Sibanzi
Uninzi lwezinto ezikhethiweyo ngoku zikhoyo kunyango lokunyanya. Ezi ziquka ukutya kunye nokuguquka kwendlela yokuphila, izidakamizwa zokulahleka kwemilinganiselo , kunye nezixhobo kunye neenkqubo ezivela ekuzalweni ngokugcwele kwi-bariatric ukuya kumaxesha amasha, amacebo angenayo.
Ehlotyeni ka-2016, i-US Food and Drug Administration (i-FDA) ivume i-device-loss loss device ebizwa ngeApireAssist, ithengiswa ngu-Aspire Bariatrics.
Yintoni i-AspireAssist?
I-AspireAssist iyisistim sokulahlekelwa kwesisindo esivunyelwe ukunyanga kokunyanya kuninzi kubantu abadala abaneminyaka engama-22 ubudala kwaye banesicingo somzimba (BMI) se-35 ukuya ku-55. Isixhobo senza ukuba abasebenzisi bakwazi ukukrazula inxalenye isisu esiswini ngokusebenzisa ishubhu esiswini (esaziwa njenge-gastrostomy tube) kwindlu yangasese emva kwesidlo ngasinye.
Isixhobo se-AspireAssist sijoliswe ekusebenziseni ixesha elide kubantu abadala abafanelekileyo abangazange bakwazi ukufezekisa ukulahleka kwesisindo esaneleyo ngeendlela ezingenasisiseko ezifana nokuguquka kwendlela yokuphila kunye nokunyuka kwemithi.
Ingaba isebenza kanjani
Njengoko kuphawuliwe ngasentla, i-AspireAssist isebenzisa ityhubhu eyenziwa ngokuvulwa esiswini, ukuvumela ukuqukwa kwesisu esiswini emva kokutya. Kwisifundo somqhubi weSullivan kunye nabo basebenzisana nabo, oku kwafunyanwa kubangelwa ukunciphisa inani elipheleleyo leekhalori ezifunyenwe ngama-30 ekhulwini.
Isixhobo se-AspireAssist siqulethe i-gastrostomy tube, njengoko kuphawuliwe ngasentla, kunye ne-valve yesango, isistim sangaphandle esine-connector, i-water water, kunye ne-tube drainage ene-clamp.
Emva kwemizuzu engama-20 ukuya kwe-30 emva kokutya, umsebenzisi we-AspireAssist ifowuni udibanisa i-gastrostomy tube kwisixhobo sangaphandle kwaye uvule i-valve yesango, ngaloo ndlela avumele ukuba isisu singene ngaphakathi kwindlu yangasese ngamandla ombane.
Kubalulekile ukuba uqaphele ukuba ukutya kufuneka kuhlolwe kakuhle ngexesha lesidlo esandulelayo ukuze kulungele ityhute ye-drainage, eyi-6 millimeters ububanzi.
Emva kokuba umlambo uphelile, umsebenzisi we-AspireAssist kufuneka achukumise ityhubhu nesisu ngesinanzi esicocekileyo, esiphuthumayo esuka kumjelo wamanzi oza kunye nesixhobo.
Yonke inkqubo iqikelelwa ukuthatha imizuzu engama-5 ukuya kwe-10.
Ukuba ungumsebenzisi wale fowuni, gcina ukhumbule ukuba kuya kubakho ukugcina ukuqeshwa okulandelelanayo rhoqo noogqirha wakho, kuba isalathisi kufuneka ithathelwe endaweni emva kweeyure eziyi-115 (malunga nama-5 ukuya kweeveki ezi-6).
Kwakhona kuyimfuneko kule tyelelo lokulandelela ukuqinisekisa ukuba i-AspireAssist isebenza kakuhle. Ubungakanani bebhubhu lungadinga ukulungiswa njengoko ulahlekelwa isisindo. Ugqirha wakho uya kuqhubeka nokubonelela ngesondlo kunye nokuphila ngcebiso ekuhambeni kokulandelelana.
Iindleko
Ngokutsho kweNcwadi yezoNyango kwiDrugs and Therapeutics, esekelwe kwingcaciso evela kumenzi, iindleko ezidibeneyo zenkqubo yokuqala kunye nomnyaka wokuqala wokulandelwa kulindeleke ukuba zibe yi-8,000 ukuya kwii-13,000 zamawaka.
Impumelelo
Kwizinto ezinokuthi zipapashwe ngokuxhaswa kwi- Gastroenterology , abaphandi be-PATHWAY bafumana ukuba aba gulane abanikezelwe unyango kunye ne-AspireAssist kunye nokucebisa ngeendlela zokuphila malunga nomnyaka bafumana ukulahlekelwa kwesisindo semali engama-31.5 ekhulwini kwindleko engaphezulu, xa kuthelekiswa kuphela I-9,8 ekhulwini yokunciphisa umzimba olahlekileyo kwiqela elabelwe ukunika iingcebiso ngokuphila kuphela.
Iziphumo ezongezelelweyo kwizifundo zangexesha elide azifumaneki, ngoko kunzima ukufumanisa ukuba imiphumo yesikhathi eside ekulahlekeni kwesisindo kunye nomgangatho wobomi uza kuba kunye no-AspireAssist.
Imiphumela
Kwi-PATHWAY ityala elikhankanywe ngasentla, ubuncinane ama-5 ekhulwini kwezigulane zineempembelelo ezichaphazelekayo kunye nezixhobo ze-AspireAssist.
Iimiphumo ezibikiwe zibandakanya iintlungu zesisu, isicupunu kunye / okanye ukuhlanza, utshintshe kwimikhwa yobomi, nokuvuvukala okanye ukucaphuka kummandla we-tube gastrostomy. Ezinye iziphumo eziye zaphawulwa ziquka ukusuleleka, ukuphuma kwegazi, kunye / okanye ukukhuphaza malunga nokuvula kwisisu.
Uninzi lwale miphumo yecala lubonakala ukulungiswa kwisithuba seentsuku ezingama-30.
Kwi-4 yezigulane ezingama-111 eziphathwe nge-AspireAssist kwi-PATHWAY ityala, isixhobo sasinxulumene neziganeko ezibi kakhulu, ezifana nesidingo sokutshintshwa kwe-tube gastrostomy, isifo sesisu kunye nesilonda.
Ngokuphawulekayo, ekuhlaziyweni kwayo kweso sixhobo, iNcwadi yezoNyango kwiDrugs kunye neTherapeutics iphelile: "I-AspireAssist ifowuni ayinakuncipha kakhulu kunokuba utyando lwabasebenzi lonyango lokunyanyisa kwaye lunokuba luncedo kwizigulane ezithile, kodwa iinkcukacha ezikhoyo ziyancinci kwaye uluhlu lweenkcazo lukhulu. "
Ezinye iinketho zeDivaysi zokuLawula ubunzima
Enye ifowuni sele isetyenziselwa unyango lokunyameka ukususela ngoJanuwari 2015. Le sixhobo esivunyiweyo se-FDA, esaziwa ngokuba yi- Maestro Rechargeable System , isebenza ngokujolisa kwindlela yokugulisa intliziyo phakathi kwengqondo kunye nesisu esinolawulo lokuvalelwa kwindlala nokuzaliswa . Iqukethe i-generator pulse generator ehlawulelwayo, kunye neendlela zetambo kunye ne-electrodes. Ezi zifakwe kwi-abdomen. Emva koko ithumela iimpembelelo zombane kwi-vagus nerve, eyanceda ukulawula isisu sokuthutha nokuthumela iimpawu kwiingqondo ukuba isisu sisenokungananto okanye sigcwele.
Ngokutsho kwe-EnteroMedics Inc., inkampani eyenza idivayisi, i-Maestro Rechargeable System ikhusela iimpawu zokuthi i-nerus vagus yayiya kubathumela kwingqondo, ngaloo ndlela iyanciphisa iimvakalelo zendlala kwaye yenza izigulane zizive ziphelile kunokuba zingenjalo.
NgoJulayi 28, 2015, i-FDA ivakalise ukuvunyelwa kwesinye isixhobo sokunyanga ukunyamezela: isisombululo sebhaluni sexeshana esibizwa ngokuba yiReShape Integrated Dual Balloon System (ReShape Dual Balloon.
Njengesixhobo se-AspireAssist, i-ReShape Dual Balloon idinga inkqubo yokugcina i- endoscopic ukufaka ifowuni, efakwe kwisisu ngomlomo nangomlomo. Njengoko kuphawulwe yi-FDA, "Isixhobo asitshintshi okanye sitshintshe isisu somzimba wesisu," kwaye izigulane zikhuthazwa ukuba "zilandele ukutya okunyamekisiwe kunye nokuzilolonga ukunyusa imizamo yazo yokulahleka kwesisindo" ngelixa usebenzisa idivayisi. Oku kunceda ukuqinisekisa ukuba izigulane ziyakwazi ukugcina ukulahleka kwesisindo xa isistim sisuswa.
Esi sixhobo senzelwe ukuba sesikhashana kwaye, ngokwe-FDA, kufuneka isuswe emva kweenyanga ezintandathu emva kokuba ifakwe kuqala.
Kucatshangelwa ukuba iReShape Dual Balloon isebenza ngokuthatha indawo ngaphakathi esiswini, oko kusenokwenzeka ukuba kubangele ukuvakalelwa, kodwa kunokubakho nezinye iindlela zokusebenza ezingabonakaliyo.
Izinketho zokuPhepha zokuLuthwa koTywala
Izinketho ezingakumbi ezingenayo kunye nezobugcisa ngokuqhelekileyo ziwela phantsi kwecandelo lotyando lwe-british, kwaye lungaquka utyando lwe-gastric surpass, i-bandage band (band band), kunye ne-sleeve gastrectomy (umtya wesisu), phakathi kwabanye.
Ukuba ngumgqatswa wokutyunjwa kwe-bariatric, umntu kufuneka abe ne-BMI engama-40 okanye ngaphezulu, okanye i-BMI engama-35 okanye ngaphezulu kumntu oneminye imeko yonyango (eyaziwa ngokuba yi "imeko ezixhatshazelisayo") ezibangelwa ukukhuluphala. .
Utyando oluthile oludumileyo lotyando-mali luya kuba yinkqubo yomkhonto wesisu, okanye i-sleeve gastrectomy. Enyanisweni, ngenxa yokusebenza kwayo kunye nokukhuselekiswa xa kuthelekiswa nezinye iinkqubo, ngokutsho komthombo we-Bariatric Surgery, inkqubo ye-gastric sleeve ngoku ibonakala ifumana i-gastric passpass njengendlela entsha ye "golide standard".
I-sleeve gastrectomy operation ijolise ukunika izigulane ukunciphisa ukutya, oko kukunciphisa ukulahleka kwesisindo. Kule nkqubo, malunga neepesenti ezingama-60 zesisu zisuswe (ngokuqhelekileyo i- laparoscopically ), njengokuba isahlulo esisele sesisu sithatha isimo se-tube okanye sleeve.
Ngenxa yokuba isisu sincinci emva kokusebenza, isigulane sesigulane sesisu sisenokuziva siza ngokukhawuleza kwaye sinokutya okungaphantsi. Ngenxa yezi zizathu, inkqubo yendlela yokugaya isisu iyaziwa ngokuba "uhlobo olunqandekileyo" lotyando lwe-bariatric.
Indlela Yokuxoxa Nogqirha Wakho
Ukuba ukhuluphele kwaye uzive sele sele uzame ukhetho oluninzi lwezonyango kunye nokutya kunye nokuguquka kwendlela yokuphila, kwaye oku akuzange kusebenzele kuwe, xubusha ezinye iinketho zakho kunye nodokotela wakho. Kubalulekile ukubeka ingcamango eninzi kunye nokuqwalaselwa kwisigqibo sokuqhubeka nokuhlinzwa okhethwayo, ingakumbi utyando lokulahlekelwa ngumzimba okanye inkqubo.
Ugqirha wakho unokuxoxa nawe izinto ezinokukhetha ukuba ube ngumntu ngamnye, unikezele nge-BMI yakho kunye nezinye izifo ezingapheliyo. Kule ngxoxo, unako ukulinganisela ubunzima kunye neengxaki zonyango lokulahleka kwesisindo okanye inkqubo.
Kubaluleke kakhulu ukuba uqiniseke ukuba uxoxa kwaye uyazi ngemiphumo emibi yenkqubo nayiphi na inkqubo, utyando, okanye isicatshulwa ocingayo, kuba ukhetho ngalunye luza kunye neminye imiphumo emibi, ezinye zazo ezinokuthi zibi.
Ngakolunye uhlangothi, ukuba ungumviwa olungele ukuhlinzwa okanye ukuqhutyelwa kwemisebenzi ethile, kwaye unolwazi olulungileyo kwaye ulungele ukulandelelana neqela lakho lezonyango okanye ugqirha kwixesha elihleliweyo elilandelelweyo emva kwenkqubo, utyando lokulahlekelwa isisindo Unokuba neenzuzo zezempilo, kubandakanywa unyango wesifo sikashukela kunye negazi eliphezulu kunye nokunciphisa ingozi yesifo senhliziyo.
Imithombo:
AspireAssist-ifowuni entsha yokulahleka kwesisindo. I-Med Lett Iidakamizwa Ther. 2016; 58: 109-110.
UDurkin M. Ukulinganisa iindlela zokukhethwa kwe-bariatric. I-ACP yangaphakathi 2016; 36 (1): 1.
FDA News Release. I-FDA iyavuma i-bhaloni yexeshana yokungcola. Ifumaneka kwi-Intanethi kwi-http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm ngoJulayi 29, 2015.
Sullivan S, Stein R, Jonnalagadda S, Mullady D. Edmundowicz S. Uphulo lokuphefumula lukhokelela ekulahlekeni kwesisindo kwizifundo ezigqithisileyo: isifundo somqhubi. Gastroenterology. 2013; 145: 1245.
Thompson CC et al. I-AspireAssist iyisisombululo esisebenzayo ekwenzeni unyango lweklasi kunye neklasi ye-III ukukhuluphala: iziphumo zoluvavanyo lweminyaka elilodwa lonyango. Gastroenterology. 2016; 150 (suppl1): S86, abstract 381.