Endoscopy 2023; 55(09): 822-835
DOI: 10.1055/a-2070-5561
Original article

Mandatory vs. optional split-dose bowel preparation for morning colonoscopies: a pragmatic noninferiority randomized controlled trial

Casandra Dolovich
1   Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
,
Claire Unruh
1   Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
,
Dana C. Moffatt
1   Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
,
Carrie Loewen
1   Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
,
Brennan Kaita
1   Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
,
Alan N. Barkun
2   Division of Gastroenterology, McGill University Health Center, Montreal, Quebec, Canada
3   Department of Clinical Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada
,
Myriam Martel
2   Division of Gastroenterology, McGill University Health Center, Montreal, Quebec, Canada
,
1   Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
4   Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
› Author Affiliations
Research Manitoba

Trial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03650725 Type of study: Pragmatic Randomized Controlled Trial


Abstract

Background We compared the effectiveness of optional split-dose bowel preparation (SDBP) with mandatory SDBP for morning colonoscopies in usual clinical practice.

Methods Adult patients undergoing outpatient early morning (8:00 AM–10:30 PM) and late morning (10:30 AM–12:00 PM) colonoscopies were included. Written bowel preparation instructions were provided based on randomization: one group were instructed to take their bowel preparation (4 L polyethylene glycol solution) as a split dose (mandatory), while the comparator group was allowed the choice of SDBP or single-dose bowel preparation administered entirely on the day before (optional). The primary end point, using noninferiority hypothesis testing with a 5 % margin, was adequate bowel cleanliness measured by the Boston Bowel Preparation Scale (BBPS) and defined by a BBPS score ≥ 6.

Results Among 770 randomized patients with complete data, there were 267 mandatory SDBP and 265 optional SDBP patients for early morning colonoscopies, and 120 mandatory SDBP and 118 optional SDBP patients for late morning colonoscopies. Optional SDBP was inferior to mandatory SDBP, with a lower proportion of adequate BBPS cleanliness for early morning colonoscopies (78.9 % vs. 89.9 %; absolute risk difference [aRD] 11.0 %, 95 %CI 5.9 % to 16.1 %), but was not statistically different for late morning colonoscopies (76.3 % vs. 83.3 %; aRD 7.1 %, 95 %CI −1.5 % to 15.5 %).

Conclusions Optional SDBP is inferior to mandatory SDBP in providing adequate bowel preparation quality for early morning colonoscopies (8:00 AM–10:30 AM), and probably inferior for late morning colonoscopies (10:30 AM–12:00 PM).

Tables 1 s–3 s



Publication History

Received: 03 October 2022

Accepted after revision: 06 April 2023

Accepted Manuscript online:
06 April 2023

Article published online:
13 June 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Cardoso R, Niedermaier T, Chen C. et al. Colonoscopy and sigmoidoscopy use among the average-risk population for colorectal cancer: a systematic review and trend analysis. Cancer Prev Res (Phila) 2019; 12: 617-630
  • 2 Lix LM, Singh H, Derksen S. et al. Gastrointestinal Endoscopy (GIE) Utilization in Manitoba. 2021 Available from (Accessed 04/19/2023): http://mchp-appserv.cpe.umanitoba.ca/reference/EndoUse_Report_Web.pdf
  • 3 Kahi CJ, Anderson JC, Rex DK. Screening and surveillance for colorectal cancer: state of the art. Gastrointest Endosc 2013; 77: 335-350
  • 4 Kastenberg D, Bertiger G, Brogadir S. Bowel preparation quality scales for colonoscopy. World J Gastroenterol 2018; 24: 2833
  • 5 Rex DK. Optimal bowel preparation—a practical guide for clinicians. Nat Rev Gastroenterol Hepatol 2014; 11: 419-425
  • 6 Hillyer GC, Basch CH, Lebwohl B. et al. Shortened surveillance intervals following suboptimal bowel preparation for colonoscopy: results of a national survey. Int J Colorect Dis 2013; 28: 73-81
  • 7 Rex DK, Imperiale TF, Latinovich DR. et al. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol 2002; 97: 1696-1700
  • 8 van Doorn S, Dekker E. Colonoscopy quality begins with a clean colon. Endoscopy 2012; 44: 639-640
  • 9 Parra-Blanco A, Ruiz A, Alvarez-Lobos M. et al. Achieving the best bowel preparation for colonoscopy. World J Gastroenterol 2014; 20: 17709
  • 10 Martel M, Barkun AN, Menard C. et al. Split-dose preparations are superior to day-before bowel cleansing regimens: a meta-analysis. Gastroenterology 2015; 149: 79-88
  • 11 Kilgore TW, Abdinoor AA, Szary NM. et al. Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc 2011; 73: 1240-1245
  • 12 El Sayed AM, Kanafani ZA, Mourad FH. et al. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc 2003; 58: 36-40
  • 13 Wang C, Yang R, Hookey L. Does it work in clinical practice? A comparison of colonoscopy cleansing effectiveness in clinical practice versus efficacy from selected prospective trials. J Can Assoc Gastroenterol 2020; 3: 111-119
  • 14 Ton L, Lee H, Taunk P. et al. Nationwide variability of colonoscopy preparation instructions. Dig Dis Sci 2014; 59: 1726-1732
  • 15 Menees SB, Kim HM, Wren P. et al. Patient compliance and suboptimal bowel preparation with split-dose bowel regimen in average-risk screening colonoscopy. Gastrointest Endosc 2014; 79: 811-820. e3
  • 16 Trasolini R, Nap-Hill E, Suzuki M. et al. Internet-based patient education prior to colonoscopy: prospective, observational study of a single center’s implementation, with objective assessment of bowel preparation quality and patient satisfaction. J Can Assoc Gastroenterol 2020; 3: 274-278
  • 17 Hassan C, Bretthauer M, Kaminski M. et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013; 45: 142-155
  • 18 Johnson DA, Barkun AN, Cohen LB. et al. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology 2014; 147: 903-924
  • 19 Lai EJ, Calderwood AH, Doros G. et al. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc 2009; 69: 620-625
  • 20 Carvajal PG, Aponte MD, Ibáñez PM. et al. A randomized controlled clinical trial of the efficacy and safety of colonoscopy preparation using a single four liter dose of polyethylene glycol (PEG) vs. two 2 liter doses of PEG vs. two low volume (1L+ 1L) doses of PEG. Rev Col Gastroenterol 2019; 34: 144-151
  • 21 Barkun AN, Martel M, Epstein IL. et al. The Bowel CLEANsing National Initiative: a low-volume same-day polyethylene glycol (PEG) preparation vs low-volume split-dose PEG with bisacodyl or high-volume split-dose PEG preparations—a randomized controlled trial. Am J Gastroenterol 2020; 115: 2068-2076
  • 22 Al AlawiS, Al DhahabH, Al SalmiI. Split dose bowel preparation before colonoscopy of PEG (Nulytely) in comparison to routine single dose bowel preparation. Saudi J Gastroenterol 2021; 27: 234
  • 23 Clark BT, Protiva P, Nagar A. et al. Quantification of adequate bowel preparation for screening or surveillance colonoscopy in men. Gastroenterology 2016; 150: 396-405
  • 24 Calderwood AH, Schroy IIIPC, Lieberman DA. et al. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc 2014; 80: 269-276
  • 25 Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc 2004; 59: 482-486
  • 26 Kim HJ, Kim TO, Shin BC. et al. Efficacy of prokinetics with a split-dose of polyethylene glycol in bowel preparation for morning colonoscopy: a randomized controlled trial. Digestion 2012; 86: 194-200
  • 27 Rostom A, Dube C, Bishay K. et al. A randomized clinical prospective trial comparing split-dose picosulfate/magnesium citrate and polyethylene glycol for colonoscopy preparation. PLoS One 2019; 14: e0211136
  • 28 Shan J, Yang M, Ran W. et al. Efficacy of single-versus split-dose polyethylene glycol electrolyte solution for morning colonoscopy: A randomized controlled study. Saudi J Gastroenterol 2020; 26: 321
  • 29 Enestvedt BK, Tofani C, Laine LA. et al. 4-Liter split-dose polyethylene glycol is superior to other bowel preparations, based on systematic review and meta-analysis. Clin Gastroenterol Hepatol 2012; 10: 1225-1231
  • 30 Radaelli F, Paggi S, Repici A. et al. Barriers against split-dose bowel preparation for colonoscopy. Gut 2017; 66: 1428-1433
  • 31 Archer T, Shirazi-Nejad AR, Al-Rifaie A. et al. Is it time we split bowel preparation for all colonoscopies? Outcomes from a national survey of bowel preparation practice in the UK. BMJ Open Gastroenterol 2021; 8: e000736
  • 32 Shafer L, Walker J, Waldman C. et al. Predictors of patient reluctance to wake early in the morning for bowel preparation for colonoscopy: a precolonoscopy survey in city-wide practice. Endosc Int Open 2018; 6: E706-E713
  • 33 Jain A, Jain R, Nugent Z. et al. Improving colonoscopy bowel preparation and reducing patient anxiety through recently developed online information resource: a cross-sectional study. J Can Assoc Gastroenterol 2022; 5: 161-168
  • 34 Unger RZ, Amstutz SP, Seo DH. et al. Willingness to undergo split-dose bowel preparation for colonoscopy and compliance with split-dose instructions. Dig Dis Sci 2010; 55: 2030-2034
  • 35 Andrealli A, Paggi S, Amato A. et al. Educational strategies for colonoscopy bowel prep overcome barriers against split-dosing: A randomized controlled trial. United European Gastroenterol J 2018; 6: 283-289
  • 36 Gamerman V, Cai T, Elsäßer A. Pragmatic randomized clinical trials: best practices and statistical guidance. Health Serv Outcomes Res Methodol 2019; 19: 23-35
  • 37 Mahmud N, Asch DA, Sung J. et al. Effect of text messaging on bowel preparation and appointment attendance for outpatient colonoscopy: a randomized clinical trial. JAMA Netw Open 2021; 4: e2034553-e2034553
  • 38 Rogers BD, Shy C, Rampgopal R. et al. Patient engagement with interactive text message system improves successful colonoscopy rates in an outpatient endoscopy center. Dig Dis 2021; 39: 399-406
  • 39 Keswani RN, Gregory DL, Wood M. et al. Colonoscopy education delivered via the patient portal does not improve adherence to scheduled first-time screening colonoscopy. Endosc Int Open 2020; 8: E401-E406