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DOI: 10.1055/a-2125-0025
Bowel cleansing effectiveness and safety of 1L PEG + Asc in the real-world setting: Observational, retrospective, multicenter study of over 13000 patients
Supported by: NorgineTRIAL REGISTRATION: Registration number (trial ID): NCT05174845, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: observational, retrospective, multicenter
Abstract
Background and study aims Effective bowel cleansing is critical for detecting lesions during colonoscopy, highlighting the importance of bowel preparations. 1L polyethylene glycol (PEG) + ascorbate (Asc) is the only recommended 1L PEG product in Europe and the United States. Its efficacy was demonstrated in large-scale controlled trials and confirmed in smaller-scale real-world studies. However, no large-scale real-world data exist.
Patients and methods This observational, retrospective, multicenter study, used outpatient follow-up data from medical records from 10 centers in Spain and two in Portugal. Outpatients aged ≥18 years using 1L PEG + Asc as bowel preparation were included. The main outcome measures were overall adequate colon cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6 with BBPS score ≥2 in each segment) and high-quality cleansing of the right colon (BBPS score=3).
Results Data from 13169 eligible patients were included. Overall cleansing success was achieved in 89.3% (95%CI 88.7%-89.8%) and high-quality cleansing in the right colon in 49.3% (95%CI 48.4%–50.2%) of patients. For the overnight split-dose and same-day regimens, overall adequate quality cleansing success rate was 94.7% and 86.7% (P<0.0001) and high-quality cleansing of the right colon rate was 65.4% and 41.4% (P<0.0001), respectively. Colonoscopy was completed in 97.3% of patients, with non-completion due to poor preparation in only 0.8%; 2.3% of patients experienced at least one adverse event (AE).
Conclusions This large-scale, real-world study demonstrates the effectiveness of 1L PEG + Asc in the total and right colon, with a low percentage of patients with AEs in routine clinical practice.
Publication History
Received: 11 January 2023
Accepted after revision: 23 June 2023
Article published online:
16 August 2023
© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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References
- 1 Froehlich F, Wietlisbach V, Gonvers J-J. 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: 378-384 DOI: 10.1016/s0016-5107(04)02776-2. (PMID: 15758907)
- 2 Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc 2003; 58: 76-79 DOI: 10.1067/mge.2003.294. (PMID: 12838225)
- 3 Chokshi RV, Hovis CE, Hollander T. et al. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc 2012; 75: 1197-1203 DOI: 10.1016/j.gie.2012.01.005.
- 4 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: 1207-1214 DOI: 10.1016/j.gie.2011.01.051 .
- 5 Byrne MF. The curse of poor bowel preparation for colonoscopy. Am J Gastroenterol 2002; 97: 1587-1590 DOI: 10.1111/j.1572-0241.2002.05855.x. (PMID: 12135005)
- 6 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 DOI: 10.1177/2050640617700014. (PMID: 28507745)
- 7 Clark BT, Laine L. High-quality bowel preparation is required for detection of sessile serrated polyps. Clin Gastroenterol Hepatol 2016; 14: 1155-1162 DOI: 10.1016/j.cgh.2016.03.044. (PMID: 27060426)
- 8 Lieberman D, Sullivan BA, Hauser ER. et al. Baseline colonoscopy findings associated with 10-year outcomes in a screening cohort undergoing colonoscopy surveillance. Gastroenterology 2020; 158: 862-874.e8 DOI: 10.1053/j.gastro.2019.07.052 .
- 9 Kaminski MF, Regula J, Kraszewska E. et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010; 362: 1795-1803 DOI: 10.1056/NEJMoa0907667. (PMID: 20463339)
- 10 Xie Q, Chen L, Zhao F. et al. A meta-analysis of randomized controlled trials of low-volume polyethylene glycol plus ascorbic acid versus standard-volume polyethylene glycol solution as bowel preparations for colonoscopy. PLoS One 2014; 9: e99092 DOI: 10.1371/journal.pone.0099092. (PMID: 24902028)
- 11 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 DOI: 10.1016/j.gie.2014.01.024.
- 12 Schreiber S, Baumgart DC, Drenth JPH. et al. Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate: a randomized phase 3 trial. Endoscopy 2019; 51: 73-84 DOI: 10.1055/a-0725-8137.
- 13 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 DOI: 10.1055/a-0638-8125.
- 14 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 DOI: 10.1053/j.gastro.2014.07.002.
- 15 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 DOI: 10.1080/17474124.2018.1478728. (PMID: 29781328)
- 16 Repici A, Spada C, Cannizzaro R. et al. Novel 1-L polyethylene glycol + ascorbate versus high-volume polyethylene glycol regimen for colonoscopy cleansing: a multicenter, randomized, phase IV study. Gastrointest Endosc 2021; 94: 823-831.e9 DOI: 10.1055/s-0043-103411.
- 17 Gandhi K, Tofani C, Sokach C. et al. Patient characteristics associated with quality of colonoscopy preparation: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2018; 16: 357-369.e10
- 18 Chung YW, Han DS, Park KH. et al. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol 2009; 43: 448-452 DOI: 10.1097/MCG.0b013e3181662442. (PMID: 18978506)
- 19 Restellini S, Kherad O, Bessissow T. et al. Systematic review and meta-analysis of colon cleansing preparations in patients with inflammatory bowel disease. World J Gastroenterol 2017; 23: 5994-6002 DOI: 10.3748/wjg.v23.i32.5994.
- 20 Cash BD, Moncrief MBC, Epstein MS. et al. Patient experience with NER1006 as a bowel preparation for colonoscopy: a prospective, multicenter US survey. BMC Gastroenterology 2021; 21: 70 DOI: 10.1186/s12876-021-01605-y.
- 21 Arieira C, Dias de Castro F, Boal Carvalho P. et al. Bowel cleansing efficacy for colonoscopy: prospective, randomized comparative study of same-day dosing with 1-L and 2-L PEG + ascorbate. Endosc Int Open 2021; 9: E1602-E1610 DOI: 10.1055/a-1520-4596.
- 22 Maida M, Sinagra E, Morreale GC. et al. Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study. World J Gastroenterol 2020; 26: 1950-1961 DOI: 10.3748/wjg.v26.i16.1950.
- 23 Bednarska O, Nyhlin N, Schmidt PT. et al. The effectiveness and tolerability of a very low-volume bowel preparation for colonoscopy compared to low and high-volume polyethylene glycol-solutions in the real-life setting. Diagnostics (Basel) 2022; 12: 1155 DOI: 10.1016/j.gie.2014.01.024.
- 24 Hassan C, East J, Radaelli F. et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy 2019; 51: 775-794 DOI: 10.1055/a-0959-0505. (PMID: 31295746)
- 25 Gu P, Lew D, Oh SJ. et al. Comparing the real-world effectiveness of competing colonoscopy preparations: results of a prospective trial. Am J Gastroenterol 2019; 114: 305-314 DOI: 10.14309/ajg.0000000000000057. (PMID: 30730859)
- 26 Pan H, Zheng XL, Fang CY. et al. Same-day single-dose vs large-volume split-dose regimens of polyethylene glycol for bowel preparation: A systematic review and meta-analysis. World J Clin Cases 2022; 10: 7844-7858 DOI: 10.12998/wjcc.v10.i22.7844. (PMID: 36158495)
- 27 Cheng YL, Huang KW, Liao WC. et al. Same-day versus split-dose bowel preparation before colonoscopy: a meta-analysis. J Clin Gastroenterol 2018; 52: 392-400 DOI: 10.1097/MCG.0000000000000860 .
- 28 Halphen M, Tayo B, Flanagan S. et al. Pharmacodynamic and Clinical evaluation of low-volume polyethylene glycol (PEG)-based bowel cleansing solutions (ner1006) using split dosing in healthy and screening colonoscopy subjects: 655. Am J Gastroenterol 2014; 109: S189 DOI: 10.1016/j.gie.2017.07.047.
- 29 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 DOI: 10.1053/j.gastro.2014.07.002.
- 30 Radaelli F, Meucci G, Sgroi G. et al. Technical performance of colonoscopy: the key role of sedation/analgesia and other quality indicators. Am J Gastroenterol 2008; 103: 1122-1130 DOI: 10.1111/j.1572-0241.2007.01778.x. (PMID: 18445096)
- 31 Hassan C, Manning J, Álvarez González MA. et al. Improved detection of colorectal adenomas by high-quality colon cleansing. Endosc Int Open 2020; 08: E928-E937 DOI: 10.1055/s-0043-103411.
- 32 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: 378-97 DOI: 10.1055/s-0043-103411.
- 33 Spada C, Koulaouzidis A, Hassan C. et al. Colonoscopy quality across Europe: a report of the European Colonoscopy Quality Investigation (ECQI) Group. Endosc Int Open 2021; 9: E1456-E1462 DOI: 10.1055/a-1486-6729. (PMID: 34540535)
- 34 Manno M, Biancheri P, Bonura GF. et al. Safety of a novel 1L-polyethylene glycol ascorbate solution for colonoscopy cleansing (REAL Study). Dig Liver Dis 2022; 54: 1508-1512 DOI: 10.1016/j.dld.2022.04.014.