Robotic transvaginal natural ori fi ce transluminal endoscopic surgery for bilateral salpingo oophorectomy
Lior Lowenstein
a,b,*
,1, Emad Matanes
a,b,1, Zeev Weiner
a,b, Jan Baekelandt
caDepartmentofObstetricsandGynecology,RambamHealthCareCampus,Haifa,Israel
bRuthandBruceRappaportFacultyofMedicine,Technion,Haifa,Israel
cGynecologicalOncologyandEndoscopy,ImeldaHospital,Bonheiden,Antwerpen,Belgium
ARTICLE INFO
Articlehistory:
Received26March2020
Receivedinrevisedform19June2020 Accepted22June2020
Availableonline23June2020
Keywords:
Robotictransvaginalsurgery
Roboticvaginalnaturalorificetransluminal endoscopicsurgery(RvNOTES)
NOTES
Bilateralsalpingo-oophorectomy(BSO) Gynecology
ABSTRACT
Objectives:Thevaginalsurgicalapproachhasnotbecomethestandardofcare,despiteitsadvantages.The HominisTMSurgicalSystemisahumanoidshapedrobot-assistedsystemthatwasdesignedspecifically forroboticvaginalnaturalorificetransluminalendoscopicsurgery(RvNOTES).Weaimedtopresentour experiencewiththefirstRvNOTESbilateralsalpingo-oophorectomy(BSO)performedbytheHominis system.
Study design: A two-center prospective study of BSO by RvNOTES in womenwith nonmalignant indicationsconductedbetweenAugustandDecember2018.Womenolderthan18yearswereofferedto participate. Exclusion criteria included a history of abdominal malignancy, pelvic or abdominal irradiation,Crohn'sdisease,pelvicinflammatorydisease,severeinfectionsinthelowerabdomen,active diverticulitis,deepinfiltratingrecto-vaginalendometriosis,andanactivevaginalinfection.Theprimary outcome of the studywas the rate of conversion to openor laparoscopicapproaches.Secondary outcomesincludedintra-andpostoperativeadverseevents,operativetime,estimatedbloodloss,length ofhospitalstay,and6-weekfollow-upassessment.
Results:Eightwomenaged50–70yearswithBMIof19–30kg/m2wererecruited.Alltheprocedureswere completedsuccessfullywithout conversionstoopensurgery.Nointraoperativecomplicationswere observed.Medianbloodlosswas10mL(range:10 50).Themediandurationoftheprocedurewas45 min(range:38 91),anddecreasedoverthestudyperiod.Surgeons’usabilityassessmentwasvery favorable,withamedianof5ona1–5scale.Themedianvisualanalogscale(VAS)scorewas1(range:1–
3).
Conclusions: This is the firstdocumentation of a surgery performed via the vagina usingrobotic instrumentationdevelopedforthispurpose.ThedisruptivetechnologyofRvNOTES,withitsfastlearning curve,willmakegynecologicalsurgeriesaccessibletomorewomen.
©2020TheAuthors.PublishedbyElsevierB.V.ThisisanopenaccessarticleundertheCCBY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction
Over thelast two decades, greater sophistication of instru- mentationhasgivenrisetolaparoscopicandrobotically-assisted proceduresfordiversesurgeries[1].Inparallel,smallerandmore natural surgical ports have been used, thus requiring less incisions. Together, these developments have yielded less
invasivesurgeries,withsaferandbetterpatientoutcomes,such as shortenedhospitalizationandpostoperative recovery times, reduced postoperative pain and risk of infection, and better cosmeticresults[2,3].Nonetheless,thechallengesofmaintaining adequatevisionandcontactoftargetorgansremain.Laparoscopic surgery poses such disadvantages for the surgeon as limited dexterity, loss of depth perception, camera instability, hand tremor, awkward movement of instruments and camera, poor ergonomics, andfatigue [4,5].FDA approval in2000 of theda Vinci Surgery System, the first robotic system for general laparoscopic surgery, has yielded improvements in these parameters[6].However,studies conductedonroboticsurgery invariousprocedureshavenotshownoverwhelmingadvantages inpatientoutcomes[7,8].Thecurrentevidence,togetherwiththe
* Correspondingauthorat:DepartmentofObstetricsandGynecology,Rambam HealthCareCampus,Haifa,Israel.
E-mailaddresses:[email protected],[email protected] (L.Lowenstein).
1 Equalcontributors.
http://dx.doi.org/10.1016/j.eurox.2020.100113
2590-1613/©2020TheAuthors.PublishedbyElsevierB.V.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/4.0/).
ContentslistsavailableatScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology: X
j o u r n al h o m e p a g e : w w w . el s e v i e r . c o m / l o c a t e / e u r o x
risks associatedwith port placementand the bulky apparatus suggestthatthefull potentialof roboticsurgery hasyettobe realized.
Comparedtoconventionallaparoscopy,vaginalnaturalorifice transluminal endoscopic surgery (vNOTES) has developed as a single-accessapproach,withtheobjectiveofobviatingthetrauma thatarisesfromabdominalwallaccess.vNOTEShasbeenfoundto be associated with reduced complications, postoperative pain, hospitalizationstayandrecoverytime,whileavoidingascar[9,10].
Ingynecologicalsurgery,thevaginalapproachiswellestablished andoftenrecommended.Forexample,vaginalaccessisconsidered the preferred option for benign hysterectomy, when feasible [11,12].Vaginalaccessisconsideredfeasibleinmorethan60%of hysterectomies for benign indications [13], including women withoutpreviousvaginaldelivery[14].However,thisapproachis underutilized in gynecological surgery due to the restricted surgical space, the lack of exposure and the limited training [15].Indeed,theproportionofvaginally-feasiblehysterectomies performedbyotherapproachesincreasedsincelaparoscopicand robot-assistedlaparoscopicsurgeriesbecamepopular[13,16];the consequenceislongeroperativetimeandhigherinfectionrates.
Thistrendsuggeststhatmoreappropriateinstrumentationcould increaseutilizationofthevaginalapproach.
Robotic-assistedtransvaginalNOTES(RvNOTES)isadisruptive technology that provides the technical capabilities that will encouragesurgeonstopreferproceduresthroughnaturalorifices, thus bridging the gaps of both robotic-assisted surgery and conventional vNOTES. RvNOTES realizes the full potential of roboticsurgeryandfacilitatesperformingproceduresvianatural orifices,withalltheassociatedadvantagestopatients.RvNOTES overcomeschallengesofvaginaaccess,suchasdistancefromthe target site and technical difficulties related to the single-port.
RoboticsystemsweredemonstratedinvNOTESinanimalmodels [17,18].Thefirsthumancasesoftransvaginalroboticsurgerywere presentedbyDr.J.Baekelandtatthe7thAnnualSERGSmeetingon RoboticGynaecologicalSurgeryinIstanbulinJune2015.
In anattempt toovercome the shortcomingsof thevaginal approach, Memic Innovative Surgery Ltd developed a robotic- assisted surgical system that combines the advantages of laparoscopic surgery, robot-assisted surgery, and the vaginal approach.TheHominisTMSurgicalSystemisahumanoidshaped robot-assistedsystemthatwas designedspecificallytofacilitate vNOTES procedures and to make the performance of robotic surgeryasnaturalaspossible.Accordingly,thehighlyarticulated humanoidshaped Hominis ArmsTM mimic the surgeon's entire upperextremity(shoulder,elbow,andwristjoints).Thesurgeon
controlsthearmswithtwojoysticksthatareverysimilarintheir structure to the mechanical arms and end-effectors. Here we demonstrate the technology of RvNOTES, using the HominisTM SurgicalSystem(MemicInnovativeSurgeryLtd.,OrYehuda,Israel), onvaginal bilateral salpingo-oophorectomy (BSO) indicated for nonmalignantetiology.
Methods
Studydesignandpatients
ThisisareportofeightwomenwhounderwentBSObyrobotic vNOTESattwosites:RambamHealthCareCampus,Haifa,Israel(N
= 7) and Imelda Hospital, Bonheiden, Belgium (N = 1), during August– December2018. Thestudywas approvedbythelocal ethics committeesof both institutions (RMB 18-0421)(Imelda:
180519).
Studyinclusioncriteriawere:age18–75years,BMI<40kg/m2, anindicationforBSO,andwillingnessandsuitabilitytoundergo RvNOTESundergeneralanesthesia.Womenwereconsiderednot suitable to undergo the procedure if they had a history of abdominalmalignancyordisease,pelvicorabdominalirradiation, chronic abdominal pain, Crohn's disease, pelvic inflammatory disease, severe infections in the lower abdomen, diverticulitis, frozen pelvis or deep infiltrating recto-vaginal endometriosis, previousvaginalsurgery,noprevioussexualintercourse,reduced accesstothevagina,oranactivevaginalinfection.Suitabilityfor undergoing the procedure was ultimately determined by a diagnosticlaparoscopy, through a 5mm entryat theumbilical site. Accordingly, thesurgeon insertedthelaparoscopic camera throughtheumbilicustoinspecttheanatomyandsuitabilityfor vaginalaccess.
All the women who underwent procedures that used the HominisTMSurgicalSystemwereinvitedforafollowupvisitatsix weekspostoperative.Thisvisitincludedaphysicalexamandthe recordingofadverseeventssincetheprocedure,andsymptomsof rectalorbladderinjury.
TheHominisTMSurgicalSystem
TheHominisTMSurgicalSystemis anendoscopicinstrument controlsystemthatisintendedforsinglesite,transvaginalsurgical procedures. The System consists of sterile (disposable and reusable)componentssuchastheHominisArmsTMandtheGYN TrocarKit,andnon-sterilecapitalequipmentsuchastheControl Console and the Motor Units (Fig. 1). The Arms are inserted
Fig.1.HominisTMSurgicalsystemcomponents:HominisArmsTMandControlConsole.
transvaginallythrough the posteriorfornix tothe pelviccavity (Fig.2),retroflexedtowardsthepointofentry(Fig.3).Thisenables performingtheprocedurewithalaparoscopicpointofviewand reachingvariousstructuresinthepelviccavity,inamannernot possiblewithtraditionalmanualvaginaltools.Foraccuracyand user-friendly capacity, each Arm corresponds tothe respective
handofthesurgeonascontrolledbytherightandleftJoysticks.
TheArmsincludearigidsection(shaft)andaflexiblesection;the latteriscomposedofthreejoints,accordingtothedesignofthe humanarm:Shoulder,Elbow,andWrist.BothShoulderandElbow jointscanrotateandflex(Fig.4).TheWristjointcanrotateabout its axis.EachJoystick hasthree correspondingjoints:Shoulder, Elbow,andWrist,suchthateachHominisArmTMmovesaccording totheJoystick'smovement.EffectorsatthedistalendsoftheArms enablegrasping,bluntdissection,approximation,andelectrosur- gery.
TheHominisTMControlConsoleis themainHuman Machine InterfacefortheHominisTMSurgicalSystem.Thesurgeonisseated and controlsthe Hominis ArmsTM through two Hominis Motor Units.TheMotorUnitscontainmotors,sensors,drivers,andthe electronicboardrequiredtodrivetheHominisArmsTM.EachMotor UnitdrivesoneArmandconnectstheArmstoanelectrosurgical generatorthroughtwoconnectors,oneformonopolarenergyand anotherfor bipolarenergy.TheMotorUnits housea motorized prismaticjointthatenablescontrolledlinearmotiontoinsertor extracttheArmsfromthepelviccavity.Themovementisoperated viatheJoysticks.TheMotorUnitsareattachedtothesurgicaltable usingaSurgicalFixationArmandcoveredwithasterilecover;and arethusnotincontactwiththepatient.Alternatively,theMotor Unitscanbeattachedtoacartasafloormountedsystem.
Fig.2.TheGYNTrocarKitisinsertedtransvaginallythroughtheposteriorfornixtothepelviccavity.
Fig.3. TheHominisArmsTMareretroflexedtowardsthepointofentry,therebyenablingperformingtheprocedurewithalaparoscopicpointofviewandreachingvarious structuresinthepelviccavity.
Fig.4.HominisJoysticksTMcomponents:rigidsection(shaft)andaflexiblesection;
thelatteriscomposedofthreejoints,accordingtothedesignofthehumanarm:
Shoulder,Elbow,andWrist.
Thesurgicalprocedure
Allthesurgerieswereperformedbytwoprimarysurgeons:L.L (Israel)andJ.B(Belgium),whowereassistedby2residentseach.
ThesurgicalprocedureusingTheHominisTMSurgicalSystemwas performedsimilarlytostandardtransvaginalsurgery.Thesurgical area and transvaginal access were prepared by the site staff according to standard of care. Following insertion of the two robotic Hominis ArmsTM through the posterior fornix, BSO proceeded as per standard of care, with dissection of the suspensoryligamentandovarianligamentusingbipolarelectro- cauteryfor hemostasis and nonpolarelectrocautery for cutting (Video).Targetorganswereremovedthroughtheposteriorfornix.
ForvaginalclosureweusedVicryl(EthiconInc.)continuoussuture.
Surgicaldatawerecollectedduringtheprocedures.Postoperative carewasinaccordancewiththelocalprotocols.
Endpointsandoutcomemeasures
Theprimaryendpointofthestudywastheoccurrenceofperi- procedural (i.e., from procedure onsetuntil hospitaldischarge) major complicationsrelatedtotheHominisTMsystem.Theseincludemajor hemorrhage(requiringtransfusion),hematoma(requiringtransfu- sionorsurgicaldrainage),bowelinjury,uretericorbladderinjury, bladder injury, pulmonary embolus, major anesthesiaproblems, wounddehiscence,andconversiontolaparotomy.
Secondary endpointswere:1)devicesuccess, definedasthe ability to perform required tasks with the HominisTM Surgical System;2)proceduresuccess,definedasdevicesuccesswithno peri-proceduralmajorcomplication; 3)usability assessment by thephysicianandoperatingroomstaffonascalefrom1(poor)to5 (good).Otherobservationalmeasuresincludedprocedureduration (dockingtime, robotictime, total operationtime, skintoskin),
duration of postoperative hospital stay, intraoperative and postoperativecomplicationsandadverseevents,blood loss,and pharmacological treatment. Every 8 h during the first 24 h followingtheprocedure,patientswereaskedtoratetheirpainona visualanalogscale,from0(nopain)to10(maximumpain).
Results
Themedianagewas64years(range:50 70)andthemedian BMIwas24kg/m2(range:19–30kg/m2.Three(37.5%)womenhad co-morbidities(Table1).The mediandurationof theprocedure was45min(range:38 91).Evaluationofthelearningcurveofthe procedures that were done in Rambam (7/8) demonstrated a decreaseinproceduretimewhencomparingbetweenthefirsttwo cases(91and60min)andthefollowingfivecases(40,38,40,51and 51min)(Fig.5).Themediandockingtimewas5min(range:1 28) (Table2).Estimatedbloodlosswasminimalinalltheprocedures, withamedianof10mL(range:10 50).
Themedianhospitalstaywasoneday(range:1 2).Themedian postoperativepainscoreaccordingtothevisualanalogscale(VAS) was1(range:1-3).Twowomenrequestedanalgesiabeyondthe routinely administered postoperative paracetamol; both were treated with oral ibuprofen. None of the women needed oral opioidsorintravenousanalgesics(Table2).
There were no conversions to open surgery and no intra- operativecomplications.Bothdeviceandproceduresuccesswere demonstrated;asalltherequiredsurgicaltaskswereperformedas intended. Qualitative assessment of ergonomics and comfort showed that operating via the Hominis platform was feasible andeasilymastered,withoutarequirementofextratechnicalskills (Table3).
Table1
Sociodemographicdataandmedicalhistory.
Age(years),medianandrange 64(50 70) Parity,medianandrange 3(0 5) Gravida,medianandrange 3(0 5) BMI(kg/m2),medianandrange 24(19 30)
Smoking,number(%) Current2(25%)Previous1(12.5%) Hypertension,number(%) 1(12.5%)
Hyperlipidemia,number(%) 2(25%) Cardiacdisease,number(%) 1(12.5%)
Diabetes,number(%) 1(12.5%)
BMI-BodyMassIndex.
Fig.5. Thedurationofsevenconsecutiveproceduresperformedatoneinstitution.
Table2
Intraoperativeandpostoperativedata.
BSOtime,minutes,median(range) 45(38 91)
Dockingtime,minutes,minutes(range) 5(1 28)
Bloodloss,ml,median(range) 10(10 50)
Painassessment(VAS:0 10),median(range) 1(1 3) Demandforanalgesics:
P.OParacetamol,number(%) 8(100%)*
P.ONSAIDS,number(%) 2(25%)
Opioids,number(%) 0
I.VAnalgesics,number(%) 0
Lengthofhospitalstay,median(range)(days) 1(1 2) VAS–visualanalogscale;NSAIDS-nonsteroidalanti-inflammatorydrugsP.O-per os;I.V-intravenous.
* Routinelyadministered.
There wereno postoperative adverse events. Atthe6-week follow-upvisit,thevaginal tissuewas fullyrecoveredin allthe participants.
Discussion
PreviousIDEALstage1reportsontransvaginalroboticsurgery usedaroboticsystemthatwasnotdevelopedfortransvaginaluse [19,20].Thosestudiesconcludedthattransvaginalroboticsurgery isfeasiblebutthatfurtherdevelopmentsinrobotictechnologyare necessarytoovercomepracticalproblemssuchasarmcollision, andtoimprovetimeefficiency.
Thisisthefirstdocumentationofasurgeryperformedviathe vaginausingrobotic-assistedinstrumentationdevelopedforthis purpose.Alltheoperationswerecompletedasintended,withno conversionstolaparoscopicoropensurgeries.Nodevice-related perioperativeorpostoperativeadverseeventswereobserved;and blood loss was minimal. The operation time (median 45 min, range:38 91)wasconsiderablyshorterthanthemeantime(182 min) reported for 18 transvaginal BSO that were not robotic- assisted[21];and similartothat reportedfor15robot-assisted laparoscopicBSOprocedures(mean47min,range:15–120)[22].In thecurrentseriesofRvNOTES,thedecreasingoperationtimewith subsequentsurgeriesindicatesarapidlearningcurve.
Thefeasibilityanduser-friendlinessofRvNOTESdemonstratedin thissmallstudyhassubstantialclinicalimplications.First,weexpect that vNOTES, as a natural incision-less procedure, will grow in attractiveness to surgeons, due to its overcoming of technical challengesthat have beenbarriers to greaterutilization ofsuch procedures.Second,weexpectthatthebenefitsofrobotic-assistance willbeparticularlyprofoundinthecontextofthe naturalsingle- accessofvNOTES.Notably,whilerobotic-assistancehasgenerally demonstrated similarpatientoutcomes as conventional laparoscopic surgeryingynecologicalprocedures[23],anumberofstudieshave reported better outcomes, including less estimated blood loss [24,25],fewerintraoperativecomplications[26],lessconversionto opensurgery[27],andshorterhospitalstay[25,28].Inthesettingof vNOTES,theseadvantagesofrobot-assistedsurgerymayincrease.
Perhaps the greatest advantage of RvNOTES will be the easy implementationofvNOTESprocedures;thefastlearningcurvewill enable performance by less experienced surgeons despite the relativelyhighlevelofexpertiserequired.Otheroutstandingfeatures ofthenovel vNOTESroboticapparatus include itsportability andeasy handlingdue to itslight weight (less than 10 pounds), scarless surgery,andaccesstoanypartoftheabdomenbyarticulationofthe flexible robotic arms. No special maintenance is required. The approachcombinesthebenefitsofvaginalproceduresandlaparo- scopictechniquesandmaintainssafetyinregardto proximityto pelvicorgans.Theeraofroboticsurgeryisexpectedtoevolverapidly, andthepotentialofthedescribeddevicemaygenerallyenhancethe precision of surgery. The advent of computer and software technology thatinterfacesbetweenthesurgeonandthepatientmaypromotea particularlyfunctionalroboticsurgerysystem.Thismayultimately facilitateminimallyinvasivesurgery,improvesurgeons’abilitiesto performgynecologicalproceduresandreducecomplications.
ThiscaseseriesdemonstratedthefeasibilityofusingRvNOTESfor BSOforbenigngynecologicindications.Astudyonhysterectomies usingRvNOTESisbeingfinalized.Thoughtheevidenceissparse, hysterectomybyvNOTESwithoutroboticassistance,comparedto laparoscopy,demonstrated lessbleeding[29], shorter operativetime andlength ofstay[30], lesscomplications, lower painscores,andless useofanalgesics[31].Thetechnicaladvantageofrobotic-assistance isexpectedtocontributesubstantiallytothealreadypositivepatient outcomesachievedinhysterectomybyvNOTES.
The disruptive technology of vNOTES has the potential to dramatically increase the types and volume of gynecological surgeries performed vaginally [32–35], and to make this non- incision surgical option accessible to more women. In addition, robotic-assistedvNOTES willfacilitatevaginalaccess fordiverse non-gynecologicalsurgeriesincludingthoseoftheupper-abdomen.
Notably,vaginalaccesswasdemonstratedassafeandfeasiblealsoin olderwomenandwomenwithobesity[36].Moreover,following transvaginalcholecystectomy,sexualfunction wasnotimpairedand qualityoflifewasreportedlyunchangedorimproved[37].
Thoughmorethanadecadeandahalfhavepassedsincethe first cholecystectomyby NOTES, the concept of natural orifice procedureshasnotbecomestandardofcare.Duringthisperiod, accumulatingevidencehasdemonstratedthesafetyandfeasibility ofnaturalorificespecimenextractionsurgery(NOSES)[38,39],as wellasofNOTES(40).Accordingly,arecentconsensusstatement was published regardingthe useof NOSES toavoid abdominal incisioninlaparoscopicsurgery[41].Inanonlinesurveyamong surgeons in Brazil,56 % of the respondentsstated they would choose a transvaginal approach for extracting a kidney, for themselvesoracloserelative[42].Amongpatientshospitalized in China, 45 % stated they would choose NOTES; the latter comprised predominantly females, and the younger and more educatedpatients[43].Clearly,NOTESingeneral,andRvNOTESin particular, represents a new paradigm for both surgeons and patients.Nonetheless,theunderutilizationofNOTESevenamong gynecologists[13,16] highlightstheurgentneedforappropriate anddesignatedinstrumentation,inadditiontotheassimilationof anewparadigm.Thisispreciselythegaptobefilledbyrobotic- assisted technology designed specifically for NOTES. Further studies are needed to evaluate the long-term outcomes and determinetheultimateutilityofthismodality.
Consent
Writteninformedconsentwasobtainedfromthepatientfor publicationoftheseimages.
Financialdisclosure
ThisstudywassupportedbyMEMICMedicalLtd.
DeclarationofCompetingInterest
L.L, E.M, Z.W report no conflict of interest, J.B discloses consultancyforAppliedMedical.
AppendixA.Supplementarydata
Supplementarymaterialrelatedtothisarticlecanbefound,inthe onlineversion,atdoi:https://doi.org/10.1016/j.eurox.2020.100113.
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Generalimpressionofthesystem 5(4 5)
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