A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy

Summary

The trial is about comparing the efficacy of Plenvu with Picoprep. Both are bowel cleansing agents prior to visual examination of the large bowel to exclude cancer disease. 400 patients who are referred for colonoscopy to a single center in North Jutland will be randomised either to Picoprep or Plenvu. These patients will then answer a questionnaire prior to colonoscopy. The questionnaire is about the most common expected side effects and the experience of cleansing og intake of the bowel agents. The effect of the two agents will examined using a special scoring system (Harefield) to determine the quality of bowel cleansing. Colonoscopist who evaluate the cleansing is blinded to which agent the patient has taken.

Timeline

Start

2022-10-01

Primary completion

2025-12-01

Completion

2025-12-01

Publications

• Background Cash BD, Moncrief MBC, Epstein MS, Poppers DM. Patient experience with NER1006 as a bowel preparation for colonoscopy: a prospective, multicenter US survey. BMC Gastroenterol. 2021 Feb 15;21(1):70. doi: 10.1186/s12876-021-01605-y.
• Background Byrne MF. The curse of poor bowel preparation for colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1587-90. doi: 10.1111/j.1572-0241.2002.05855.x. No abstract available.
• Background Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.
• Background Weir MA, Fleet JL, Vinden C, Shariff SZ, Liu K, Song H, Jain AK, Gandhi S, Clark WF, Garg AX. Hyponatremia and sodium picosulfate bowel preparations in older adults. Am J Gastroenterol. 2014 May;109(5):686-94. doi: 10.1038/ajg.2014.20. Epub 2014 Mar 4.
• Background Jin Z, Lu Y, Zhou Y, Gong B. Systematic review and meta-analysis: sodium picosulfate/magnesium citrate vs. polyethylene glycol for colonoscopy preparation. Eur J Clin Pharmacol. 2016 May;72(5):523-32. doi: 10.1007/s00228-016-2013-5. Epub 2016 Jan 28.
• Background Maida M, Sinagra E, Morreale GC, Sferrazza S, Scalisi G, Schillaci D, Ventimiglia M, Macaluso FS, Vettori G, Conoscenti G, Di Bartolo C, Garufi S, Catarella D, Manganaro M, Virgilio CM, Camilleri S. Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study. World J Gastroenterol. 2020 Apr 28;26(16):1950-1961. doi: 10.3748/wjg.v26.i16.1950.
• Background Halphen M, Heresbach D, Gruss HJ, Belsey J. Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc. 2013 Jul;78(1):121-31. doi: 10.1016/j.gie.2013.02.009. Epub 2013 Mar 24.
• Background Lawrance IC, Willert RP, Murray K. A validated bowel-preparation tolerability questionnaire and assessment of three commonly used bowel-cleansing agents. Dig Dis Sci. 2013 Apr;58(4):926-35. doi: 10.1007/s10620-012-2449-0. Epub 2012 Oct 25.
• Background Lyseng-Williamson KA. Macrogol (polyethylene glycol) 4000 without electrolytes in the symptomatic treatment of chronic constipation: a profile of its use. Drugs Ther Perspect. 2018;34(7):300-310. doi: 10.1007/s40267-018-0532-0. Epub 2018 Jun 15.

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