroccasionallyduringsurgeryandrecovery.IunderstandthatmydoctorandhissurgicalteamarenotperfectandatnopointhaveIbeenguaranteedanyoutcomesorresults.IhavebeengiventheopportunitytoaskallmyquestionsandIbelievethatIhavealltheinformationnecessarytomakeareasonabledecision.Therefore,Ielecttogivemyconsentandproceedwiththeabovesurgery,aswitnessedbymysignaturebelow.

PatientSignature___________________________________________________________Date_________________

WitnessSignature___________________________________________________________Date_________________