Observational Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Dec 16, 2021; 13(12): 659-672
Published online Dec 16, 2021. doi: 10.4253/wjge.v13.i12.659
Efficacy and tolerability of high and low-volume bowel preparation compared: A real-life single-blinded large-population study
Vincenzo Occhipinti, Paola Soriani, Francesco Bagolini, Valentina Milani, Emanuele Rondonotti, Maria Laura Annunziata, Flaminia Cavallaro, Sara Vavassori, Maurizio Vecchi, Luca Pastorelli, Gian Eugenio Tontini
Vincenzo Occhipinti, Digestive Endoscopy and Gastroenterology Unit, A. Manzoni Hospital, ASST Lecco, Lecco 23900, Italy
Vincenzo Occhipinti, Paola Soriani, Francesco Bagolini, Maria Laura Annunziata, Flaminia Cavallaro, Sara Vavassori, Maurizio Vecchi, Luca Pastorelli, Gian Eugenio Tontini, Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
Paola Soriani, Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Carpi Hospital, Carpi 41012, Italy
Valentina Milani, Scientific Directorate, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
Emanuele Rondonotti, Gastroenterology Unit, Ospedale Valduce, Como 22100, Italy
Flaminia Cavallaro, Maurizio Vecchi, Gian Eugenio Tontini, Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy
Sara Vavassori, Luca Pastorelli, Gastroenterology and Hepatology Unit, ASST Santi Paolo e Carlo, Milan 20142, Italy
Maurizio Vecchi, Gian Eugenio Tontini, Department of Pathophysiology and Transplantation, University of Milan, Milan 20122, Italy
Luca Pastorelli, Department of Biomedical Sciences for Health, University of Milan, Milan 20122, Italy
Author contributions: Occhipinti V contributed to the acquisition, analysis, and interpretation of data, drafting and critical revision of the manuscript; Soriani P, Bagolini F, Annunziata ML, Cavallaro F, Vavassori S, Vecchi M contributed to the acquisition of data and critical revision of the manuscript; Milani V analyzed the data; Rondonotti E contributed to the analysis and interpretation of data, critical revision of the manuscript; Pastorelli L contributed to the acquisition, analysis and interpretation of data, critical revision of the manuscript; Tontini GE contributed to the study concept and design, acquisition, analysis and interpretation of data, critical revision of the manuscript and study supervision.
Institutional review board statement: The study was approved by the local Ethics Committee of San Raffaele Hospital (Approval No. 90/INT/2014).
Informed consent statement: A specific written informed consent was taken from all the study participants.
Conflict-of-interest statement: The authors declare that there is no conflict of interest.
Data sharing statement: Dataset of this study is available from the corresponding author at luca.pastorelli@unimi.it, upon reasonable request. Informed consent for data sharing was not obtained but the presented data are anonymized and risk of identification is low.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Luca Pastorelli, MD, PhD, Associate Professor, Gastroenterology Unit, IRCCS Policlinico San Donato, Piazza Malan, San Donato Milanese 20097, Italy. luca.pastorelli@unimi.it
Received: April 24, 2021
Peer-review started: April 24, 2021
First decision: June 13, 2021
Revised: June 25, 2021
Accepted: December 2, 2021
Article in press: December 2, 2021
Published online: December 16, 2021
Abstract
BACKGROUND

Low-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials (RCT). However, most RCTs do not provide data about clinical outcomes including lesions detection rate. Moreover, real-life comparisons are lacking.

AIM

To compare efficacy (both in terms of adequate bowel preparation and detection of colorectal lesions) and tolerability of a high-volume (HV: 4 L polyethylene glycol, PEG) and a low-volume (LV: 2 L PEG plus bisacodyl) bowel preparation in a real-life setting.

METHODS

Consecutive outpatients referred for colonoscopy were prospectively enrolled between 1 December 2014 and 31 December 2016. Patients could choose either LV or HV preparation, with a day-before schedule for morning colonoscopies and a split-dose for afternoon procedures. Adequate bowel preparation according to Boston Bowel Preparation Scale (BBPS), clinical outcomes including polyp detection rate (PDR), adenoma detection rate (ADR), advanced adenoma detection rate (AADR), sessile/serrated lesion detection rate (SDR) and cancer detection rate and self-reported tolerability of HV and LV were blindly assessed.

RESULTS

Total 2040 patients were enrolled and 1815 (mean age 60.6 years, 50.2% men) finally included. LV was chosen by 52% of patients (50.8% of men, 54.9% of women). Split-dose schedule was more common with HV (44.7% vs 38.2%, P = 0.005). High-definition scopes were used in 33.4% of patients, without difference in the two groups (P = 0.605). HV and LV preparations showed similar adequate bowel preparation rates (89.2% vs 86.6%, P = 0.098), also considering the two different schedules (HV split-dose 93.8% vs LV split-dose 93.6%, P = 1; HV day-before 85.5% vs LV day-before 82.3%, P = 0.182). Mean global BBPS score was higher for HV preparations (7.1 ± 1.7 vs 6.8 ± 1.6, P < 0.001). After adjustment for sex, age and indications for colonoscopy, HV preparation resulted higher in PDR [Odds ratio (OR) 1.32, 95%CI: 1.07-1.63, P = 0.011] and ADR (OR 1.29, 95%CI 1.02–1.63, P = 0.038) and comparable to LV in AADR (OR 1.51, 95%CI 0.97-2.35, P = 0.069), SDR and cancer detection rate. The use of standard-definition colonoscopes was associated to lower PDR (adjusted OR 1.59, 95%CI: 1.22-2.08, P < 0.001), ADR (adjusted OR 1.71, 95%CI: 1.26–2.30, P < 0.001) and AADR (adjusted OR 1.97, 95%CI: 1.09-3.56, P = 0.025) in patients receiving LV preparation. Mean Visual Analogue Scale tolerability scored equally (7, P = 0.627) but a ≥ 75% dose intake was more frequent with LV (94.6% vs 92.1%, P = 0.003).

CONCLUSION

In a real-life setting, PEG-based low-volume preparation with bisacodyl showed similar efficacy and tolerability compared to standard HV preparation. However, with higher PDR and ADR, HV should still be considered as the reference standard for clinical trials and the preferred option in screening colonoscopy, especially when colonoscopy is performed with standard resolution imaging.

Keywords: Bowel preparation volume, Polyethylene glycol, Bisacodyl, Colonoscopy, Colonic adenomas, Tolerability

Core Tip: Quality of bowel preparation is one of the main factors influencing outcomes of colonoscopy. This prospective real-life study compared bowel cleansing (according to the Boston Bowel Preparation Scale), clinically relevant colonoscopy outcomes (lesions detection rate) and tolerability of a standard high-volume bowel preparation and a low-volume preparation (2 L polyethylene glycol + bisacodyl). Even if the two study groups did not show differences in terms of adequate bowel preparation, the use of the high-volume preparation was associated with higher polyp and adenoma detection rates. There were no differences in terms of advanced adenomas, sessile/serrated lesions and cancer detections. Performance of low-volume preparation seems influenced by image resolution of colonoscopes, with fewer lesions detected compared to high-volume when using standard-definition colonoscopes. The two preparations were comparable in terms of patients’ self-reported tolerability, but complete adherence to preparation was more common with the low-volume product.