Does It work in Clinical Practice? A Comparison of Colonoscopy Cleansing Effectiveness in Clinical Practice Versus Efficacy from Selected Prospective Trials

Chang Nancy Wang, Ruobing Yang, Lawrence Hookey, Chang Nancy Wang, Ruobing Yang, Lawrence Hookey

Abstract

Background: Adequate bowel preparation is essential for a high-quality colonoscopy. Many randomized controlled trials (RCTs) have investigated bowel preparation protocols, including split-dose and low-volume regimens. However, RCTs are conducted in an ideal, controlled setting, and translation of trial results to clinical practice is challenging. In this study, we compared the quality of bowel preparations of real-world patients from clinical practice with those enrolled in several prospective trials.

Methods: Bowel preparation quality, defined by the Ottawa Bowel Preparation Scale (OBPS), from four RCTs and one prospective trial were compared with two observational diary studies. Bowel preparations were polyethylene glycol preparation (PEG) or sodium picosulfate plus magnesium citrate (P/MC) taken via traditional or split-dose timing regimen. Age, sex, average number of bowel movements per day, comorbidities, colonoscopy indication and colonoscopy completion rates were also collected.

Results: Patients enrolled in prospective trials had a better OBPS by one point when compared with those in observational clinical practice studies (P<0.049), after controlling for age, sex, colonoscopy indication and type of bowel preparation used. We also found that each 10-year increase in age was associated with a 0.2 point increase in OBPS (P=0.008), and men were associated with a 0.5 increase in OBPS when compared with women P=0.014).

Conclusion: Patients from clinical practice have higher OBPS than prospective trial patients. Increased age and male sex were also associated with increased OBPS. We believe increased patient motivation and education around bowel preparation regimen plays an important role in the success of bowel preparations.

Keywords: Bowel preparation quality; Efficacy versus effectiveness; Split-dose regimen.

© The Author(s) 2019. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology.

Figures

Figure A1.
Figure A1.

References

    1. Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc 2003;58(1):76–9.
    1. MacPhail ME, Hardacker KA, Tiwari A , et al. . Intraprocedural cleansing work during colonoscopy and achievable rates of adequate preparation in an open-access endoscopy unit. Gastrointest Endosc 2015;81(3):525–30.
    1. Dik VK, Moons LM, Hüyük M , et al. ; Colonoscopy Quality Initiative Predicting inadequate bowelpreparation for colonoscopy in participants receiving split-dose bowel preparation: Development and validation of a prediction score. Gastrointest Endosc 2015;81(3):665–72.
    1. 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;69(3 Pt 2):626–30.
    1. Froehlich F, Wietlisbach V, Gonvers JJ , et al. . 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;61(3):378–84.
    1. Ness RM, Manam R, Hoen H , et al. . Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol 2001;96(6):1797–802.
    1. 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;104(3):703–9.
    1. Lebwohl B, Kastrinos F, Glick M , et al. . The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc 2011;73(6):1207–14.
    1. Neerincx M, Terhaar sive Droste JS, Mulder CJ , et al. . Colonic work-up after incomplete colonoscopy: Significant new findings during follow-up. Endoscopy 2010;42(9):730–5.
    1. Shah HA, Paszat LF, Saskin R , et al. . Factors associated with incomplete colonoscopy: A population-based study. Gastroenterology 2007;132(7):2297–303.
    1. Rex DK, Imperiale TF, Latinovich DR , et al. . Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol 2002;97(7):1696–700.
    1. Park JS, Sohn CI, Hwang SJ , et al. . Quality and effect of single dose versus split dose of polyethylene glycol bowel preparation for early-morning colonoscopy. Endoscopy 2007;39(7):616–9.
    1. Malik P, Balaban DH, Thompson WO , et al. . Randomized study comparing two regimens of oral sodium phosphates solution versus low-dose polyethylene glycol and bisacodyl. Dig Dis Sci 2009;54(4):833–41.
    1. Marmo R, Rotondano G, Riccio G , et al. . 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;72(2):313–20.
    1. 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(6):1240–5.
    1. Belsey J, Crosta C, Epstein O , et al. . Meta-analysis: The relative efficacy of oral bowel preparations for colonoscopy 1985-2010. Aliment Pharmacol Ther 2012;35(2):222–37.
    1. Johnson DA, Barkun AN, Cohen LB , et al. ; 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. Am J Gastroenterol 2014;109(10):1528–45.
    1. Saltzman JR, Cash BD, Pasha SF , et al. . Bowel preparation before colonoscopy. Gastrointest Endosc 2015;81(4):781–94.
    1. Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: A randomized, controlled trial. Gastrointest Endosc 2012;75(3):537–44.
    1. Katz PO, Rex DK, Epstein M , et al. . A dual-action, low-volume bowel cleanser administered the day before colonoscopy: Results from the SEE CLEAR II study. Am J Gastroenterol 2013;108(3):401–9.
    1. Vanner S, Hookey LC. Timing and frequency of bowel activity in patients ingesting sodium picosulphate/magnesium citrate and adjuvant bisacodyl for colon cleansing before colonoscopy. Can J Gastroenterol 2011;25(12):663–6.
    1. Lawrance IC, Willert RP, Murray K. Bowel cleansing for colonoscopy: Prospective randomized assessment of efficacy and of induced mucosal abnormality with three preparation agents. Endoscopy 2011;43(5):412–8.
    1. Rex DK, Katz PO, Bertiger G , et al. . Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: The SEE CLEAR I study. Gastrointest Endosc 2013;78(1):132–41.
    1. 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(1):79–88.
    1. Schulz C, Müller J, Sauter J , et al. . Superiority of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) in comparison to a prior-day schedule (AM/PM) for colonoscopy preparation. a randomized single-blinded study. J Gastrointestin Liver Dis 2016;25(3):295–302.
    1. 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(7):2030–4.
    1. Radaelli F, Paggi S, Repici A , et al. . Barriers against split-dose bowel preparation for colonoscopy. Gut 2017;66(8):1428–33.
    1. Möller HJ. Effectiveness studies: Advantages and disadvantages. Dialogues Clin Neurosci 2011;13(2):199–207.
    1. Singal AG, Higgins PD, Waljee AK. A primer on effectiveness and efficacy trials. Clin Transl Gastroenterol 2014;5:e45.
    1. Price D, Hillyer EV, van der Molen T. Efficacy versus effectiveness trials: Informing guidelines for asthma management. Curr Opin Allergy Clin Immunol 2013;13(1):50–7.
    1. Yannopoulos D, Aufderheide TP, Abella BS , et al. . Quality of CPR: An important effect modifier in cardiac arrest clinical outcomes and intervention effectiveness trials. Resuscitation 2015;94:106–13.
    1. Khalili K, Menezes R, Kim TK , et al. . The effectiveness of ultrasound surveillance for hepatocellular carcinoma in a Canadian centre and determinants of its success. Can J Gastroenterol Hepatol 2015;29(5):267–73.
    1. Hayat U, Lee PJW, Lopez R , et al. . Online educational video improves bowel preparation and reduces the need for repeat colonoscopy within three years. Am J Med 2016;129(11):1219.e1–9.
    1. Walter BM, Klare P, Neu B , et al. . Development and testing of an automated 4-day text messaging guidance as an aid for improving colonoscopy preparation. JMIR MHealth UHealth 2016;4(2):e75.
    1. Park J-S, Kim MS, Kim H , et al. . A randomized controlled trial of an educational video to improve quality of bowel preparation for colonoscopy. BMC Gastroenterol 2016;16(1):64.
    1. Melicharkova A, Flemming J, Vanner S , et al. . A low-residue breakfast improves patient tolerance without impacting quality of low-volume colon cleansing prior to colonoscopy: A randomized trial. Am J Gastroenterol 2013;108(10):1551–5.
    1. Flemming JA, Green J, Melicharkova A , et al. . Low-residue breakfast during the preparation for colonoscopy using a polyethylene glycol electrolyte solution: A randomised non-inferiority trial. BMJ Open Gastroenterol 2015;2(1):e000029.
    1. Fowler S, Vanner S, Hookey LC. Safety, efficacy and tolerance of pico-salax for colon cleansing prior to colonoscopy in an elderly population. Can J Gastroenterol Hepatol 2009;99 (suppl A).
    1. Arya A, Vanner S, Hookey LC. Factors affecting the quality of bowel preparation: A single-centre prospective study. Can J Gastroenterol Hepatol 2014;88 (suppl A).
    1. Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc 2004;59(4):482–6.
    1. Bucci C, Rotondano G, Hassan C , et al. . Optimal bowel cleansing for colonoscopy: Split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc 2014;80(4):566–76.e2.
    1. Seo EH, Kim TO, Park MJ , et al. . Optimal preparation-to-colonoscopy interval in split-dose PEG bowel preparation determines satisfactory bowel preparation quality: An observational prospective study. Gastrointest Endosc 2012;75(3):583–90.
    1. Prieto-Frías C, Muñoz-Navas M, Betés MT , et al. . Split-dose sodium picosulfate–magnesium citrate colonoscopy preparation achieves lower residual gastric volume with higher cleansing effectiveness than a previous-day regimen. Gastrointest Endosc 2016;83(3):566–73.
    1. 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(5):811–20.e3.
    1. Sharara AI, Harb AH, Sarkis FS , et al. . Body mass index and quality of bowel preparation: Real life vs. clinical trials. Arab J Gastroenterol 2016;17(1):11–6.

Source: PubMed

3
Abonner