Efficacy, Tolerability, and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases: The French Multicentre CLEAN Study.

Adolescent Adult Aged Aged, 80 and over Cathartics / administration & dosage Citrates / administration & dosage Colitis, Ulcerative / diagnosis Colonoscopy / adverse effects Crohn Disease / diagnosis Female Humans Inflammatory Bowel Diseases / diagnosis Male Middle Aged Organometallic Compounds / administration & dosage Picolines / administration & dosage Polyethylene Glycols / administration & dosage Prospective Studies Young Adult

Inflammatory bowel disease [IBD] bowel preparations colonoscopy

Journal

Journal of Crohn's & colitis

ISSN: 1876-4479

Titre abrégé: J Crohns Colitis

Pays: England

ID NLM: 101318676

Informations de publication

Date de publication:
19 Sep 2019

Historique:

pubmed: 21 2 2019

medline: 13 2 2020

entrez: 21 2 2019

Statut: ppublish

Résumé

Standard high-volume polyethylene glycol [PEG] bowel preparations [PEG-4L] are recommended for patients with inflammatory bowel disease [IBD] undergoing colonoscopy. However, low-volume preparations [≤2 L of active volume] are often used in clinical practice. The aim of this study was to evaluate the efficacy, tolerability, and safety of the various bowel preparations for patients with IBD, including low-volume preparations. We conducted a French prospective multicentre observational study over a period of 1 month. Patients aged 18-75 years with IBD with an indication of colonoscopy independent of the study were enrolled. The choice of the preparation was left to the investigators, as per their usual protocol. The patients' characteristics, disease, and colonoscopy characteristics were recorded, and they were given self-reported questionnaires. Twenty-five public and private hospitals enrolled 278 patients. Among them, 46 had a disease flare and 41 had bowel stenoses. Bowel preparations for colonoscopy were as follows: 42% received PEG-2L, 29% received sodium picosulfate [Pico], 15% received PEG-4L, and 14% had other preparations. The preparation did not reach the Boston's score efficacy outcome in the PEG-4L group in 51.2% of the patients [p = 0.0011]. The preparation intake was complete for 59.5% in the PEG-4L group, compared with 82.9% in the PEG-2L group and 93.8% in the Pico group [p < 0.0001]. Tolerability, as assessed by the patients' VAS, was significantly better for both Pico and PEG-2L compared with PEG-4L, and better for Pico compared with PEG-2L [p = 0.008; p = 0.0003]. In multivariate analyses, low-volume preparations were independent factors of efficacy and tolerability. Adverse events occurred in 4.3% of the patients. Preparations with PEG-2L and Pico were equally safe, with better efficacy and tolerability outcomes compared with PEG-4L preparations. The best efficacy/tolerance/safety profile was achieved with the Pico preparation.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

We conducted a French prospective multicentre observational study over a period of 1 month. Patients aged 18-75 years with IBD with an indication of colonoscopy independent of the study were enrolled. The choice of the preparation was left to the investigators, as per their usual protocol. The patients' characteristics, disease, and colonoscopy characteristics were recorded, and they were given self-reported questionnaires.

RESULTS RESULTS

Twenty-five public and private hospitals enrolled 278 patients. Among them, 46 had a disease flare and 41 had bowel stenoses. Bowel preparations for colonoscopy were as follows: 42% received PEG-2L, 29% received sodium picosulfate [Pico], 15% received PEG-4L, and 14% had other preparations. The preparation did not reach the Boston's score efficacy outcome in the PEG-4L group in 51.2% of the patients [p = 0.0011]. The preparation intake was complete for 59.5% in the PEG-4L group, compared with 82.9% in the PEG-2L group and 93.8% in the Pico group [p < 0.0001]. Tolerability, as assessed by the patients' VAS, was significantly better for both Pico and PEG-2L compared with PEG-4L, and better for Pico compared with PEG-2L [p = 0.008; p = 0.0003]. In multivariate analyses, low-volume preparations were independent factors of efficacy and tolerability. Adverse events occurred in 4.3% of the patients.

CONCLUSIONS CONCLUSIONS

Preparations with PEG-2L and Pico were equally safe, with better efficacy and tolerability outcomes compared with PEG-4L preparations. The best efficacy/tolerance/safety profile was achieved with the Pico preparation.

Identifiants

DOI: 10.1093/ecco-jcc/jjz040 PMID: 30785181

pubmed: 30785181

pii: 5319124

doi: 10.1093/ecco-jcc/jjz040

doi:

Substances chimiques

Cathartics 0

Citrates 0

Organometallic Compounds 0

Picolines 0

Polyethylene Glycols 3WJQ0SDW1A

picosulfate sodium LR57574HN8

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

Pagination

1121-1130

Investigateurs

Arnaud Boureille (A)

Antoine Blain (A)

Claire Gay (C)

Stéphane Koch (S)

Sylvain Ambregna (S)

Fanny Vaurie (F)

Stéphanie François (S)

Bérenger Martin (B)

Khadija Agouzal (K)

Lucile Boivineau (L)

Julien Branche (J)

Romain Gerard (R)

Alban Benezech (A)

Belinda Aider (B)

Clea Rouillon (C)

Guillaume Perrod (G)

Stéphanie De Montigny (S)

Philippe Aygalenq (P)