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)

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