Colonoscopy Outcomes by Duration of NPO Status Prior to Colonoscopy

NPO Status Prior to Colonoscopy Evidence-based Synthesis Program

Table 1. Study Characteristics

Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Abdul-Baki Inclusion Criteria: ambulatory N=382 NPO status group 1a: Split-dose PEG-E with 2L For RCTs 200813 outpatient adults undergoing consumed evening before and 2L day of Sequence generation: elective colonoscopies Age (yr): 55 colonoscopy (to be completed 2 hours before adequate Location: Gender (Male %): ~61 the procedure) + tegaserod 6 mg pills (1 tablet Lebanon Exclusion Criteria: patients Race (%): NR night before and one 2.5 hours before Allocation concealment: <18 years of age, presence of BMI: NR procedure); (n=92) adequate Study design: severe renal impairment, NPO status group 1b: matched placebo (n=107) RCT (4-way) moderate or severe hepatic Co-existing conditions (%) Blinding: yes, impairment, a history of bowel Inflammatory bowel disease: 4 Patients allowed regular diet until 6 pm day endoscopist, participant Funding source: obstruction, known allergies before colonoscopy and water until procedure (tegaserod) Industry to PEG or tegaserod Indications for colonoscopy time (%) Incomplete outcome data: Screening: 25 NPO status group 2a: PEG-E consumed no Abdominal pain: 24 evening before colonoscopy + tegaserod 6 mg Changes in bowel habits: 15 pills (1 tablet night before and one 1.5 hours Selective outcome Rectal bleeding: 21 before procedure) (n=94) reporting: no Anemia: 4 NPO status group 2b: matched placebo (n=89) Surveillance of colon Risk of bias: Low cancer/polyps: 7 Patients allowed liquid diet until 6 pm day before colonoscopy and water until procedure time

Sedation: conscious

Study withdrawals: none

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Aoun 200514 Inclusion Criteria: ambulatory N=141 NPO status group 1: PEG-E split-dose - 2L For RCTs outpatient adults undergoing Age (yr): 57 (range 20-84) night prior and 2L morning; finish morning dose Sequence generation: Location: elective colonoscopies Gender (Male %): 57 at least 1.5 hours before procedure, regular diet adequate Lebanon Race (%): NR until 6:30 pm day before colonoscopy; water Exclusion Criteria: patients BMI: NR allowed up to colonoscopy (n=68) Allocation concealment: Study design: <18 years of age, presence of adequate RCT a severe illness (cardiac, Co-existing conditions (%) NPO status group 2: 4L PEG-E - 6:00 to 10:00 renal, or Inflammatory bowel disease: 4 pm day before procedure; liquid diet only day Blinding: yes, Funding source: metabolic), active alcoholism, before colonoscopy; only water after midnight endoscopists None reported drug addiction, major Indications for colonoscopy (n=73) psychiatric illness, known (%) Incomplete outcome data: allergies to PEG Abdominal pain: 28 Sedation: conscious no Screening: 25 Changes in bowel habits: 15 Study withdrawals: none Selective outcome Rectal bleeding: 14 reporting: no Anemia: 4 Family history of colorectal Risk of bias: :Low cancer: <1 Arya 201315 Inclusion Criteria: patients N=147, 14 excluded. 133 NPO status group 1: Rapid-prep ShudhTM colon For RCTs 21–70 years of age referred completed study cleanse (SCC) - patients start SCC around 6 Sequence generation: Location: USA for colonoscopy with good (demographics based on 133) am on morning of colonoscopy drinking 240- adequate general physical status 480 ml every 5 minutes (total 1-2 L); last glass Study design: (American Society of Age (yr): 44 ≥2 hours prior to procedure (n=74) Allocation concealment: RCT Anesthesiologists [ASA] class Gender (Male %): 38 Day prior to colonoscopy, patients instructed to unclear 1 or 2) Race (%): white 88; black 8 eat light breakfast up to 12 pm and then stay on Funding source: BMI: NR clear liquids Blinding: yes, None reported Exclusion Criteria: history of endoscopists chronic heart, liver, or kidney Co-existing conditions (%): NR NPO status group 2: Half-Lytely® colon prep disease; hypertension, (HCP) - 2 bisacodyl delayed-release tablets Incomplete outcome data: diabetes mellitus, arthritis Indications for colonoscopy taken at 1 pm; patients start drinking 2L solution yes (spine, shoulder, hip and (%) after a bowel movement or around 7 pm if no knee joints) severe Screening: 42 bowel activity occurred (n=73) Selective outcome constipation, or concurrent Rectal bleeding: 20 Patients stay on clear liquids entire day prior to reporting: no severe diarrhea, ileus, Mild constipation: 19 colonoscopy suspected intestinal Abdominal pain: 11 Risk of bias: Moderate obstruction, bowel Anemia: 3 Sedation: NR perforation, previous Mild diarrhea: 3 gastrointestinal tract surgery, Study withdrawals: 10% (n=14) excluded prior gastro-paresis, toxic colitis, to procedure (no-shows) ulcerative colitis, pregnancy, and lactation

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Athreya 201116 Inclusion Criteria: elective N=325 NPO status group 1: PM group- 2 sachets For RCTs colonoscopy patients PicoPrep-3™ day prior and 3rd sachet 6 to 7 am Sequence generation: not Location: Age (yr): 57 (24-92) on day of procedure; solids ceased after 8 am applicable Australia Exclusion Criteria: prior Gender (Male %): 50 day prior; clear fluids continued until 4 hrs prior surgical resection, patients Race (%): NR to procedure (n=150) Allocation concealment: Study design: who had taken GlycoPrep™ BMI: NR inadequate (alteration) CCT (polyethylene glycol NPO status group 2: AM group- 3 sachets electrolyte) as the bowel Co-existing conditions (%): NR PicoPrep-3™ day prior to procedure; solids Blinding: Investigator Funding source: preparation or those ceased after 8 am day prior; clear fluids None reported administered a Fleet™ Indications for colonoscopy continued until midnight prior to procedure Incomplete outcome data: enema on arrival, and failure (%) (n=175) no to achieve caecal intubation Symptoms (not specified): 36 Screening: 35 Sedation: conscious Selective outcome Family history: 21 reporting: no Family history & symptoms: 8 Study withdrawals: none Risk of bias: High Barclay 200417 Inclusion Criteria: ambulatory N=303 randomized, 47 NPO status group 1: 3-dose regimen; aqueous For RCTs outpatient adults undergoing excluded. 256 completed study NaP day before procedure; 2nd dose 5 hours Sequence generation: Location: USA elective colonoscopies (demographics based on 256) later; 3rd dose 3 hours before scheduled time of adequate procedure (n=131) Study design: Exclusion Criteria: patients Age (yr): medians 57-59 Allocation concealment: RCT <18 years of age, congestive Gender (Male %): 45 NPO status group 2: 2-dose regimen (n=125) not reported heart failure, renal Race (%): NR a) morning colonoscopy; aqueous NaP day Funding source: insufficiency (creatinine > 120 BMI: NR before procedure; 2nd dose 5 hours later (same Blinding: yes, Industry lmol/L), ascites day) endoscopists Co-existing conditions (%) b) afternoon colonoscopy; aqueous NaP day Diabetes: 9 before procedure; 2nd dose 5 hours before Incomplete outcome data: On diuretics: 11 scheduled time of procedure yes

Indications for colonoscopy All patients: clear fluid diet for 24 hours before Selective outcome (%) colonoscopy; instructed to drink 3.8L of reporting: no Rectal bleeding/+ FOBT: 29 commercially available carbohydrate-electrolyte Abdominal pain: 25 solution during preparation period Risk of bias: Moderate Screening: 23 Changes in bowel habits: 20 Sedation: NR

Study withdrawals: 18% (n=47) excluded prior to procedure

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Bryant 201318 Inclusion Criteria: mostly N=1,785 NPO status group 1: Afternoon colonoscopies; 1) Study design: outpatients (89%) undergoing prep to procedure interval 5-7.5 hrs (n=768) retrospective Location: colonoscopy Age (yr): <55 34%; ≥55 66% a) 2L PEG at 5-7 pm day before + 2L PEG Australia Gender (Male %): 53 before 8 am day of colonoscopy 2) Population: consecutive Exclusion Criteria: patients Race (%): NR b) 2 sachets sodium picosulphate at 1 pm and 5 Study design: with a prior history of large BMI: NR pm day before + 1L PEG before 8 am day of 3) Analysis of findings Retrospective bowel resection, colonoscopy a. Was the method for observational colonoscopies where cecal Co-existing conditions (%): NR handling missing data intubation could not be NPO status group 2: Morning colonoscopies; reported and appropriate? Funding source: achieved due to an Indications for colonoscopy prep to procedure interval 8.5-17 h; (n=1,017) appears to be no missing None reported obstructing lesion, and (%) a) 4L PEG between 2 pm and 7 pm day before data colonoscopy reports which Anemia/Rectal bleeding: 37 colonoscopy did not report on bowel Screening: 34 b) 2 sachets sodium picosulphate at 9 am and 1 b. Were the preparation Altered bowel habit: 12 pm day before + 1L PEG at 4 pm characteristics of the Colitis: 6 different NPO groups Other: 11 All patients: low-residue diet 2 days before and similar? unclear only clear fluids 1 day before colonoscopy; fast for 4-6 hours before procedure Risk of bias: Moderate

Sedation: by proceduralist using fentanyl and midazolam, or with propofol sedation by anesthetist

Study withdrawals (%): NA Chiu 200620 Inclusion Criteria: patients N=121 NPO status group 1: PEG-ELS; 2L between 5 For RCTs who had colon neoplasms and 6 am day of colonoscopy (6-8 hr NPO Sequence generation: not Location: Taiwan detected during the first Age (yr): 57 interval) (n=61) described screening colonoscopy Gender (Male %): 68 Study design: Race (%): NR, presumed all NPO status group 2: PEG-ELS 2L at 8 pm Allocation concealment: RCT Exclusion Criteria: inability to Asian evening before colonoscopy (13-16 hr NPO unclear (“sealed discontinue the use of BMI: 25 interval) (n=60) envelopes”) Funding source: antiplatelet agents or None anticoagulants, presence of Co-existing conditions (%): NR Low-fiber diet advised for two days before the Blinding: colonoscopist minute polyps that had been procedure Note: Secondary removed during the screening Indications for colonoscopy Incomplete outcome data: colonoscopy colonoscopy using biopsy (%) Sedation: conscious yes forceps, invasive cancer that Colorectal neoplasms 100 required surgical intervention, Study withdrawals: 3 (2%) did not ingest prep Selective outcome failure to complete total and were excluded reporting: no colonoscopy for any reason at the health checkup Risk of bias: Moderate

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Chiu 201119 Inclusion Criteria: Chinese N=3,079 NPO status group 1: PEG-ELS 2L between 3 1) Study design: patients age 40 to 80 years; and 4 am morning of colonoscopy (5-9 hr NPO retrospective Location: Taiwan received total colonoscopy; Age (yr): 51 interval) (n=1,552) considered average-risk (a) Gender (Male %): 53 2) Population: consecutive Study design: no history CRC, adenoma, or Race (%): Asian 100 NPO status group 2: PEG-ELS 2L between 8 Retrospective IBD; b) no criteria for BMI: NR (abdominal girth and 9 pm evening before colonoscopy (>8 hr 3) Analysis of findings observational hereditary non-polyposis reported) NPO interval) (n=1,527) a. Was the method for CRC, familial adenomatous handling missing data Funding source: polyposis, or other polyposis Co-existing conditions (%): NR 2 days before procedure, patients advised to reported and appropriate? In part by syndrome; c) no 1st degree start low-fiber diet; 1 day before procedure, appears to be no missing research grant relative with CRC; d) no Indications for colonoscopy patients advised to drink only clear liquids and data from Department symptoms of colorectal (%): NR avoid solid foods of Health of malignancy [bloody stool, b. Were the Taiwan abdominal pain, change in Sedation: NR characteristics of the body weight, or documented different NPO groups iron deficiency anemia]; e) no Study withdrawals: None similar? no, differences in history of CRC screening abdominal girth between tests within 5 yrs; and f) no groups long-term use of aspirin, non- steroidal anti-inflammatory Risk of bias: Moderate drug, or a cyclooxygenase 2 inhibitor)

Exclusion Criteria: NR Church 199821 Inclusion Criteria: ambulatory N=317 NPO status group 1: 4L PEG starting at 8 am For RCTs outpatient adults undergoing day of procedure (n=157) Sequence generation: not Location: USA elective colonoscopies in the Age (yr): 60 described afternoon Gender (Male %): 57 NPO status group 2: 4L PEG starting at 6 pm Study design: Race (%): NR evening before procedure (n=160) Allocation concealment: RCT Exclusion Criteria: NR BMI: NR not described All patients; liquid diet day before; after prep Funding source: Co-existing conditions (%): NR allowed water by mouth only until examination Blinding: yes, None reported endoscopists Indications for colonoscopy Sedation: NR (%) Incomplete outcome data: Neoplasm follow-up: 48 Study withdrawals: none no Family history of CRC: 14 Symptoms (not specified): 14 Selective outcome Polyp on prior exam: 11 reporting: no Other: 13 Risk of bias: Moderate

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) De Salvo 200622 Inclusion Criteria: patients N=273 (demographic NPO status group 1: Sodium phosphate 40 mL For RCTs scheduled for colonoscopy information for 265 who at 6 pm day prior to colonoscopy and 6 am day Sequence generation: Location: Italy who were able to follow followed the cleansing of colonoscopy (≥5 hours) (n=83) adequate cleansing regimen regimen) Study design: NPO status group 2: Magnesium sulfate 15mg Allocation concealment: RCT Exclusion Criteria: pregnancy, Age (yr): 61 and senna 12mg in 200 mL water 5 pm day NR age >75 years, previous Gender (Male %): 53 prior to colonoscopy (>8 hours) (n=92) Funding source: operation on small/large Race (%): NR Blinding: colonoscopists None reported bowel, renal failure, known BMI: NR NPO status group 3: PEG 2 L at 6 pm day prior that scored bowel electrolyte disorders, heart to colonoscopy plus Biscodyl 4 tablets at 10 pm preparation failure, liver disease with Co-existing conditions (%): NR day prior to colonoscopy (>8 hours) (n=98) ascities Incomplete outcome data: Indications for colonoscopy On day before colonoscopy, patients to avoid yes (%): NR solid food after 12 pm; colonoscopy performed after 11 am Selective outcome reporting: Study withdrawals: 8/273 (3%) Risk of bias: Moderate

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Di Palma 201123 Inclusion Criteria: adult Study 1 (ITT population) Study 1 (split dose) For RCTs outpatients undergoing N=364 NPO status group 1a: oral sulfate solution (16 Sequence generation: Location: USA colonoscopy for routine oz + additional water) evening before adequate clinical indications Age (yr): 56 colonoscopy; 2nd dose at approximately 6 am Study design: Gender (Male %): 46 day of colonoscopy (hours unclear) (n=190) Allocation concealment: RCT Exclusion Criteria: ileus or Race (%): white 86, black 9 adequate suspected bowel obstruction, BMI: NR NPO status group 1b: 1L PEG-EA evening Funding source: bowel perforation, previous before colonoscopy and 1L approximately 6 am Blinding: colonoscopists Industry alimentary tract surgery, Indications for colonoscopy day of colonoscopy (hours unclear) (n=189) significant gastroparesis or (%): NR Incomplete outcome data: gastric outlet obstruction, Study withdrawals: 16/379 (4%) yes toxic colitis or megacolon, Study 2 (ITT population) severe ulcerative colitis or N=387 Study 2 (same day) Selective outcome those pregnant or lactating NPO status group 2a: oral sulfate solution (total reporting: no Age (yr): 57 of 32oz + additional water) evening before Gender (Male %): 45 colonoscopy (hours unclear) (n=204) Risk of bias: Moderate Race (%): white 87, black 11 BMI: NR NPO status group 2b: 2L PEG-EA evening before colonoscopy (hours unclear) (n=204) Indications for colonoscopy (%): NR Study withdrawals: 26/408 (6%)

Co-existing conditions (%): Sulfate preparation subjects had light breakfast Overall 356/787 subjects and clear liquids for lunch and dinner; PEG-EA (45%) had a history of heart subjects had normal breakfast, light lunch, and disease, renal failure, clear soup or yogurt for dinner hypertension, and diabetes Sedation: NR

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) El Sayed 200324 Inclusion Criteria: ambulatory N=187 NPO status group 1: 2L PEG at 6 pm day For RCTs outpatients scheduled for before colonoscopy; no dietary restrictions Sequence generation: Location: elective morning colonoscopy Age (yr): 56 except for light liquid dinner before 7 pm; 5mg adequate Lebanon Gender (Male %): 56 of bisacodyl at 8 pm; 1L PEG at least 2 hrs Exclusion Criteria: age < 18, Race (%): NR before colonoscopy (n=91) Allocation concealment: Study design: presence of serious BMI: NR adequate RCT conditions such as severe NPO status group 2: 3 Sachets of PEG in 3L of cardiac, renal or metabolic Co-existing conditions (%) water beginning 6 pm (finish within 4 hrs); start Blinding: single-blinded Funding source: diseases, active alcoholism, History of surgery: clear liquid diet on morning of day before (endoscopist) None Reported drug addiction, major None: 95 colonoscopy; fast after midnight (n=96) psychiatric illness; known Abdominoperineal resection: 1 Incomplete outcome data: allergy to PEG or bisacodyl, Left colectomy: 2 no and refusal to consent to the Right colectomy: 1 Sedation: Moderate sedation (Midazolam and study Segmental colectomy: 1 Mepiridine) Selective outcome reporting: no Indications for colonoscopy Study withdrawals: NR (%) Risk of bias: Low Anemia: 6 Abdominal pain: 23 Rectal bleeding: 24 Follow-up after colonic resection: 5 Family history of CRC: 7 Change in bowel habits: 24 Follow-up after polypectomy: 4 Positive FOBT: 3 Screening: 18 Follow-up of IBD: 5

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Eun 201125 Inclusion Criteria: Outpatients N=300 NPO status group 1: 4L PEG consumed over 3 1) Study design: aged between 18 and 80 hours starting at 5 am for morning colonoscopy prospective Location: Korea years scheduled for elective Age (yr): 52 (mean time from end of prep to procedure = 3.7 colonoscopy Gender (Male %): 51 hrs) (n=149) 2) Population consecutive Study design: Race (%): NR Prospective Exclusion Criteria: Age<18, BMI: 23 NPO status group 2: Same but starting at 8 am 3) Analysis of findings observational presence of serious illness for afternoon colonoscopy (mean time from end a. Was the method for such as severe cardiac, renal Co-existing conditions (%) of prep to procedure = 4.9 hrs; P < .001 vs handling missing data Funding source: or metabolic disease, drug Chronic diseases: 32 group 1) (n=151) reported and appropriate? Research Fund addiction or major psychiatric Constipation: 11 none reported of Hanyang illness; known allergy to PEG, Prior Hysterectomy: 11 Sedation: NR University prior history of bowel b. Were the resection and refusal of Indications for colonoscopy Study withdrawals: 7 failed to reach cecum characteristics of the consent to study (%) different NPO groups Screening: 25 similar? yes Family history of CRC: 2 Surveillance: 6 Risk of bias: Low Hematochezia: 12 Anemia: 3 Abdominal pain: 30 Bowel habit changes: 17 Suspicion of polyp on imaging: 6

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Flemming 201226 Inclusion Criteria: age 18 and N=250 enrolled; demographic NPO status group 1: Picosulfate, magnesium For RCTs older, elective colonoscopy at data for 236 (14 randomized oxide, & citric acid (Pico-Salax); 1st dose at 7 Sequence generation: Location: Canada 1 hospital but never participated because pm, 2nd dose 4 hrs before colonoscopy (n=119) adequate target numbers reached) Study design: Exclusion Criteria: ileus or NPO status group 2: Pico-Salax; 2 doses Allocation concealment: RCT bowel obstruction, significant Age (yr): 56 evening before colonoscopy (5 pm, 11 pm) adequate constipation (<3 bowel Gender (Male %): 46 (n=117) Funding source: movements/week with or Race (%): NR Blinding: endoscopists University without regular laxatives), BMI: NR Both groups: 2 5-mg tablets bisacodyl for 2 blinded to dosing regimen research unit previous colorectal surgery, consecutive nights before colonoscopy; only ascites, previously Co-existing conditions (%) clear fluids on day before colonoscopy; Incomplete outcome data: recognized renal impairment, Hypertension: 28% encouraged to drink 3-4 L Gatorade or similar 6% withdrawals active IBD, pregnancy, recent Diabetes: 7% evening before colonoscopy (<6 mos) MI or unstable Selective outcome angina Indications (%) Sedation: NR reporting: Family history CRC: 44% Screening: 12% Study withdrawals: 14 (6%); 6 split dose, 8 Risk of bias: Moderate History of adenoma: 18% evening before dose Positive FOBT: 6.8% Bleeding: 6.9% Altered bowel habits: 6.0% Diarrhea: 3.4% Other: 3.0%

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Frommer 199727 Inclusion Criteria: NR N=487 NPO status group 1: 45 ml NaP solution at 6 For RCTs pm day before colonoscopy and 6 am on Sequence generation: Location: Exclusion Criteria: inability to Age (yr): 63 morning of colonoscopy (n=166) unclear Australia understand instructions, heart Gender (Male %): 55 failure, pregnancy, age above Race (%): NR NPO status group 2: 3L PEG at 2 pm day Allocation concealment: Study design: 90, raised creatinine, right BMI: NR before colonoscopy (N=160) unclear RCT hemicolectomy, use of additional agents (enemas or Co-existing conditions (%): NPO status group 3: 45ml NaP at 7 am and 7 Blinding: single blinded Funding source: defoaming agents), a Diverticulosis:3.3 pm on day before colonoscopy; instructed to In part by CB significant error in having drink minimum of 800 ml water or clear fluid Incomplete outcome data: Fleet Company performed cleansing Indications for colonoscopy within 1 hr (n=161) no Inc. instructions, and failure to (%): NR reach cecum or IC valve All patients: avoid foods with small seeds and Selective outcome nuts for 5 days; take 3 tablets of bisacodyl in reporting: no afternoon two days before colonoscopy; day before colonoscopy no solid food/clear liquids Risk of bias: Moderate throughout the day

Sedation: NR

Study withdrawals: NR Gupta 200728 Inclusion Criteria: age N=201 NPO status group 1: NaP-based fluid (90 mL For RCTs between 18 and 80 with 300 mL lemonade) at 6 am on day of Sequence generation: Location: India Age (yr): NR colonoscopy (“colonoscopy preferably unclear Exclusion Criteria: prior bowel Gender (Male %): NR scheduled” after11 am) (n=102) Study design: surgery, suspected bowel Race (%): NR Allocation concealment: RCT obstruction, contraindication BMI: NR NPO status group 2: NaP-based fluid (same) at adequate to phosphate preparation 5 pm day before (“timing of colonoscopy for the Funding source: (cardiovascular or renal Co-existing conditions (%): NR evening group was adjusted as indicated by the Blinding: investigators Not reported insufficiency); inconvenienced scheduled appointment list”) (n=99) blinded to timing of prep by the timing of bowel Indications for colonoscopy preparation (%): NR Both groups: allowed to consume clear liquids Incomplete outcome data: (as desired) in the preceding 12 hours no NOTE: reported groups were (UNCLEAR WHAT THIS MEANS) comparable in terms of Selective outcome demographic data and Sedation: combination of pethidine reporting: no indications for colonoscopy hydrochloride (50mg) and midazolam (2mg) as an intravenous bolus unless contraindicated Risk of bias: Moderate (1/2 dose for pts over 65 yrs)

Study withdrawals: None

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Gurudu 201029 Inclusion Criteria: consecutive N=1,345 NPO status group 1: Split-dose prep 1) Study design: afternoon colonoscopies 1) 4L PEG am (n=226): start 4L PEG at 5 am retrospective Location: USA (after 1 pm) from July 2008 to Age (yr): 61 day of procedure April 2009 Gender (Male %): 52 2) 2L PEG am (n=39): start 2L PEG + 4 tablets 2) Population: consecutive Study design: Race (%): NR bisacodyl at 5 am day of procedure Retrospective Exclusion Criteria: None BMI: Overall NR, reported for 3) Split Dose: 2L PEG evening before 3) Analysis of findings observational poor, good prep etc. procedure and starting at 5 am day of (n=48) a. Was the method for NPO status group 2: 1 day prep handling missing data Funding source: Co-existing conditions (%): NR 1) 2L PEG pm (n=656): 2L PEG + 4 tablets reported and appropriate? None bisacodyl day prior to procedure appears to be no missing Indications for colonoscopy 2) 4L PEG pm (n=376): 4L PEG day prior data (%): Screening/surveillance: 61% All patients allowed drink clear liquids up to 3 b. Were the Anemia/bleeding: 11% hrs before procedure characteristics of the Diarrhea: 8% different NPO groups Abdominal pain; 4% Sedation: Conscious sedation similar? bowel Colitis: 3% preparations were not Constipation: 2% Study withdrawals: None distributed equally Other: 11% (difference adjusted statistically)

Risk of bias: Moderate Gurudu 201230 Inclusion Criteria: patients N=5,175 NPO status group 1: POST-SDP - Split prep 1) Study design: undergoing screening/ (PEG or MoviPrep), 3L night before starting at 6 retrospective Location: USA surveillance colonoscopy Age (yr): 61 pm and 1 L at least 4 hours before scheduled Gender (Male %): 50 procedure; NPO for at least 3 hours prior to 2) Population: consecutive Study design: Exclusion Criteria: incomplete Race (%): NR procedure (n=1,615) Retrospective data, prior colon resection, BMI: 28 3) Analysis of findings observational and colonoscopy for NPO status group 2: Pre-SDP - All prep (PEG a. Was the method for indications of bleeding, Co-existing conditions (%): NR or MoviPrep) the night before (n=3,560) handling missing data Funding source: anemia, IBD, repeated reported and appropriate? None colonoscopy in same patient Indications for colonoscopy All patients instructed to be NPO for at least 3 yes, all included during the study after an (%): hrs before procedure initial colonoscopy detected Screening and surveillance b. Were the adenomas was also excluded included only Sedation: mainly moderate, few got MAC also characteristics of the different NPO groups Study withdrawals: NR similar? yes

Risk of bias: High

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Huffman 201031 Inclusion Criteria: scheduled N=301 NPO status group 1: Various split-dose bowel 1) Study design: for EGD and colonoscopy on preps (PEG, NaP); complete prep by at least 2 prospective Location: USA same day after split-dose Age (yr): 55 hrs before procedure (mean NPO = 5.1 hrs) bowel prep Gender (Male %): 41 (n=254) 2) Population: not Study design: Race (%): NR consecutive Prospective Exclusion Criteria: gastric BMI: NR NPO status group 2: Various bowel preps observational resection, known (PEG, NaP) evening before (mean NPO = 13.5 3) Analysis of findings gastroparesis, or slow GE Co-existing conditions (%): hrs) (n=47) a. Was the method for Funding source: DM: 18 handling missing data None Opioid use:15 Sedation: NR reported and appropriate? Metocloporamide Use: 3 NR Study withdrawals: NR Indications for colonoscopy b. Were the (%): NR characteristics of the different NPO groups similar? yes, group sizes and outpatient to inpatient ratios differed between groups

Risk of bias: Moderate

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Johanson 200732 Inclusion Criteria: males and N=402 NPO status group 1: 20 NaP tablets at 6 pm For RCTs non-pregnant, non-lactating evening before colonoscopy and 12 tablets next Sequence generation: not Location: 10 females ≥18 years; scheduled Age (yr): 56 day 3-5 hrs before colonoscopy (n=200); this described sites, USA for colonoscopy Gender (Male %): 44 group was allowed light breakfast day before Race (%): white 86; black 10; colonoscopy (up to 12 noon) with no solid food Allocation concealment: Study design: Exclusion Criteria: renal other 3 after noon (clear liquids only) adequate RCT insufficiency; serum BMI: NR electrolyte abnormalities at NPO status group 2: 4 bisacodyl tablets with Blinding: single blinded Funding source: screening; uncontrolled CHF, Co-existing conditions (%): NR water at 12 noon day prior colonoscopy Pharmaceutical unstable angina, untreated followed by 2L PEG taken after a bowel Incomplete outcome data: industry dysrhythmia, current use of Indications for colonoscopy movement or a maximum of 6 hrs after 16% excluded from final digitalis preparations or (%): NR ingestion of bisacodyl tablets (n=202); this analysis medications known to prolong group allowed only clear liquids entire day QT interval; MI, PTCA or before colonoscpy Selective outcome CABG within previous 3 reporting: no months; ascites; current Sedation: Patients were sedated but type of acute exacerbation of IBD; sedation not reported Risk of bias: Moderate toxic colitis or toxic megacolon; severe chronic Study withdrawals: 1 patient withdrew; 16% constipation; ileus; excluded from final analysis perforation; ileostomy; colostomy, hypomotility syndrome; gastric bypass or stapling; history of gastric retention; impaired gag reflex; history of aspiration; dysphagia; treatment with investigational drug or product; participation in drug study within past 30 days; treatment within 21 days with another NaP preparation; known allergy to NaP; or any other clinically significant disease that would expose the patient to increased risk of an adverse event

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Kao 201133 Inclusion Criteria: ambulatory N= 834 NPO status group 1: PM colonoscopy; 4 For RCTs GI clinic patients between 18- different regimens 8-10 H before colonoscopy Sequence generation: Location: Canada 75 years who underwent Age (yr): 50 (n=287); included PEG, NaP, Pico- adequate elective outpatient Gender (Male %): 39 Salax+magnesium citrate Study design: colonoscopy Race (%): NR Allocation concealment: RCT BMI: NR NPO status group 2: AM colonoscopy; 4 adequate Exclusion Criteria: renal different prep regimens 10-14 h before Funding source: insufficiency, CHF, acute Co-existing conditions (%): colonoscopy (n=491) Blinding: single blinded None coronary syndrome recent or NR unstable angina, liver All patients; clear liquid diet the day before Incomplete outcome data: cirrhosis or ascites, chronic Indications for colonoscopy colonoscopy; hydrate liberally with water or no furosemide therapy, previous (%): NR clear electrolyte replacement solution until 2 hrs colon resection, and known or before procedure Selective outcome suspected bowel obstruction, reporting: no megacolon or ileus Sedation: NR Risk of bias: Low Study withdrawals: None

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Kastenberg 2001, Inclusion Criteria: either N=886 randomized (859 NPO status group 1: 20 tablets NaP at 6 pm For RCTs 200734,35 gender, at least 18 years old, received study product) evening before and repeat 3-5 hrs before Sequence generation: scheduled for colonoscopy, colonoscopy (n=420) adequate Location: able to swallow tablets Age (yr): 56 Multiple sites, without difficulty, and gave Gender (Male %): 48 NPO status group 2: 4L PEG evening before Allocation concealment: USA written informed consent Race (%): white 87, African- colonoscopy (n=425) adequate American 8, Hispanic 5 Study design: Exclusion Criteria: evidence BMI: NR Sedation: NR Blinding: single blinded RCT of acute or chronic renal insufficiency; cardiovascular Co-existing conditions (%): NR Study withdrawals: 1.6% (14 patients) Incomplete outcome data: Funding source: disease (uncontrolled no Pharmaceutical congestive heart failure, Indications for colonoscopy Industry unstable angina pectoris, or, (%): NR Selective outcome within past 3 months, PTCA, reporting: no MI, or CABG); ascites; electrolyte imbalance Risk of bias: Low (hyponatremia, hyperphosphatemia, or hypocalcemia); colon disease (acute exacerbation of chronic IBD, chronic constipation [<2 bowel movements per week for >1 year], ileus and/or acute obstruction, ileostomy, right or transverse colostomy, subtotal colectomy [≥50% of colon removed] with ileosigmoidostomy [patients with right or left hemicolectomy alone were eligible], hypomotility syndrome, megacolon, or idiopathic pseudoobstruction

65 NPO Status Prior to Colonoscopy Evidence-based Synthesis Program

Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Khan 201036 Inclusion Criteria: adults, N=412 NPO status group 1: NaP tablets (n=93) or 2L For RCTs and CCTs scheduled for outpatient PEG + ascorbic acid (n=64) administered by Sequence generation: not Location: USA colonoscopy Age (yr): NR split-dose (exact timing unknown) (total n=157) applicable Gender (Male %): NR Study design: Exclusion Criteria: NR Race (%): NR NPO status group 2: 4L PEG the evening Allocation concealment: CCT BMI: NR before (exact timing unknown) (n=255) not described

Funding source: Co-existing conditions (%): NR Sedation: NR Blinding: unclear Not reported Indications for colonoscopy Study withdrawals (%): bowel preparation Incomplete outcome data: (%): NR scoring incomplete for 49/412 (12%) yes

Selective outcome reporting: no

Risk of bias: High Koh 201137 Inclusion Criteria: NR N=80 NPO status group 1: 4L PEG between 6 and 8 For RCTs and CCTs am; ate lunch between 12 and 12:30 pm (n=40) Sequence generation: Location: Korea Exclusion Criteria: diabetes Age (yr): 53 inadequate (odd and even mellitus, hyperthyroidism or Gender (Male %): 66 NPO status group 2: 4L PEG between 6 and 8 days) Study design: hypothyroidism, taking Race (%): NR am; no lunch (n=40) RCT prokinetic or antispasmotic BMI: NR Allocation concealment: medication, history of bowel All colonoscopies between 2 and 4 pm inadequate Funding source: resection Co-existing conditions (%): University chronic disease 23; previous Sedation: conscious sedation/analgesia with IV Blinding: endoscopists research fund abdominal surgery 11 midazolam and pethidine titrated as required were blinded

Indications for colonoscopy Incomplete outcome data: (%) no Screening: 48 Altered bowel habit: 28 Selective outcome Bowel symptoms: 18 reporting: no Anemia: 8 Risk of bias: High

66 NPO Status Prior to Colonoscopy Evidence-based Synthesis Program

Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Kolts 199338 Inclusion Criteria: consecutive N=113 NPO status group 1: NaP (90ml fluid) at 6 pm For RCTs and CCTs outpatients requiring an and 6 am plus at least 36oz water 1 hour after 6 Sequence generation: Location: USA elective colonoscopy Age (yr): 54 pm dose (n=34) unclear Gender (Male %): 39 (lower % Study design: Exclusion Criteria: acute male in NPO group 1) NPO status group 2: 4L GoLYTELY (PEG) at 6 Allocation concealment: RCT diverticulitis, active IBD, Race (%): NR pm day before (n=38) pharmacist distributed unstable cardiovascular or BMI: NR preparations Funding source: respiratory status, allergies to NPO status group 3: Castor oil (60ml fluid) at 6 University all available conscious Co-existing conditions (%): NR pm plus at least 36oz water 1 hour after (n=41) Blinding: endoscopists research fund sedation medications, MI or were blinded cerebrovascular accident in Indications for colonoscopy All patients: liquid diet day before with NPO last 2 months, serum (%) after midnight Incomplete outcome data: creatinine > 2.0 mg/dl, GI bleed: 36 no massive ascites, delayed Polyps: 39 Sedation: IV sedation gastric emptying Anemia: 4 Selective outcome Diarrhea: 9 reporting: no Constipation: 3 Risk of bias: Moderate Kössi 200739 Inclusion Criteria: consecutive N=214 enrolled; demographic Morning colonoscopies: 45 ml NaP at 7 am and 1) Study design: outpatients data for 204 analyzed 7 pm day before colonoscopy prospective Location: USA Exclusion Criteria: None Age (yr): 54 Afternoon colonoscopies: 45 ml NaP at 6 pm 2) Population: consecutive Study design: reported Gender (Male %): 45 day before and 6 am on day of colonoscopy Prospective Race (%): NR 3) Analysis of findings observational BMI: NR Created 3 groups: a. Was the method for NPO status group 1: 6 hours or less between handling missing data Funding source: Co-existing conditions (%) 2nd dose of prep and colonoscopy (n=53) reported and appropriate? Not reported Diverticulosis (moderate to yes severe): 11 NPO status group 2: 6 to 12 hours between 2nd dose of prep and colonoscopy (n=90) b. Were the Indications for colonoscopy characteristics of the (%): NR NPO status group 3: 12 hours or more between different NPO groups 2nd dose of prep and colonoscopy (n=61) similar? yes

All patients: instructed to not eat vegetables, Risk of bias: Low berries, fruits, or bread containing seeds for 1 wk before colonoscopy; encouraged to drink 2-3 liters of clear liquids during bowel prep

Sedation: NR

Study withdrawals: 5% (10/214)

67 NPO Status Prior to Colonoscopy Evidence-based Synthesis Program

Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Longcroft- Inclusion Criteria: receiving N=227 NPO status group 1: same-day regimen, 2 1) Study design: Wheaton 201240 colonoscopy under National sachets of sodium picosulphate at 7 and 10 am prospective Bowel Cancer Screening Age (yr): median 65 (range: on morning of afternoon procedure; NPO <3 Location: UK Programme; age 59 to 70 60-71) hours (n=132) 2) Population: consecutive years Gender (Male %): 75 Study design: Race (%): NR NPO status group 2: 2-day regimen, pts used 3 3) Analysis of findings Obsersvational Exclusion Criteria: known BMI: NR sachets of sodium picosulphate at noon and 5 a. Was the method for (Prospective renal impairment (CKD grade pm on day before and 1 at 8am on day of handling missing data Cohort) 3, Creatinine>150; Co-existing conditions (%): NR afternoon procedure; NPO 4-8 hours (n=95) reported and appropriate? eGFR<40); congestive appears all were included Funding source: cardiac failure; sodium <130 Indications for colonoscopy All patients: light diet day before procedure (no None reported (%): NR vegetables/fruit); increase fluid intake for 24 hrs b. Were the leading up to procedure characteristics of the different NPO groups Sedation: NPO Status 1: 1.27, NPO Status 2: similar? yes 1.20 (Mean sedation level where 1=awake, 2=drowsy, 3=asleep) Note: endoscopist and screening nurse were Study withdrawals: NR blinded to the preparation regimen.

Risk of bias: Low Manno 201241 Inclusion Criteria: 18 years of N=336 NPO status group 1: 3L PEG starting at 3 pm For RCTs age or older, either a positive day before and 1L PEG over 1 hr starting 3 hrs Sequence generation: Location: Italy FOBT or in surveillance post- Age (yr): 61 before procedure (n=168) adequate polypectomy with elective Gender (Male %): 71 Study design: colonoscopy scheduled Race (%): NR NPO status group 2: 4L PEG over 4 hrs starting Allocation concealment: RCT between 9:00 am and 1:00 BMI: NR at 3 pm day before colonoscopy (n=168) adequate pm Funding source: Co-existing conditions (%) All patients: low fiber diet for 3 days before Blinding: investigator None reported Exclusion Criteria: presence Prior abdominal surgery: 21 procedure of severe cardiac, renal or Constipation: 10 Incomplete outcome data: hepatic impairment; known Diabetes: 4 Sedation: conscious sedation no allergy or hypersensitivity to any constituent of preparation Indications for colonoscopy Study withdrawals: None Selective outcome (%) reporting: no Positive FOBT: 70 Polypectomy follow-up: 30 Risk of bias: Low

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Marmo 201042 Inclusion Criteria: N=randomized 895 (ITT NPO status group 1: High volume (4L PEG-ES) For RCTs “appropriate indication” to includes 868) or low volume (2L PEG-ES + ascorbic acid); Sequence generation: Location: Italy colonoscopy half taken afternoon before, half early morning adequate Age (yr): 58 on day of colonoscopy (n=435) Study design: Exclusion Criteria: pregnant Gender (Male %): 58 Allocation concealment: RCT or lactating women; age <18 Race (%): NR NPO status group 2: Same as above with doses adequate years; significant BMI: NR taken 2 hours apart starting around 6:30 pm Funding source: gastroparesis or gastric outlet evening before colonoscopy (n=433) Blinding: single-blind None reported obstruction or ileus; known or Co-existing conditions (%): suspected bowel obstruction Diabetes: 5 All patients: low fiber diet for 3 days before Incomplete outcome data: or perforation; procedure; light breakfast and lunch plus yes (3%) phenylketonuria or glucose-6- Indications for colonoscopy semiliquid dinner day before taking bowel prep; phosphate dehydrogenase (%): NPO after midnight before procedure Selective outcome deficiency; severe chronic Symptoms: 41 reporting: no renal failure (creatinine Screening: 13 Sedation: NR clearance <30 mL/minute); Surveillance: 16 Risk of bias: Low severe congestive heart Polypectomy/resection: 8 Study withdrawals (%): failure (New York Heart Type of prep unknown:18 (2) Association class III or IV); Incorrect prep 9 (1) dehydration; severe acute inflammatory disease; compromised swallowing reflex or mental status; uncontrolled hypertension (SBP >170 mm Hg, DBP >100 mm Hg); toxic colitis; or megacolon

69 NPO Status Prior to Colonoscopy Evidence-based Synthesis Program

Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Mathus-Vliegen Inclusion Criteria: consecutive N=200 randomized (12 did not NPO status group 1 (afternoon colonoscopies): For RCTs 201343 ambulant patients referred for receive allocated intervention); 2L PEG or PEG+ascorbate solution starting at 6 Sequence generation: colonoscopy; age ≥ 18; patients were randomized to pm day before and 2L morning of procedure adequate Location: physically able to take bowel PEG or PEG+ascorbate (exact time not reported) (n=89) Netherlands preparation at home solution and then completed Allocation concealment: split-dose or single-dose prep NPO status group 2 (morning colonoscopies): adequate Study design: Exclusion Criteria: pregnant based colonoscopy time 4L PEG or PEG+ascorbate solution starting at 6 RCT or lactating, inpatient, heart pm evening before (n=99) Blinding: endoscopists failure, severe dehydration, Age (yr): 60 were blinded Funding source: GI ulcers, hypersensitivity to Gender (Male %): 48 All patients: 2-day low-fiber diet recommended NR PEG< ileus, (partial) Race (%): NR Incomplete outcome data: colectomy, colostomy, BMI: NR Sedation: NR yes (efficacy data missing phenylketonuria, glucose-6- for 20%, safety data phosphate deficiency, Co-existing conditions (%): NR Study withdrawals (%): missing for 6%) enrolled in population- Did not receive allocated intervention: 6% screening program Indications for colonoscopy For efficacy outcome: Selective outcome (%): a. Failed examination: 6% of those receiving reporting: no Polyp surveillance: 37 intervention GI bleeding: 21 b. Missing data: 9% of those receiving Risk of bias: Moderate Changed stool pattern: 21 intervention Familiar screening/surveillance: 12 Anemia: 5 IBD: 4

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Matro 201044 Inclusion Criteria: age ≥ 18; N=125 randomized (9 NPO status group 1 (AM prep): 1L PEG 7 hours For RCTs scheduled for elective, withdrew prior to taking prep; 1 before procedure and 1L 4 hours before Sequence generation: Location: USA outpatient afternoon (12 pm additional patient in AM group procedure (n=65) adequate or later) colonoscopy did not undergo colonoscopy) Study design: NPO status group 2 (PM/AM prep): 1L PEG + Allocation concealment: RCT Exclusion Criteria: pregnancy, Age (yr): 52 250 ml clear liquid at 6 pm and 1L 4 hours adequate breast feeding, known or Gender (Male %): 46 before procedure (n=60) Funding source: suspected gastroparesis, Race (%): NR Blinding: endoscopists Industry chronic nausea or vomiting, BMI: NR All patients: low-residue breakfast before 10 am were blinded bowel obstruction, day before then clear liquids until 2.5 hours hypomotility syndrome, Co-existing conditions (%): before colonoscopy (medications with sips of Incomplete outcome data: severe constipation, >50% Diabetes: 8 water allowed within 2.5 hours of procedure) 7% colon resection, known Thyroid disease: 7 glucose-6-phosphate Hypertension: 30 Sedation: monitored anesthesia with propofol- Selective outcome dehydrogenase deficiency, GERD: 9 based sedation reporting: no PEG allergy, significant IBD: 4 psychiatric illness Pulmonary disease: 4 Study withdrawals (%): 7% did not take prep Risk of bias: Low Cardiovascular disease: 24

Indications for colonoscopy (%): Screening: 51 Surveillance: 17 Symptoms: 32 Paoluzi 199345 Inclusion Criteria: NR N=160 randomized; data for NPO status group 1: 2L PEG at 6 to 8 pm For RCTs 132 evening before; 1L PEG at 6 to 7 am; fast or Sequence generation: Location: Italy Exclusion Criteria: presence clear liquids after starting prep (n=80) unclear of stenosis, suspected Age (yr): 51 Study design: perforation of the gut, colonic Gender (Male %): 60 NPO status group 2: 35g castor oil at 4 pm day Allocation concealment: RCT resection, pregnancy Race (%): NR before; cleansing enema evening before and unclear BMI: NR morning of procedure; low residual semi-liquid Funding source: diet for 2 days before exam with fast from eve Blinding: endoscopists NR Co-existing conditions (%): NR of exam (n=80) were blinded

Indications for colonoscopy Colonoscopies performed 8-9:30 am Incomplete outcome data: (%): 17.5% IBD: 46 Sedation: NR Cancer: 4 Selective outcome Polyps: 17 Study withdrawals: 24/160 (15%) did not reporting: no Haematochezia: 19 present on day of examination; additional 4 patients in PEG group did not complete solution Risk of bias: Moderate because of side effects and did not complete adequacy of prep outcomes

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Park 200746 Inclusion Criteria: consecutive N=303 NPO status group 1: 3L PEG between 8 and 11 For RCTs individuals undergoing pm evening before procedure; 1L PEG early Sequence generation: not Location: Korea medical check−up Age (yr): 49 morning (at least 2 hours prior to procedure) described colonoscopy at Gender (Male %): 81 (n=152) Study design: university−affiliated medical Race (%): NR Allocation concealment: RCT center BMI: NR NPO status group 2: 4L PEG between 8 and 11 not described pm evening before procedure (n=151) Funding source: Exclusion Criteria: age < 18 Co-existing conditions (%): NR Blinding: Colonoscopists None reported years; serious medical Colonoscopies performed 8-9:30 am blinded, groups evenly conditions such as severe Indications for colonoscopy allocated cardiac, renal, or metabolic (%): NR Sedation: NR disease; active alcoholism, Incomplete outcome data: drug addiction, or major Study withdrawals: None no psychiatric illness; known allergy to PEG; previous Selective outcome surgical bowel resection or reporting: no gynecologic surgery; refusal of consent to participate in Risk of bias: Low study Park 201047 Inclusion Criteria: men and N=285randomized (analyzed NPO status group 1: 2L PEG 8 pm evening For RCTs women >18 years of age 232) before procedure, 2L PEG 5 am day of Sequence generation: Location: Korea scheduled for colonoscopy in procedure (n=80) adequate the morning Age (yr): 52 Study design: Gender (Male %): 63 NPO status group 2: 250 ml magnesium citrate Allocation concealment: RCT Exclusion Criteria: serious Race (%): NR 8 pm evening before procedure, 2L PEG 5 am inadequate (an medical conditions such as BMI: 24 day of procedure (n=73) investigator managed the Funding source: severe cardiac, renal, printed allocation No funding hepatic, or metabolic Co-existing conditions (%): NR NPO status group 3: 4L PEG 10 pm evening schedule) diseases; active alcoholism, before procedure (n=79) drug addiction, or major Indications for colonoscopy Blinding: investigator psychiatric illness; known (%): NR All patients: thick liquid diet at dinner evening allergy to PEG; history of before procedure; NPO after 6 pm Incomplete outcome data: prior colon or rectal surgery yes Sedation: NR Selective outcome Study withdrawals: 19% (postponed or reporting: no canceled procedure or changed to pm) Risk of bias: High

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Parra-Blanco Inclusion Criteria: consecutive N=197 randomized, 177 NPO status group 1: 3L PEG-ELS starting at 6 For RCTs 200648 outpatients, scheduled for included in analysis am day of colonoscopy (n=43) (NOTE: 39.5% Sequence generation: elective colonoscopy had morning colonoscopy) adequate Location: Spain (morning or afternoon), age Age (yr): 54 18-85 Gender (Male %): 48 NPO status group 2: 45 mL NaP 8 pm evening Allocation concealment: Study design: Race (%): NR before and 45 mL 6 am day of colonoscopy unclear RCT Exclusion Criteria: BMI: NR (n=45)a (NOTE: 53.3% had morning Pregnancy, partial or total colonoscopy) Blinding: endoscopists Funding source: colectomy, IBD (known or Co-existing conditions (%): NR and attending nurse Government, suspected) NPO status group 3: 3L PEG-ELS starting at 8 blinded to prep regimen Education Indications for colonoscopy pm evening before colonoscopy (n=45) (NOTE: (%) 68.9% had morning colonoscopy) Incomplete outcome data: Chronic constipation: 24 yes Polyp surveillance: 13 NPO status group 4: 45mL NaP at 3 pm and 8 pm day before colonoscopy (n=44)a (NOTE: Selective outcome 77.3% had morning colonoscopy) reporting: no

Colonoscopies: 9 am to 3 pm Risk of bias: Moderate

Patients NaP groups encouraged to drink fluids liberally (at least 2L) during cleansing period

All patients: received Bysacodyl (15 mg) day before colonoscopy and low-fiber diet recommended; allowed clear fluids after completing bowel preparation

Sedation: NR

Study withdrawals: 10 (20/197 consecutive outpatients initially included in the study)

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Rex 201349 Inclusion Criteria: men and N=608 randomized; NPO status group 1: P/MC; first dose in 5 oz For RCTs (SEE CLEAR I women, 18 to 80 years, at demographic data for 603 water between 5 and 9 pm evening before Sequence generation: study) least 3 spontaneous bowel followed by 40 oz clear liquid over next several unclear movements/week for 1 month Age (yr): 55 (median) hours; second dose in 5 oz water 5 to 9 hours Location: USA before colonoscopy Gender (Male %): 41 before procedure followed by 24 oz clear liquid Allocation concealment: Race (%): white 88; (n=305) adequate Study design: Exclusion Criteria: acute black/African American 11 RCT abdominal conditions; active BMI: 29.5 NPO status group 2: 2 5-mg bisacodyl tablets Blinding: IBD; colon disease (including taken in afternoon before colonoscopy; after gastroenterologists and Funding source: toxic megacolon, toxic colitis, Co-existing conditions (%): NR first bowel movement or 6 hours 2L PEG-3550 assistants were blinded Industry idiopathic pseudo-obstruction, (n=298) hypomotility syndrome); Indications for colonoscopy Incomplete outcome data: ascites; GI disorders (such as (%): NR All patients limited to clear liquid diet 24 hours yes (1%) active ulcers, gastric outlet before procedure obstruction, retention, Selective outcome gastroparesis, and ileus); Sedation: NR reporting: no uncontrolled angina and/or MI within past 3 months; CHF or Study withdrawals: 0.8% not treated and Risk of bias: Low uncontrolled hypertension; excluded; 0.7% did not complete study known renal insufficiency with abnormal creatinine or serum potassium levels at screening; history of colorectal surgery or upper GI surgery

Use of lithium, laxatives, constipating drugs, antidiarrheal agents, or oral iron preparations not allowed during the study

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Seo 201250 Inclusion Criteria: 18 to 85 N=366 NPO status group 1: 2L PEG at 6 pm on day 1) Study design: years, outpatients before, 2L PEG at least 2 hours before prospective Location: Korea Age (yr): 55 procedure (n=366) Exclusion Criteria: pregnancy, Gender (Male %): 48 2) Population: consecutive Study design: breastfeeding, history of Race (%): NR NPO status group 2: N/A Prospective surgical large-bowel BMI: 23 3) Analysis of findings observational resection, severe renal All patients instructed to start low fiber diet 3 a. Was the method for failure, drug addiction or Co-existing conditions (%) days before colonoscopy; regular diet for handling missing data Funding source: major psychiatric illness, Hypertension: 14 breakfast and lunch and soft diet for dinner the reported and appropriate? NR allergy to PEG, refusal to Diabetes: 7 day before colonoscopy; allowed only clear appears all were included participate in study Stroke: 1 liquids until 2 hours before colonoscopy Liver cirrhosis: 2 b. Were the Constipation: 20 Sedation: NR characteristics the different NPO groups Indications for colonoscopy Study withdrawals: None similar? unclear (%) Screening: 40 Risk of bias: Moderate Surveillance: 17 Symptoms: 43 Vanner 201151 Inclusion Criteria: N=100 NPO status group 1: PSLX, 1st dose at 7 pm, 1) Study design: colonoscopy for routine 2nd dose at 6 am before colonoscopy scheduled prospective Location: Canada clinical indication Age (yr): 60 after 11 am (interval >5 hrs) (n=32) Gender (Male %): 42 2) Population: unclear if Study design: Exclusion Criteria: congestive Race (%): NR NPO status group 2: PSLX 1st dose at 5 pm, 2nd consecutive Prospective heart failure, renal BMI: NR dose at 10 pm evening before colonoscopy observational insufficiency, ileus or bowel scheduled before 11 am (interval >9 hrs) (n=68) 3) Analysis of findings obstruction, previous Co-existing conditions (%): NR a. Was the method for Funding source: colorectal surgery, ascites, All patients: 10 mg bisacodyl tablet at 6 pm handling missing data Internal funding active IBD, recent (<6 mo) MI Indications for colonoscopy days 3 and 2 before colonoscopy; low fiber diet reported and appropriate? only or unstable angina (%): NR 5 days before colonoscopy; clear fluid diet day appears all were included before colonoscopy; encouraged to drink 4L of carbohydrate electrolye sports drink on day of b. Were the clear fluids and until leaving home for procedure characteristics the different NPO groups Sedation: NR similar? unclear

Study withdrawals: unclear; 5 incomplete Risk of bias: Moderate colonoscopies (4 abdominal discomfort, 1 poor preparation and sigmoid stricture)

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Patient Characteristics Study/Region/ Inclusion/Exclusion Criteria (expressed in means unless NPO status groups Risk of Bias Funding Source otherwise noted) Varughese 201052 Inclusion Criteria: age > 19 N=136 randomized NPO status group 1: 1 gallon PEG between 6 For RCTs years, elective colonoscopy am and 10 am day of colonoscopy (interval >3 Sequence generation: Location: USA scheduled from 1 pm onward Age (yr): 52 hrs) (n=68) adequate Gender (Male %): 52 Study design: Exclusion Criteria: history of Race (%): white 45; Hispanic NPO status group 2: 1 gallon PEG between 5 Allocation concealment: RCT colon resection, suspicion of 49; other 6 pm and 9 pm day before colonoscopy (interval unclear bowel obstruction BMI: 28.5 >16 hrs) (n=68) Funding source: Blinding: yes, No funding Co-existing conditions (%): NR Group 1 was allowed breakfast on day before endoscopists were blinded colonoscopy followed by clear liquids for lunch Indications for colonoscopy and dinner; Group 2 advised to take only clear Incomplete outcome data: (%): liquid on day before colonoscopy no CRC screening: 54 Diagnostic/therapeutic: 46 Both groups allowed clear liquids the morning of Selective outcome the procedure with NPO after 10 am reporting: no NOTE: study terminated early - interim analysis showed Sedation: Meperidine+midazolam (32%); larger effect size than monitored anesthesia care (68%) Risk of bias: Moderate anticipated Study withdrawals: None Voiosu 201353 Inclusion Criteria: clear N=181 randomized (patient NPO status group 1: 2L PEG at 5 to 7 pm day For RCTs indication for colonoscopy, characteristics for n=165) before and 2L PEG at 5 to 7 am day of Sequence generation: Location: age >18 years colonoscopy (n=94 randomized, 95 analyzed) unclear Romania Age (yr): 60 Exclusion Criteria: refusal to Gender (Male %): 54 NPO status group 2: P/MC 1st dose at 1 pm, 2nd Allocation concealment: Study design: sign consent or preference for Race (%): NR dose at 7 pm day before colonoscopy (plus 250 adequate RCT a specific bowel prep product, BMI: NR ml fluid/hour between1 and 11 pm) (n=87 stenosing colorectal cancer or randomized, 80 analyzed) Blinding: endoscopists Funding source: intestinal obstruction, Co-existing conditions (%): NR were blinded NR previous colonic resection, Colonoscopies: 8 am to 2 pm severe concomitant disease Indications for colonoscopy Incomplete outcome data: (heart, renal or liver failure; (%): Sedation: propofol at 1 center, midazolam at 1 yes pulmonary disease; Rectal bleeding: 24 center electrolyte imbalance; CRC screening: 18 Selective outcome neuropsychiatric conditions) Diarrhea: 14 Study withdrawals: 9.6% of group 1, 8.0% of reporting: no Anemia: 10 group 2 Constipation: 7 Risk of bias: Moderate Abdominal pain: 7 Referral for polypectomy: 6 Other: 16

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AE = adverse event; CRC = colorectal cancer; DBP = diastolic blood pressure; FOBT = fecal occult blood test; hrs = hours; IBD = inflammatory bowel disease; L = liter(s); MI = myocardial infarction; CHF = congestive heart failure; NaP = sodium phosphate; PEG = polyethylene glycol; PEG-E or PEG-ELS = polyethylene glycol electrolyte solution; P/MC or PSLX = sodium picosulfate and magnesium citrate; SBP = systolic blood pressure

a Patients with co-morbid conditions (chronic renal failure, symptomatic ischemic heart disease, congestive heart failure, hypertension with poor pharmacological control) allocated to NaP groups were given PEG-ELS instead (Group 2 followed Group 1 protocol, Group 4 followed Group 3 protocol) and evaluated on an intention-to-treat analysis