Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution.
Ascorbic Acid
/ pharmacology
Cathartics
/ administration & dosage
Colon
/ diagnostic imaging
Colonoscopy
/ methods
Colorectal Neoplasms
/ diagnosis
Female
Humans
Male
Middle Aged
Outcome Assessment, Health Care
Polyethylene Glycols
/ administration & dosage
Preoperative Care
/ methods
Quality Improvement
Sulfates
/ pharmacology
Bowel preparation
Colonoscopy
Colorectal cancer
Endoscopy
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
10
05
2019
revised:
26
06
2019
accepted:
30
06
2019
pubmed:
15
8
2019
medline:
22
5
2020
entrez:
15
8
2019
Statut:
ppublish
Résumé
Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists. Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed. Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than OSS (74.5-77.3% vs. 67.8-69.8%). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%). When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.
Sections du résumé
BACKGROUND & AIMS
Colonoscopy requires bowel cleansing for gut mucosa visualization; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of two randomized trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists.
METHODS
Patients received NER1006, 2L PEG + ascorbate (2LPEG), or oral sulfate solution (OSS) as a 2-day evening/morning regimen (N2D) or NER1006 morning-only dosing (N1D). Treatment-blinded site endoscopists assessed cleansing using the Harefield Cleansing Scale (HCS). Analyses were conducted in a modified full analysis set, including (mFAS; n = 1378) or excluding (mFAS2; n = 1319) imputed failures, and in patients with 100% treatment adherence (mFAS100; n = 1047). Overall cleansing success (HCS grade A/B), overall high-quality cleansing (HCS grade A), and high-quality segments (HCS 3-4) per treatment population were analyzed.
RESULTS
Overall cleansing success was higher with N2D than 2LPEG (92.7-97.5% vs. 87.9-93.0%), and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (68.0-72.1% and 64.0-68.4% vs. 50.7-56.0%). Without imputed failures, N2D delivered more overall high-quality cleansing than OSS (74.5-77.3% vs. 67.8-69.8%). More high-quality segments were demonstrated with N2D and N1D versus 2 LPEG (82.5-87.1% and 79.4-84.4% vs. 70.4-76.3%) and with N2D versus OSS (82.7-89.5% vs. 78.1-84.4%).
CONCLUSION
When assessed by site endoscopists, NER1006 delivers greater high-quality cleansing than 2LPEG or OSS.
Identifiants
pubmed: 31409579
pii: S1590-8658(19)30684-X
doi: 10.1016/j.dld.2019.06.026
pii:
doi:
Substances chimiques
Cathartics
0
Sulfates
0
Polyethylene Glycols
3WJQ0SDW1A
Ascorbic Acid
PQ6CK8PD0R
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1671-1677Informations de copyright
Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.