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

作者信息

Vecchi Maurizio, Tontini Gian Eugenio, Fiori Giancarla, Bocus Paolo, Carnovali Marino, Cesaro Paola, Costamagna Guido, Paolo Dhanai Di, Elli Luca, Fedorishina Olga, Hinkel Carsten, Jakobs Ralf, Kashin Sergey, Magnoli Michela, Manes Gianpiero, Melnikova Ekaterina, Orsatti Anna, Ponchon Thierry, Prada Alberto, Radaelli Franco, Sferrazza Sandro, Soru Pietro, Valats Jean Christophe, Veselov Victor, Spada Cristiano, Uebel Peter

机构信息

Department of Pathophysiology and Organ Transplantation, University of Milan, Milan, Italy; IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Milan, Italy.

Divisione di Endoscopia, Istituto Europeo di Oncologia, IRCCS, Milan, Italy.

出版信息

Dig Liver Dis. 2025 Feb;57(2):574-583. doi: 10.1016/j.dld.2024.09.024. Epub 2024 Nov 18.

DOI:
10.1016/j.dld.2024.09.024
PMID:39562215
Abstract

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 (H, CH) 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.

摘要

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