Article
Author: SPINA, Luisa ; VETRONE, Lorenzo Maria ; GARANINA, Elena ; Veselov, Victor ; Hinkel, Carsten ; PENAGINI, Roberto ; LOMBARDO, Vincenza ; SCHETTINO, Mario ; BUNKOVA, Elena ; Melnikova, Ekaterina ; ARPURT, Jean Pierre ; Costamagna, Guido ; RONDONOTTI, Emanuele ; BENINI, Marco ; REALDON, Stefano ; BLANC, Pierre ; CANNIZZARO, Renato ; DICEMBRE, Luca Pio ; OCCHIPINTI, Pietro ; TESTONI, Pier Alberto ; Jakobs, Ralf ; AMATO, Arnaldo ; GUSEYNOVA, Sabina ; OREKHOV, Aleksei ; NIKOLSKAYA, Karine ; PUZZONO, Marta ; BULANOVA, Natalia ; RUDLER, Franz ; TUKTAGULOV, Nikita ; KUVAEV, Roman ; Fiori, Giancarla ; Sferrazza, Sandro ; Paolo, Dhanai Di ; MAIERO, Stefania ; ZIMMERMANN, Tim ; VLADIMIROVA, Alexandra Alekseevna ; BALZARINI, Marco ; Prada, Alberto ; Elli, Luca ; OVECHKIN, Vyacheslav ; Cesaro, Paola ; Fedorishina, Olga ; REICHE, Pamela ; CAVALLARO, Flaminia ; VOLLMAR, Johanna ; BOSSA, Fabrizio ; Magnoli, Michela ; PISANI, Antonio ; HERBERG, Philipp ; MASSELLA, Arianna ; PRETTI, Cinzia ; BRAVI, Ivana ; Spada, Cristiano ; Uebel, Peter ; NEUSTROEV, Vladimir Gennadievich ; Orsatti, Anna ; PAPPARELLA, Luigi Giovanni ; Valats, Jean Christophe ; Tontini, Gian Eugenio ; Ponchon, Thierry ; BORDIN, Dmitry ; CADONI, Sergio ; BONATO, Giulia ; LOVERA, Mauro ; JANKE, Daniel ; GUERRA, Maria ; Vecchi, Maurizio ; PIOCHE, Mathieu ; Radaelli, Franco ; Kashin, Sergey ; BELLON, Serge ; Bocus, Paolo ; DEVANI, Massimo ; Carnovali, Marino ; CODAZZI, Manuela ; CIPRANDI, Giorgio ; MARANGI, Stefania ; ZARA, Federica ; MUTIGNANI, Massimiliano ; SEGATO, Sergio ; ATTARDO, Simona ; KHITARYAN, Alexandr ; TROVATO, Cristina ; Soru, Pietro ; Manes, Gianpiero ; HARTMANN, Dirk ; SHAPINA, Marina ; VIALE, Edi
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.