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Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study

BACKGROUND: The effectiveness of colonoscopy strictly depends on adequate bowel cleansing. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution (Plenvu; Norgine, Harefield, United Kingdom) has been introduced on the evidence of three phase-3 randomized controlled trials, but it had...

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Autores principales: Maida, Marcello, Sinagra, Emanuele, Morreale, Gaetano Cristian, Sferrazza, Sandro, Scalisi, Giuseppe, Schillaci, Dario, Ventimiglia, Marco, Macaluso, Fabio Salvatore, Vettori, Giovanni, Conoscenti, Giuseppe, Di Bartolo, Concetta, Garufi, Serena, Catarella, Domenico, Manganaro, Michele, Virgilio, Clara Maria, Camilleri, Salvatore
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Baishideng Publishing Group Inc 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201146/
https://www.ncbi.nlm.nih.gov/pubmed/32390705
http://dx.doi.org/10.3748/wjg.v26.i16.1950
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author Maida, Marcello
Sinagra, Emanuele
Morreale, Gaetano Cristian
Sferrazza, Sandro
Scalisi, Giuseppe
Schillaci, Dario
Ventimiglia, Marco
Macaluso, Fabio Salvatore
Vettori, Giovanni
Conoscenti, Giuseppe
Di Bartolo, Concetta
Garufi, Serena
Catarella, Domenico
Manganaro, Michele
Virgilio, Clara Maria
Camilleri, Salvatore
author_facet Maida, Marcello
Sinagra, Emanuele
Morreale, Gaetano Cristian
Sferrazza, Sandro
Scalisi, Giuseppe
Schillaci, Dario
Ventimiglia, Marco
Macaluso, Fabio Salvatore
Vettori, Giovanni
Conoscenti, Giuseppe
Di Bartolo, Concetta
Garufi, Serena
Catarella, Domenico
Manganaro, Michele
Virgilio, Clara Maria
Camilleri, Salvatore
author_sort Maida, Marcello
collection PubMed
description BACKGROUND: The effectiveness of colonoscopy strictly depends on adequate bowel cleansing. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution (Plenvu; Norgine, Harefield, United Kingdom) has been introduced on the evidence of three phase-3 randomized controlled trials, but it had never been tested in the real-life. AIM: To assess the effectiveness and tolerability of the 1 L preparation compared to 4 L and 2 L- PEG solutions in a real-life setting. METHODS: All patients undergoing a screening or diagnostic colonoscopy after a 4, 2 or 1 L PEG preparation, were consecutively enrolled in 5 Italian centers from September 2018 to February 2019. The primary endpoints of the study were the assessment of bowel cleansing success and high-quality cleansing of the right colon. The secondary endpoints were the evaluation of tolerability, adherence and safety of the different bowel preparations. Bowel cleansing was assessed through the Boston Bowel Preparation Scale. Adherence was defined as consumption of at least 75% of each dose, while tolerability was evaluated through a semi-quantitative scale. Safety was systematically monitored through adverse events reporting. RESULTS: Overall, 1289 met the inclusion criteria and were enrolled in the study. Of these, 490 patients performed a 4 L-PEG preparation (Selgesse(®)), 566 a 2 L-PEG cleansing (Moviprep(®) or Clensia(®)) and 233 a 1 L-PEG preparation (Plenvu(®)). Bowel cleansing by Boston Bowel Preparation Scale was 6.5 ± 1.5 overall and 6.3 ± 1.5, 6.2 ± 1.5, 7.3 ± 1.5 (P < 0.001) in the subgroups of 4 L, 2 L and 1 L-PEG preparation, respectively. Cleansing success was achieved in 72.4%, 74.1% and 90.1% (P < 0.001), while a high-quality cleansing of the right colon in 15.9%, 12.0% and 41.4% (P < 0.001) for 4 L, 2 L and 1 L-PEG preparation groups, respectively. The 1 L preparation was the most tolerated compared to the 2 and 4 L-PEG solutions in the absence of serious adverse events within any of the three groups. Multiple regression models confirmed 1 L PEG-ASC preparation as an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability. CONCLUSION: This study supports the effectiveness and tolerability of 1 L PEG-ASC, also showing it is an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability.
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spelling pubmed-72011462020-05-09 Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study Maida, Marcello Sinagra, Emanuele Morreale, Gaetano Cristian Sferrazza, Sandro Scalisi, Giuseppe Schillaci, Dario Ventimiglia, Marco Macaluso, Fabio Salvatore Vettori, Giovanni Conoscenti, Giuseppe Di Bartolo, Concetta Garufi, Serena Catarella, Domenico Manganaro, Michele Virgilio, Clara Maria Camilleri, Salvatore World J Gastroenterol Observational Study BACKGROUND: The effectiveness of colonoscopy strictly depends on adequate bowel cleansing. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution (Plenvu; Norgine, Harefield, United Kingdom) has been introduced on the evidence of three phase-3 randomized controlled trials, but it had never been tested in the real-life. AIM: To assess the effectiveness and tolerability of the 1 L preparation compared to 4 L and 2 L- PEG solutions in a real-life setting. METHODS: All patients undergoing a screening or diagnostic colonoscopy after a 4, 2 or 1 L PEG preparation, were consecutively enrolled in 5 Italian centers from September 2018 to February 2019. The primary endpoints of the study were the assessment of bowel cleansing success and high-quality cleansing of the right colon. The secondary endpoints were the evaluation of tolerability, adherence and safety of the different bowel preparations. Bowel cleansing was assessed through the Boston Bowel Preparation Scale. Adherence was defined as consumption of at least 75% of each dose, while tolerability was evaluated through a semi-quantitative scale. Safety was systematically monitored through adverse events reporting. RESULTS: Overall, 1289 met the inclusion criteria and were enrolled in the study. Of these, 490 patients performed a 4 L-PEG preparation (Selgesse(®)), 566 a 2 L-PEG cleansing (Moviprep(®) or Clensia(®)) and 233 a 1 L-PEG preparation (Plenvu(®)). Bowel cleansing by Boston Bowel Preparation Scale was 6.5 ± 1.5 overall and 6.3 ± 1.5, 6.2 ± 1.5, 7.3 ± 1.5 (P < 0.001) in the subgroups of 4 L, 2 L and 1 L-PEG preparation, respectively. Cleansing success was achieved in 72.4%, 74.1% and 90.1% (P < 0.001), while a high-quality cleansing of the right colon in 15.9%, 12.0% and 41.4% (P < 0.001) for 4 L, 2 L and 1 L-PEG preparation groups, respectively. The 1 L preparation was the most tolerated compared to the 2 and 4 L-PEG solutions in the absence of serious adverse events within any of the three groups. Multiple regression models confirmed 1 L PEG-ASC preparation as an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability. CONCLUSION: This study supports the effectiveness and tolerability of 1 L PEG-ASC, also showing it is an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability. Baishideng Publishing Group Inc 2020-04-28 2020-04-28 /pmc/articles/PMC7201146/ /pubmed/32390705 http://dx.doi.org/10.3748/wjg.v26.i16.1950 Text en ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved. http://creativecommons.org/licenses/by-nc/4.0/ This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.
spellingShingle Observational Study
Maida, Marcello
Sinagra, Emanuele
Morreale, Gaetano Cristian
Sferrazza, Sandro
Scalisi, Giuseppe
Schillaci, Dario
Ventimiglia, Marco
Macaluso, Fabio Salvatore
Vettori, Giovanni
Conoscenti, Giuseppe
Di Bartolo, Concetta
Garufi, Serena
Catarella, Domenico
Manganaro, Michele
Virgilio, Clara Maria
Camilleri, Salvatore
Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study
title Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study
title_full Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study
title_fullStr Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study
title_full_unstemmed Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study
title_short Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study
title_sort effectiveness of very low-volume preparation for colonoscopy: a prospective, multicenter observational study
topic Observational Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201146/
https://www.ncbi.nlm.nih.gov/pubmed/32390705
http://dx.doi.org/10.3748/wjg.v26.i16.1950
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