Digestive Diseases and Sciences

, Volume 58, Issue 4, pp 926–935

A Validated Bowel-Preparation Tolerability Questionnaire and Assessment of Three Commonly Used Bowel-Cleansing Agents

Original Article

Abstract

Background and Study Aims

Bowel-cleansing studies are frequently underpowered, poorly designed, and with subjective assessments. Consensus on tolerability of the bowel-cleansing agents is thus lacking. This study developed and validated a bowel-preparation tolerability questionnaire and used it to assess the tolerability of three bowel-cleansing agents, sodium phosphate (NaP), polyethylene glycol (PEG), and sodium picosulphate (Pico), in a prospective randomized single-blinded trial of ambulatory patients.

Patients and Methods

The bowel-preparation tolerability questionnaire was validated in 125 consecutive patients and then bowel-preparation agent tolerability was assessed in 634 patients in a prospective randomized single-blinded trial.

Results

The questionnaire’s internal consistency was satisfactory with good to excellent “test–retest” reliability for aggregate tolerability and visual analogue scores. Validity assessment confirmed it as reliable and accurate. Of 634 patients, 97.8 % took >75 % of the allocated preparation and 98.9 % completed the questionnaire. Overall, Pico was better tolerated than PEG (p < 0.001) and NaP (p < 0.001). NaP was better tolerated than PEG (p < 0.001). Regardless of the bowel-preparation agent used, males tolerated them better than females (p = 0.009) as did patients having their procedure in the AM. Older patients, however, tolerated all preparations better than younger patients (p = 0.006).

Conclusions

This study used the first validated bowel-preparation tolerability questionnaire and identified that age, sex, and procedure time all impacted tolerability. Overall, Pico was best tolerated, but PEG’s tolerability in patients ≥60 years was equal to that of Pico and NaP, suggesting that PEG can be recommended for older patients to avoid the electrolyte disturbances associated with the osmotic preparations.

Keywords

Fleet Picoprep Colonlytely Colonoscopy Bowel preparation Assessment 

References

  1. 1.
    Byrne MF. The curse of poor bowel preparation for colonoscopy. Am J Gastroenterol. 2002;97:1587–1590.PubMedCrossRefGoogle Scholar
  2. 2.
    Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007;25:373–384.PubMedCrossRefGoogle Scholar
  3. 3.
    Cohen SM, Wexner SD, Binderow SR, et al. Prospective, randomized, endoscopic-blinded trial comparing precolonoscopy bowel cleansing methods. Dis Colon Rectum. 1994;37:689–696.PubMedCrossRefGoogle Scholar
  4. 4.
    Golub RW, Kerner BA, Wise WE Jr, et al. Colonoscopic bowel preparations–which one? A blinded, prospective, randomized trial. Dis Colon Rectum. 1995;38:594–599.PubMedCrossRefGoogle Scholar
  5. 5.
    Frommer D. Cleansing ability and tolerance of three bowel preparations for colonoscopy. Dis Colon Rectum. 1997;40:100–104.PubMedCrossRefGoogle Scholar
  6. 6.
    Schmidt LM, Williams P, King D, Perera D. Picoprep-3 is a superior colonoscopy preparation to Fleet: a randomized, controlled trial comparing the two bowel preparations. Dis Colon Rectum. 2004;47:238–242.PubMedCrossRefGoogle Scholar
  7. 7.
    Law WL, Choi HK, Chu KW, Ho JW, Wong L. Bowel preparation for colonoscopy: a randomized controlled trial comparing polyethylene glycol solution, one dose and two doses of oral sodium phosphate solution. Asian J Surg. 2004;27:120–124.PubMedCrossRefGoogle Scholar
  8. 8.
    Tjandra JJ, Chan M, Tagkalidis PP. Oral sodium phosphate (Fleet) is a superior colonoscopy preparation to Picopre (sodium picosulfate-based preparation). Dis Colon Rectum. 2006;49:616–620.PubMedCrossRefGoogle Scholar
  9. 9.
    Bitoun A, Ponchon T, Barthet M, et al. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy. Aliment Pharmacol Ther. 2006;24:1631–1642.PubMedCrossRefGoogle Scholar
  10. 10.
    Kastenberg D, Barish C, Burack H, et al. Tolerability and patient acceptance of sodium phosphate tablets compared with 4-L PEG solution in colon cleansing: combined results of 2 identically designed, randomized, controlled, parallel group, multicenter phase 3 trials. J Clin Gastroenterol. 2007;41:54–61.PubMedCrossRefGoogle Scholar
  11. 11.
    Lichtenstein GR, Grandhi N, Schmalz M, et al. Clinical trial: sodium phosphate tablets are preferred and better tolerated by patients compared to polyethylene glycol solution plus bisacodyl tablets for bowel preparation. Aliment Pharmacol Ther. 2007;26:1361–1370.PubMedCrossRefGoogle Scholar
  12. 12.
    Schanz S, Kruis W, Mickisch O, et al. Bowel preparation for colonoscopy with sodium phosphate solution versus polyethylene glycol-based lavage: a multicenter trial. Diagn Ther Endosc. 2008;2008:713521.PubMedCrossRefGoogle Scholar
  13. 13.
    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;104:703–709.PubMedCrossRefGoogle Scholar
  14. 14.
    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;43:412–418.PubMedCrossRefGoogle Scholar
  15. 15.
    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;72:313–320.PubMedCrossRefGoogle Scholar
  16. 16.
    Belsey J, Epstein O, Heresbach D. Systematic review: adverse event reports for oral sodium phosphate and polyethylene glycol. Aliment Pharmacol Ther. 2008.Google Scholar
  17. 17.
    Hsu CW, Imperiale TF. Meta-analysis and cost comparison of polyethylene glycol lavage versus sodium phosphate for colonoscopy preparation. Gastrointest Endosc. 1998;48:276–282.PubMedCrossRefGoogle Scholar
  18. 18.
    Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy—a meta-analysis. Colorectal Dis. 2006;8:247–258.PubMedCrossRefGoogle Scholar
  19. 19.
    Rejchrt S, Bures J, Siroky M, et al. A prospective, observational study of colonic mucosal abnormalities associated with orally administered sodium phosphate for colon cleansing before colonoscopy. Gastrointest Endosc. 2004;59:651–654.PubMedCrossRefGoogle Scholar
  20. 20.
    Zwas FR, Cirillo NW, Eisen RN, el-Serag HB. Colonic mucosal abnormalities associated with oral sodium phosphate solution. Gastrointest Endosc. 1996;43:463–466.PubMedCrossRefGoogle Scholar
  21. 21.
    Menees S, Higgins P, Korsnes S, Elta G. Does colonoscopy cause increased ulcerative colitis symptoms? Inflamm Bowel Dis. 2007;13:12–18.PubMedCrossRefGoogle Scholar
  22. 22.
    Ell C, Fischbach W, Bronisch HJ, et al. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008;103:883–893.PubMedCrossRefGoogle Scholar
  23. 23.
    Worthington J, Thyssen M, Chapman G, Chapman R, Geraint M. A randomised controlled trial of a new 2-l polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin. 2008;24:481–488.PubMedCrossRefGoogle Scholar
  24. 24.
    Park SS, Sinn DH, Kim YH, et al. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 l) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010;105:1319–1326.PubMedCrossRefGoogle Scholar
  25. 25.
    Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305:160–164.PubMedCrossRefGoogle Scholar
  26. 26.
    Kastenberg D, Chasen R, Choudhary C, et al. Efficacy and safety of sodium phosphate tablets compared with PEG solution in colon cleansing: two identically designed, randomized, controlled, parallel group, multicenter phase III trials. Gastrointest Endosc. 2001;54:705–713.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2012

Authors and Affiliations

  1. 1.Centre for Inflammatory Bowel DiseasesFremantle HospitalFremantleAustralia
  2. 2.The School of Medicine and Pharmacology, Fremantle HospitalUniversity of Western AustraliaFremantleAustralia
  3. 3.Statistical Consulting Group, School of Mathematics and StatisticsUniversity of Western AustraliaCrawleyAustralia

Personalised recommendations