Multi-centre Failed Bowel Prep RCT

NCT02976805 | Completed Phase 3

• 1 other identifier: HSREB108472
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-centre randomized clinical trial comparing the efficacy of two different bowel preparation regimens for patients who have already failed a bowel preparation for colonoscopy.

Conditions

Colonoscopy; Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Adequate bowel preparation

  BBPS total score ≥6 and/or all segment scores ≥2.

  Once after colonoscopy

Secondary Outcomes (5)

• Mean BBPS total score

  Once after colonoscopy

• Bowel preparation was adequate after washing to visualize lesions > 5 mm of importance to the procedure and there is no need to shorten the interval of the next colonoscopy

  Once after colonoscopy

• Validated patient tolerability questionnaire for bowel preparation score

  Once after colonoscopy

• Bowel preparation related adverse event

  After colonoscopy and 14 days after colonoscopy

• Right sided BBPS sub-score

  Up to 4 weeks after colonoscopy

Other Outcomes (8)

• Detection rate by histology (polyp, adenoma, advanced adenoma (>1 cm, villous component, sessile serrated adenoma, or high grade dysplasia), and adenocarcinoma)

  Once after colonoscopy

• Cecal intubation rate

  Once after colonoscopy

• Subject product completion (% of total required intake)

  Once after colonoscopy

Study Arms (2)

Regimen A

EXPERIMENTAL

4L PegLyte + 15 mg bisacodyl

Drug: 4L PegLyte + 15 mg bisacodyl

Regimen B

EXPERIMENTAL

6L PegLyte + 15 mg bisacodyl

Drug: 6L PegLyte + 15 mg bisacodyl

Interventions

4L PegLyte + 15 mg bisacodyl DRUG

Randomized

Also known as: Regimen A

Regimen A

6L PegLyte + 15 mg bisacodyl DRUG

Randomized

Also known as: Regimen B

Regimen B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anyone undergoing a repeat colonoscopy due to failed bowel preparation at index colonoscopy. Failure is defined as preparation quality inadequate to detect lesions \> 5 mm after washing and requiring a shortened colonoscopy interval as a result.
• Age \> 18 years
• Outpatient colonoscopy
• Indication for full colonoscopy

You may not qualify if:

• Subject refusal
• Able to comprehend the trial
• Index colonoscopy performed as an inpatient
• Pregnancy or breastfeeding
• Allergies to the employed bowel preparations
• Any colonic surgery
• History of ischemic colitis
• Congestive heart failure
• Chronic renal failure
• Cirrhosis
• Severe electrolyte imbalance
• Non-adherence to index bowel preparation defined as failure to follow diet instructions and/or consume the entire volume of bowel preparation medication as prescribed for any reason (ex. eating a normal diet on the day of colonoscopy, PEG intolerance, etc…)
• Use of bowel preparation in an off-label manner for the index colonoscopy.
• Inability to follow verbal and written instructions in English or French.
• Ileus, gastric outlet obstruction, gastrointestinal obstruction, bowel preforation

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Academic Medical Organization of Southwestern Ontario: collaborator
• Pendopharm: collaborator
• University of Alberta: collaborator
• Université de Montréal: collaborator
• McGill University: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (4)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

CHUM

Montreal, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Related Publications (29)

• ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.

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• Rex DK. Optimal bowel preparation--a practical guide for clinicians. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):419-25. doi: 10.1038/nrgastro.2014.35. Epub 2014 Apr 1.

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• 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.

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• Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the U.S. multi-society task force on colorectal cancer. Gastrointest Endosc. 2014 Oct;80(4):543-562. doi: 10.1016/j.gie.2014.08.002. No abstract available.

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• Yee R, Manoharan S, Hall C, Hayashi A. Optimizing bowel preparation for colonoscopy: what are the predictors of an inadequate preparation? Am J Surg. 2015 May;209(5):787-92; discussion 792. doi: 10.1016/j.amjsurg.2014.12.018. Epub 2015 Feb 12.

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• MacPhail ME, Hardacker KA, Tiwari A, Vemulapalli KC, Rex DK. Intraprocedural cleansing work during colonoscopy and achievable rates of adequate preparation in an open-access endoscopy unit. Gastrointest Endosc. 2015 Mar;81(3):525-30. doi: 10.1016/j.gie.2014.05.002. Epub 2014 Jul 3.

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• Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.

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• Ben-Horin S, Bar-Meir S, Avidan B. The outcome of a second preparation for colonoscopy after preparation failure in the first procedure. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):626-30. doi: 10.1016/j.gie.2008.08.027.

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• 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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• Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.

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• Hookey LC, Vanner SJ. Pico-salax plus two-day bisacodyl is superior to pico-salax alone or oral sodium phosphate for colon cleansing before colonoscopy. Am J Gastroenterol. 2009 Mar;104(3):703-9. doi: 10.1038/ajg.2008.167. Epub 2009 Feb 17.

  PMID: 19223885 BACKGROUND

• Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.

  PMID: 21481857 BACKGROUND

• Clark BT, Rustagi T, Laine L. What level of bowel prep quality requires early repeat colonoscopy: systematic review and meta-analysis of the impact of preparation quality on adenoma detection rate. Am J Gastroenterol. 2014 Nov;109(11):1714-23; quiz 1724. doi: 10.1038/ajg.2014.232. Epub 2014 Aug 19.

  PMID: 25135006 BACKGROUND

• Seeff LC, Richards TB, Shapiro JA, Nadel MR, Manninen DL, Given LS, Dong FB, Winges LD, McKenna MT. How many endoscopies are performed for colorectal cancer screening? Results from CDC's survey of endoscopic capacity. Gastroenterology. 2004 Dec;127(6):1670-7. doi: 10.1053/j.gastro.2004.09.051.

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• Nationwide Colonoscopy Program for the Uninsured [cited 2015 September 21]. Available from: http://www.colonoscopyassist.com/After_Colonoscopy.html.

  BACKGROUND

• Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

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• Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.

  PMID: 20883845 BACKGROUND

• Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014 Aug;80(2):269-76. doi: 10.1016/j.gie.2014.01.031. Epub 2014 Mar 12.

  PMID: 24629422 BACKGROUND

• Ibanez M, Parra-Blanco A, Zaballa P, Jimenez A, Fernandez-Velazquez R, Fernandez-Sordo JO, Gonzalez-Bernardo O, Rodrigo L. Usefulness of an intensive bowel cleansing strategy for repeat colonoscopy after preparation failure. Dis Colon Rectum. 2011 Dec;54(12):1578-84. doi: 10.1097/DCR.0b013e31823434c8.

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• Kim JW, Han JH, Boo SJ, Ko OB, Park SK, Park SH, Yang DH, Jung KW, Kim KJ, Ye BD, Myung SJ, Yang SK, Kim JH, Byeon JS. Rescue bowel preparation: same day 2 L polyethylene glycol addition, not superior to bisacodyl addition 7 days later. Dig Dis Sci. 2014 Sep;59(9):2215-21. doi: 10.1007/s10620-014-3125-3. Epub 2014 Apr 20.

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• Fayad NF, Kahi CJ, Abd El-Jawad KH, Shin AS, Shah S, Lane KA, Imperiale TF. Association between body mass index and quality of split bowel preparation. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1478-85. doi: 10.1016/j.cgh.2013.05.037. Epub 2013 Jun 28.

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• 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.

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• 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.

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• ASGE Standards of Practice Committee; Pasha SF, Shergill A, Acosta RD, Chandrasekhara V, Chathadi KV, Early D, Evans JA, Fisher D, Fonkalsrud L, Hwang JH, Khashab MA, Lightdale JR, Muthusamy VR, Saltzman JR, Cash BD. The role of endoscopy in the patient with lower GI bleeding. Gastrointest Endosc. 2014 Jun;79(6):875-85. doi: 10.1016/j.gie.2013.10.039. Epub 2014 Apr 2. No abstract available.

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• Rahimi RS, Singal AG, Cuthbert JA, Rockey DC. Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1727-33. doi: 10.1001/jamainternmed.2014.4746.

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• Sey MSL, Von Renteln D, Sultanian R, McDonald C, Bouin M, Chande N, Sandhu A, Yan B, Martel M, Barkun A. A Multicenter Randomized Controlled Trial Comparing Two Bowel Cleansing Regimens for Colonoscopy After Failed Bowel Preparation. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1283-e1291. doi: 10.1016/j.cgh.2021.07.015. Epub 2021 Jul 10.

  PMID: 34256147 DERIVED

• Sey MSL, von Renteln D, Sultanian R, McDonald C, Martel M, Barkun A. Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol. BMJ Open. 2019 Jul 9;9(7):e029573. doi: 10.1136/bmjopen-2019-029573.

  PMID: 31289092 DERIVED

MeSH Terms

Interventions

Bisacodyl; OOS-A regimen; Regimen B

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Michael Sey, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: November 29, 2016
• Study Start: February 13, 2017
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)