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; Ricardo Gorjão; José Cotter; Vicente Lorenzo-Zúñiga García; Miguel Angel Pantaleón Sánchez; David Carral Martínez; Fernando Sábado; Elena Pérez Arellano; Blas José Gómez Rodríguez; Antonio López Cano; Salvador Machlab; Cátia Arieira; Fatma Akriche; Carmen Turbí Disla; Sarbelio Rodriguez Muñoz

doi:10.1055/a-2125-0025

Endoscopy International Open, Inhaltsverzeichnis

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

¹Gastroenterology, Hospital Clínico Universitario San Carlos, Madrid, Spain (Ringgold ID: RIN16267)

,

Ricardo Gorjão

²Gastroenterology, Hospital CUF Descobertas, Lisboa, Portugal (Ringgold ID: RIN162265)

,

José Cotter

³Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal

⁴Life and Health Sciences Research Institute (ICVS), School of Medicine, Universidade do Minho, Braga/Guimarães, Portugal (Ringgold ID: RIN56059)

⁵Gastroenterology, ICVS/3B’s—PT Government Associate Laboratory, Braga/Guimarães, Portugal

,

Vicente Lorenzo-Zúñiga García

⁶Gastroenterology, Hospital HM Sant Jordi, Barcelona, Spain

,

Miguel Angel Pantaleón Sánchez

⁷Gastroenterology, Hospital del Mar, Barcelona, Spain (Ringgold ID: RIN16548)

,

David Carral Martínez

⁸Gastroenterology, Hospital San Rafael, A Coruña, Spain (Ringgold ID: RIN221888)

,

Fernando Sábado

⁹Gastroenteroloy, Consorcio Hospitalario Provincial de Castelló, Castellón, Spain

,

Elena Pérez Arellano

¹⁰Gastroenterology, Hospital Universitario La Zarzuela, Madrid, Spain (Ringgold ID: RIN207202)

,

Blas José Gómez Rodríguez

¹¹Gastroenterology, Hospital Quirón Salud Sagrado Corazón, Sevilla, Spain

,

Antonio López Cano

¹²Gastroenterology, Hospital Doctor López Cano, Cádiz, Spain

,

Salvador Machlab

¹³Gastroenterology, Parc Taulı́ Hospital Universitari, Institut d’Investigació i Innovació Parc Taulı́ I3PT, Sabadell, Spain

,

Cátia Arieira

³Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal

,

Fatma Akriche

¹⁴Medical Affairs, Norgine, Harefield, United Kingdom of Great Britain and Northern Ireland

,

Carmen Turbí Disla

¹⁴Medical Affairs, Norgine, Harefield, United Kingdom of Great Britain and Northern Ireland

,

Sarbelio Rodriguez Muñoz

¹⁵Gastroenterology, Hospital Ruber Juan Bravo, Madrid, Spain

› Institutsangaben

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

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