Evaluation of Information on Bowel Preparation for Morning Colonoscopy

NCT03650725 | Completed

• 1 other identifier: H2018:202
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In randomized controlled trials, split-dose bowel preparation for colonoscopy has been shown to provide better bowel cleansing than day before bowel preparation. However, people who volunteer to be in clinical trials may be more adherent to a challenging bowel preparation regimen than people in the general community undergoing colonoscopy. This may be especially true for colonoscopies scheduled for the morning, when the later dose of the split-dose bowel preparation would be administered in the early morning hours. Hence the results of the available trials may not be applicable to patients undergoing morning colonoscopy in routine medical practices. Aims: To compare the effectiveness of mandatory split-dose bowel preparation to optional split-dose bowel preparation protocols for morning colonoscopies in a non-inferiority pragmatic trial. Anticipated results and significance: The study will produce a better understanding of the most effective approach to bowel preparation for early morning colonoscopies and suggest specific recommendations for colonoscopy practice.

Conditions

Colonoscopy; Patient Compliance

Keywords

Colonoscopy; bowel preparation

Outcome Measures

Primary Outcomes (1)

• Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments

  Proportion with adequate cleansing as measured by Boston Bowel Preparation Scale Score ≥2 in all segments. Boston Bowel Preparation Scale Score is reported as score of 0 to 3 in 3 segments of the colon. The score is then summed for a total score of 0 to 9. Higher Boston score, better quality of bowel cleanliness.

  At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months

Secondary Outcomes (14)

• Composite with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment; phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation.

  Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months

• Amount of laxative intake

  In the 24 hours before the scheduled colonoscopy,expected average within 3 months

• Proportion with split dose laxative intake

  In the 24 hours before the scheduled colonoscopy,expected average within 3 months

• Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)

  At the scheduled colonoscopy procedure, expected average within 3 months

• Endoscopic Outcome 2: Withdrawal time during colonoscopy performance

  At the scheduled colonoscopy procedure, expected average within 3 months

Other Outcomes (1)

• Quality of bowel cleanliness as measured by total Ottawa Bowel Preparation Scale Score (0-14)

  At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months

Study Arms (2)

Mandatory Split bowel preparation

Patients will be advised to take 4 liters of polyethylene glycol (PEG), split into two 2 liter doses. The first 2 liters are to be taken starting at 1800 hours the day before the colonoscopy, and the second dose is to be taken starting 4-5 hours prior to the scheduled time for the colonoscopy. Each dose will be taken within a 2-hour time span.

Other: Mandatory Split bowel preparation

Optional Split bowel preparation

Patients will be advised on split-dose bowel preparation (as per option 1), but will also receive instructions on day before bowel preparation. The instructions will indicate that split-dose bowel preparation is the optimal preparation for cleansing the bowel and for visualizing polyps, but they may choose day before bowel preparation if the split dose preparation is too difficult for them.

Interventions

Mandatory Split bowel preparation OTHER

Intervention describes the standard of care patient split bowel preparation instructions as mandatory, instead of giving patient instructions with option of choice between split or day before bowel prep.

Also known as: Instructions for Bowel preparation before colonoscopy

Mandatory Split bowel preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Description of Population: We will enroll all persons who are scheduled to undergo colonoscopy by one of the four participating gastroenterologists at an outpatient hospital-based endoscopy centre in Winnipeg, Canada, in this trial. These four gastroenterologists have been in practice for 10 years or greater, and all perform over 400 colonoscopies annually. Patients are referred to these gastroenterologists by a centralized referral program, which is responsible for scheduling the procedure and for distributing the bowel preparation instructions- This program is randomly assigning to mandatory and optional split preparation as part of routine care; stratified randomization by early vs. later morning.

You may qualify if:

• Must be 18 years of age or older
• Must have colonoscopy appointment with any 4 of the participating GI doctors at Health Sciences Centre-Winnipeg
• Must use 4 liter type of bowel preparation

You may not qualify if:

• Has colonoscopy appointment with non-participating GI doctor and/or a non-participating endoscopy hospital/clinic
• Patient and/or referral doctor requested a non-4 liter bowel preparation

Sponsors & Collaborators

• Harminder Singh: lead

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Related Publications (23)

• 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.

  PMID: 24686267 BACKGROUND

• 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.

  PMID: 25863216 BACKGROUND

• Horton N, Garber A, Hasson H, Lopez R, Burke CA. Impact of Single- vs. Split-Dose Low-Volume Bowel Preparations on Bowel Movement Kinetics, Patient Inconvenience, and Polyp Detection: A Prospective Trial. Am J Gastroenterol. 2016 Sep;111(9):1330-7. doi: 10.1038/ajg.2016.273. Epub 2016 Jul 5.

  PMID: 27377521 BACKGROUND

• Radaelli F, Paggi S, Hassan C, Senore C, Fasoli R, Anderloni A, Buffoli F, Savarese MF, Spinzi G, Rex DK, Repici A. Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme. Gut. 2017 Feb;66(2):270-277. doi: 10.1136/gutjnl-2015-310685. Epub 2015 Dec 9.

  PMID: 26657900 BACKGROUND

• Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.

  PMID: 25053529 BACKGROUND

• 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.

  PMID: 19251013 BACKGROUND

• 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.

  PMID: 25239068 BACKGROUND

• 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.

  PMID: 23335011 BACKGROUND

• Ton L, Lee H, Taunk P, Calderwood AH, Jacobson BC. Nationwide variability of colonoscopy preparation instructions. Dig Dis Sci. 2014 Aug;59(8):1726-32. doi: 10.1007/s10620-014-3262-8. Epub 2014 Jul 2.

  PMID: 24985353 BACKGROUND

• Clark BT, Protiva P, Nagar A, Imaeda A, Ciarleglio MM, Deng Y, Laine L. Quantification of Adequate Bowel Preparation for Screening or Surveillance Colonoscopy in Men. Gastroenterology. 2016 Feb;150(2):396-405; quiz e14-5. doi: 10.1053/j.gastro.2015.09.041. Epub 2015 Oct 9.

  PMID: 26439436 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

• Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.

  PMID: 26782820 BACKGROUND

• Menees SB, Kim HM, Wren P, Zikmund-Fisher BJ, Elta GH, Foster S, Korsnes S, Graustein B, Schoenfeld P. Patient compliance and suboptimal bowel preparation with split-dose bowel regimen in average-risk screening colonoscopy. Gastrointest Endosc. 2014 May;79(5):811-820.e3. doi: 10.1016/j.gie.2014.01.024. Epub 2014 Mar 13.

  PMID: 24631492 BACKGROUND

• Singh H, Kaita L, Taylor G, Nugent Z, Bernstein C. Practice and documentation of performance of colonoscopy in a central Canadian health region. Can J Gastroenterol Hepatol. 2014 Apr;28(4):185-90. doi: 10.1155/2014/635932.

  PMID: 24729991 BACKGROUND

• Porostocky P, Chiba N, Colacino P, Sadowski D, Singh H. A survey of sedation practices for colonoscopy in Canada. Can J Gastroenterol. 2011 May;25(5):255-60. doi: 10.1155/2011/783706.

  PMID: 21647459 BACKGROUND

• Singh H, Nugent Z, Demers AA, Kliewer EV, Mahmud SM, Bernstein CN. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology. 2010 Oct;139(4):1128-37. doi: 10.1053/j.gastro.2010.06.052. Epub 2010 Jun 20.

  PMID: 20600026 BACKGROUND

• Singh H, Penfold RB, De Coster C, Au W, Bernstein CN, Moffatt M. Predictors of serious complications associated with lower gastrointestinal endoscopy in a major city-wide health region. Can J Gastroenterol. 2010 Jul;24(7):425-30. doi: 10.1155/2010/714591.

  PMID: 20652157 BACKGROUND

• Loftus R, Nugent Z, Graff LA, Schumacher F, Bernstein CN, Singh H. Patient satisfaction with the endoscopy experience and willingness to return in a central Canadian health region. Can J Gastroenterol. 2013;27(5):259-66. doi: 10.1155/2013/615206.

  PMID: 23712300 BACKGROUND

• Singh H, Bay D, Ip S, Bernstein CN, Nugent Z, Gheorghe R, Wightman R. Pathological reassessment of hyperplastic colon polyps in a city-wide pathology practice: implications for polyp surveillance recommendations. Gastrointest Endosc. 2012 Nov;76(5):1003-8. doi: 10.1016/j.gie.2012.07.026.

  PMID: 23078924 BACKGROUND

• Pruthi D, Duerksen DR, Singh H. The practice of gastrostomy tube placement across a Canadian regional health authority. Am J Gastroenterol. 2010 Jul;105(7):1541-50. doi: 10.1038/ajg.2009.756. Epub 2010 Jan 26.

  PMID: 20104220 BACKGROUND

• Singh H, Turner D, Xue L, Targownik LE, Bernstein CN. Risk of developing colorectal cancer following a negative colonoscopy examination: evidence for a 10-year interval between colonoscopies. JAMA. 2006 May 24;295(20):2366-73. doi: 10.1001/jama.295.20.2366.

  PMID: 16720822 BACKGROUND

• Shaffer SR, Lambert P, Unruh C, Harland E, Helewa RM, Decker K, Singh H. Optimizing Timing of Follow-Up Colonoscopy: A Pilot Cluster Randomized Trial of a Knowledge Translation Tool. Am J Gastroenterol. 2024 Mar 1;119(3):547-555. doi: 10.14309/ajg.0000000000002542. Epub 2023 Oct 3.

  PMID: 37787644 DERIVED

• Dolovich C, Unruh C, Moffatt DC, Loewen C, Kaita B, Barkun AN, Martel M, Singh H. Mandatory vs. optional split-dose bowel preparation for morning colonoscopies: a pragmatic noninferiority randomized controlled trial. Endoscopy. 2023 Sep;55(9):822-835. doi: 10.1055/a-2070-5561. Epub 2023 Apr 6.

  PMID: 37023789 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Harminder Singh, MD, MPH

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 29, 2018
• Study Start: June 30, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)