RESUMO
BACKGROUND AND STUDY AIMS: The high volume and poor palatability of 4âL of polyethylene glycol (PEG)-based bowel cleansing preparation required before a colonoscopy represent a major obstacle for patients. The aim of this study was to compare two low volume PEG-based preparations with standard 4âL PEG in individuals with a positive fecal immunochemical test (FIT) within organized screening programs in Italy. PATIENTS AND METHODS: A total of 3660 patients with a positive FIT result were randomized to receive, in a split-dose regimen, 4âL PEG or 2âL PEG plus ascorbate (PEG-A) or 2âL PEG with citrate and simethicone plus bisacodyl (PEG-CS). The noninferiority of the low volume preparations vs. 4âL PEG was tested through the difference in proportions of adequate cleansing. RESULTS: A total of 2802 patients were included in the study. Adequate bowel cleansing was achieved in 868 of 926 cases (93.7â%) in the 4âL PEG group, in 872 out of 911 cases in the PEG-A group (95.7â%, difference in proportions â+â1.9â%, 95â% confidence interval [CI] â-â0.1 to 3.9), and in 862 out of 921 cases in the PEG-CS group (93.6â%, difference in proportionsâ -â0.2â%, 95â%CI â-â2.4 to 2.0). Bowel cleansing was adequate in 95.5â% of cases when the preparation-to-colonoscopy interval was between 120 and 239 minutes, whereas it dropped to 83.3â% with longer intervals. Better cleansing was observed in patients with regular bowel movements (95.6â%) compared with those with diarrhea (92.4â%) or constipation (90.8â%). CONCLUSION: Low volume PEG-based preparations administered in a split-dose regimen guarantee noninferior bowel cleansing compared with 4âL PEG. Constipated patients require a personalized preparation. TRIAL REGISTRATION: EudraCT 2012â-â003958â-â82.