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Mannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial
Maurizio Vecchi1, Gian Eugenio Tontini1, Giancarla Fiori2
1Department of Pathophysiology and Organ Transplantation, University of Milan, Milan, Italy; IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Milan, Italy.
Background:
Bowel preparation represents a significant issue to high-quality colonoscopy. Oral mannitol requires a single dose, is of low volume, and has a pleasant taste and rapid action.
Aims:
This SATISFACTION study compared single-dose (same day) oral mannitol 100 g/750 mL with standard split-dose PEG-ASC2 L (MoviPrep®).
Methods:
The primary endpoint was the proportion of patients with adequate bowel cleansing. Secondary endpoints included efficacy (adenoma detection rate, caecal intubation rate, time of evacuation), safety (intestinal gases concentration, haemato-chemical parameters, adverse events), and patient satisfaction.
Results:
The study included 703 patients (352 treated with mannitol and 351 with PEG-ASC). Mannitol was not inferior to PEG-ASC for the primary endpoint (91.1 % and 95.5 %, respectively; p-value for the non-inferiority =0.0131). There was no significant difference for secondary efficacy endpoints. The acceptability profile was significantly better in the mannitol group for ease of use, taste, and willingness to reuse (p < 0.0001 for all). The concentration of intestinal gases (H2, CH4) was similar between groups and well below those potentially critical.
Conclusions:
The SATISFACTION study indicated that low-volume, single-dose mannitol may satisfy an unmet clinical need since it was more acceptable to the patient and not inferior to the split-dose PEG-ASC for bowel cleansing efficacy.
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