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Background <p>Sufficient cleansing of the colonic mucosa is of great importance during colonoscopy emphasizing the need for effective preparation agents. Studies evaluating the efficacy of a novel 1&#xa0;L polyethylene glycol with ascorbate (1&#xa0;L-PEG-Asc), Plenvu<sup>®</sup>, versus standard 2&#xa0;L polyethylene glycol with ascorbate (2&#xa0;L-PEG-Asc), Moviprep<sup>®</sup>, have shown promising results regarding bowel cleansing. Nonetheless superiority of 1&#xa0;L-PEG-Asc has not been shown.</p> Methods <p>In this single-center randomized controlled superiority trial, participants of the Danish national colorectal cancer screening program scheduled for colonoscopy were randomized to either 1&#xa0;L-PEG-Asc or 2&#xa0;L-PEG-Asc administered as evening/morning split-dose. Primary endpoint was efficacy of the bowel preparation assessed as bowel cleansing success according to Boston Bowel Preparation Scale (BBPS), adequate defined as BBPS ≥ 2 in each segment. Secondary outcomes included excellent bowel preparation defined as BBPS = 3 in each segment, nausea, vomiting, willingness to repeat the cleansing, and lesion detection defined as polyp, adenoma, sessile serrated lesion, and cancer detection.</p> Results <p>1275 participants were randomized to 1&#xa0;L-PEG-Asc (<i>n</i> = 629) or 2&#xa0;L-PEG-Asc (<i>n</i> = 646). 1&#xa0;L-PEG-Asc achieved superior frequencies for adequate (92.2% vs. 86.1%, <i>p</i> &lt; 0.001) and excellent preparation (59.2% vs. 43.8%, <i>p</i> &lt; 0.001). Nausea (57.4% vs. 46.6%, <i>p</i> &lt; 0.001) and vomiting (13.9% vs. 8.7%, <i>p</i> = 0.006) were more frequent in the 1&#xa0;L-PEG-Asc group. Despite this, more participants were willing to repeat cleansing with this agent again (82% vs. 76%, <i>p</i> = 0.009). No difference was seen among lesion detection between the groups.</p> Conclusions <p>1&#xa0;L-PEG-Asc showed superior bowel cleansing efficacy, but increased rates of vomit and nausea compared to 2&#xa0;L-PEG-Asc. Despite this, willingness to repeat the cleansing with the same agent was more frequent in the 1&#xa0;L-PEG-Asc group.</p> Trial registration <p>EudraCT number: 2018-003304-39. Trial registration date 29/10 2018, study start date 17/10 2019.</p>

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A randomized controlled superiority trial of 1 L (Plenvu) versus 2 L (Moviprep) polyethelene glycol plus ascorbate in a FIT-based colorectal cancer screening setting (PLEMO)

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  • 发表日期：

    2026年5月20日

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  • Søren Roepstorff,
  • Thomas Bryrup,
  • Morten Rasmussen

摘要

Background

Sufficient cleansing of the colonic mucosa is of great importance during colonoscopy emphasizing the need for effective preparation agents. Studies evaluating the efficacy of a novel 1 L polyethylene glycol with ascorbate (1 L-PEG-Asc), Plenvu®, versus standard 2 L polyethylene glycol with ascorbate (2 L-PEG-Asc), Moviprep®, have shown promising results regarding bowel cleansing. Nonetheless superiority of 1 L-PEG-Asc has not been shown.

Methods

In this single-center randomized controlled superiority trial, participants of the Danish national colorectal cancer screening program scheduled for colonoscopy were randomized to either 1 L-PEG-Asc or 2 L-PEG-Asc administered as evening/morning split-dose. Primary endpoint was efficacy of the bowel preparation assessed as bowel cleansing success according to Boston Bowel Preparation Scale (BBPS), adequate defined as BBPS ≥ 2 in each segment. Secondary outcomes included excellent bowel preparation defined as BBPS = 3 in each segment, nausea, vomiting, willingness to repeat the cleansing, and lesion detection defined as polyp, adenoma, sessile serrated lesion, and cancer detection.

Results

1275 participants were randomized to 1 L-PEG-Asc (n = 629) or 2 L-PEG-Asc (n = 646). 1 L-PEG-Asc achieved superior frequencies for adequate (92.2% vs. 86.1%, p < 0.001) and excellent preparation (59.2% vs. 43.8%, p < 0.001). Nausea (57.4% vs. 46.6%, p < 0.001) and vomiting (13.9% vs. 8.7%, p = 0.006) were more frequent in the 1 L-PEG-Asc group. Despite this, more participants were willing to repeat cleansing with this agent again (82% vs. 76%, p = 0.009). No difference was seen among lesion detection between the groups.

Conclusions

1 L-PEG-Asc showed superior bowel cleansing efficacy, but increased rates of vomit and nausea compared to 2 L-PEG-Asc. Despite this, willingness to repeat the cleansing with the same agent was more frequent in the 1 L-PEG-Asc group.

Trial registration

EudraCT number: 2018-003304-39. Trial registration date 29/10 2018, study start date 17/10 2019.