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).

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.