The Bowel CLEAnsing: A National Initiative (B-CLEAN)

The purpose of this study is to compare diet, type of bowel preparation and time of colonoscopy to determine if one method is better than the other and, if they are the same, identify the one which is the most convenient for the patients.

Study Overview

• Status: Completed
• Conditions: Subjets Requiring a Colonoscopy
• Intervention / Treatment: Drug: High volume PEG split-dose; Other: Clear liquid diet; Other: Early colonoscopy (stratified); Other: Low residue diet; Drug: Low volume PEG split-dose; Drug: High volume PEG non split, day before; Other: Later colonoscopy (stratified); Drug: Low volume PEG non split, same day

Detailed Description

The objective of the current proposed trial is thus to compare the cleanliness achieved with PEG high-volume (2L+2L) split-dose versus PEG (1L+1L)+Bisacodyl low-volume split-dose, or PEG high volume (4L) non-split day before versus PEG low volume (2L) non-split same day preparation, according to time of endoscopy (early or later), as well as assess the role of diet (low residue or clear liquid diet) according to these different Canadian outpatient preparation regimens.

• Study Type: Interventional
• Enrollment (Actual): 3476
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1S 4L8
    • Hôpital St-Sacrement, CHU de Québec-Université Laval
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Forzani & MacPhail Colon Cancer Screening Centre
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • St. Paul's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Health Sciences center and St. Boniface Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII HSC
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Western University
    • Ottawa, Ontario, Canada, K1H 1A2
      • The Ottawa Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2W 2J3
      • CHUM
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatients
• 18 years or older
• Able to comprehend the trial
• Have an indication for full colonoscopy

Exclusion Criteria:

Subjects are excluded from enrollment into the study if any of the following are present:

General exclusion criteria:

• Subject refusal
• Previous bowel preparation in the last 14 days
• Pregnancy or breastfeeding
• Reduced mobility

Medical/Endoscopic exclusion criteria:

• Suspected or diagnosed with bowel obstruction
• Any colonic surgery
• Toxic megacolon
• Ileus
• Ischemic colitis
• Decompensated heart failure
• Severe acute renal failure
• Severe liver disease
• Severe electrolyte imbalance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1) Early colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Drug: High volume PEG split-dose; Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.; Other Names: Colyte® or PegLyte®; Other: Clear liquid diet; Other: Early colonoscopy (stratified); "Early" appointments: 7:30 AM to 10h30 AM
Active Comparator: 1) Early colonoscopy; 2) High-dose, split-dose; 3)Low residue	Drug: High volume PEG split-dose; Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.; Other Names: Colyte® or PegLyte®; Other: Early colonoscopy (stratified); "Early" appointments: 7:30 AM to 10h30 AM; Other: Low residue diet
Active Comparator: 1) Early colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Other: Clear liquid diet; Other: Early colonoscopy (stratified); "Early" appointments: 7:30 AM to 10h30 AM; Drug: Low volume PEG split-dose; Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.; Other Names: Bi-PegLyte®
Active Comparator: 1) Early colonoscopy; 2) Low volume split-dose; 3)Low residue	Other: Early colonoscopy (stratified); "Early" appointments: 7:30 AM to 10h30 AM; Other: Low residue diet; Drug: Low volume PEG split-dose; Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.; Other Names: Bi-PegLyte®
Active Comparator: 1) Early colonoscopy; 2) High-dose, day before; 3)Clear liquid	Other: Clear liquid diet; Other: Early colonoscopy (stratified); "Early" appointments: 7:30 AM to 10h30 AM; Drug: High volume PEG non split, day before; Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.; Other Names: Colyte® or PegLyte®
Active Comparator: 1) Early colonoscopy; 2) High-dose, day before; 3)Low residue	Other: Early colonoscopy (stratified); "Early" appointments: 7:30 AM to 10h30 AM; Other: Low residue diet; Drug: High volume PEG non split, day before; Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.; Other Names: Colyte® or PegLyte®
Active Comparator: 1) Later colonoscopy; 2) High-dose, split-dose; 3)Clear liquid	Drug: High volume PEG split-dose; Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.; Other Names: Colyte® or PegLyte®; Other: Clear liquid diet; Other: Later colonoscopy (stratified); "Later" appointments: 10:30 AM to 4:30 PM.
Active Comparator: 1) Later colonoscopy; 2) High-dose, split-dose; 3)Low residue	Drug: High volume PEG split-dose; Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.; Other Names: Colyte® or PegLyte®; Other: Low residue diet; Other: Later colonoscopy (stratified); "Later" appointments: 10:30 AM to 4:30 PM.
Active Comparator: 1) Later colonoscopy; 2) Low volume split-dose; 3)Clear liquid	Other: Clear liquid diet; Drug: Low volume PEG split-dose; Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.; Other Names: Bi-PegLyte®; Other: Later colonoscopy (stratified); "Later" appointments: 10:30 AM to 4:30 PM.
Active Comparator: 1) Later colonoscopy; 2) Low volume split-dose; 3)Low residue	Other: Low residue diet; Drug: Low volume PEG split-dose; Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.; Other Names: Bi-PegLyte®; Other: Later colonoscopy (stratified); "Later" appointments: 10:30 AM to 4:30 PM.
Active Comparator: 1) Later colonoscopy; 2) Low volume day before; 3)Clear liquid	Other: Clear liquid diet; Other: Later colonoscopy (stratified); "Later" appointments: 10:30 AM to 4:30 PM.; Drug: Low volume PEG non split, same day; Bi-PegLyte® will be provided to the subject, who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.; Other Names: Bi-PegLyte®
Active Comparator: 1) Later colonoscopy; 2) Low volume day before; 3)Low residue	Other: Low residue diet; Other: Later colonoscopy (stratified); "Later" appointments: 10:30 AM to 4:30 PM.; Drug: Low volume PEG non split, same day; Bi-PegLyte® will be provided to the subject, who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.; Other Names: Bi-PegLyte®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bowel cleansing according to the Boston Scale	Day of colonoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
Subject willingness to repeat the preparation (survey)	Day of colonoscopy
Withdrawal time and total procedural time	Day of colonoscopy
Cecal or ileal intubation rate for colonoscopies	Day of colonoscopy
Polyp detection and polypectomy rate	Day of colonoscopy
Right colon polyp detection rate	Day of colonoscopy
Specific lesional rates identified according to pathology	up to 30 days
% of preparation taken by the subject	Day of colonoscopy
Subject travel time to endoscopy unit (hrs)	Day of colonoscopy
Incontinence	Day of colonoscopy
Fecal Immunochemical Test value	Day of colonoscopy
Montreal score compared to BBPS	Day of colonoscopy
Ottawa Bowel Preparation Scores compared to BBPS	Day of colonoscopy

Collaborators and Investigators

• Sponsor: Alan Barkun
• Collaborators: Pendopharm

Publications and helpful links

General Publications

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• Cesaro P, Hassan C, Spada C, Petruzziello L, Vitale G, Costamagna G. A new low-volume isosmotic polyethylene glycol solution plus bisacodyl versus split-dose 4 L polyethylene glycol for bowel cleansing prior to colonoscopy: a randomised controlled trial. Dig Liver Dis. 2013 Jan;45(1):23-7. doi: 10.1016/j.dld.2012.07.011. Epub 2012 Aug 21.
• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
• Chorev N, Chadad B, Segal N, Shemesh I, Mor M, Plaut S, Fraser G, Geller A, Gal E, Niv Y. Preparation for colonoscopy in hospitalized patients. Dig Dis Sci. 2007 Mar;52(3):835-9. doi: 10.1007/s10620-006-9591-5.
• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
• de Leone A, Tamayo D, Fiori G, Ravizza D, Trovato C, De Roberto G, Fazzini L, Dal Fante M, Crosta C. Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG: Bowel cleansing for late-morning colonoscopy. World J Gastrointest Endosc. 2013 Sep 16;5(9):433-9. doi: 10.4253/wjge.v5.i9.433.
• El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. doi: 10.1067/mge.2003.318.
• Eun CS, Han DS, Hyun YS, Bae JH, Park HS, Kim TY, Jeon YC, Sohn JH. The timing of bowel preparation is more important than the timing of colonoscopy in determining the quality of bowel cleansing. Dig Dis Sci. 2011 Feb;56(2):539-44. doi: 10.1007/s10620-010-1457-1. Epub 2010 Nov 2.
• Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
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• Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.
• Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
• Hendry PO, Jenkins JT, Diament RH. The impact of poor bowel preparation on colonoscopy: a prospective single centre study of 10,571 colonoscopies. Colorectal Dis. 2007 Oct;9(8):745-8. doi: 10.1111/j.1463-1318.2007.01220.x. Epub 2007 Mar 7.
• Jayanthi V, Ramathilakam B, Malathi S, Dinakaran N, Balasubramanian V. Comparison of polyethylene glycol versus combination of magnesium sulphate and bisacodyl for colon preparation. Trop Gastroenterol. 2000 Jan-Mar;21(1):18-9.
• Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
• Jung YS, Seok HS, Park DI, Song CS, Kim SE, Lee SH, Eun CS, Han DS, Kim YS, Lee CK. A clear liquid diet is not mandatory for polyethylene glycol-based bowel preparation for afternoon colonoscopy in healthy outpatients. Gut Liver. 2013 Nov;7(6):681-7. doi: 10.5009/gnl.2013.7.6.681. Epub 2013 Aug 14.
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• Ko CW, Dominitz JA. Complications of colonoscopy: magnitude and management. Gastrointest Endosc Clin N Am. 2010 Oct;20(4):659-71. doi: 10.1016/j.giec.2010.07.005.
• Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci. 2013 Apr;58(4):926-35. doi: 10.1007/s10620-012-2449-0. Epub 2012 Oct 25.
• Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061. Erratum In: Gastroenterology. 2006 Aug;131(2):688.
• Manno M, Pigo F, Manta R, Barbera C, Bertani H, Mirante VG, Dabizzi E, Caruso A, Olivetti G, Hassan C, Zullo A, Conigliaro R. Bowel preparation with polyethylene glycol electrolyte solution: optimizing the splitting regimen. Dig Liver Dis. 2012 Jul;44(7):576-9. doi: 10.1016/j.dld.2012.02.012. Epub 2012 Mar 26.
• Marmo R, Rotondano G, Riccio G, Marone A, Bianco MA, Stroppa I, Caruso A, Pandolfo N, Sansone S, Gregorio E, D'Alvano G, Procaccio N, Capo P, Marmo C, Cipolletta L. Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions. Gastrointest Endosc. 2010 Aug;72(2):313-20. doi: 10.1016/j.gie.2010.02.048. Epub 2010 Jun 19.
• Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8.
• Matro R, Shnitser A, Spodik M, Daskalakis C, Katz L, Murtha A, Kastenberg D. Efficacy of morning-only compared with split-dose polyethylene glycol electrolyte solution for afternoon colonoscopy: a randomized controlled single-blind study. Am J Gastroenterol. 2010 Sep;105(9):1954-61. doi: 10.1038/ajg.2010.160. Epub 2010 Apr 20.
• Parente F, Marino B, Crosta C. Bowel preparation before colonoscopy in the era of mass screening for colo-rectal cancer: a practical approach. Dig Liver Dis. 2009 Feb;41(2):87-95. doi: 10.1016/j.dld.2008.06.005. Epub 2008 Jul 26.
• Park DI, Park SH, Lee SK, Baek YH, Han DS, Eun CS, Kim WH, Byeon JS, Yang SK. Efficacy of prepackaged, low residual test meals with 4L polyethylene glycol versus a clear liquid diet with 4L polyethylene glycol bowel preparation: a randomized trial. J Gastroenterol Hepatol. 2009 Jun;24(6):988-91. doi: 10.1111/j.1440-1746.2009.05860.x.
• Park SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18.
• Parra-Blanco A, Nicolas-Perez D, Gimeno-Garcia A, Grosso B, Jimenez A, Ortega J, Quintero E. The timing of bowel preparation before colonoscopy determines the quality of cleansing, and is a significant factor contributing to the detection of flat lesions: a randomized study. World J Gastroenterol. 2006 Oct 14;12(38):6161-6. doi: 10.3748/wjg.v12.i38.6161.
• Rabeneck L, Saskin R, Paszat LF. Onset and clinical course of bleeding and perforation after outpatient colonoscopy: a population-based study. Gastrointest Endosc. 2011 Mar;73(3):520-3. doi: 10.1016/j.gie.2010.10.034. Epub 2010 Dec 31.
• Rex DK, Bond JH, Winawer S, Levin TR, Burt RW, Johnson DA, Kirk LM, Litlin S, Lieberman DA, Waye JD, Church J, Marshall JB, Riddell RH; U.S. Multi-Society Task Force on Colorectal Cancer. Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2002 Jun;97(6):1296-308. doi: 10.1111/j.1572-0241.2002.05812.x. No abstract available.
• Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
• Schuman E, Balsam PE. Probable anaphylactic reaction to polyethylene glycol electrolyte lavage solution. Gastrointest Endosc. 1991 May-Jun;37(3):411. doi: 10.1016/s0016-5107(91)70761-x. No abstract available.
• Scott SR, Raymond PL, Thompson WO, Galt DJ. Efficacy and tolerance of sodium phosphates oral solution after diet liberalization. Gastroenterol Nurs. 2005 Mar-Apr;28(2):133-9. doi: 10.1097/00001610-200503000-00008.
• Seo EH, Kim TO, Park MJ, Heo NY, Park J, Yang SY. Low-volume morning-only polyethylene glycol with specially designed test meals versus standard-volume split-dose polyethylene glycol with standard diet for colonoscopy: a prospective, randomized trial. Digestion. 2013;88(2):110-8. doi: 10.1159/000353244. Epub 2013 Aug 15.
• Shah S, Prematta T, Adkinson NF, Ishmael FT. Hypersensitivity to polyethylene glycols. J Clin Pharmacol. 2013 Mar;53(3):352-5. doi: 10.1177/0091270012447122. Epub 2013 Jan 24. No abstract available.
• Sharma VK, Nguyen CC, Crowell MD, Lieberman DA, de Garmo P, Fleischer DE. A national study of cardiopulmonary unplanned events after GI endoscopy. Gastrointest Endosc. 2007 Jul;66(1):27-34. doi: 10.1016/j.gie.2006.12.040.
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• Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, Harford WV. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):700-6. doi: 10.1016/j.gie.2008.09.047.
• Soweid AM, Kobeissy AA, Jamali FR, El-Tarchichi M, Skoury A, Abdul-Baki H, El-Zahabi L, El-Sayyed A, Barada KA, Sharara AI, Mourad F, Arabi A. A randomized single-blind trial of standard diet versus fiber-free diet with polyethylene glycol electrolyte solution for colonoscopy preparation. Endoscopy. 2010 Aug;42(8):633-8. doi: 10.1055/s-0029-1244236. Epub 2010 Jul 9.
• Stollman N, Manten HD. Angioedema from oral polyethylene glycol electrolyte lavage solution. Gastrointest Endosc. 1996 Aug;44(2):209-10. doi: 10.1016/s0016-5107(96)70150-5. No abstract available.
• Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE; American Society of Colon and Rectal Surgeons; American Society for Gastrointestinal Endoscopy; Society of American Gastrointestinal and Endoscopic Surgeons. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Gastrointest Endosc. 2006 Jun;63(7):894-909. doi: 10.1016/j.gie.2006.03.918. No abstract available. Erratum In: Gastrointest Endosc. 2006 Jul;64(1):154.
• Wu KL, Rayner CK, Chuah SK, Chiu KW, Lu CC, Chiu YC. Impact of low-residue diet on bowel preparation for colonoscopy. Dis Colon Rectum. 2011 Jan;54(1):107-12. doi: 10.1007/DCR.0b013e3181fb1e52.
• Xie Q, Chen L, Zhao F, Zhou X, Huang P, Zhang L, Zhou D, Wei J, Wang W, Zheng S. A meta-analysis of randomized controlled trials of low-volume polyethylene glycol plus ascorbic acid versus standard-volume polyethylene glycol solution as bowel preparations for colonoscopy. PLoS One. 2014 Jun 5;9(6):e99092. doi: 10.1371/journal.pone.0099092. eCollection 2014.
• Barkun AN, Martel M, Epstein IL, Halle P, Hilsden RJ, James PD, Rostom A, Sey M, Singh H, Sultanian R, Telford JJ, von Renteln D. The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1469-e1477. doi: 10.1016/j.cgh.2021.09.005. Epub 2021 Sep 9.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Outpatient
• Other Study ID Numbers: V2015-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No