Miguel Muñoz-Navas1, José Luis Calleja2, Guillermo Payeras3, Antonio José Hervás4, Luis Esteban Abreu5, Víctor Orive6, Pedro L Menchén7, José María Bordas8, José Ramón Armengol9, Cristina Carretero1, Vicente Pons Beltrán10, Inmaculada Alonso-Abreu11, Román Manteca12, Adolfo Parra-Blanco13,14, Fernando Carballo15, Juan Manuel Herrerías16, Carlos Badiola17. 1. Instituto de Investigación Sanitaria de Navarra (Idisna), Clínica Universidad de Navarra, Pamplona, Spain. 2. Department of Gastroenterology, IDIPHIM, Hospital Universitario Puerta de Hierro, Joaquin Rodrigo 2, Majadahonda, 28222, Madrid, Spain. joseluis.calleja@uam.es. 3. Hospital Infanta Elena Valdemoro, Madrid, Spain. 4. Hospital General Universitario Reina Sofía, Córdoba, Spain. 5. Department of Gastroenterology, IDIPHIM, Hospital Universitario Puerta de Hierro, Joaquin Rodrigo 2, Majadahonda, 28222, Madrid, Spain. 6. Hospital Basurto, Bilbao, Spain. 7. Hospital General Universitario Gregorio Marañón, Madrid, Spain. 8. Hospital Clínic de Barcelona, Barcelona, Spain. 9. Hospital Universitari Vall d'Hebrón, Barcelona, Spain. 10. Hospital Universitari i Politècnic la Fe, Valencia, Spain. 11. Hospital Universitario de Canarias, La Laguna, Spain. 12. Hospital Regional Universitario Carlos Haya, Málaga, Spain. 13. Hospital Universitario Central de Asturias, Oviedo, Spain. 14. School of Medicine of Pontificia, Universidad Católica de Chile, Santiago, Chile. 15. Hospital Universitario Virgen de la Arrixaca, Murcia, Spain. 16. Hospital Virgen Macarena, Sevilla, Spain. 17. Laboratorios Casen Recordati S.L., Zaragoza, Spain.
Abstract
PURPOSE: The purpose of this study is to compare the efficacy and acceptability of an evening-before regimens of sodium picosulfate/magnesium citrate (SPMC) and polyethylene glycol (PEG) as bowel cleansers and to explore the results of a same-day regimen of SPMC. METHODS: Multicenter, randomized, observer-blinded, parallel study carried out in subjects who were 18-80 years old and were undergoing diagnostic colonoscopy for the first time. The primary outcome was treatment success, which was a composite outcome defined by (1) the evaluation of the overall preparation quality as "excellent" or "good" by two blinded independent evaluators with the Fleet(®) Grading Scale for Bowel Cleansing and (2) a subject's acceptability rating of "easy to take" or "tolerable." The primary outcome was analyzed using a logistic regression with site, gender, and age group (age ≥65 years and <65 years) as factors. RESULTS:Four hundred ninety subjects were included in the efficacy evaluation. Although treatment success was significantly higher in subjects assigned to the evening-before regimen of SPMC vs. subjects assigned to the evening-before PEG, when evaluating the two individual components for treatment success, there were significant differences in the ease of completion but not in the quality of preparation. The same-day SPMC regimen was superior to both the evening-before regimen of SPMC and PEG in terms of the quality of preparation, especially regarding the proximal colon. CONCLUSIONS: An evening-before regimen of SPMC is superior to an evening-before regimen of PEG in terms of subject's acceptability. The same-day SPMC regimen provides better cleansing levels in the proximal colon.
RCT Entities:
PURPOSE: The purpose of this study is to compare the efficacy and acceptability of an evening-before regimens of sodium picosulfate/magnesium citrate (SPMC) and polyethylene glycol (PEG) as bowel cleansers and to explore the results of a same-day regimen of SPMC. METHODS: Multicenter, randomized, observer-blinded, parallel study carried out in subjects who were 18-80 years old and were undergoing diagnostic colonoscopy for the first time. The primary outcome was treatment success, which was a composite outcome defined by (1) the evaluation of the overall preparation quality as "excellent" or "good" by two blinded independent evaluators with the Fleet(®) Grading Scale for Bowel Cleansing and (2) a subject's acceptability rating of "easy to take" or "tolerable." The primary outcome was analyzed using a logistic regression with site, gender, and age group (age ≥65 years and <65 years) as factors. RESULTS: Four hundred ninety subjects were included in the efficacy evaluation. Although treatment success was significantly higher in subjects assigned to the evening-before regimen of SPMC vs. subjects assigned to the evening-before PEG, when evaluating the two individual components for treatment success, there were significant differences in the ease of completion but not in the quality of preparation. The same-day SPMC regimen was superior to both the evening-before regimen of SPMC and PEG in terms of the quality of preparation, especially regarding the proximal colon. CONCLUSIONS: An evening-before regimen of SPMC is superior to an evening-before regimen of PEG in terms of subject's acceptability. The same-day SPMC regimen provides better cleansing levels in the proximal colon.
Authors: David H Balaban; Byrd S Leavell; Michael J Oblinger; William O Thompson; Nancy D Bolton; Daniel J Pambianco Journal: Am J Gastroenterol Date: 2003-04 Impact factor: 10.864
Authors: Vladimir Kojecky; Jan Matous; Radan Keil; Milan Dastych; Radek Kroupa; Zdena Zadorova; Michal Varga; Jiri Dolina; Milan Kment; Ales Hep Journal: Int J Colorectal Dis Date: 2017-09-24 Impact factor: 2.571
Authors: Ralf Kiesslich; Stefan Schubert; Michael Mross; Tobias Klugmann; Michael Klemt-Kropp; Imke Behnken; Gillaume Bonnaud; Eric Keulen; Marcel Groenen; Michael Blaker; Thierry Ponchon; Wilfred Landry; Meredin Stoltenberg Journal: Endosc Int Open Date: 2017-04