Bowel cleansing efficacy for colonoscopy: prospective, randomized comparative study of same-day dosing with 1-L and 2-L PEG + ascorbate

Abstract

Background and study aims Polyethylene glycol (PEG) bowel preparations are effective but associated with high ingestion volume. In this study, 1-L PEG and 2-L PEG preparations were compared in a randomized, colonoscopist-blinded, single-center trial.

Patients and methods Patients were aged > 18 years, required colonoscopy, and provided informed consent. Randomization was 1:1 to 1-L PEG or 2-L PEG, based on hospital identification number (odd or even). Preparations were administered using same-day dosing adjusted for colonoscopy start time. The primary endpoint was successful bowel preparation on the Boston Bowel Preparation Scale (BBPS) (no segment scored < 2).

Results A total of 852 patients were randomized. In the intention-to-treat (ITT) population, significantly more patients had diabetes in the 2-L PEG arm, resulting in the creation of the modified-ITT population (mITT) that excluded diabetic patients to correct the imbalance (1-L PEG, n = 239; 2-L PEG, n = 238). In the mITT, there was no significant difference in successful cleansing between 1-L PEG and 2-L PEG (88.3 % vs. 82.4 %; P = 0.067). Excellent cleansing (BBPS 7–9; no segment < 2) was significantly improved with 1-L PEG (60.7 % vs. 50.4 %; P < 0.024), as were mean scores in the right and left colon (right: 2.47 vs. 2.30; P < 0.008; left: 2.55 vs. 2.39; P = 0.008). Adverse events were mild to moderate in intensity and none resulted in discontinuation. Rates of nausea and vomiting were significantly higher with 1-L PEG, but that did not affect successful cleansing.

Conclusions The lower-volume 1-L PEG was associated with higher levels of excellent bowel cleansing and greater mean segmental scores on the BBPS than 2-L PEG.

• References

• 1 Nishihara R, Wu K, Lochhead P. et al. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med 2013; 369: 1095-1105
• 2 Brenner H, Chang-Claude J, Jansen L. et al. Reduced risk of colorectal cancer up to 10 years after screening, surveillance, or diagnostic colonoscopy. Gastroenterology 2014; 146: 709-717
• 3 Kaminski MF, Wieszczy P, Rupinski M. et al. Increased rate of adenoma detection associates with reduced risk of colorectal cancer and death. Gastroenterology 2017; 153: 98-105
• 4 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
• 5 Clark BT, Rustagi T, Laine L. What level of bowel prep quality requires early repeat colonoscopy: systematic review and meta-analysis of the impact of preparation quality on adenoma detection rate. Am J Gastroenterol 2014; 109: 1714-1724
• 6 Anderson JC, Butterly LF, Robinson CM. et al. Impact of fair bowel preparation quality on adenoma and serrated polyp detection: data from the New Hampshire colonoscopy registry by using a standardized preparation-quality rating. Gastrointest Endosc 2014; 80: 463-470
• 7 Hassan C, Bretthauer M, Kaminski MF. et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2013; 45: 142-150
• 8 Kaminski MF, Thomas-Gibson S, Bugajski M. et al. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2017; 49: 378-397
• 9 Johnson DA, Barkun AN, Cohen LB. et al. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the U.S. multi-society task force on colorectal cancer. Gastrointest Endosc 2014; 80: 543-562
• 10 Spada C, Cannizzaro R, Bianco MA. et al. Preparation for colonoscopy: Recommendations by an expert panel in Italy. Dig Liver Dis 2018; 50: 1124-1132
• 11 Spadaccini M, Frazzoni L, Vanella G. et al. Efficacy and tolerability of high- vs low-volume split-dose bowel cleansing regimens for colonoscopy: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2020; 18: 1454-1465.e14
• 12 Tariq H, Kamal MU, Sapkota B. et al. Evaluation of the combined effect of factors influencing bowel preparation and adenoma detection rates in patients undergoing colonoscopy. BMJ Open Gastroenterol 2019; 6: e000254
• 13 Eun CS, Han DS, Hyun YS. et al. The timing of bowel preparation is more important than the timing of colonoscopy in determining the quality of bowel cleansing. Dig Dis Sci 2011; 56: 539-544
• 14 Lee YJ, Kim ES, Choi JH. et al. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy 2015; 47: 1018-1027
• 15 Gálvez M, Zarate AM, Espino H. et al. A short telephone-call reminder improves bowel preparation, quality indicators and patient satisfaction with first colonoscopy. Endosc Int Open 2017; 5: E1172-E1178
• 16 Lieberman DA, Rex DK, Winawer SJ. et al. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology 2012; 143: 844-857
• 17 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 quiz e14-15
• 18 Clark BT, Laine L. High-quality Bowel preparation is required for detection of sessile serrated polyps. Clin Gastroenterol Hepatol 2016; 14: 1155-1162
• 19 Fischbach W, Elsome R, Amlani B. Characteristics of right-sided colonic neoplasia and colonoscopy barriers limiting their early detection and prognosis: a review of the literature. Expert Rev Gastroenterol Hepatol 2018; 12: 585-596
• 20 Singh S, Singh PP, Murad MH. et al. Prevalence, risk factors, and outcomes of interval colorectal cancers: a systematic review and meta-analysis. Am J Gastroenterol 2014; 109: 1375-1389
• 21 Xiang L, Zhan Q, Zhao X-H. et al. Risk factors associated with missed colorectal flat adenoma: a multicenter retrospective tandem colonoscopy study. World J Gastroenterol 2014; 20: 10927-10937
• 22 Sawhney MS, Dickstein J, LeClair J. et al. Adenomas with high-grade dysplasia and early adenocarcinoma are more likely to be sessile in the proximal colon. Colorectal Dis 2015; 17: 682-688
• 23 Kim SH, Kim JH, Keum B. et al. A randomized, endoscopist-blinded, prospective trial to compare the efficacy and patient tolerability between bowel preparation protocols using sodium picosulfate magnesium citrate and polyethylene-glycol (1 L and 2 L) for Colonoscopy. Gastroenterol Res Pract 2020; 2020: 9548171
• 24 Munsterman ID, Cleeren E, van der Ploeg T. et al. Pico-Bello-Klean study: effectiveness and patient tolerability of bowel preparation agents sodium picosulphate-magnesium citrate and polyethylene glycol before colonoscopy. A single-blinded randomized trial. Eur J Gastroenterol Hepatol 2015; 27: 29-38
• 25 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
• 26 Ell C, Fischbach W, Layer P. et al. Randomized, controlled trial of 2 L polyethylene glycol plus ascorbate components versus sodium phosphate for bowel cleansing prior to colonoscopy for cancer screening. Curr Med Res Opin 2014; 30: 2493-2503
• 27 Plenvu powder for oral solution – Summary of Product Characteristics (SmPC) – (eMC). https://www.medicines.org.uk/emc/product/8578
• 28 Bisschops R, Manning J, Clayton LB. et al. Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. Endoscopy 2019; 51: 60-72
• 29 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
• 30 Halphen M, Heresbach D, Gruss H-J. et al. Validation of the Harefield Cleansing Scale: a tool for the evaluation of bowel cleansing quality in both research and clinical practice. Gastrointest Endosc 2013; 78: 121-131
• 31 Repici A, Coron E, Sharma P. et al. Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution. Dig Liver Dis 2019; 51: 1671-1677
• 32 Calderwood AH, Thompson KD, Schroy PC. et al. Good is better than excellent: bowel preparation quality and adenoma detection rates. Gastrointest Endosc 2015; 81: 691-699.e1
• 33 Pontone S, Hassan C, Maselli R. et al. Multiple, zonal and multi-zone adenoma detection rates according to quality of cleansing during colonoscopy. United European Gastroenterol J 2016; 4: 778-783
• 34 Adike A, Buras MR, Gurudu SR. et al. Is the level of cleanliness using segmental Boston bowel preparation scale associated with a higher adenoma detection rate?. Ann Gastroenterol 2018; 31: 217-223
• 35 DeMicco MP, Clayton LB, Pilot J. et al. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc 2018; 87: 677-687.e3