This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H-2 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 H-2, CH4, and O-2 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 H-2 or CH4 concentrations above the critical thresholds. In patients with H-2 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 H-2 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 () and with EudraCT (eudract_number: 2019-002856-18).

Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study / M. Carnovali, C. Spada, P. Uebel, P. Bocus, R. Cannizzaro, F. Cavallaro, B.M. Cesana, P. Cesaro, G. Costamagna, D. Dipaolo, A.P. Ferrari, C. Hinkel, S. Kashin, A. Massella, E. Melnikova, A. Orsatti, T. Ponchon, A. Prada, F. Radaelli, S. Sferrazza, P. Soru, P.A. Testoni, G.E. Tontini, M. Vecchi, G. Fiori, A. Zade Samir, A. Arnaldo, A. Adriano, A. Jean Pierre, A. Simona, B. Marco, B. Serge, B. Marco, B. Pierre, B. Giulia, B. Dimitriy, B. Ivana, B. Natalia, B. Elena, C. Sergio, C. Sonia, C. Elena Yurievna, C. Giorgio, C. Cristina, C. Manuela, E. Luca, F. Olga, H. Dirk, J. Ralf, J. Daniel, K. Olga, K. Irina, K. Alexandr, L. Vincenza, L. Mauro, M. Stefania, M. Gianpiero, M. Giuseppina, M. Ekaterina, M. Donatella, M. Massimiliano, O. Pietro, P. Marta, P. Lucio, P. Mathieu, P. Antonio, P. Ekaterina, P. Cinzia, P. Marta, R. Stefano, R. Pamela, R. Penagini, R. Kuvaev, R. Emanuele, S. Mario, S. Sergio, S. Kirill, S. Luisa, T. Cristina, V. Jean Christophe, V. Natalino, V. Victor, V. Edi, V. Johanna, Z. Dmitry, Z. Tim. - In: CLINICAL AND TRANSLATIONAL SCIENCE. - ISSN 1752-8062. - (2023), pp. 1-11. [Epub ahead of print] [10.1111/cts.13486]

Factors influencing the presence of potentially explosive gases during colonoscopy: Results of the SATISFACTION study

G.E. Tontini;M. Vecchi;
2023

Abstract

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H-2 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 H-2, CH4, and O-2 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 H-2 or CH4 concentrations above the critical thresholds. In patients with H-2 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 H-2 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 () and with EudraCT (eudract_number: 2019-002856-18).
Settore MED/12 - Gastroenterologia
2023
17-feb-2023
Article (author)
File in questo prodotto:
File Dimensione Formato  
Clinical Translational Sci - 2023 - Carnovali - Factors influencing the presence of potentially explosive gases during.pdf

accesso aperto

Descrizione: Article
Tipologia: Publisher's version/PDF
Dimensione 720.02 kB
Formato Adobe PDF
720.02 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/964856
Citazioni
  • ???jsp.display-item.citation.pmc??? 0
  • Scopus 4
  • ???jsp.display-item.citation.isi??? 4
social impact