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GIEGUIDELINEOptimizingadequacyofbowelcleansingforcolonoscopy:recommendationsfromtheU.
S.
Multi-SocietyTaskForceonColorectalCancerColorectalcancer(CRC)isthesecondleadingcauseofcancer-relateddeathsintheUnitedStates.
1ColonoscopycanpreventCRCbythedetectionandremovalofprecan-cerouslesions.
InadditiontoCRCscreeningandsurveil-lance,colonoscopyisusedwidelyforthediagnosticevaluationofsymptomsandotherpositiveCRCscreeningtests.
Regardlessofindication,thesuccessofcolonoscopyislinkedcloselytotheadequacyofpreprocedurebowelcleansing.
Unfortunately,upto20%–25%ofallcolonoscopiesarereportedtohaveaninadequatebowelpreparation.
2,3Thereasonsforthisrangefrompatient-relatedvariablessuchascompliancewithpreparationinstructionsandavarietyofmedicalconditionsthatmakebowelcleansingmoredifculttounit-specicfactors(eg,extendedwaittimesafterschedulingofcolonoscopy).
4Adverseconse-quencesofineffectivebowelpreparationincludeloweradenomadetectionrates,longerproceduraltime,lowercecalintubationrates,increasedelectrocauteryrisk,andshorterintervalsbetweenexaminations.
3,5–7Bowelpreparationformulationsintendedforprecolono-scopycleansingareassessedbasedontheirefcacy,safety,andtolerability.
Lackofspecicorgantoxicityisconsideredtobeaprerequisiteforbowelpreparations.
Betweencleansingefcacyandtolerability,however,theconse-quencesofinadequatecleansingsuggestthatefcacyshouldbeahigherprioritythantolerability.
Consequently,thechoiceofabowelcleansingregimenshouldbebasedoncleansingefcacyrstandpatienttolerabilitysecond.
However,ef-cacyandtolerabilityarecloselyinterrelated.
Forexample,acleansingagentthatispoorlytoleratedandthusnotfullyingestedmaynotachieveanadequatecleansing.
Thegoalsofthisconsensusdocumentaretoprovideexpert,evidence-basedrecommendationsforclinicianstooptimizecolonoscopypreparationqualityandpatientsafety.
RecommendationsareprovidedusingtheGradesofRecommendationAssessment,DevelopmentandEvalu-ation(GRADE)scoringsystem,whichweighsthestrengthoftherecommendationandthequalityoftheevidence.
8METHODSSearchstrategyComputerizedmedicalliteraturesearcheswerecon-ductedfromJanuary1980(rstyearofapprovalofpolyeth-yleneglycol–electrolytelavagesolution[PEG-ELS]–basedpreparationbytheFoodandDrugAdministration[FDA])uptoAugust2013usingMEDLINE,PubMedEMBASE,Sco-pus,CENTRAL,andISIWebofknowledge.
Weusedahigh-lysensitivesearchstrategytoidentifyreportsofrandomizedcontrolledtrials9withacombinationofmedi-calsubjectheadingsadaptedtoeachdatabaseandtextwordsrelatedtocolonoscopyandgastrointestinalagents,bowelpreparation,genericname,andbrandname.
ThecompletesearchtermsareavailableinAppendixA.
Recur-sivesearchesandcross-referencingalsowereperformedusinga"similararticles"function;handsearchesofarticleswereidentiedafteraninitialsearch.
WeincludedallfullypublishedadulthumanstudiesinEnglishorFrench.
Asystematicreviewofpublishedarticlesandabstractspresentedatnationalmeetingswasperformedtocollectandselecttheevidence.
Ameta-analysisandconsensusagreementwereusedtoanalyzetheevidence.
Expertconsensuswasusedtoformulatetherecommendations.
TheGRADEsystemwasusedtoratethestrengthoftherecommendations.
Theguidelinewasreviewedbycommit-teesofandapprovedbythegoverningboardsofthemem-bersocietiesoftheMulti-SocietyTaskForceonColorectalCancer(AmericanCollegeofGastroenterology,AmericanGastroenterologicalAssociation,andAmericanSocietyofGastrointestinalEndoscopy).
EFFECTOFINADEQUATEPREPARATIONONPOLYP/ADENOMADETECTIONANDRECOMMENDEDFOLLOW-UPINTERVALSRecommendations:1.
Preliminaryassessmentofpreparationqualityshouldbemadeintherectosigmoidcolon,andiftheindica-tionisscreeningorsurveillanceandthepreparationclearlyisinadequatetoallowpolypdetectiongreaterthan5mm,theprocedureshouldbeeithertermi-natedandrescheduledoranattemptshouldbemadeatadditionalbowelcleansingstrategiesthatcanbedeliveredwithoutcancellingtheprocedureCopyright2014bytheAmericanSocietyforGastrointestinalEndoscopy,theAmericanGastroenterologicalAssociation,andtheAmericanCollegeofGastroenterology.
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4:2014GASTROINTESTINALENDOSCOPY543thatday(Strongrecommendation,low-qualityevidence)2.
Ifthecolonoscopyiscompletetocecum,andthepreparationultimatelyisdeemedinadequate,thentheexaminationshouldberepeated,generallywithamoreaggressivepreparationregimen,within1year;intervalsshorterthan1yearareindicatedwhenadvancedneoplasiaisdetectedandthereisinadequatepreparation(Strongrecommenda-tion,low-qualityevidence)3.
Ifthepreparationisdeemedadequateandthecolo-noscopyiscompletedthentheguidelinerecommen-dationsforscreeningorsurveillanceshouldbefollowed(Strongrecommendation,high-qualityevidence)Inadequatecolonicpreparationisassociatedwithreducedadenomadetectionrates(ADRs).
Alargeprospec-tiveEuropeanstudyof5832patientsenrolledin21centersacross11countriesexaminedtheassociationofprepara-tionqualityandpolypidenticationduringcolonoscopyperformedforarangeofcommonindications.
High-qualitypreparationwasassociatedwithidenticationofpolypsofallsizes(oddsratio[OR],1.
73;95%condenceinterval[CI],1.
28–2.
36),andwithpolypsgreaterthan10mminsize(OR,1.
72;95%CI,1.
11–2.
67).
2Ananalysisofanationalendoscopicdatabaseexaminedtheassocia-tionofpreparationqualityandpolypidenticationin93,004colonoscopies.
3Colonpreparation(asenteredbytheendoscopistatthetimeoftheprocedure)wasdichot-omizedintoadequate(excellent,good,andfair/adequate)andinadequate(fair,inadequate,andpoor).
Inadjustedmodels,adequatepreparationwaspredictiveofdetectionofallpolyps(OR,1.
21;95%CI,1.
16–1.
25),butnotpolypsgreaterthan9mmand/orsuspectedcancer(OR,1.
5;95%CI,0.
98–1.
11).
Similarly,asingle-centerstudybasedataUSVeteransAffairsMedicalCenterexaminedpreparationqual-ityandADRsin8800colonoscopiesperformedbetween2001and2010.
10Whencomparingthoseexaminationswithaninadequate/poorpreparation(nZ829)withthosewithanadequatepreparation(nZ5162),overallpolypdetectionwasreduced(OR,0.
66;95%CI,0.
56–0.
83).
Tworetrospectivesingle-centerstudiesexaminedtheassociationofpreparationqualityandadenomamissrateswhenthepreparationwasconsideredinadequateandtheexaminationwasrepeatedwithinashortinterval.
11,12Missrateswerethetotaladenomasfoundonthesecondexaminationdividedbythetotaladenomasfoundonbothexaminations.
In1study11therewere12,787colonos-copieswith3047(24%)suboptimalpreparations(fairorpoor).
Repeatcolonoscopywithin3yearsin216individ-ualswhoachievedadequatepreparationshowedanoveralladenomamissrateof42%,andamissrateof27%forlesions10mmorlargerinsize.
Theotherstudyidentied373average-riskscreeningpatientswithpoororinade-quatepreparation.
12Repeatcolonoscopyin133patients(77%achievedexcellentorgoodpreparation)showeda47%overalladenomamissrate.
AsingleprospectiveKoreanstudyevaluated277individ-ualsafteracompletecolonoscopyandthenaper-protocolrepeat"tandem"colonoscopywithin3monthsoftheinitialexamination.
13ThepatientadenomamissrateincreasedasbaselinepreparationqualitydecreasedontheAronchickscale.
Inthe19patientswithpoorpreparationtheade-nomaandadvancedadenomamissrateswere47%and37%,respectively,comparedwith21%and9%inthosewithexcellentpreparation(PZ.
024).
Surveysreportthatinthesettingofapoorpreparation,endoscopists'recommendationsforfollow-upevaluationvaryanderronshorterreturnintervals.
14,15In1study65board-certiedgastroenterologistsand13gastroenter-ologyfellows14wereshownimagesofpreparationsof"excellenttointermediatequality.
"Witha"nearlyperfect"preparation,a10-yearintervalgenerallywasrecommendedforanormalscreeningcolonoscopy.
However,recommen-dationswerequitevariableforthelower-qualityprepara-tions,rangingfrommorethan5yearstoanimmediaterepeatprocedure.
Asurveyofgastroenterologists(nZ116)preparingforboardcerticationfoundthat83%wouldrecommendfollow-upevaluationin3yearsorlessfor1–2smalladenomasandasuboptimalpreparation.
15Severalstudieshaveexaminedactualrecommendationsforfollow-upevaluationwithintheframeworkofclinicalpractice.
Onestudyabstractedchartsfrom152physiciansin55NorthCarolinapracticeson125consecutivepersonsineachpractice.
16Preparationqualitywasnotreportedin32%oftheexaminations.
Bowelpreparationsratedlessthanexcellentwereassociatedwithmoreaggressivesurveil-lanceforthosefoundwithnopolypsorsmalland/orme-diumadenomas.
Aprospectivesingle-centerstudyof296patientsshowedthatwhenendoscopistsencounteredapoorpreparationtheyrecommendedfollow-upintervalsthatmoreoftenwerenonadherentwithguidelines(34%nonadherentvs20%adherent;PZ.
01).
17Aprospectivestudyestimatedthatforeach1%ofbowelpreparationsdeemedinadequateandrequiringrepeatcolonoscopyatashortenedinterval,thecostsofdeliveringcolonoscopyover-allwereincreasedby1%.
5Thesesubstantialadverseeffectsofinadequatepreparationaretherationaleforestablishingatargetforratesofadequatepreparation(seelater).
DOSINGANDTIMINGOFCOLONCLEANSINGREGIMENSRecommendations:1.
Useofasplit-dosebowelcleansingregimenisstronglyrecommendedforelectivecolonoscopy(Strongrecommendation,high-qualityevidence)2.
Asame-dayregimenisanacceptablealternativetosplitdosing,especiallyforpatientsundergoinganaf-ternoonexamination(Strongrecommendation,high-qualityevidence)Bowelcleansingforcolonoscopy544GASTROINTESTINALENDOSCOPYVolume80,No.
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Theseconddoseofsplitpreparationideallyshouldbegin4–6hoursbeforethetimeofcolonoscopywithcompletionofthelastdoseatleast2hoursbeforetheproceduretime(Strongrecommenda-tion,moderate-qualityevidence)Split-doseregimensWhenpreparationagentsareadministeredentirelythedaybeforecolonoscopy,chymefromthesmallintestineentersthecolonandaccumulates,producingalmthatcoatstheproximalcolonandimpairsdetectionofatlesions.
Thelengthoftimebetweenthelastdoseofprep-arationandtheinitiationofcolonoscopycorrelateswiththequalityoftheproximalcoloncleansing.
18–20In1studythechanceofgoodorexcellentpreparationoftherightcolondecreasedbyupto10%foreachadditionalhourbetweentheendofingestingthepreparationandthestartofthecolonoscopy.
20"Splitting"impliesthatroughlyhalfofthebowelcleansingdoseisgivenonthedayofthecolonoscopy.
Overwhelminglyconsistentdatashowsuperiorefcacywithasplitdosecomparedwiththetraditionalregimenofadministeringthepreparationthedaybeforetheprocedure.
18,21–24SplitdosingleadstohigherADRs.
25,26Fourguidelineshaveendorsedsplitdosingofpreparationsforcolonoscopy.
27–30Same-dayregimensSame-daybowelcleansingisaneffectivealternativetosplitdosingforpatientswithanafternooncolonos-copy.
31–34Inalarge,single-blind,prospectivestudy,same-daypreparationprovidedbettermucosalcleansing,lesssleepdisturbance,bettertolerance,lessimpactonactivitiesofdailyliving,andgreaterpatientpreferencescorescomparedwithsplitdosing.
35Obstaclestosplitandsame-dayregimensAnecdotally,anesthesiaproviderssometimesopposesplitandsame-daydosingbecauseofconcernforaspira-tionrisk.
Anevidenced-basedguidelinefromtheAmericanSocietyofAnesthesiologists,however,statesthatingestionofclearliquidsuntil2hoursbeforesedationdoesnotaffectresidualgastricvolume.
36Furthermore,2endo-scopicstudiesfoundthatingestionofbowelcleansingagentsonthedayofcolonoscopydidnotaffectresidualgastricvolumes,indicatingthattherateofgastricemptyingofbowelpreparationsissimilartootherclearliquids.
37,38Preoperativedehydrationmaybeagreatersafetyconcernthandrinkingclearliquidsbeforeanesthesia.
Asecondobjectiontosplitdosingisthatpatientssched-uledforearlymorningproceduresmaybeunwillingtogetupduringthenighttotaketheseconddoseoflaxatives.
Acceptanceofandcompliancewithsplit-dosebowelpreparationishighandshouldnotposeadeterrenttopre-scribingsplit-dosepreparationsforcolonoscopy.
39,40Theriskoffecalincontinenceduringtransittotheendoscopycenterisincreasedonlyminimallywithsplitdosing.
40DIETDURINGBOWELCLEANSINGRecommendation:1.
Byusingasplit-dosebowelcleansingregimen,dietrecommendationscanincludeeitherlow-residueorfullliquidsuntiltheeveningonthedaybeforecolo-noscopy(Weakrecommendation,moderate-qualityevidence)Traditionally,patientsareinstructedtoingestonlyclearliquidsthedaybeforecolonoscopy.
Recentrandom-izedtrialsreportthataliberalizeddietthedaybeforecolonoscopyisassociatedwithbettertoleranceofthepreparationandcomparableorbetterbowelcleansing.
41–48Thedietregimensinthesetrialswerevar-iableandincludedaregulardietuntil6PM,regularbreak-fast,low-residuebreakfast,lunchandsnack,asoftdiet,andasemiliquiddiet(heterogeneity:PZ.
008;IZ62%).
Withthisdegreeofheterogeneitywearereluctanttorecommendaregulardietthedaybeforecolonoscopy.
Accordingly,alow-residuedietforpartorallofthedaybeforecolonoscopycanbeconsideredforpatientswithoutotheridentiablepreproceduralrisksforinade-quatecolonpreparation.
Pendingadditionalstudy,colo-noscopistscarefullyshouldevaluateanycompromiseinefcacyifdietaryexibilityisallowed.
USEFULNESSOFPATIENTEDUCATIONANDNAVIGATORSFOROPTIMIZINGPREPARATIONRESULTSRecommendations:1.
Healthcareprofessionalsshouldprovidebothoralandwrittenpatienteducationinstructionsforallcomponentsofthecolonoscopypreparationandemphasizetheimportanceofcompliance(Strongrecommendation,moderate-qualityevidence)2.
Thephysicianperformingthecolonoscopyshouldensurethatappropriatesupportandprocessmeasuresareinplaceforpatientstoachieveadequatecolonos-copypreparationquality(Strongrecommendation,low-qualityevidence)Apatienteducationprogramadministeredbyhealthcareprofessionalsincreasespatientcompliance,improvesquality,anddecreasesrepeatexaminationsandcosts.
49Theuseofbothverbalandwritteninstructions,comparedwithwritteninstructionsonly,isanindependentpredictorofadequatebowelpreparationquality.
Educationaltoolssuchasbooklets,informationleaets,animations,andvi-sualaidsshouldbestandardizedandvalidated,50,51andshouldbeeffectiveacrossarangeofhealthliteracyanded-ucationlevels.
4,52Theuseofanovelpatienteducationalbookletonprecolonoscopypreparationresultedinbetterbowelpreparationqualityscoresthanthoseachievedusingconventionalinstructions(OR,3.
7;95%CI,2.
3–5.
8).
53www.
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4:2014GASTROINTESTINALENDOSCOPY545BowelcleansingforcolonoscopyTrainedpatientnavigatorshelpguidepatientsthroughthecolonoscopyprocess.
Theyprovideeducationtopatients,addressbarrierstocolonoscopy,reviewbowelpreparationprotocolsandappointments,andensurethatpatientshaveanescortforappointments.
Patientnaviga-torsforurbanminoritiesinopen-accessreferralsystemsresultedinanincreaseforscreeningcolonoscopycomple-tionrates.
54,55Insafety-nethospitalsthecostsofnaviga-tionareoffsetbyincreasedscreeningcomplianceandnavigationiscosteffective.
56Barrierstosuccessfulnaviga-tionincludedincompletecontactinformation,languageproblems,andinsurancelapses.
Theimpactofthesex,ethnicity,andprofessionalstatusofthepatientnavigatorneedsadditionalevaluation.
RATINGTHEQUALITYOFBOWELPREPARATIONDURINGCOLONOSCOPYRecommendations:1.
Adequacyofbowelpreparationshouldbeassessedafterallappropriateeffortstoclearresidualdebrishavebeencompleted(Strongrecommendation,low-qualityevidence)2.
Measurementoftherateofadequatecoloncleansingshouldbeconductedroutinely(Strongrecommen-dation,moderate-qualityevidence)3.
Adequatepreparation,denedascleansingthatal-lowsarecommendationofascreeningorsurveil-lanceintervalappropriatetothendingsoftheexamination,shouldbeachievedin85%ormoreofallexaminationsonaper-physicianbasis(Strongrecommendation,low-qualityevidence)Reportingthequalityofthebowelpreparationisarequiredelementofthecolonoscopyreport.
57,58Inclinicaltrialscleansingqualityoftenisestimatedusingscalesthatdowngradequalityforretaineduid.
Inclinicalpractice,however,retaineduidandmuchofthesemisoliddebrisinthecoloncanberemovedbyintraproceduralcleansing.
Becausethecapacitytoconducteffectivemucosalinspec-tionisestablishedafterintraproceduralcleansing,theprep-arationqualityinclinicalpracticeshouldbeassessedonlyafterappropriateintraproceduralwashingandsuctioninghasbeencompleted.
Forthisreason,theuseofavalidatedbowelpreparationscalethatincludesscoringretaineduid(eg,Aronchick,Ottawa)isnotrecommended.
TheUSMulti-SocietyTaskForce(USMSTF)considerstheoperationaldenitionofanadequatepreparationisoneinwhichthecolonoscopistcananddoesrecommendafollow-upscreeningorsurveillanceintervalforthenextcolonoscopythatisappropriatefortheexaminationndings.
Unfortu-nately,thescoresinvalidatedscalesthatcorrespondtothepointatwhichthepreparationmeetstheUSMSTFoper-ationaldenitionofanadequatepreparation(abilitytofollowtherecommendedscreeningorsurveillanceinterval)generallyareuncertain.
Inclinicalpracticecliniciansoftenuseanimpreciselydened4-pointscaleofexcellent,good,fair,andpoor.
Inthisscheme,excellentandgoodarewidelyviewedasadequate,butsomeresearchindicatesthatmanyfairpreparationsinclinicalpracticealsoareadequate.
10TheUSMSTFpreviouslyrecommendedthatclinicianscouldconsiderthepreparationadequateifaftersuctioningandwashingthemucosaduringtheprocedureitwasdeemedadequateforthedetectionoflesionsgreaterthan5mminsize.
59Thisconceptisnotpartofavalidatedbowelpreparationscalebutitdoesreectcurrentconceptsaboutthesizesofcolorectallesionsthatareclinicallymostimportanttodetect.
60Additionalresearchisneededtodevelopvalidatedscalesforscoringbowelcleansingthatdonotconsiderretaineduidandincludedenedpointsthatcorrespondtoadequatepreparation.
Currently,theBostonBowelPreparationscalecomesclosesttomeetingthesecriteriabecauseitdoesnotconsiderretaineduidandaBostonBowelPreparationScalescoreof5orhigherwasassociatedwithonlya2%rateofrecommendingshort-enedfollow-upintervals.
61Adetailedreviewofbowelprep-arationscalesisshowninAppendixB.
Whicheverscaleisusedinpractice,werecommendthatthemethodfordeninganadequatepreparationshouldincludewhetherthecolonoscopistrecommendstheexpectedscreeningorsurveillanceintervalsbasedonthecolonoscopyndings,andthattheabilitytodetectlesionsgreaterthan5mminsizethroughoutthecolonisaclini-callyrelevanttestofadequacyandappropriatenesstofollowscreeningandsurveillanceintervals.
Furthermore,endoscopistsareencouragedtosubmitprocedurereportsintoadataregistrythatbenchmarksperformanceandqual-itymeasuresagainstminimallyacceptednationalthresh-oldsandmeanlevelsofperformanceamongpeers.
IftherateofadequatebowelpreparationforanendoscopistisbelowtheUSMSTFrecommendedbenchmarkof85%,animprovementinitiativeshouldbeundertaken.
Highratesofinadequatepreparationscanreectlowpatientcompli-ance,failuretoadjustpreparationregimensformedicalpredictorsofinadequatepreparation,orsignalthatpro-cessesandpoliciesoftheendoscopyunitneedrevision.
FDA-APPROVEDPREPARATIONSRecommendations:1.
Selectionofabowel-cleansingregimenshouldtakeintoconsiderationthepatient'smedicalhistory,med-ications,and,whenavailable,theadequacyofbowelpreparationreportedfrompriorcolonoscopies(Strongrecommendation,moderate-qualityevidence)2.
Asplit-doseregimenof4LPEG-ELSprovideshigh-qualitybowelcleansing(Strongrecommendation,high-qualityevidence)3.
Inhealthynonconstipatedindividuals,a4-LPEG-ELSformulationproducesabowel-cleansingquality546GASTROINTESTINALENDOSCOPYVolume80,No.
4:2014www.
giejournal.
orgBowelcleansingforcolonoscopythatisnotsuperiortoalower-volumePEGformula-tion(Strongrecommendation,high-qualityevidence)Polyethyleneglycol–electrolytelavagesolution(PEG-ELS)–basedcleansingagentsareavailablein4L(consid-eredlargeorhighvolume)oras2Lplusanadjunct(consideredlowvolume).
Sodiumphosphate(NaP)solu-tion(FleetPhospho-SodaandFleetEZ-PREP;C.
B.
FleetCo,Lynchburg,VA)isahyperosmoticcleansingagentthatwaswithdrawnfromtheUSover-the-counter(OTC)marketinDecember2008becauseofconcernregardingphosphate-inducedrenaldisease.
62AprescriptiontabletformulationofNaP(OsmoPrep;SalixPharmaceuticals,Raleigh,NC)remainsavailable,althoughaboxedwarningabouttheriskofacutephosphatenephropathyhasbeenaddedtothelabel.
62Recentlyapprovedlow-volumeagentsincludeoralsulfatesolution(OSS)(SUPREP;BraintreeLab-oratories,Braintree,MA),sodiumpicosulfate/magnesiumcitrate(Prepopik;FerringPharmaceuticals,Inc,Parsippany,NJ),andacombinationofPEG-ELSandOSS(SUCLEAR;BraintreeLaboratories).
Polyethyleneglycol–electrolytelavagesolutionReduced-volume,FDA-approvedPEG-ELSformulationsweredevelopedtoimprovetolerance.
Oneoftheseprep-arations(2-LPEG-ELSwithbisacodyl,HalfLytely;BraintreeLaboratories),recentlywasremovedfromthemarket.
Another2-LPEG-ELSproductcontainssupplementalascor-bateandsodiumsulfate(MoviPrep;SalixPharmaceuticals).
Several4-LPEG-ELS–basedpreparationshavebeenapprovedbytheFDA,includingColyte(AlavenPharmaceu-ticals,Marietta,GA),Gavilyte(GavisPharmaceuticals,Som-erset,NJ),Golytely(BraintreeLaboratories),andNulytely(BraintreeLaboratories),whichissulfatefree.
High-volumePEG-ELS(R3L)wascomparedwithlow-volumePEG-ELS(!
3L)in28trialsyielding7208intention-to-treat(ITT)patients(3456high-volumePEG-ELS;3752low-volumePEG-ELS).
18,63–89Twenty-onetrialsincludedanalyzablebowel-cleanlinessoutcomes.
64–72,74–76,79,81–86,88,89High-volumePEG-ELSdidnotshowasignicantincreaseinbowelcleanliness(OR,1.
03;95%CI,0.
80–1.
32).
EighttrialsincludedaPEG-ELSsplitdoseinwhich2Lwereadministeredthedaybeforeand2Lwereadminis-teredthedayoftheprocedurecomparedwithaPEG-ELSnonsplitregimenregardlessofdosage,yielding1990ITTpatients(846PEG-ELSsplit[2L2L]dose;1144PEGnon-split).
18,46,66,81,84,85,90,91Sixtrialswereanalyzable,resultinginsignicantlyincreasedcleanlinessforthePEG-ELSsplit-doseregimen(2L2L)comparedwiththePEG-ELSnon-splitdose(OR,4.
38;95%CI,1.
88–10.
21).
46,66,81,84,85,90Becausetheyareiso-osmotic,PEG-ELSregimensoftenareconsideredpreferredregimensinpatientswhoarelesslikelytotolerateuidshifts,includingpatientswithrenalinsufciency,congestiveheartfailure,andadvancedliverdisease.
OralsulfatesolutionTwotrialsevaluatedOSS.
92,93OnetrialcomparedOSSinasplit-doseregimenwith4LPEG-ELStakenthedaybeforeandfoundmoresuccessfulpreparationswithOSS(98.
4%vs89.
6%;P!
.
04,per-protocoldata).
93ThesecondtrialcomparedOSSwithPEG-ELS2Lplusascorbate.
BothOSSand2LPEG-ELSplusascorbateweremoreeffectivewhengiveninsplitdoses,andtheFDAapprovedOSSforsplit-doseadministrationonly.
92Thecombinedresultsof923ITTpatients(462OSS,461PEG)foundthatOSSdidnotincreasebowelcleanliness(OR,1.
12;95%CI,0.
77–1.
62).
92,93SodiumpicosulfateSodiumpicosulfate(PICO),astimulantlaxativeoftencombinedwithamagnesiumsalt,recentlywasintroducedtotheUSmarketafterconsiderableexperienceinCanada,Europe,andAustralia.
EleventrialscomparedPICOvsPEG-ELSandyielded3097ITTpatients(1385PICO,1715PEG-ELS).
77,94–103ThePICOpreparationswerecombinedeitherwithmagnesiumoxideormagnesiumcitrate.
TentrialsincludedanalyzablecleanlinessdatacomparingPICOwithPEG-ELS.
94–103ThePICOformulationdidnotshowasignicantincreaseinefcacycomparedwithPEG-ELS(OR,0.
92;95%CI,0.
63–1.
36).
EighttrialscomparedPICOwithNaP,yielding1792ITTpatients(966PICO,826NaP).
77,97,104–109Threetrialsincludedanalyzablecleanlinessdata,PICOwasnotsupe-riortoNaP(OR,0.
60;95%CI,0.
22–1.
65).
97,106,107Only1trialcomparedthePICOsplit-doseregimenvsPICOthedaybeforeorthesamedayincluding250ITTpatients(127split,123notsplit).
110PICOsplit-dosecomparedwithPICOday-beforeorsame-dayregimenhadasignicantlyhigherproportionofbowelcleanliness(OR,3.
54;95%CI,1.
95–6.
45).
SodiumphosphateOralNaPuseforbowelpreparationhasdecreasedbecauseoftherareoccurrenceofrenaldamagefromtubulardepositionofcalciumphosphate.
111,112PotentialriskfactorsforNaP-inducednephropathyincludethefollowing:femalesex,pre-existingrenalinsufciency,inadequatehydrationduringbowelpreparation,reducedtimeintervalbetweenthe2dosesofsodiumphosphate(!
12h),hypertension,olderage,andcertainmedications(diuretics,nonsteroidalanti-inammatorydrugs,andrenin-angiotensininhibitors).
113Forty-eighttrialswereincludedinacomparisonofNaPvsPEG-ELS,yielding11,368ITTpatients(5529PEGvs5839NaP).
75–77,97,108,114–157Thirty-threetrialsincludedanalyzablebowel-cleanlinessoutcomes.
75,76,97,108,114,115,117,119,121,124,126,127,129–133,136,137,139–141,143,145,146,148,150–156TheuseofNaPdidnotshowanincreaseinbowelcleanliness(OR,1.
02;95%CI,0.
77–1.
36)butwasassociatedwithbetterwillingnesstorepeattheregimen(OR,2.
61;95%CI,1.
48–4.
59).
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4:2014GASTROINTESTINALENDOSCOPY547BowelcleansingforcolonoscopyComparisonsofNaPwithOSSandPICOwerediscussedpreviously.
Threetrials144,158,159wereincludedinthecomparisonoftheNaPsplit-doseregimenwithNaPthedaybeforetheprocedureorthesamedayforatotalof598ITTpatients(355splitvs243nonsplit).
144,158,159Twotrials158,159includedanalyzabledataandshowedbettercleansingwithsplit-doseregimens(OR,2.
35;95%CI,1.
27–4.
34).
158,159AlthoughNaPiseffectiveandwelltoleratedbymostpatients,theriskofadverseeventsmakesitunsuitableasarst-lineagent.
Furthermore,NaPisnotrecommendedinpatientswithrenalinsufciency(creatinineclear-ance,!
60mL/min/1.
73m2),pre-existingelectrolytedis-turbances,congestiveheartfailure(NewYorkHeartAssociationclassIIIorIVorejectionfraction!
50%),cirrhosis,orascites.
CautionshouldbeusedinprescribingNaPtopatientswhoareelderly,hypertensive,ortakingangiotensin-convertingenzymeinhibitors,nonsteroidalanti-inammatorydrugs,ordiuretics.
OTCNON–FDA-APPROVEDPREPARATIONSRecommendations:1.
TheOTCbowelcleansingagentshavevariableef-cacythatrangesfromadequatetosuperior,depend-ingontheagent,dose,timingofadministration,andwhetheritisusedaloneorincombination;regard-lessoftheagent,theefcacyandtolerabilityareenhancedwithasplit-doseregimen(Strongrecom-mendation,moderate-qualityevidence)2.
AlthoughtheOTCpurgativesgenerallyaresafe,cautionisrequiredwhenusingtheseagentsincertainpopulations;forexample,magnesium-basedpreparations(bothOTCandFDA-approvedformula-tions)shouldbeavoidedinpatientswithchronickid-neydisease(Weakrecommendation,verylowqualityevidence)TheuseofOTCproductsforbowelcleansingbeforeco-lonoscopyisdeemedtobesafeforusebythepublicwithoutadvicefromahealthcareprofessional.
TheefcacyandsafetyoftheseproductsforspecicindicationsmaybeunprovenbecausetheFDA'soversightofOTCproductsgenerallyisconductedbytherapeuticclassratherthanforindividualdrugs.
Consequently,anOTCproductmayhavelittleornosupportingevidenceorcomparativedatashowingeitherefcacyorsafetyrelativetootheravailableproducts.
ProductsmarketedspecicallyforcolonoscopybowelpreparationmustbeevaluatedinrandomizedtrialstoassesstheirefcacyandsafetyandthenmustreceiveapprovalviaaNewDrugApplication(NDA)fromtheFDA.
Suchproductsareavailableonlybyprescription.
ForapurgativeagenttobemarketedwithoutanapprovedNDAitmustmeettherequirementsforOTCagentsassetforthintheLaxativeMonograph(Unpublisheddata).
TheFDAspecicallyrecognizedonly2bowelcleansingkits,160andanykitwithdifferentcomponentswouldrequireanapprovedNDAand/orfurtheramendmenttothemonograph(highlyunlikely).
Thesecleaningkitsareasfollows:magnesiumcitrateoralsolution,bisacodyltab-lets,andbisacodylsuppositories;andmagnesiumcitrateoralsolution,phenolphthalein,andsodiumbicarbonate–sodiumbitartratesuppositories.
TheseOTCmedicationsorcombinationscanberecom-mendedbyphysiciansaspartofabowel-cleansingregimeninpreparingpatientsforsurgeryorforpreparingthecolonforx-rayorendoscopicexamination.
ThefollowingsectionreviewsavailabledataonseveralOTCagentsthathavebeenusedforbowelcleansingbeforecolonoscopy.
PEG-3350powderPEG-3350powder,anOTClaxativemarketedforconsti-pation,isavailableasan8.
3-ozbottle(238g).
Whenusedforaprecolonoscopybowelpreparation,thecontentsof1bottleoftenaremixedwith64ouncesofGatorade(Pep-siCo,Chicago,IL)tocreatea2-LPEGformulation.
Insomeinstances,cliniciansprescribebisacodyltabletsormagne-siumcitrateinconjunctionwiththePEG-3350powder.
Fiverandomizedcontrolledtrials(total,1556patients)havecomparedPEG-3350powder,eitheraloneorcom-binedwithanadjunct,withcommerciallyavailable4LPEG-ELS.
69,73,80,84,161In1study,satisfactorycoloncleansingwaslessfrequentwithPEG-3350powderthanwith4LPEG-ELS(68%vs83%;PZ.
018).
69Intheremaining4studies,including1studythatused306gratherthan238g,theproportionofpa-tientshavinganadequatebowelpreparationwascompara-blewithPEG-3350powderand4LPEG-ELS.
29–31Tolerabilitybasedontasteandoverallexperiencewasbet-terwithPEG-3350powderthanwith4LPEG-ELSin4studies,73,80,84,161andnodifferenceintolerabilitywasobservedin1series.
69AdverseeventswithPEG-3350overallarerare.
AlthoughhyponatremiaisapotentialriskwhenusingahypotoniclavagesolutionsuchasPEGpowder,nostatis-ticaldifferencesinserumelectrolytelevelswereobservedin3studiesthatcomparedPEGpowdervs4LPEG-ELS.
80,84,161Reportsofhyponatremiahaveoccurredwhenadministeredtheeveningbefore,butnotwithsplit-doseregimens.
162WidespreaduseofPEG-3350forbowelpreparationseemstohavebeenremarkablysafe,butadditionalevaluationofsafetyandiswarrantedanddesirable.
MagnesiumcitrateMagnesiumcitrate,awidelyusedagentintheUnitedStates,wasevaluatedin4randomizedtrials,including2trialsthatcombineditwitheitherPEG-ELSorNaPsolu-tion.
81,163–165Magnesiumcitrate(300mL3)wassuperiortoNaPsolution(45mL2),producinggood548GASTROINTESTINALENDOSCOPYVolume80,No.
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.
001).
165Atran-sientincreaseinserummagnesiumlevelmaybeobserved,buthasnotbeenreportedtocauseclinicaladverseeventsinhealthypersons.
Theuseofmagnesium-basedprepara-tionsinpatientswithchronickidneydiseaseshouldbeavoidedbecauseofpossiblemagnesiumtoxicity.
166,167APEG-ELS–basedregimenispreferredinsuchcases.
OtherOTCproductsSennawasstudiedin4randomizedcontrolledtrials,eitheralone(3trials)orcombinedwith2LPEG-ELS(1trial),comparingitwitheitherhigh-orlow-volumePEG-ELS.
71,168–170High-dosesenna(24tabletsof12mgeach)wasaseffectiveas4LPEG-ELSin2studies,althoughpatientsreceivingsennaexperiencedsignicantlymorecrampsandabdominalpain.
168,170Low-dosesenna(3–12tablets)hasbeencombinedwith2LPEG-ELStoincreaseitscleansingeffect.
71,169In2randomizedtrialsthatcomparedbisacodyl(30–40mg)withNaPsolution,bisa-codylachievedsignicantlylowerratesofsatisfactorybowelcleansing.
171,149PatienttolerabilityforbisacodylandNaPsolutionwascomparablewiththeexceptionofnausea,whichwasmorecommonwithNaP.
ADJUNCTSTOCOLONCLEANSINGBEFORECOLONOSCOPYRecommendation:1.
Theroutineuseofadjunctiveagentsforbowelcleansingbeforecolonoscopyisnotrecommended(Weakrecommendation,moderate-qualityevidence)Numerousadjunctiveagents,intendedtoenhancepur-gationand/orvisualizationofthemucosa,havebeeninves-tigatedforprecolonoscopycleansingofthemucosa.
Thesehaveincludedsimethicone,avoredelectrolytesolutions(eg,Gatorade),prokinetics,spasmolytics,bisacodyl,senna,oliveoil,andprobiotics.
Noneconsistentlyhaveshownimprovedefcacy,safety,ortolerabilityofthebowelprep-aration.
Currently,theroutineuseofadjunctiveagentsforcoloniccleansingbeforecolonoscopyisnotrecommen-ded,buttheagentsmaybeusefulinselectcircumstances,atthediscretionoftheprescribingphysician.
Simethiconeisthebest-studiedadjunctiveagentforbowelcleansing.
Inameta-analysisof7randomizedtrialscomparingcolonoscopybowelpurgativewithorwithouttheadditionofsimethicone,theoverallefcacyofcolonpreparationwascomparable(OR,2.
06;95%CI,0.
56–7.
53;PZ.
27),despiteanotablereductioninthepresenceofintraluminalbubbles(OR,39.
3;95%CI,11.
4–135.
9;P%.
01)inthegroupreceivingsimethicone.
172Thedosageofsimethiconevariedbetweenstudies,rangingfrom120to240mg,or45mLofa30%solution.
76,172–174Inrandomizedtrials,prokineticssuchasmetoclopra-mide,domperidone,cisapride,andtegaserodhavenotimprovedpatienttolerabilityorqualityofthebowelpreparation.
175–178Mosaprideanditopride,2motility-enhancingagentscurrentlyinclinicaldevelopment,improvedpreproceduretolerabilitywithsignicantreductionsinnausea,vomiting,bloating,andabdominalpain,177andimprovedefcacyinpatientsreceivingsplit-dosepreparations.
178AlverinecitrateaddedasaspasmolyticadjunctproducednoincreaseinpreparationqualityortolerancewhencomparedwithNaPaloneinarandomizedtrialof147patients.
179Sennaandbisacodylhavebeenusedasadjunctstolow-volumePEG-ELS–basedagentswithimprovedtolerability,68althoughthequalityofthebowelpreparationwasnotaseffectivecomparedwithstandard-volumesolutions.
71,74,161Ascorbatewasstudiedinarandomizedtrialcomparing2low-volumePEG-ELSpreparations.
PEG-ELScitrate-sime-thiconewithbisacodylandPEGascorbateshowedsimilartolerability,safety,acceptability,andcompliance.
180Anotherrandomizedstudyof107patientsshowedbettercoloncleansingwith2LPEG-ELSascorbatecomparedwithPEG-ELSwithbisacodyl.
181WhencombinedwithGatorade,PEG,80orPEG-3350powder,84theseformula-tionshaveshownadequatebowelcleansingbutinconsis-tentsatisfactionacrossstudies.
80,84Oliveoilfollowedbylow-volumePEG-ELSimprovedcleansingqualityintherightcolon,buthadnoimpactintheleftcoloncomparedwith4LPEG-ELS.
63TheuseofmentholcandylozengesrecentlywasshowntoincreasepalatabilityandimproveingestionofPEG-ELS.
182A2-weekcourseofaprobioticcontainingBacillussubtilisandStreptococcusfaeciumbeforeNaPinconstipatedpatientsimprovedcleansingcomparedwithplacebo,buthadnoeffectinpatientswithnormaldefecation.
183DIFFERENCESINPATIENTPREFERENCE/WILLINGNESSTOREPEATCOMPARISONSRecommendations:1.
Split-dosebowelcleansingisassociatedwithgreaterwillingnesstorepeatregimencomparedwiththedaybeforeregimen(Strongrecommendation,high-qualityevidence)2.
Theuseoflow-volumebowelcleansingagentsisassociatedwithgreaterwillingnesstoundergoarepeatcolonoscopy(Strongrecommendation,high-qualityevidence)Meta-analysisdatafrom5randomizedblindedtrialsshowedbetterpatientsatisfactionandadherencewithfewerpreparationdiscontinuations(OR,0.
52;95%CI,02.
8–0.
98;PZ.
04)withasplit-doseregimen.
21Split-dosePEG-ELSsignicantlyincreasedthenumberofadequatebowelpreparations(OR,3.
7;95%CI,2.
79–491;P!
.
01).
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4:2014GASTROINTESTINALENDOSCOPY549Bowelcleansingforcolonoscopyrandomizedpatientsscheduledforearlymorningcolonos-copywhounderwentday-beforevssplit-dose4LPEG-ELS;andadversesymptomssuchasnausea,vomiting,andbloatingweremorefrequentinthesingle-dosegroup.
184Intrialsofhigh-volumePEG-ELS(R3L)comparedwithlow-volumePEG-ELS(!
3L),willingnesstorepeatbowelcleansingregimenwaslowerinthehigh-volumegroup(OR,0.
34;95%CI,0.
18–0.
64)63,66,69,70,78,79,81,83,85andhigherforthesplit-dosegroup(OR,1.
76;95%CI,1.
06–2.
91;PZ.
03).
39ForOSS,willingnesstorepeatwasnotre-portedinanyofthestudies.
92,93Willingnesstorepeatthesamepreparationwashigherwithsplit-dosePICOthanwithPEG-ELS(OR,8.
77;95%CI,3.
28–23.
43)97,106,107,185andwasnotreportedinthe1trialcomparingaPICOsplit-doseregimenvsaPICOday-beforeorsame-dayregimen.
110InthestudiescomparingPEG-3350powderwithPEG-ELS,willingnesstorepeatwashigherwithPEG-3350powder.
69,84Aprospectivestudyexaminednewsymptomsaftercolonoscopyin247previouslyasymptomaticpeople186whocompletedastandardizedinterviewat7and30daysaftercolonoscopy.
Bloatingorabdominalpainoccurredin34%intheweekafterandin6%betweendays7and30.
Onmultivariateanalysis,women(OR,1.
78,95%CI,1.
21–2.
62)andlongerprocedureduration(20–29min:OR,1.
06;95%CI,0.
64–1.
75;30–39min:OR,1.
77;95%CI,1.
03–3.
05;R40min:OR,2.
63;95%CI,1.
49–4.
63)wereassociatedwithminorcomplications.
Mostsymptom-aticsubjects(94%)lost2orfewerdaysfromnormalactiv-itiesforthecolonoscopyitself,preparation,orrecovery.
SELECTIONOFBOWELPREPARATIONINSPECIFICPOPULATIONSRecommendations:1.
Thereisinsufcientevidencetorecommendspecicbowelpreparationregimensforelderlypersons;however,werecommendthatNaPpreparationsbeavoidedinthispopulation(Strongrecommenda-tion,low-qualityevidence)2.
Thereisinsufcientevidencetorecommendspecicbowelpreparationregimensforchildrenandadoles-centsundergoingcolonoscopy;however,werecom-mendthatNaPpreparationsshouldnotbeusedinchildrenyoungerthanage12orinthosewithriskfactorsforcomplicationsfromthismedication(Strongrecommendation,verylowqualityevidence)3.
NaPshouldbeavoidedinpatientswithknownorsuspectedinammatoryboweldisease(Weakrecommendation,verylowqualityevidence)4.
Additionalbowelpurgativesshouldbeconsideredinpatientswithriskfactorsforinadequatepreparation(eg,patientswithapriorinadequatepreparation,historyofconstipation,useofopioidsorotherconstipatingmedications,priorcolonresection,dia-betesmellitus,orspinalcordinjury)(Weakrecom-mendation,low-qualityevidence)AdetaileddiscussionofpatientfactorsthatpredictinadequatepreparationispresentedinAppendixC5.
Low-volumepreparationsorextendedtimedeliveryforhigh-volumepreparationsarerecommendedforpatientsafterbariatricsurgery(Weakrecommen-dation,verylowqualityevidence)6.
Tapwaterenemasshouldbeusedtopreparetheco-lonforsigmoidoscopyinpregnantwomen(Strongrecommendation,verylowqualityevidence)7.
Thereisinsufcientevidencetorecommendspecicregimensforpersonswithahistoryofspinalcordinjury;additionalbowelpurgativesshouldbeconsid-ered(Weakrecommendation,verylowqualityevidence)Subgroupsofindividualsmaybenetfromtailoringthebowelpreparationregimenbecauseofconcernsabouttolerability,effectiveness,oradverseeventsrelatedtothepreparation.
AdvancedageAlthoughadvancedageisapredictorofsuboptimalbowelpreparation,overalltoleranceofthebowelprepara-tionissimilarbetweenoctogenariansandyoungerpatientsundergoingcolonoscopy.
187,188In2trialsof72and116elderlypatients,respectively,randomizedtoreceiveeitherNaPorPEG-ELS,therewasnosignicantdifferenceintolerabilityorqualityofthebowelcleansing.
116,189Therewere,however,moreelectrolyteabnormalitiesintheNaPgroupin1study,189andassociatedseriouselectrolyteab-normalitieshavebeenreportedintheelderly.
190,191Hypo-kalemiawasassociatedwithuseofPEG-ELSinelderlypatients.
192Alargepopulation-basedretrospectivestudyof50,660individualsolderthanage65whounderwentoutpatientcolonoscopyinOntarioreportedthatseriousevents,includingnonelectivehospitalization,emergencydepartmentvisit,ordeathwithin7daysofcolonoscopyweresimilarbetweenthosereceivingPEG-ELSorPICO(28per1000proceduresforeachgroup).
193PediatricsSelectionofbowelpreparationregimensforpediatricpatientsshouldbeindividualizedaccordingtothepatient'sage,clinicalstate,andanticipatedwillingnessorabilitytocomplywiththespecicmedications.
194Maintenanceofadequatehydrationduringcolonoscopypreparationisimportant,especiallyinchildren.
195Fewcontrolledtrialsofbowelpreparationregimenshavebeenperformedinpediatricpatients,althoughmanyregimenshavebeendescribed.
196Inpatientadministrationissometimesrequired.
Ingestionofclearliquidsfor24hoursalongwiththeadministrationofanormalsalineenema(10mL/kg)usuallyissufcientforinfantswithnormalorfrequentbowel550GASTROINTESTINALENDOSCOPYVolume80,No.
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194,197Olderchildrentypicallycanundergobowelpreparationwithintestinallavageorlaxativesandenemas.
196,198Inastudyofchildrenaged1.
5–19years,me-toclopramidefollowedbyPEG-ELSatadoseof40mL/kg/hresultedinclearstoolafter2.
6hours,althoughnausea,emesis,anddistensionwerecommon.
199Ofnote,11ofthe20childreninthisstudyhadnasogastricadministrationofthelavagebecauseoftheunpleasanttaste.
Inarandom-izedstudycomparing3regimens(PEG-ELSvsmagnesiumcitratewithsennosides[eg,X-Prep,sennadryextract]vsbisacodyltabletsplusanenema),thePEG-ELSsolutionre-sultedinthehighest-qualitycoloncleansingbutwasleastwelltolerated.
200AnotherpurgativeoptionusedinchildrenisPEG-3350administeredatadoseof1.
5g/kg/dfor4daysbeforetheprocedure,withaclearliquiddietonthefourthday(sometimesincombinationwithanenema).
201,202OtherregimensusingPEG-3350,includinga1-dayprepara-tion,alsohavebeeneffective,althoughtherearenocontrolledtrialsusingthisagentinchildren.
203,204Inarandomizedtrialcomparingacombinedpre-parationofPICO,magnesiumoxide,andcitricacidwithPEG-ELSinchildren,thecombinedpreparationwasbettertoleratedwithsimilarcleansingeffectiveness.
205AnotherrandomizedstudycomparingPICOwithmagnesiumcitratewithbisacodyltabletsinadditiontophosphateenemasfoundthattheoralPICOregimenwassuperiortothebisa-codylregimen.
206Sodiumphosphateisassociatedwithimprovedtolera-bilityandlessdiscomfortinchildrencomparedwithPEG-ELS207,208ormagnesiumcitratewithenemas.
209ThebowelcleansingeffectivenessofNaPwassuperiortoPEGin1study207andsimilarinanotherstudy.
208Inarandom-izedstudycomparingaprepackageddietkitincludingmagnesiumcitrateandbisacodyllaxativeswithNaP,the2regimenshadcomparabletolerability,althoughthequalityofcleansingwassuperiorwiththemagnesiumcitrateregimen.
210TheIsraeliSocietyofPediatricGastroenter-ologyandNutritionreviewedtheevidenceofadverseeventswithoralNaPandrecommendedthatNaPshouldnotbeusedinchildrenyoungerthan12yearsofage,chil-drenwithanytypeofkidneydisease,childrentreatedwithmedicationsthataffectrenalfunction,childrenwithsignif-icantcomorbidities(eg,liverdisease,hypertension,hypo-parathyroidism,diabetes,andheartdisease),childrenathighriskfordehydrationorelectrolyteimbalance,andchil-drenwithileusorsuspectedseverecolitis.
211TheIsraeliSocietyofPediatricGastroenterologyandNutritionhas6recommendedproductsascoloncleansingagentsforchildren:PEG-ELS,NaP(foragesR12y),PICO,PEG-3350,bisacodyl,andenemas.
InammatoryboweldiseaseTheuseofNaP-containingbowelpreparationscanbeassociatedwiththedevelopmentofsupercialmucosalabnormalitiesthatmayresemblefeaturesofearlyinam-matoryboweldisease.
97,212–219Inaprospectivestudyof730patientswithoutknowninammatoryboweldisease,mucosallesionsresultingfromNaPwerereportedin3.
3%.
217Inaprospective,randomized,single-blindedtrialin634patients,Lawranceetal97reportedthatpreparation-inducedmucosalinammationwas10-foldgreaterwithNaP(PZ.
03)andPICO(PZ.
03)comparedwithPEG.
Inanotherprospective,randomized,single-blindedtrialin97patients,aphthoid-likemucosallesionswerere-portedin2.
3%ofpatientsreceivingPEGcomparedwith24.
5%ofpatientswhoreceivedNaPsolution.
216AlthoughthesemucosalchangesmaymimicthechangesofCrohn'sdisease,thehistologicappearanceisdistinctiveandper-mitsdifferentiationfromidiopathicinammatoryboweldisease.
214,220AfterbariatricsurgeryTherecurrentlyisnopublishedclinicaltrialevidencetorecommendspecicregimensforpersonswithahistoryofpriorbariatricsurgery.
Patientswithrestrictivegastricsur-geryshouldbecounseledtouselow-volumepreparations,orifhigh-volumepreparationsareusedthetimelinesforingestionneedtobeextended.
Inaddition,patientsshouldbeadvisedtoconsumesugar-freedrinksandliquidfoodstoavoidsymptomsrelatedtodumpingfromthehighsugarcontent.
221PregnancyColonoscopyrarelyisindicatedduringpregnancy.
Ifnecessary,itshouldbedeferreduntilthesecondtrimesterwheneverpossibleandalwaysshouldhaveastrongindica-tionwithacarefulassessmentofriskvsbenet.
222There-fore,thesafetyandefcacyofbowelpreparationshavenotbeenwellstudiedinthisgroup.
TheUSFDAhasassignedcategoriesofriskforuseofmedicationsduringpregnancy(http://www.
drugs.
com/pregnancy-categories.
html).
BothPEG-ELSandNaPsolutionsarecategoryCmedications.
LowdosesofPEG-ELSwerereportedtobesafeinastudyof225pregnantpatientswhoweretreatedforconstipa-tion.
223Antenatalfailureofbonegrowthandmineraliza-tionwasreportedinacaseofamotherwhorepeatedlyhadtakenphosphateenemasduringpregnancy.
224TheAmericanGastroenterologicalAssociationrecommendsthatNaPshouldbeavoided225whereastheAmericanSoci-etyofGastrointestinalEndoscopystatesthatNaPprepara-tionsshouldbeusedwithcautionowingtopossibleuidandelectrolyteabnormalities.
222Onesurveyfoundthatonly12.
9%ofobstetricianspreviouslyhaveorwouldpre-scribePEG-ELStoapregnantpatientcomparedwith53.
8%ofgastroenterologists(P!
.
001).
226Incontrast,29.
1%ofobstetriciansvs7.
7%ofthesurveyedgastroenter-ologistspreviouslyhaveorwouldprescribeanoralNaPpreparationinapregnantpatient.
AlthoughPEG-ELSisconsideredalow-riskoption,tapwaterenemasarerecom-mendedbytheAmericanGastroenterologicalAssociationforlowerendoscopybecausefullcolonoscopyrarelyisindicatedduringpregnancy.
225www.
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4:2014GASTROINTESTINALENDOSCOPY551BowelcleansingforcolonoscopySALVAGEOPTIONSFORINADEQUATEPREPARATIONThereisinsufcientevidencetorecommendasinglesalvagestrategyforthosepatientsencounteredwithapoorpreparationthatprecludeseffectivecompletionofthecolonoscopy.
Thefollowingoptionscanbeconsideredinsuchcases:Recommendations:1.
Large-volumeenemascanbeattemptedforpatientswho,presentingonthedayofcolonoscopy,reportbrownefuentdespitecompliancewiththepre-scribedcolon-cleansingregimen(Weakrecom-mendation,verylowqualityevidence)2.
Through-the-scopeenemawithcompletioncolonos-copyonthesamedaycanbeconsidered,especiallyforthosepatientswhoreceivepropofolsedation(Weakrecommendation,verylowqualityevidence)3.
Wakingthepatiententirelyfromsedationandcontinuingwithfurtheroralingestionofcatharticwithsame-dayornext-daycolonoscopyhasbeenasso-ciatedwithbetteroutcomesthandelayedcolonoscopy(Weakrecommendation,low-qualityevidence)Althoughmultiplestudieshaveaddressedriskfactorsforinadequatepreparation,onlyasinglestudyexaminedsuchfactorsforasecondexamination.
In235patientswhounderwentasecondcolonoscopyspecicallybecauseofinadequatepreparation,thesecondexaminationfailedagainbecauseofinadequatepreparationin54ofthose235patients(23%).
227Next-daycolonoscopy(relativetoanyothertiming)wasassociatedwithareducedriskofrepeatfailure(OR,0.
31;95%CI,0.
1–0.
92).
Recognizingin-dividualslikelytohaveapoorpreparationatthetimeofarrivaltotheendoscopysuitemightallowforsalvageef-fortsbeforesedation.
Onestudyfoundthatthosereport-ingbrownliquidorsolidefuenthada54%chanceofhavingafairorpoorpreparation.
228Insuchcases,furtherpreparationwithlarge-volumeenemasoradditionaloralpreparationcouldbeconsidered.
Twostudiesdescribetheuseofathrough-the-scopeenematechniqueasasalvageregimenduringcolonos-copy.
229,230Ineachstudy,thepatientsarerecoveredfrompropofolsedationandthenpermittedtousethebathroomtoevacuateresidualuid.
Theearlierofthe2studiesdescribesapplicationofthetechniquein21adults(meanage,66y)foundtohaveinadequatepreparation.
230Afterpassingthecolonoscopeasproximallyaspossible,eitheraphosphateenema(133mL/19g)followedbyabisacodylenema(37mL/10mg)(10cases)or2bisacodylenemas(11cases)wereinstilledintothecolonthroughtheaccessorychannelofthecolonoscope.
Theinvestiga-torsreportedsuccess(colon"wellprepared")inallcases.
Theotherstudyevaluated26adults(medianage,59y)inwhomtheAronchickscalewasusedtoassessthequalityofthepreparationintherectosigmoidregion.
227Forthosedeterminedtohavepoororinadequatepreparation,arescueenema(polyethyleneglycolsolution/500mL)wasinstilledatthelevelofthehepaticexureviathebiopsychannel.
Byusingthistechnique,96%(25of26)werecleansedsuccessfully(excellentorgood).
Ineachcasethecolonoscopywascompletedsuccessfully.
Finally,Ibanezetal231reportedon51adultpatients(meanage,61.
5y)withapreviouslyfailedoutpatientcolo-noscopyasaresultofinadequatepreparationinwhomtheythentriedanintensivebowel-cleansingstrategybeforethesecondprocedure.
TheBostonBowelPrepara-tionScalewasappliedatthetimeoftheinitialcolonoscopyandthosewithascoreof0or1onanysegmentweredeemedinadequate.
Thebowelregimeninthesecasesincludedalow-berdietfor72hoursfollowedbyaliquiddietonthedaybeforetheprocedure.
Ontheeveningoftheprocedure,10mgofbisacodylwasadministeredalongwith1.
5LofPEG-ELS.
Asecond1.
5-LdoseofPEG-ELSwasadministeredonthedayofthecolonoscopy.
Byusingthisapproach,90%(46of51)hadanadequatepreparationasassessedbytheBostonBowelPreparationScale(ie,R2eachsegment).
Overall,thedataonmanagementofpatientswithinad-equatepreparationarelimited.
Avarietyofmeasuresthatuseadditionaloralpurgativesorenemasarelikelytobeeffective.
Supplementalmeasuresaimedateffectivecolo-noscopyandactedonassoonasdeemedsafearelikelytoresultinfewerpatientsbeinglosttofollow-upevalua-tion.
Patientswhopresenttotheendoscopyunitwithpersistentbrownefuentareatincreasedriskofinade-quatepreparationandmaywarrantmoreorallaxativesorenemasbeforeanyattemptatcolonoscopy.
SUMMARYIneffectivebowelcleansingforcolonoscopyresultsinmissedprecancerouslesionsandincreasedcostsrelatedtoearlyrepeatprocedures.
Efcacyandtolerabilityofbowelpreparationsareimportantandrelatedgoals,butef-cacyisofprimaryimportancebecauseofthesubstantialconsequencesofinadequatecleansing.
Adequatebowelpreparationimpliesthatthecolonoscopistwillrecommendascreeningorsurveillanceintervalconsistentwiththend-ingsoftheexaminationandcurrentscreeningandsurveil-lanceguidelines.
Therateofadequatebowelcleansingshouldbeatleast85%,andhigherwheneverpossible.
Awarenessofmedicalfactorsthatincreasetheriskofinad-equatepreparationandnonmedicalfactorsthatpredictpoorcompliancewithinstructionscandirectphysicianstotheuseofmoreefcaciousoraggressivepreparationregimensormoreextensiveeducation(includingnaviga-tion),respectively.
Somepatientswhopresentwithinade-quatepreparationcanhavetheirproceduressalvagedby552GASTROINTESTINALENDOSCOPYVolume80,No.
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Bowelpreparationqualityshouldbejudgedafterintraproceduraleffortstoenhancecleansingqualityhavebeencompleted.
ACKNOWLEDGMENTSTheUSMSTFmembersarerepresentativesfromtheAmericanCollegeofGastroenterology,theAmericanGastroenterologicalAssociation,andtheAmericanSocietyforGastrointestinalEndoscopy.
Thisdocumentwasapprovedbythegoverningbodiesofthese3societies.
Thismaterialistheresultofworksupported,inpart,byresourcesfromTheVeteransHealthAdministration.
TheviewsexpressedinthisarticledonotnecessarilyrepresenttheviewsoftheDepartmentofVeteransAffairs.
Abbreviations:ADR,adenomadetectionrate;CI,condenceinterval;CRC,colorectalcancer;FDA,FoodandDrugAdministration;ITT,intention-to-treat;NaP,sodiumphosphate;NDA,NewDrugApplication;OR,oddsratio;OSS,oralsulfatesolution;OTC,over-the-counter;PEG-ELS,polyethyleneglycol–electrolytelavagesolution;PICO,sodiumpicosulfate;USMSTF,USMulti-SocietyTaskForce.
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DISCLOSURESTheseauthorsdisclosethefollowing:DavidJohnsonhasservedasaconsultantandclinicalinvestigatorforEpigenomics,asaconsultantforGivenImaging,andasaclinicalinvestigatorforExactSciences;A.
BarkunhasservedasaconsultantforOlympus,Inc,andPendo-pharm,Inc,andhasreceivedclinicalresearchsupportfromBostonScienticandCook;L.
B.
Cohenhasservedasaconsultantandonthespeaker'sbureauandreceivedresearchsupportfromSalix,andasaconsultantforBraintree;T.
KaltenbachhasbeenaresearchgrantrecipientandconsultantforOlympusAmerica,Inc,D.
J.
RobertsonhasservedasaconsultantforGivenImag-ing;D.
A.
LiebermanhasservedonthescienticadvisoryboardsforExactSciences,GivenImaging,andRoche,andasaconsultantforMOTUS;andD.
K.
RexhasreceivedresearchsupportandservedasaconsultantforBraintreeLaboratoriesandFerringPharmaceuticals,GivenImaging,andOlympusAmericaCorp,hasservedasaconsultantforEpigenomicsandExactSciences,andhasservedonthespeaker'sbureauforBostonScien-tic,Inc.
Theremainingauthorsdisclosenoconicts.
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226.
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231.
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232.
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236.
CalderwoodAH,JacobsonBC.
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237.
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239.
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DavidA.
Johnson1AlanN.
Barkun2LarryB.
Cohen3JasonA.
Dominitz4TonyaKaltenbach5MyriamMartel2DouglasJ.
Robertson6,7C.
RichardBoland8FrancesM.
Giardello9DavidA.
Lieberman10TheodoreR.
Levin11DouglasK.
Rex12Currentafliations:EasternVirginiaMedicalSchool,Norfolk,Virginia(1),McGillUniversityHealthCenter,McGillUniversity,Montreal,Canada(2),IcahnSchoolofMedicineatMountSinai,NewYork,NewYork(3),VeteransAffairsPugetSoundHealthCareSystemandUniversityofWashington,Seattle,Washington(4),VeteransAffairsPaloAlto,StanfordUniversitySchoolofMedicine,PaloAlto,California(5),WhiteRiverJunctionVeteransAffairsMedicalCenter(6),GeiselSchoolofMedicineatDartmouth,Dartmouth-HitchcockMedicalCenter,WhiteRiverJunction,Vermont(7),BaylorUniversityMedicalCenter,Dallas,Texas(8),JohnsHopkinsUniversitySchoolofMedicine,Baltimore,Maryland(9),OregonHealthandScienceUniversity,Portland,Oregon(10),KaiserPermanenteMedicalCenter,WalnutCreek,California(11),IndianaUniversitySchoolofMedicine,Indianapolis,Indiana(12).
Reprintrequests:DavidA.
Johnson,MD,EasternVeteransAffairsMedicalSchool,Norfolk,Virginia.
ThisarticleisbeingpublishedjointlyinGastrointestinalEndoscopy,Gastroenterology,andAmericanJournalofGastroenterology.
www.
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orgVolume80,No.
4:2014GASTROINTESTINALENDOSCOPY559BowelcleansingforcolonoscopyAPPENDIXAKeyWordSearchesforUSMSTFDocument("PatientCompliance"[medicalsubjectheadings(MeSH)]OR"AppointmentsandSchedules"[MeSH]OR"patientsatisfaction"[MeSH]OR"PatientAcceptanceofHealthCare"[MeSH]ORcomplian*[ti]ORaccept*[ti]ORadheren*[ti]ORsatisfaction*[ti])(educat*[ti]ORcomprehension[tiab]ORunderstanding[tiab]OR"Educa-tionalStatus"[MeSH]OR"HealthEducation"[MeSH]OR"PatientEducationasTopic"[MeSH]OR"education"[sh])("colonoscopy"[MeSH]ORsigmoidoscop*[tiab]ORproctosigmoidoscop*[tiab]OR"gastrointestinalendoscopy"[tiab]ORcolonoscop*[tiab])("Laxatives"[MeSH]OR"Laxatives"[PharmacologicalAction]ORlaxa-tive*[tiab]OR"Cathartics"[MeSH]OR"Cathartics"[Phar-macologicalAction]OR"therapeuticirrigation"[MeSH]ORpreparat*[tiab]ORclean*[tiab]ORcathartic*[tiab]OR"PolyethyleneGlycols"[MeSH]OR"polyethylenegly-col"[tiab]OR"magnesiumcitrate"[tw]OR"Sodiumphos-phate"[tw]OR"Sodiumpicosulphate"[tw]OR"magnesiumoxide"[tw]OR"citricacid"[tw]ORGolytely[tw]ORNulytely[tw]ORGlycolax[tw]ORTrilyte[tw]ORColyte[tw]ORHalfLytely[tw]ORMoviprep[tw]ORMir-alax[tw]ORClenz-lyte[tw]ORPEG-3350[tw]ORGavilax[tw]ORGavilyte[tw]ORPegLyte[tw]ORClearlax[tw]ORPurelax[tw]ORLax-lyte[tw]ORDulcolax[tw]ORGly-coPrep[tw]ORVisicol[tw]ORFleet[tw]OROsmoprep[tw]ORPico-salax[tw]ORPurg-odan[tw]ORCitro-Mag[tw]ORPicoPrep[tw]ORBi-Peglyte[tw])("food,formu-lated"[MeSH]OR"diet"[MeSH]OR"electrolytes"[MeSH]OR"fasting"[MeSH]OR"diettherapy"[sh]OR"dietary-ber"[MeSH]ORdiets[ti]ORdietary[ti]ORdiet[ti]ORformulat*[ti]).
APPENDIXBBowelPreparationQualityScalesBowelpreparationqualityhasbeendescribedusingavarietyofapproaches,typicallycategorizingthequalityasexcellent,good,fair,orpoor.
However,thesetermslackstandardizeddenitions.
Automatedprocessesforquanticationofthequalityofabowelpreparationareunderdevelopment,butarenotreadyforclinicalapplica-tion.
232Forabowelpreparationscaletobeofclinicalvalue,itshouldbebothvalidandreliable.
233Validityre-ferstomeasuringwhatisintendedtobemeasured,asdeterminedbyexperts.
Reliabilityreferstothereproduc-ibility,suchasbetweendifferentobserversexaminingthesameinformation.
28Numerousbowelpreparationqualityscaleshavebeenreported,butfewhaveundergoneaformalassessmentofvalidity.
TheAronchickscale(Table1)describestheper-centageofuidorstoolthatcoversthebowelsurfaceandhaskintraclasscorrelationcoefcientsrangingfromverygood(0.
79)forthececumtopoor(0.
31)forthedistalco-lon.
234Giventhattherearenoreliabilitydataandthescaledowngradesqualityforretaineduid,thisscaleisnotrecommendedforclinicalpractice.
TheOttawascaleassessescleanlinessanduidvolumeseparately.
233Cleanlinessfortheright,mid-,andrectosig-moidsegmentsarescoredseparatelywithscoresof0–4foreachsegment.
Asummaryscoreisreportedforoverallcleanliness(Fig.
1).
Additionally,thequantityofuidisscoredfrom0(perfect)to2(large)andthisisaddedtothecleanlinessvaluewithamaximumtotalof14(solidstoolthroughoutwithlotsofuid).
Inthevalidationstudy,theOttawascalewasfoundtohaveasignicantlyhigherPearsoncorrelationcoefcientthantheAronchickscale(0.
89vs0.
62;P!
.
001).
Furthermore,thekstatisticandintraclasscorrelationcoefcientwassignicantlyhigher(0.
94vs0.
77;P!
.
001).
233Becausethescalere-portsthequalityofthepreparationbeforewashingandsuctioning,theOttawascaleisnotrecommendedforclin-icalpractice.
TheBostonBowelPreparationScalewasdevelopedspecicallyforapplicationduringwithdrawalofthecolon-oscope,afterallbowelcleansinghasbeencompleted.
235TheBostonBowelPreparationScaleinvolvesassigningeachof3regionsofthecolon(right,transverse,andleft)ascorefrom0to3(Table2).
EachsegmentscoreissummedforatotalBostonBowelPreparationScalescorerangingfrom0to9(with9correspondingtoaperfectlycleancolonand0correspondingtoanonprep-pedcolon).
Iftheprocedureisabortedbecauseofaninadequatepreparation,thentheproximalsegmentsareassignedascoreof0.
Apriori,thedevelopersrecommen-dedthatascoreoflessthan5correspondstoaninade-quatebowelpreparation.
Thescaledevelopershavepublished4endoscopicimagesdepictingexamplesofpreparationscorrespondingtoscoresof0–3.
Further-more,a15-minutetrainingvideowasdevelopedandisavailableontheInternet(https://www.
cori.
org/bbps/login.
php).
Inthevalidationstudy,theweightedkstatis-ticforintra-observeragreementforthetotalBostonBowelPreparationScalescorewas0.
77,andtheintraclasscorrelationcoefcientforinterobserveragreementwas0.
74.
235Constructvalidityalsowastested,comparingtheBostonBowelPreparationScalescorewithatradi-tionalscoringsystem(excellent,good,fair,poor,orun-satisfactory),theperceptionofinadequatebowelpreparation,thepolypdetectionrate,andtheinsertionandwithdrawaltimesfrom633screeningcolonoscopies.
TherewasasignicantdecreasingtrendinthemeanBos-tonBowelPreparationScalescoreassignedtoeachcate-goryusingthetraditionalsystem(Pfortrend!
.
001).
Thepolypdetectionratewas40%.
ForpatientswithaBostonBowelPreparationScalescoreof5orgreaterthepolypdetectionratewas40%,comparedwith24%forthosewithascoreoflessthan5(P!
.
02),andarepeatcolonoscopyowingtoinadequatepreparation560GASTROINTESTINALENDOSCOPYVolume80,No.
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.
001).
Furthermore,thetotalBostonBowelPrepara-tionScalescoreswerecorrelatedinverselywithbothinsertionandwithdrawaltimes.
Inafollow-upvalidationstudy,theintraclasscorrelationcoefcientwas0.
91andtheintraraterreliabilitywassubstantial(weightedk,0.
78).
236TheBostonBowelPreparationScalewasusedprospectivelyby12attendinggastroenterologistsin983screeningcolonoscopiesandshowedanassociationbe-tweenhigherBostonBowelPreparationScalescoresandpolypdetectionintherightandleftcolon,althoughnoassociationwasfoundforthetransversecolon.
236TheBostonBowelPreparationScalehasthebestdataforavalidatedscoringsystem.
APPENDIXCRiskFactorsforInadequatePreparationWeidentied16reports(15observationalstudies2,4,61,228,237–247and1trial248)thatidentiedpatient-relatedvariablesassociatedwithapoor-qualitybowelcleansing.
Observationalstudiesthatusedonlyuni-variateanalysis(nZ5)werenotconsideredfurther.
237,238,242,247,248AssessmentofbowelpreparationinmoststudiesreliedonAronchick-likescalesthathadeither4or5categories,whichthenweredichotomizedtoadequate(excellent/good)orinadequate(fair/poor)preparations.
Intotal,the10observationalstudiesusingmultivariateanalysisevaluated25,376participantsandonaveragepreparationwasdeemedinadequate23.
8%ofthetime(range,10.
3%–33%).
Regardingbasicdemographics,ageandsexwereevalu-atedinall10studies.
Olderage61,241,243,245andmalesex61,243,244occasionallywereassociatedwithinadequatepreparation.
Higherbodymassindexwasassociatedwithinadequatepreparationin2ofthe7studiesinwhichitwasrecorded.
61,239Fourstudiesreportedasignicantasso-ciationofinadequatepreparationwithinpatientrelativetooutpatientstatus.
2,239,243,244Pastmedicalandsurgicalhistoryalsoareimportantpredictorsofpreparationquality.
Thosewithamorecomplicatedpastmedicalhistoryeithermeasuredasacompositescoreorbythenumberofmedicationsusedaremoredifculttoprepareadequately.
Forexample,inalarge(nZ5832)multicenterstudyperformedinEu-ropeandCanada,thosewithanAmericanSocietyofAn-esthesiologistsstatusofclassIIIthroughclassVweresignicantlylesslikelytoaccomplishahigh-qualityprep-arationrelativetoAmericanSocietyofAnesthesiologistsclassIpatients(OR,0.
51;95%CI,0.
32–0.
73).
2NguyenandWieland245retrospectivelyanalyzedreportsof300screeningcolonoscopypatientsandfoundthatpatientswith8ormoreprescriptionsweresignicantlymorelikelytohaveapoorcolonoscopypreparation(OR,6.
52;95%CI,5.
12–8.
56).
Neurologicconditionsassoci-atedwithpoormobilitysuchasstrokeandParkinson'sFigure1.
Ottawascale.
TheOttawabowelpreparationqualityscaleuseguide.
(1)PartAofthescaleisappliedtoeachcolonsegment:rightcolon(Right),midcolon(Mid),andtherectosigmoidcolon(Recto-Sigmoid).
(2)Theuidquantityisaglobalvaluefortheentirecolon.
(3)Thescoreiscalculatedbyaddingtheratingsof0–4foreachcolonsegmentandtheuidquantityratingof0–2.
(4)Thescalehasarangefrom0(perfect)to14(solidstoolineachcolonsegmentandlotsofuid;ie,acompletelyunpreparedcolon).
(5)Beforeusingthescaleinastudyoraudit,ob-serversneedtoperformacalibrationexercise.
ModiedwithpermissionfromGastrointestEndosc2004;59:482-486.
TABLE1.
AronchickBowelPreparationScaleExcellent:smallvolumeofclearliquidorO95%ofsurfaceseenGood:largevolumeofclearliquidcovering5%–25%ofthesurfacebutO90%ofthesurfaceseenFair:somesemisolidstoolthatcouldbesuctionedorwashedawaybutO90%ofthesurfaceseenPoor:semisolidstoolthatcouldnotbesuctionedorwashedawayand!
90%ofthesurfaceseenInadequate:re-preparationneededwww.
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4:2014GASTROINTESTINALENDOSCOPY561Bowelcleansingforcolonoscopydisease61,228,239,244alsofrequentlywereassociatedwithinadequatepreparation.
Ahistoryofpriorgastrointestinalsurgicalresection61,240,245alsowasfoundtobeassociatedwithpoorerpreparationquality.
Certaindrugssuchastri-cyclicantidepressants239,244andnarcotics239occasionallywereseenasariskfactorforpoorpreparation.
Diabetesmellitusisassociatedwithahigherproportionofpatientswithinadequatebowelpreparationatthetimeofcolonoscopy.
248,249Inasmalltrial(nZ99)usinga6-LPEG-ELSpreparation,nondiabeticpatientshadprepara-tionsratedasgoodorbetterin97%ofcasesrelativeto62%ofcasesindiabeticpatients.
248In1smallstudyof54nondiabeticand45diabeticpatientsundergoingoutpa-tientcolonoscopyafteringesting6LofPEG,blindedre-viewdocumentedasuperiorbowelpreparationinthenondiabeticgroup.
248Onesmallstudyrandomized198diabeticpatientsundergoingcolonoscopytoreceiveeither4LofPEGwith10ozofmagnesiumcitrateorthesamepreparationwithanadditionaldoseofmagnesiumcitrateonthedaybeforetheusualpreparation.
249Agoodprepa-rationwasreportedin70%receivingtheadditionalmagne-siumcitratecomparedwith54%receivingtheusualpreparation(PZ.
02).
Segmentalcolonicresectionisassociatedwithlower-qualitybowelpreparation.
In1prospectivestudy,bowelpreparationwasratedasunsatisfactorysignicantlymoreofteninthosewithpriorbowelresection(60.
9%)thanincontrols(43.
5%;PZ.
02).
250Unsatisfactorypreparationwasobservedin64.
0%ofpatientswithapriorgastricresec-tionandin59.
7%ofpatientswithapriorcolonicresection,despitetheadministrationof4LPEG-ELSonthemorningofthecolonoscopy.
Inaprospectivestudyof362patientsun-dergoingcolonoscopy,priorhistoryofcolorectalresectionwasassociatedwithanincreasedrateofinadequatebowelpreparation(OR,7.
5;95%CI,3.
4–17.
6).
240Personswithspinalcordinjuryhaveneurogenicboweldysfunction251thatmayreducetheeffectivenessoftradi-tionalbowelpurgativeregimens.
Inarandomizedstudycomparing4LPEG-ELS,oralNaP(90mLindivideddoses),andacombinationofboth(dosesnotspecied)in36pa-tientswithspinalcordinjury,adifferencewasfoundinbowelpreparationqualitybetweengroups,withatleast73%ofbowelpreparationsratedas"unacceptable.
"252In1caseseries,spinalcordinjurypatientsundergoingcolo-noscopyweregivenanextendedbowelpreparationcon-sistingofaclearliquiddietand20ozofmagnesiumcitrateonday1,4LofPEG-ELSonday2,followedbyNaP/biphosphateenemas(asneededtofacilitateevacua-tion),andadditionalNaP/biphosphateenemasonday3(thedayofcolonoscopy)untilthereturnwasclearoffecalmatter.
253All18patientswerereportedtohaveanaccept-ablebowelpreparation,with4patientsrequiringnasogas-trictubeplacementtocompletethepreparation.
Theobjectiveofstudiesdeterminingriskfactorsforinadequatepreparationisthepotentialtodevelopareli-ablepredictivemodeltoidentifyindividualswhowouldbenetfromatailoredapproachtothepreparation.
Recently,asinglegroupofinvestigatorsdevelopedsuchapredictivemodelinalarge(nZ2811)prospectivestudyperformedintheoutpatientsettingacross18medicalcen-ters.
61Inmultivariateanalysis,manyofthefactorshigh-lightedearlierwereconrmedasriskfactorsincludingthefollowing:olderage(OR,1.
10;95%CI,1.
00–1.
02);malesex(OR,1.
2;95%CI,1.
02–1.
15);increasedbodymassindex(OR,1.
1;95%CI,1.
03–1.
1),Parkinson'sdisease(OR,3.
2;95%CI,1.
2–9.
3),andpriorcolorectalsurgery(OR,1.
6;95%CI,1.
2–2.
2).
However,whenusingasplit-doseregimen,themodelhadonlymodestpredictiveabil-ity(areaunderthereceiveroperatingcharacteristiccurve,0.
63)inthevalidationset.
TABLE2.
BostonBowelPreparationScale0:Unpreparedcolonsegmentwithmucosanotseenbecauseofsolidstoolthatcannotbecleared1:Portionofmucosaofthecolonsegmentseen,butotherareasofthecolonsegmentarenotwellseenbecauseofstaining,residualstool,and/oropaqueliquid2:Minoramountofresidualstaining,smallfragmentsofstool,and/oropaqueliquid,butmucosaofcolonsegmentisseenwell3:Entiremucosaofcolonsegmentseenwell,withnoresidualstaining,smallfragmentsofstool,oropaqueliquid562GASTROINTESTINALENDOSCOPYVolume80,No.
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