一次性切割吻合器及切割組件文獻臨床評估報告.產(chǎn)品信息產(chǎn)品名稱一次性切割吻合器及切割組件預期用途適用于消化道重建及其它臟器切除手術(shù)中的吻合口創(chuàng)建及殘端或切口的閉合。規(guī)格型號一次性切割吻合器及切割組件基本尺寸單位：毫米型號規(guī)格基本尺寸切割長度有效縫合長度切割組件釘槽數(shù)（個）總長極限偏差基本尺寸極限偏差基本尺寸極限偏差型號規(guī)格吻合釘高度代號極限偏差YQH55250±555±557±5JQH552.52±0.356752707577753.853761003201001021004.541001.4適應癥和禁忌癥適應癥一次性切割吻合器及切割組件適用于消化道重建及其他臟器切除手術(shù)中的吻合口創(chuàng)建及殘端或切口的閉合。禁忌癥切勿在缺血或壞死的組織上使用該器械。不能用于肝脾組織的縫合。.文獻搜索通過文獻搜索的方式去評估一次性切割吻合器及切割組件的臨床性能、安全性能和風險收益，所搜集臨床文獻均來自以公開發(fā)表的文章，包括了不良事件報告、進一步的臨床研究和上市后研究等等。.方法學文獻搜索日期

2016.5.10-2017.5.10文獻搜索和評價人員1982年1982年-至今3.4文獻搜索關(guān)鍵詞使用PUBMED數(shù)據(jù)庫進行文獻搜索，所用涉及產(chǎn)品的關(guān)鍵詞見表2所示。表2一次性切割吻合器及切割組件搜索情況產(chǎn)品關(guān)鍵詞搜尋結(jié)果表格DisposableLinearcutter&linearcuttercartridgesLinearcutterstaplerclinical45itemsFig.1Fig.1DisposableLinearcutter&linearcuttercartridges臨床文獻搜尋結(jié)果通過文獻檢索，最終得到45篇臨床文獻，其中30篇與一次性切割吻合器及切割組件有關(guān)，這些文章均為原始文獻或回顧性文獻。文獻著作的作者均為吻合器的專家。3.5數(shù)據(jù)相關(guān)性3.5.1臨床相關(guān)性直線型切割吻合器的出現(xiàn)對推助腔鏡外科和微創(chuàng)外科起了極大的作用,90年代初如果沒有直線型切割吻合器的發(fā)明,就沒有胸腔鏡外科的快速發(fā)展。直線切割吻合器的并發(fā)癥:采用切割縫合器最棘手的并發(fā)癥是擊發(fā)之后,發(fā)現(xiàn)釘未能閉合,這在處理大血管如下肺靜脈的時候常常是致命的,或者發(fā)現(xiàn)釘未能將組織很好地縫合。要避免上述并發(fā)癥,應該規(guī)范使用切割縫合器,限制重復使用的次數(shù),并根據(jù)組織的厚度選擇合適的釘倉。3.5.2技術(shù)相關(guān)性常州瑞索斯醫(yī)療設(shè)備有限公司的一次性切割吻合器及切割組件產(chǎn)品和市場上美國EthiconEndo-Surgery,Inc美國WASTON以及西班牙JJPHospitalariaS.L的切割吻合器產(chǎn)品具有相類似的設(shè)計原理和臨床操作原理，見表3。表3一次性切割吻合器及切割組件產(chǎn)品對比產(chǎn)品名稱ENDOPATHandPROXIMATELinearCuttersandStaplersLinearCutterSatpler口REZA中DisposablelinearcuttingstaplerDisposablelinearcutter&linearcuttercartridges公司EthiconEndo-Surgery,Inc.JJPHOSPITALARIAGRENA常州瑞索斯醫(yī)療設(shè)備有限公司預期用途適用于消化道重建及其它臟器切除手術(shù)中的吻合口創(chuàng)建及殘端或切口的閉合。適用于消化道重建及其它臟器切除手術(shù)中的吻合口創(chuàng)建及殘端或切口的閉合。適用于消化道重建及其它臟器切除手術(shù)中的吻合口創(chuàng)建及殘端或切口的閉合。適用于消化道重建及其它臟器切除手術(shù)中的吻合口創(chuàng)建及殘端或切口的閉合。材料TATATATA切割長度（mm）55/75/10060/80/10055/75/10055/75/100釘高（mm）///2.5/3.85/4.5閉合釘高（mm）/4.文獻評價4.2.1Disposablelinearcutter&linearcuttercartridges文獻摘要和分析文獻摘要節(jié)選自上搜索的文獻，鑒于文獻量較大，此處選取其中的篇列于下表:序號文獻名稱文獻作者摘要臨床結(jié)論1OperativetherapyofexternalrectalprolapsewithastaplerR.SchererExternalrectalprolapseisararecondition,whichismorecommoninoldandmultimorbidwomen.Inrecentyearsfivesurgicalmethodshavebecomeestablishedfromamongthemultitudeofoperativeprocedureswhichhavebeendescribed.Oneofthemostrecenttechniquesisperinealstapledprolapseresection(PSP)whichisdescribedinthisarticle.Aftercompleteeversionoftherectalprolapseitisresectedinto2halvesusingalinearcutterbyincisionsat3oclockandoclocklithotomypositions,followedbystepwiseresectionwithacurvedcutteralongtheventralanddorsalcircumference.Thereislowevidenceforthetreatmentofexternalrectalprolapse.ForPSPonlycaseseriesexistwithresultsthataresimilartothosefromothertechniques;however,comparativestudiesarenearlycompletelylacking.ThePSPisarelativelynewsurgicaltechniqueforthetreatmentofexternalrectalprolapse.Itisasafesurgicalprocedure.Duetothelackofevidenceitshouldremainreservedforoldand/ormultimorbidpatients.ThePSPisarelativelynewsurgicaltechniqueforthetreatmentofexternalrectalprolapse.Itisasafesurgicalprocedure.Duetothelackofevidenceitshouldremainreservedforoldand/ormultimorbidpatients.2NewTechniqueofIntracorporealAnastomosisandTransvaginalSpecimenExtractionforLaparoscopicSigmoidColectomyZhengWang,Xing-MaoZhang,Hai-TaoZhou,Jian-WeiLiang,Zhi-XiangZhou*Background:Despitethegrowingacceptanceoflaparoscopiccolonsurgery,anabdominalincisionisneededtoremovethespecimenandperformananastomosis.Recently,naturalorificespecimenextraction(NOSE)andintracorporealanastomosishavebeenproposedtominimizeabdominalwalltraumaandimprovethequalityoflaparoscopiccolonresectionsObjective:Toevaluatethefeasibilityandsafetyofanewapproachcombiningintracorporealdelta-shapedanastomosisandtransvaginalTheproceduresofintracorporealdelta-shapedanastomosisandtransvaginalspecimenextractionaresafeandoncologicallyacceptableforselectedcoloncancercases.

序號文獻名稱文獻作者摘要臨床結(jié)論specimenextractionfortotallylaparoscopicsigmoidcolectomy.MaterialsandMethods:Mobilizationofbowelanddissectionoflymphnodeswereperformedlaparoscopically.Afterbothproximalanddistalincisaledgesabout10.0cmdistancefromsigmoidneoplasmweretransectedwithanEndoscopicLinearCutter-Straight,asmallincisionabout1.0cmwascreatedontheeachcolonwallofthecontralateralsideofthemesentery.ThenanvilsofanEndoscopicLinearCutter-Straightwereinsertedintoeachcolonthroughthesmallincisions,andincisionandanastomosisbetweenthewallsofeachcolonwereperformedwithalinearstapler.AV-shapedanastomosiswasmadeonthewallandtheremnantopeningswasreclosedwiththeEndoscopicLinearCutter-Straight.Theculdotomywasenlargedwithlaparoscopicultrasounddissector.Transvaginalextractionofspecimenswasaccomplishedthroughawoundprotector.Results:Surgerywasperformedfor11patientswithsigmoidcancer.Nointraoperativecomplicationsorconversionsoccurred.Themeanoperatingtimewas132min.Allthepatientsweretreatedlaparoscopicallywithoutanypostoperativecomplications.

序號文獻名稱文獻作者摘要臨床結(jié)論3Comparisonofstandard4-rowversus6-row3-Dlinearcutterstaplerincreationofgastrointestinalsystemanastomoses:aprospectiverandomizedtrialAlperSozutek,TahsinColak,AhmetDag,TolgaOlmezOBJECTIVE:Thisprospectivestudywasconductedtocomparetheclinicaloutcomesofa6-row3-Dlinearcutterwiththestandard4-rowlinearcutterinpatientswhounderwentelectivegastrointestinalsurgeryanastomosis.METHOD:Patientswhounderwentelectiveopengastrointestinalsurgerythatincludedstapledanastomosisusingalinearcutter(ProximateH,EthiconEndo-Surgery,Cincinnati,OH)betweenJanuary2011andMay2011wereincludedinthestudy.Thepatientswererandomlyassignedtotwogroupsaccordingtothelinearcutterthatwasusedinthesurgery:thestandard4-rowcutter(theSgroup)orthenew6-rowcutter(theNgroup).Thegroupswerecomparedbasedonthepatientdemographicdata,thelaboratoryparameters,thepreoperativediagnosis,thesurgeryperformed,theoperationtime,intra-orpostoperativecomplications,thetimetooraltoleranceandthelengthofthehospitalstay.RESULTS:TheSgroupincluded11maleandninefemalepatientswithameanageof65±12(35-84)years,whiletheNgroupincluded13maleandeightfemalepatientswithameanageof62±11(46-79)years(p=0.448,p=0.443,respectively).Anastomoticlinebleedingwasobservedineight(40%)patientsintheSgroupandinone(4.7%)patientintheNgroup(p=0.006).Dehiscenceoftheanastomosislinewasobservedintwo(10%)patientsintheSgroupandnoneintheNgroup(p=0.131).Anastomoticleakagedevelopedinthree(15%)patientsintheSgroupandinone(4.7%)patientintheNgroup(p=0.269).Themeanhospitalstaywas12.65±6.1daysintheSgroupand9.52±2.9daysintheNgroup(p=0.043).The6-row3-Dlinearcutterisasafeandeasilyappliedinstrumentthatcanbeusedtocreateanastomosesingastrointestinalsurgery.Thenewstaplerprovidessomeusagebenefitsandisalsosuperiortothestandardlinearcutterwithregardtoanastomoticlinebleeding.4AntimesentericFunctionalEnd-to-EndHandsewn(Kono-S)AnastomosisAlessandroFicheraMarcoZoccaliToruKonoAlessandroFicheraIntroductionAnastomoticrecurrenceisafrequenteventafterbowelresectionforCrohn'sdisease.Todate,noanastomotictechniquehasbeenproventobesuperiorinreducingsurgicalrecurrenceratesinthissetting.Inthisarticle,wedescribeourtechniqueinperforminganewantimesentericfunctionalend-to-endhandsewn(Kono-S)anastomosis.TheKono-Sanastomosisisasafeanastomotictechnique.Long-termstudiesareneededtoconfirmitsefficacyinpreventingsurgicalrecurrence.

序號文獻名稱文獻作者摘要臨床結(jié)論MethodsThesegmentofboweltoberesectedisidentifiedandmobilized.Thebowelisthendividedtransverselywithalinearstapler-cutterdevice.Theinterveningmesenteryisdividedclosetothebowel.Thecornersofthetwostapledlinesaresuturedtogether,andthetwostapledlinesareapproximatedwithinterruptedsutures.Anantimesentericlongitudinalenterotomyisperformedonbothsides,startingnomorethan1cmawayfromthestapleline,toallowatransverselumenof7—8cm.Theopeningsareclosedtransverselyintwolayers.ResultsFromMay1,2010toJuly31,2011weperformed46Kono-Sanastomoses.Onepatienthadacontainedanastomoticleaksuccessfullytreatedconservatively.Currently,18patients(43%)haveundergonefollow-upendoscopicsurveillancewithanaverageRutgeert'sscoreof0.7(0—3)atameanof6.8months.5StapledversushandsewnmethodsforileocolicanastomosesKrokidisM1,FanelliF,OrgeraG,TsetisD,MouzasI,BezziM,KouroumalisE,PasarielloR,HatzidakisA.BackgroundIleocolicanastomosesarecommonlyperformedforright-sidedcoloncancerandCrohn'sdisease.Theanastomosismaybeconstructedusingalinearcutterstaplerorbysuturing.Individualtrialscomparingstapledversushandsewnileocolicanastomoseshavefoundlittledifferenceinthecomplicationratebuttheyhavelackedadequatepowertodetectpotentialsmalldifference.ThisisanupdateofaCochranereviewfirstpublishedin2007.ObjectivesTocompareoutcomesofileocolicanastomosesperformedusingstaplingandhandsewntechniques.Thehypothesistestedwasthatthestaplingtechniqueisassociatedwithfewercomplications.SearchmethodsMEDLINE,EMBASE,CochraneColorectalCancerGroupspecialisedStapledfunctionalendtoendileocolicanastomosisisassociatedwithfewerleaksthanhandsewnanastomosis.

序號文獻名稱文獻作者摘要臨床結(jié)論registerSR-COLOCA,CochraneLibraryweresearchedforrandomisedcontrolledtrialscomparinguseofalinearcuterstaplerwithanytypeofsuturingtechniqueforileocolicanastomosesinadultsfrom1970to2005andwereupdatedinDecember2010.Abstractspresentedtothefollowingsocietymeetingsbetween1970and2010werehandsearched:AmericanSocietyofColonandRectalSurgeons,theAssociationofColoproctologyofGreatBritainandIreland,EuropeanAssociationofColoproctology.SelectioncriteriaRandomisedcontrolledtrialscomparinguseoflinearcutterstapler(isoperistalticsidetosideorfunctionalendtoend)withanytypeofsuturingtechniqueinadults.DatacollectionandanalysisEligiblestudieswereselectedandtheirmethodologicalqualityassessed.Relevantresultswereextractedandmissingdatasoughtfromtheauthors.RevMan5wasusedtoperformmeta-analysiswhenthereweresufficientdata.Sub-groupanalysesforcancerinflammatoryboweldiseaseasindicationforileocolicanastomoseswereperformed.MainresultsAfterobtainingindividualdatafromauthorsforstudiesthatincludeotheranastomoses,seventrials(includingoneunpublished)with1125ileocolicparticipants(441stapled,684handsewn)wereincluded.Thefivelargesttrialshadadequateallocationconcealment.Stapledanastomosiswasassociatedwithsignificantlyfeweranastomoticleakscomparedwithhandsewn(S=11/441,HS=42/684,OR0.48[0.24,0.95]p=0.03).Onestudyperformedroutineradiologytodetectasymptomaticleaks.Forthesub-groupof825cancerpatientsinfourstudies,stapledanastomosisledtosignificantlyfeweranastomoticleaks(S=4/300,HS=35/525,OR0.28[0.10,0.75]p=0.01).Insubgroupanalysisofnon-cancerpatients(3studies,264patients)therewerenodifferencesfoanyreportedoutcomes.Allotheroutcomes:stricture,anastomotic

序號文獻名稱文獻作者摘要臨床結(jié)論haemorrhage,anastomotictime,re-operation,mortality,intra-abdominalabscess,woundinfection,lengthofstay,showednosignificantdifference.6Amodelingmethodforlaparoscopicleftlateralsegmentliverresection:reportof71casesZHAOGuo-dong,HUMing-gen,LIURongObjective:Tosummarizetheexperiencewithamodelingmethodforlaparoscopicleftlateralsegmentliverresection(LLLR).Methods:ThesurgicalproceduresofLLLRwerecarriedoutwiththepatientplacedinasupinepositionand4trocarsplacedontheabdomen.Aftercompletedissociationoftheleftlobe,thesegmentIIandIIIvascularpedicleswerefreedwithaharmonicscalpelandtransectedwithalinearcutterstapler.Thelefthepaticvein(LHV)wasdissociatedwithaharmonicscalpelwithaslightlyleftdirectionofliverdissection,followedbycompleteresectionoftheLHVandfinallybywoundsurfacemanagement,specimenremoval,wounddrainage,andabdominalincisionclosure.ResultsBetweenJuly,2003andAugust,2010,thismodelingmethodforLLLRwasperformedsuccessfullyin48caseswithoutconversiontolaparotomy.Themeanoperationtimewas75±30.8min,bloodlosswas58±36.4ml,andlengthofpostoperativehospitalstaywas4.8±1.5days.Postoperativecomplicationsoccurredin3cases,includingascitesin2casesandmildbiliaryleakagelcase,allcuredconservativelyThismodelingmethodcansimplifythesurgicalprocedureofLLLR,reducebloodloss,andavoidairembolismduetoveininjury.Beinglesstechnicallydemanding,thismethodcanbesafelyperformedinhospitalsatvariouslevels.7Orthotopicilealbladdersubstitutionfollowingradicalcystectomyusingthelinear-cutterstaplingdevice.Abou-ElelaA1,Abou-ElelaA,AlfaiomyH,ElshafeiA.Weevaluatedthesafety,efficacy,andpotentialbenefitsofusingthelinear-cutterstaplersintheilealreanastomosisandilealpouchreconstructionfollowingradicalcystectomyinpatientswithinvasivecarcinomaoftheurinarybladder.Radicalcystectomyandorthotopicilealbladdersubstitutionprocedureswereperformedin40patientswithinvasivecarcinomaoftheurinarybladder.In20patientsthelinear-cutterstaplingdevicewasusedfortheileo-ilialreanastomosisandreconstructionofthepouch,whileintheother20patientsthestandardhand-suturingtechniquewasused.Usingthelinear-cutterstaplerintheileo-ilealreanastromasisandilealpouchreconstructionsavedapproximately60to90minutesofoperativetime,andtherewasalsoasignificantreductionofbloodlossduringthisperiod.Theleakagerateandhospitalstaywerelessinpatientswithastapledpouch.Urodynamiccharacteristicswerecomparabletostandardilealneobladders.

序號文獻名稱文獻作者摘要臨床結(jié)論8Collis—Nissenfundoplicationusingacomputer-poweredrightanglelinearcuttingstaplerinchildrenTsubasaTakahashiTadaharuOkazakiAkihiroShimotakaharaGeoffreyJ.LaneAtsuyukiYamatakaWereviewedourclinicalexperienceofusingacomputer-poweredrightanglelinearcutter(CPRALC)forCollis-Nissenfundoplication(CNF)inthreechildrenwithgastroesophagealreflux(GER)orfailedNissenassociatedwithshortesophagus.Case1wasa13-month-oldfemalewithpersistentGERaftertype-Cesophagealatresiarepair.Case2wasa2-year-oldfemalewithdysphagiasecondarytofundicwrapmigrationafterlaparoscopicNissen.Case3wasa3-year-oldmalewithposttype-Cesophagealatresiarepair,dysphagiasecondarytofundicwrapmigrationafteropenNissen.Allhadshortesophagusconfirmedpre-orintra-operatively.Aftertheesophaguswasmobilized,CollisverticalgastroplastywasperformedusingCPRALCparalleltothelessercurvetoelongatetheesophagus.Nissenfundoplicationwasperformedlooselyaroundtheneo-esophagus.Therewerenointra-orpost-operativecomplications,althoughcase3stillhasmilddysphagia,requiringdilatation.ThisisthefirstreportofCNFperformedusingCPRALCinchildren.ItwouldappeartobesafeandeffectivefortreatingchildrenwithGERorfailedNissenassociatedwithshortesophagus.9StudyofoperativeproceduresoflaparoscopyandlaparescopicallyassistedsigmoidtransplantationforVaginalconstructionLINGBin,SUNMin-wen,SUNFang-lin,ZHANGAi-jun,HUWei-ping,LIJia,NINGZhong?liangObjectiveToexploretheproceduresandtheclinicalsignificanceoflaparoscopyandlapar~copicallyassistedsigmoidtransplantationforvaginalconstruction.MethodsNcedureoflaparoscopicallyassistedsigmoidcolpepeiesis：withtheauxiliaryoflaparoscopy,dissecttedthedistalportionofthesigmoidwithendoscopiclinearcuter,thena4.cmincisionWasnladeintheleftlowerabdomentoretractanddissecttheproximalportionofsigmoid.Aftertheproximalportionoftransplant?sigmoidWasclosed,theproximalcutendofreserved.sigmoidWasplacedwiththeanvilandmadeapurse?stringsuture,thenputbacksigmoidintotheperitonealcavity.AcurvedintraluminalstaplerWasinsertedfromtheanUStothemostdistalcutendofreservedsigmoidtoend-endanastomosethereserved—sigmoid.Finny,Theproceduresoflaparoscopyand1aparoscopyassistedsigmoidtransplantationforvaginalconstructionCanreplacethetraditionallaparotomy.

序號文獻名稱文獻作者摘要臨床結(jié)論anartificialcanalWasnladebetweenurethravesicaeandrectumandthetransplant—sigmoidwiththebloodsupplyWa