This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).
Carnovali, M., Spada, C., Uebel, P., Bocus, P., Cannizzaro, R., Cavallaro, F., Cesana, B. M., Cesaro, P., Costamagna, G., Dipaolo, D., Ferrari, A. P., Hinkel, C., Kashin, S., Massella, A., Melnikova, E., Orsatti, A., Ponchon, T., Prada, A., Radaelli, F., Sferrazza, S., Soru, P., Testoni, P. A., Tontini, G. E., Vecchi, M., Fiori, G., Adyshirin, Z. S., Amato, A., Anesi, A., Arpurt, J. P., Attardo, S., Balzarini, M., Bellon, S., Benini, M., Blanc, P., Bonato, G., Bordin, D., Bravi, I., Bulanova, N., Bunkova, E., Cadoni, S., Carparelli, S., Chashkova, E. Y., Ciprandi, G., Ciuffini, C., Codazzi, M., Elli, L., Fedorishina, O., Hartmann, D., Jakobs, R., Janke, D., Kamalova, O., Karpova, I., Khitaryan, A., Lombardo, V., Lovera, M., Maiero, S., Manes, G., Martino, G., Merkulova, E., Mura, D., Mutignani, M., Occhipinti, P., Pescarolo, M., Petruzziello, L., Pioche, M., Pisani, A., Poltorykhina, E., Pretti, C., Puzzono, M., Realdon, S., Reiche, P., Roberto, P., Roman, K., Rondonotti, E., Schettino, M., Segato, S., Shishin, K., Spina, L., Stefania, M., Trovato, C., Valats, J. C., Vena, N., Veselov, V., Viale, E., Vollmar, J., Zavyalov, D., Zimmermann, T. A., Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study, <<CLINICAL AND TRANSLATIONAL SCIENCE>>, 2023; 16 (5): 759-769. [doi:10.1111/cts.13486] [https://hdl.handle.net/10807/250874]
Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study
Spada, Cristiano;Cannizzaro, Rino;Cavallaro, Fabio;Cesana, Bruno Mario;Cesaro, Paola;Costamagna, Guido;Sferrazza, Silvia;Amato, Arianna;Ciprandi, Guido;Ciuffini, Cristina;Lovera, Mauro;Mutignani, Massimiliano;Petruzziello, Lucio;Zimmermann, Thomas Alexander
2023
Abstract
This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).
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