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CC BY-NC-ND 4.0 · Endosc Int Open 2023; 11(08): E785-E793
DOI: 10.1055/a-2125-0025
Original article

Bowel cleansing effectiveness and safety of 1L PEG + Asc in the real-world setting: Observational, retrospective, multicenter study of over 13000 patients

José Miguel Esteban López-Jamar
1   Gastroenterology, Hospital Clínico Universitario San Carlos, Madrid, Spain (Ringgold ID: RIN16267)
,
Ricardo Gorjão
2   Gastroenterology, Hospital CUF Descobertas, Lisboa, Portugal (Ringgold ID: RIN162265)
,
José Cotter
3   Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal
4   Life and Health Sciences Research Institute (ICVS), School of Medicine, Universidade do Minho, Braga/Guimarães, Portugal (Ringgold ID: RIN56059)
5   Gastroenterology, ICVS/3B’s—PT Government Associate Laboratory, Braga/Guimarães, Portugal
,
Vicente Lorenzo-Zúñiga García 
6   Gastroenterology, Hospital HM Sant Jordi, Barcelona, Spain
,
Miguel Angel Pantaleón Sánchez
7   Gastroenterology, Hospital del Mar, Barcelona, Spain (Ringgold ID: RIN16548)
,
David Carral Martínez
8   Gastroenterology, Hospital San Rafael, A Coruña, Spain (Ringgold ID: RIN221888)
,
Fernando Sábado 
9   Gastroenteroloy, Consorcio Hospitalario Provincial de Castelló, Castellón, Spain
,
Elena Pérez Arellano
10   Gastroenterology, Hospital Universitario La Zarzuela, Madrid, Spain (Ringgold ID: RIN207202)
,
Blas José Gómez Rodríguez
11   Gastroenterology, Hospital Quirón Salud Sagrado Corazón, Sevilla, Spain
,
Antonio López Cano
12   Gastroenterology, Hospital Doctor López Cano, Cádiz, Spain
,
Salvador Machlab
13   Gastroenterology, Parc Taulı́ Hospital Universitari, Institut d’Investigació i Innovació Parc Taulı́ I3PT, Sabadell, Spain
,
Cátia Arieira 
3   Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal
,
Fatma Akriche
14   Medical Affairs, Norgine, Harefield, United Kingdom of Great Britain and Northern Ireland
,
Carmen Turbí Disla
14   Medical Affairs, Norgine, Harefield, United Kingdom of Great Britain and Northern Ireland
,
Sarbelio Rodriguez Muñoz
15   Gastroenterology, Hospital Ruber Juan Bravo, Madrid, Spain
› Author AffiliationsSupported by: Norgine

TRIAL REGISTRATION: Registration number (trial ID): NCT05174845, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: observational, retrospective, multicenter
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Are real-world data studies on bowel preparation for colonoscopy necessary? Aren’t RCTs enough?Endosc Int Open 2023; 11(12): E1143-E1144
DOI: 10.1055/a-2187-7514

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.

Keywords

Colonoscopy - NER1006 - Plenvu - Polyethylene glycol - bowel preparation

Supporting information



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/).

Georg Thieme Verlag KG
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Comment to this article:

Endoscopy International Open – recently publishedEndoscopy 2023; 55(10): 978-978
DOI: 10.1055/a-2142-1348

 

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