David A. Johnson|Alan Barkun|Lauren Cohen|Jason A. Dominitz|Tonya Kaltenbach|Myriam Martel|Douglas J. Robertson|Ricardo Boland|Frances M. Giardello|David A. Lieberman|Theodore R. Levin|Douglas K. Rex
Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations From the US Multi-Society Task Force on Colorectal Cancer
Eastern Virginia Medical School|McGill University Health Centre|Icahn School of Medicine at Mount Sinai|VA Puget Sound Health Care System|University of Washington|Palo Alto Veterans Institute for Research|Stanford University|McGill University Health Centre|Dartmouth College|Baylor University Medical Center|Johns Hopkins Medicine|Johns Hopkins University|Oregon Health & Science University|Kaiser Permanente Walnut Creek Medical Center|Indiana University – Purdue University Indianapolis
colorectal cancer crc second leading cause cancerrelated deaths united states 1 colonoscopy prevent crc detection removal precancerous lesions addition crc screening surveillance colonoscopy used widely diagnostic evaluation symptoms positive crc screening tests regardless indication success colonoscopy linked closely adequacy preprocedure bowel cleansing unfortunately 2025 colonoscopies reported inadequate bowel preparation 2 3 reasons range patientrelated variables compliance preparation instructions variety medical conditions make bowel cleansing difficult unitspecific factors eg extended wait times scheduling colonoscopy 4 adverse consequences ineffective bowel preparation include lower adenoma detection rates longer procedural time lower cecal intubation rates increased electrocautery risk shorter intervals examinations 3 5 6 7 bowel preparation formulations intended precolonoscopy cleansing assessed based efficacy safety tolerability lack specific organ toxicity considered prerequisite bowel preparations cleansing efficacy tolerability however consequences inadequate cleansing suggest efficacy higher priority tolerability consequently choice bowel cleansing regimen based cleansing efficacy first patient tolerability second however efficacy tolerability closely interrelated example cleansing agent poorly tolerated thus fully ingested may achieve adequate cleansing goals consensus document provide expert evidencebased recommendations clinicians optimize colonoscopy preparation quality patient safety recommendations provided using grades recommendation assessment development evaluation grade scoring system weighs strength recommendation quality evidence 8 methods search strategy computerized medical literature searches conducted january 1980 first year approval polyethylene glycolelectrolyte lavage solution pegelsbased preparation food drug administration fda august 2013 using medline pubmed embase scopus central isi web knowledge used highly sensitive search strategy identify reports randomized controlled trials 9 combination medical subject headings adapted database text words related colonoscopy gastrointestinal agents bowel preparation generic name brand name complete search terms available appendix recursive searches crossreferencing also performed using similar articles function hand searches articles identified initial search included fully published adult human studies english french systematic review published articles abstracts presented national meetings performed collect select evidence metaanalysis consensus agreement used analyze evidence expert consensus used formulate recommendations grade system used rate strength recommendations guideline reviewed committees approved governing boards member societies multisociety task force colorectal cancer american college gastroenterology american gastroenterological association american society gastrointestinal endoscopy effect inadequate preparation polypadenoma detection recommended followup intervals recommendations preliminary assessment preparation quality made rectosigmoid colon indication screening surveillance preparation clearly inadequate allow polyp detection greater 5 mm procedure either terminated rescheduled attempt made additional bowel cleansing strategies delivered without cancelling procedure day strong recommendation lowquality evidence colonoscopy complete cecum preparation ultimately deemed inadequate examination repeated generally aggressive preparation regimen within 1 year intervals shorter 1 year indicated advanced neoplasia detected inadequate preparation strong recommendation lowquality evidence preparation deemed adequate colonoscopy completed guideline recommendations screening surveillance followed strong recommendation highquality evidence inadequate colonic preparation associated reduced adenoma detection rates adrs large prospective european study 5832 patients enrolled 21 centers across 11 countries examined association preparation quality polyp identification colonoscopy performed range common indications highquality preparation associated identification polyps sizes odds ratio 173 95 confidence interval ci 128236 polyps greater 10 mm size 172 95 ci 111267 2 analysis national endoscopic database examined association preparation quality polyp identification 93004 colonoscopies 3 colon preparation entered endoscopist time procedure dichotomized adequate excellent good fairadequate inadequate fair inadequate poor adjusted models adequate preparation predictive detection polyps 121 95 ci 116125 polyps greater 9 mm andor suspected cancer 15 95 ci 098111 similarly singlecenter study based us veterans affairs medical center examined preparation quality adrs 8800 colonoscopies performed 2001 2010 10 comparing examinations inadequatepoor preparation n829 adequate preparation n5162 overall polyp detection reduced 066 95 ci 056083 two retrospective singlecenter studies examined association preparation quality adenoma miss rates preparation considered inadequate examination repeated within short interval 11 12 miss rates total adenomas found second examination divided total adenomas found examinations 1 study 11 12787 colonoscopies 3047 24 suboptimal preparations fair poor repeat colonoscopy within 3 years 216 individuals achieved adequate preparation showed overall adenoma miss rate 42 miss rate 27 lesions 10 mm larger size study identified 373 averagerisk screening patients poor inadequate preparation 12 repeat colonoscopy 133 patients 77 achieved excellent good preparation showed 47 overall adenoma miss rate single prospective korean study evaluated 277 individuals complete colonoscopy perprotocol repeat tandem colonoscopy within 3 months initial examination 13 patient adenoma miss rate increased baseline preparation quality decreased aronchick scale 19 patients poor preparation adenoma advanced adenoma miss rates 47 37 respectively compared 21 9 excellent preparation p024 surveys report setting poor preparation endoscopists recommendations followup evaluation vary err shorter return intervals 14 15 1 study 65 boardcertified gastroenterologists 13 gastroenterology fellows 14 shown images preparations excellent intermediate quality nearly perfect preparation 10year interval generally recommended normal screening colonoscopy however recommendations quite variable lowerquality preparations ranging 5 years immediate repeat procedure survey gastroenterologists n116 preparing board certification found 83 would recommend followup evaluation 3 years less 12 small adenomas suboptimal preparation 15 several studies examined actual recommendations followup evaluation within framework clinical practice one study abstracted charts 152 physicians 55 north carolina practices 125 consecutive persons practice 16 preparation quality reported 32 examinations bowel preparations rated less excellent associated aggressive surveillance found polyps small andor medium adenomas prospective singlecenter study 296 patients showed endoscopists encountered poor preparation recommended followup intervals often nonadherent guidelines 34 nonadherent vs 20 adherent p01 17 prospective study estimated 1 bowel preparations deemed inadequate requiring repeat colonoscopy shortened interval costs delivering colonoscopy overall increased 1 5 substantial adverse effects inadequate preparation rationale establishing target rates adequate preparation see later dosing timing colon cleansing regimens recommendations use splitdose bowel cleansing regimen strongly recommended elective colonoscopy strong recommendation highquality evidence sameday regimen acceptable alternative split dosing especially patients undergoing afternoon examination strong recommendation highquality evidence second dose split preparation ideally begin 46 h time colonoscopy completion last dose least 2 h procedure time strong recommendation moderatequality evidence splitdose regimens preparation agents administered entirely day colonoscopy chyme small intestine enters colon accumulates producing film coats proximal colon impairs detection flat lesions length time last dose preparation initiation colonoscopy correlates quality proximal colon cleansing 18 19 20 1 study chance good excellent preparation right colon decreased 10 additional hour end ingesting preparation start colonoscopy 20 splitting implies roughly half bowel cleansing dose given day colonoscopy overwhelmingly consistent data show superior efficacy split dose compared traditional regimen administering preparation day procedure 18 21 22 23 24 split dosing leads higher adrs 25 26 four guidelines endorsed split dosing preparations colonoscopy 27 28 29 30 sameday regimens sameday bowel cleansing effective alternative split dosing patients afternoon colonoscopy 31 32 33 34 large singleblind prospective study sameday preparation provided better mucosal cleansing less sleep disturbance better tolerance less impact activities daily living greater patient preference scores compared split dosing 35 obstacles split sameday regimens anecdotally anesthesia providers sometimes oppose split sameday dosing concern aspiration risk evidencedbased guideline american society anesthesiologists however states ingestion clear liquids 2 h sedation affect residual gastric volume 36 furthermore 2 endoscopic studies found ingestion bowel cleansing agents day colonoscopy affect residual gastric volumes indicating rate gastric emptying bowel preparations similar clear liquids 37 38 preoperative dehydration may greater safety concern drinking clear liquids anesthesia second objection split dosing patients scheduled early morning procedures may unwilling get night take second dose laxatives acceptance compliance splitdose bowel preparation high pose deterrent prescribing splitdose preparations colonoscopy 39 40 risk fecal incontinence transit endoscopy center increased minimally split dosing 40 diet bowel cleansing recommendation using splitdose bowel cleansing regimen diet recommendations include either lowresidue full liquids evening day colonoscopy weak recommendation moderatequality evidence traditionally patients instructed ingest clear liquids day colonoscopy recent randomized trials report liberalized diet day colonoscopy associated better tolerance preparation comparable better bowel cleansing 41 42 43 44 45 46 47 48 diet regimens trials variable included regular diet 6 pm regular breakfast lowresidue breakfast lunch snack soft diet semiliquid diet heterogeneity p008 i62 degree heterogeneity reluctant recommend regular diet day colonoscopy accordingly lowresidue diet part day colonoscopy considered patients without identifiable preprocedural risks inadequate colon preparation pending additional study colonoscopists carefully evaluate compromise efficacy dietary flexibility allowed usefulness patient education navigators optimizing preparation results recommendations health care professionals provide oral written patient education instructions components colonoscopy preparation emphasize importance compliance strong recommendation moderatequality evidence physician performing colonoscopy ensure appropriate support process measures place patients achieve adequate colonoscopy preparation quality strong recommendation lowquality evidence patient education program administered health care professionals increases patient compliance improves quality decreases repeat examinations costs 49 use verbal written instructions compared written instructions independent predictor adequate bowel preparation quality educational tools booklets information leaflets animations visual aids standardized validated 50 51 effective across range health literacy education levels 4 52 use novel patient educational booklet precolonoscopy preparation resulted better bowel preparation quality scores achieved using conventional instructions 37 95 ci 2358 53 trained patient navigators help guide patients colonoscopy process provide education patients address barriers colonoscopy review bowel preparation protocols appointments ensure patients escort appointments patient navigators urban minorities openaccess referral systems resulted increase screening colonoscopy completion rates 54 55 safetynet hospitals costs navigation offset increased screening compliance navigation cost effective 56 barriers successful navigation included incomplete contact information language problems insurance lapses impact sex ethnicity professional status patient navigator needs additional evaluation rating quality bowel preparation colonoscopy recommendations adequacy bowel preparation assessed appropriate efforts clear residual debris completed strong recommendation lowquality evidence measurement rate adequate colon cleansing conducted routinely strong recommendation moderatequality evidence adequate preparation defined cleansing allows recommendation screening surveillance interval appropriate findings examination achieved 85 examinations perphysician basis strong recommendation lowquality evidence reporting quality bowel preparation required element colonoscopy report 57 58 clinical trials cleansing quality often estimated using scales downgrade quality retained fluid clinical practice however retained fluid much semisolid debris colon removed intraprocedural cleansing capacity conduct effective mucosal inspection established intraprocedural cleansing preparation quality clinical practice assessed appropriate intraprocedural washing suctioning completed reason use validated bowel preparation scale includes scoring retained fluid eg aronchick ottawa recommended us multisociety task force usmstf considers operational definition adequate preparation one colonoscopist recommend followup screening surveillance interval next colonoscopy appropriate examination findings unfortunately scores validated scales correspond point preparation meets usmstf operational definition adequate preparation ability follow recommended screening surveillance interval generally uncertain clinical practice clinicians often use imprecisely defined 4point scale excellent good fair poor scheme excellent good widely viewed adequate research indicates many fair preparations clinical practice also adequate 10 usmstf previously recommended clinicians could consider preparation adequate suctioning washing mucosa procedure deemed adequate detection lesions greater 5 mm size 59 concept part validated bowel preparation scale reflect current concepts sizes colorectal lesions clinically important detect 60 additional research needed develop validated scales scoring bowel cleansing consider retained fluid include defined points correspond adequate preparation currently boston bowel preparation scale comes closest meeting criteria consider retained fluid boston bowel preparation scale score 5 higher associated 2 rate recommending shortened followup intervals 61 detailed review bowel preparation scales shown appendix b whichever scale used practice recommend method defining adequate preparation include whether colonoscopist recommends expected screening surveillance intervals based colonoscopy findings ability detect lesions greater 5 mm size throughout colon clinically relevant test adequacy appropriateness follow screening surveillance intervals furthermore endoscopists encouraged submit procedure reports data registry benchmarks performance quality measures minimally accepted national thresholds mean levels performance among peers rate adequate bowel preparation endoscopist usmstf recommended benchmark 85 improvement initiative undertaken high rates inadequate preparations reflect low patient compliance failure adjust preparation regimens medical predictors inadequate preparation signal processes policies endoscopy unit need revision fdaapproved preparations recommendations selection bowelcleansing regimen take consideration patients medical history medications available adequacy bowel preparation reported prior colonoscopies strong recommendation moderatequality evidence splitdose regimen 4 l pegels provides highquality bowel cleansing strong recommendation highquality evidence healthy nonconstipated individuals 4l pegels formulation produces bowelcleansing quality superior lowervolume peg formulation strong recommendation highquality evidence polyethylene glycolelectrolyte lavage solution pegelsbased cleansing agents available 4 l considered large high volume 2 l plus adjunct considered low volume sodium phosphate nap solution fleet phosphosoda fleet ezprep cb fleet co lynchburg va hyperosmotic cleansing agent withdrawn us overthecounter otc market december 2008 concern regarding phosphateinduced renal disease 62 prescription tablet formulation nap osmoprep salix pharmaceuticals raleigh nc remains available although boxed warning risk acute phosphate nephropathy added label 62 recently approved lowvolume agents include oral sulfate solution oss suprep braintree laboratories braintree sodium picosulfatemagnesium citrate prepopik ferring pharmaceuticals inc parsippany nj combination pegels oss suclear braintree laboratories polyethylene glycolelectrolyte lavage solution reducedvolume fdaapproved pegels formulations developed improve tolerance one preparations 2l pegels bisacodyl halflytely braintree laboratories recently removed market another 2l pegels product contains supplemental ascorbate sodium sulfate moviprep salix pharmaceuticals several 4l pegelsbased preparations approved fda including colyte alaven pharmaceuticals marietta ga gavilyte gavis pharmaceuticals somerset nj golytely braintree laboratories nulytely braintree laboratories sulfate free highvolume pegels 3 l compared lowvolume pegels 3 l 28 trials yielding 7208 intentiontotreat itt patients 3456 highvolume pegels 3752 lowvolume pegels 18 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 twentyone trials included analyzable bowelcleanliness outcomes 64 65 66 67 68 69 70 71 72 74 75 76 79 81 82 83 84 85 86 88 89 highvolume pegels show significant increase bowel cleanliness 103 95 ci 080132 eight trials included pegels split dose 2 l administered day 2 l administered day procedure compared pegels nonsplit regimen regardless dosage yielding 1990 itt patients 846 pegels split 2 l2 l dose 1144 peg nonsplit 18 46 66 81 84 85 90 91 six trials analyzable resulting significantly increased cleanliness pegels splitdose regimen 2 l2 l compared pegels nonsplit dose 438 95 ci 1881021 46 66 81 84 85 90 isoosmotic pegels regimens often considered preferred regimens patients less likely tolerate fluid shifts including patients renal insufficiency congestive heart failure advanced liver disease oral sulfate solution two trials evaluated oss 92 93 one trial compared oss splitdose regimen 4 l pegels taken day found successful preparations oss 984 vs 896 p 04 perprotocol data 93 second trial compared oss pegels 2 l plus ascorbate oss 2 l pegels plus ascorbate effective given split doses fda approved oss splitdose administration 92 combined results 923 itt patients 462 oss 461 peg found oss increase bowel cleanliness 112 95 ci 077162 92 93 sodium picosulfate sodium picosulfate pico stimulant laxative often combined magnesium salt recently introduced us market considerable experience canada europe australia eleven trials compared pico vs pegels yielded 3097 itt patients 1385 pico 1715 pegels 77 94 95 96 97 98 99 100 101 102 103 pico preparations combined either magnesium oxide magnesium citrate ten trials included analyzable cleanliness data comparing pico pegels 94 95 96 97 98 99 100 101 102 103 pico formulation show significant increase efficacy compared pegels 092 95 ci 063136 eight trials compared pico nap yielding 1792 itt patients 966 pico 826 nap 77 97 104 105 106 107 108 109 three trials included analyzable cleanliness data pico superior nap 060 95 ci 022165 97 106 107 1 trial compared pico splitdose regimen vs pico day day including 250 itt patients 127 split 123 split 110 pico splitdose compared pico daybefore sameday regimen significantly higher proportion bowel cleanliness 354 95 ci 195645 sodium phosphate oral nap use bowel preparation decreased rare occurrence renal damage tubular deposition calcium phosphate 111 112 potential risk factors napinduced nephropathy include following female sex preexisting renal insufficiency inadequate hydration bowel preparation reduced time interval 2 doses sodium phosphate 12 h hypertension older age certain medications diuretics nonsteroidal antiinflammatory drugs reninangiotensin inhibitors 113 fortyeight trials included comparison nap vs pegels yielding 11368 itt patients 5529 peg vs 5839 nap 75 76 77 97 108 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 thirtythree trials included analyzable bowelcleanliness outcomes 75 76 97 108 114 115 117 119 121 124 126 127 129 130 131 132 133 136 137 139 140 141 143 145 146 148 150 151 152 153 154 155 156 use nap show increase bowel cleanliness 102 95 ci 077136 associated better willingness repeat regimen 261 95 ci 148459 comparisons nap oss pico discussed previously three trials 144 158 159 included comparison nap splitdose regimen nap day procedure day total 598 itt patients 355 split vs 243 nonsplit 144 158 159 two trials158 159 included analyzable data showed better cleansing splitdose regimens 235 95 ci 127434 158 159 although nap effective well tolerated patients risk adverse events makes unsuitable firstline agent furthermore nap recommended patients renal insufficiency creatinine clearance60 mlmin173 m2 preexisting electrolyte disturbances congestive heart failure new york heart association class iii iv ejection fraction50 cirrhosis ascites caution used prescribing nap patients elderly hypertensive taking angiotensinconverting enzyme inhibitors nonsteroidal antiinflammatory drugs diuretics otc nonfdaapproved preparations recommendations otc bowel cleansing agents variable efficacy ranges adequate superior depending agent dose timing administration whether used alone combination regardless agent efficacy tolerability enhanced splitdose regimen strong recommendation moderatequality evidence although otc purgatives generally safe caution required using agents certain populations example magnesiumbased preparations otc fdaapproved formulations avoided patients chronic kidney disease weak recommendation low quality evidence use otc products bowel cleansing colonoscopy deemed safe use public without advice health care professional efficacy safety products specific indications may unproven fdas oversight otc products generally conducted therapeutic class rather individual drugs consequently otc product may little supporting evidence comparative data showing either efficacy safety relative available products products marketed specifically colonoscopy bowel preparation must evaluated randomized trials assess efficacy safety must receive approval via new drug application nda fda products available prescription purgative agent marketed without approved nda must meet requirements otc agents set forth laxative monograph unpublished data fda specifically recognized 2 bowel cleansing kits 160 kit different components would require approved nda andor amendment monograph highly unlikely cleaning kits follows magnesiu