Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution.

Humanitas University, Milan, Italy. Centre Hospitalier Universitaire Hotel Dieu, Nantes, France. Department of Gastroenterology and Hepatology, Veterans Affairs Medical Center, Kansas City, MO, USA; Department of Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, KS, USA. Fondazione Policlinico Universitario A. Gemelli, Rome, Italy. Western General Hospital, Edinburgh, UK. Klinikum Forchheim, Forchheim, Germany. Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí, Spain; Endos Medicina, Barcelona, Spain. Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada. Electronic address: baumgart@ualberta.ca.

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2019;(12):1671-1677
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Abstract

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.

Methodological quality

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MeSH terms : Colon