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High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials.


ABSTRACT: Background and study aims? Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods? This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation?+?clear fluids) 1?+?1?L polyethylene glycol (PEG) NER1006 versus 2?+?1?L PEG?+?ascorbate (2LPEG) or 1?+?2?L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0-4 (high-quality?=?HCS 3-4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results? In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29?% vs. 20?%; P ?

SUBMITTER: Epstein MS 

PROVIDER: S-EPMC7165002 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials.

Epstein Michael S MS   Benamouzig Robert R   Halonen Juha J   Bisschops Raf R  

Endoscopy international open 20200417 5


<b>Background and study aims </b> Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. <b>Patients and methods </b> This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol  ...[more]

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