Mannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial.

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.