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©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
Effectiveness of very low-volume preparation for colonoscopy: A prospective, multicenter observational study
Marcello Maida, Emanuele Sinagra, Gaetano Cristian Morreale, Sandro Sferrazza, Giuseppe Scalisi, Dario Schillaci, Marco Ventimiglia, Fabio Salvatore Macaluso, Giovanni Vettori, Giuseppe Conoscenti, Concetta Di Bartolo, Serena Garufi, Domenico Catarella, Michele Manganaro, Clara Maria Virgilio, Salvatore Camilleri
Marcello Maida, Gaetano Cristian Morreale, Serena Garufi, Michele Manganaro, Salvatore Camilleri, Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta 93100, Italy
Emanuele Sinagra, Giuseppe Conoscenti, Gastroenterology and Endoscopy Unit, Istituto San Raffaele Giglio, Cefalù 90015, Italy
Sandro Sferrazza, Giovanni Vettori, Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento 38014, Italy
Giuseppe Scalisi, Concetta Di Bartolo, Domenico Catarella, Clara Maria Virgilio, Gastroenterology Unit, ARNAS Garibaldi, Catania 95100, Italy
Dario Schillaci, Gastroenterology Unit, Basarocco Hospital, Niscemi 93015, Caltanissetta, Italy
Marco Ventimiglia, Fabio Salvatore Macaluso, Department of Internal Medicine, Villa Sofia-Cervello Hospital, Palermo 90100, Italy
Author contributions: Maida M, Sinagra E and Macaluso FS are guarantors of integrity of entire study and contributed to the manuscript drafting and manuscript revision for important intellectual content; Maida M, Sinagra E, Morreale GC, Macaluso FS and Sferrazza S contributed to the manuscript editing; Ventimiglia M performed the statistical analysis; all authors contributed to data collection and had full control over preparation of manuscript.
Institutional review board statement: The study received Ethics Committee approval and was conducted in accordance with the principles of the Declaration of Helsinki and good clinical practice.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors have no proprietary, financial, professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented in, or the review of this manuscript.
Data sharing statement: Technical appendix, statistical code, and dataset are available from the corresponding author at marcello.maida@hotmail.it. Participants gave informed consent for data sharing.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Marcello Maida, MD, Doctor, Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Via Giacomo Cusmano 1, Caltanissetta 93100, Italy. marcello.maida@hotmail.it
Received: January 10, 2020
Peer-review started: January 10, 2020
First decision: March 6, 2020
Revised: March 26, 2020
Accepted: April 21, 2020
Article in press: April 21, 2020
Published online: April 28, 2020
ARTICLE HIGHLIGHTS
Research background
The effectiveness of colonoscopy strictly depends on adequate bowel cleansing. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution has been introduced on the evidence of three phase-3 randomized controlled trials.
Research motivation
The 1 L PEG-ASC solution has never been tested in a real-life setting, where patients’ characteristics may differ from those of randomized controlled trials volunteers, and where the incidence of adverse events (AEs) may even be higher.
Research objectives
In this study, we aimed 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.
Research methods
Patients undergoing a screening or diagnostic colonoscopy after a 4, 2 or 1 L PEG preparation, were consecutively enrolled in 5 Italian centers. Bowel cleansing was assessed through the Boston Bowel Preparation Scale (BBPS). 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 AEs reporting.
Research results
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 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%, while a high-quality cleansing of the right colon in 15.9%, 12.0% and 41.4% 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 AEs 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.
Research conclusions
The effectiveness and tolerability of 1 L PEG-ASC show that it is an independent predictor of overall cleansing success, high-quality cleansing of the right colon and of tolerability
Research perspectives
This very-low-volume solution will be useful to improve the quality and tolerability of bowel preparation increasing, and the adherence to colorectal cancer screening and surveillance programs.
