Evaluation of Information on Bowel Preparation for Morning Colonoscopy

Colonoscopy Clinical Trial

Official title:

Evaluation of Information Provided to Patients Provided About Bowel Preparation for Morning Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650725
• Other study ID #: H2018:202
• Status: Completed
• Start date: June 30, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patient will be randomized by the central booking office. Patient experience survey will be administered prior to colonoscopy. Chart review will be done to obtain data from the medical records and endoscopy reports. Please see outcomes and planned analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colonoscopy
• Patient Compliance

Intervention

Other:
• Mandatory Split bowel preparation
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.

Locations

Country	Name	City	State
Canada	Health Sciences Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Harminder Singh

Country where clinical trial is conducted

Canada, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of bowel cleanliness as measured by total Ottawa Bowel Preparation Scale Score (0-14)	Ottawa Bowel Scale score is calculated as a sum of scores in the 3 segments of colon (0-4) plus amount of fluid (0-2). All of the scores in the segments will be recorded and then summed. Comparison will be as continuous variable as dichotomous score = 7. Lower the score on Ottawa scale, better the cleansing quality.	At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Primary	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	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.	Determine the proportion with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment (composite and separate analysis for these 2 outcomes); phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation (indicator of staff workload generated).. This is a composite measure of number of individuals in each of the listed categories. Each will also be reported separately.	Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Secondary	Amount of laxative intake	Amount of laxative intake before colonoscopy will be compared in the two groups.	In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Secondary	Proportion with split dose laxative intake	Split dose refers to taking half the dose of the laxative day before colonoscopy and half on the day of the colonoscopy.	In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Secondary	Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)	Compare cecal intubation rate between the groups.	At the scheduled colonoscopy procedure, expected average within 3 months
Secondary	Endoscopic Outcome 2: Withdrawal time during colonoscopy performance	Compare withdrawal time between the groups.	At the scheduled colonoscopy procedure, expected average within 3 months
Secondary	Endoscopic Outcome 3: total time for performance of colonoscopy	Compare total procedure time between the groups.	At the scheduled colonoscopy procedure, expected average within 3 months
Secondary	Endoscopic Outcome 4: polyps during colonoscopy	Compare polyp detection (adenoma, sessile serrated polyps) detection rates between the groups.	At the scheduled colonoscopy procedure, expected average within 3 months
Secondary	Patient experience data outcome 1: use of split dose bowel preparation	We will determine the proportion reporting: use of split dose and day before bowel preparation	Before scheduled colonoscopy procedure, expected average within 3 months
Secondary	Patient experience data outcome 2: complete intake of all of the prescribed laxative	We will determine the proportion reporting consumption of all of the laxative	Before scheduled colonoscopy procedure, expected average within 3 months
Secondary	Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy	We will determine the proportion reporting incontinence episodes during bowel preparation and during travel to the colonoscopy appointment	Before scheduled colonoscopy procedure, expected average within 3 months
Secondary	Patient experience data outcome 4: Sleep in night before colonoscopy	We will determine and compare the total duration of sleep	Before scheduled colonoscopy procedure, expected average within 3 months
Secondary	Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation	We will determine the proportion reporting patient willingness to repeat colonoscopy using same preparation	Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Secondary	Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5)	We will determine and compare the pre-colonoscopy anxiety rating, assessed on 5 point Likert scale (1-5). Higher values represent higher anxiety.	Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Secondary	Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10)	We will determine and compare difficulty with bowel preparation rating, as reported by patients on a ten point Likert scale (1-10). Higher values represent less difficulty (i.e. more tolerance)	Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months