Giovanni Di Nardo1, Marina Aloi2, Salvatore Cucchiara2, Cristiano Spada3, Cesare Hassan3, Fortunata Civitelli2, Federica Nuti2, Chiara Ziparo2, Andrea Pession4, Mario Lima5, Giuseppe La Torre6, Salvatore Oliva2. 1. Departments of Pediatrics, Pediatric Gastroenterology Unit, and giovanni.dinardo@uniroma1.it. 2. Departments of Pediatrics, Pediatric Gastroenterology Unit, and. 3. Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Rome, Italy; and. 4. Departments of Paediatrics, Pediatric Gastroenterology and Nutrition Unit, and. 5. Pediatric Surgery, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. 6. Public Health and Infectious Diseases, "Sapienza" University of Rome, Rome, Italy;
Abstract
BACKGROUND: The ideal preparation regimen for pediatric colonoscopy remains elusive, and available preparations continue to represent a challenge for children. The aim of this study was to compare the efficacy, safety, tolerability, and acceptance of 4 methods of bowel cleansing before colonoscopy in children. METHODS: This randomized, investigator-blinded, noninferiority trial enrolled all children aged 2 to 18 years undergoing elective colonoscopy in a referral center for pediatric gastroenterology. Patients were randomly assigned to receive polyethylene glycol (PEG) 4000 with simethicon (PEG-ELS group) or PEG-4000 with citrates and simethicone plus bisacodyl (PEG-CS+Bisacodyl group), or PEG 3350 with ascorbic acid (PEG-Asc group), or sodium picosulfate plus magnesium oxide and citric acid (NaPico+MgCit group). Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale. The primary end point was overall colon cleansing. Tolerability, acceptability, and compliance were also evaluated. RESULTS:Two hundred ninety-nine patients were randomly allocated to the 4 groups. In the per-protocol analysis, PEG-CS+Bisacodyl, PEG-Asc, and NaPico+MgCit were noninferior to PEG-ELS in bowel-cleansing efficacy of both the whole colon (P = .910) and colonic segments. No serious adverse events occurred in any group. Rates of tolerability, acceptability, and compliance were significantly higher in the NaPico+MgCit group. CONCLUSIONS: Low-volume PEG preparations (PEG-CS+Bisacodyl, PEG-Asc) and NaPico+MgCit are noninferior to PEG-ELS in children, representing an attractive alternative to high-volume regimens in clinical practice. Because of the higher tolerability and acceptability profile, NaPico+MgCit would appear as the most suitable regimen for bowel preparation in children.
RCT Entities:
BACKGROUND: The ideal preparation regimen for pediatric colonoscopy remains elusive, and available preparations continue to represent a challenge for children. The aim of this study was to compare the efficacy, safety, tolerability, and acceptance of 4 methods of bowel cleansing before colonoscopy in children. METHODS: This randomized, investigator-blinded, noninferiority trial enrolled all children aged 2 to 18 years undergoing elective colonoscopy in a referral center for pediatric gastroenterology. Patients were randomly assigned to receive polyethylene glycol (PEG) 4000 with simethicon (PEG-ELS group) or PEG-4000 with citrates and simethicone plus bisacodyl (PEG-CS+Bisacodyl group), or PEG 3350 with ascorbic acid (PEG-Asc group), or sodium picosulfate plus magnesium oxide and citric acid (NaPico+MgCit group). Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale. The primary end point was overall colon cleansing. Tolerability, acceptability, and compliance were also evaluated. RESULTS: Two hundred ninety-nine patients were randomly allocated to the 4 groups. In the per-protocol analysis, PEG-CS+Bisacodyl, PEG-Asc, and NaPico+MgCit were noninferior to PEG-ELS in bowel-cleansing efficacy of both the whole colon (P = .910) and colonic segments. No serious adverse events occurred in any group. Rates of tolerability, acceptability, and compliance were significantly higher in the NaPico+MgCit group. CONCLUSIONS: Low-volume PEG preparations (PEG-CS+Bisacodyl, PEG-Asc) and NaPico+MgCit are noninferior to PEG-ELS in children, representing an attractive alternative to high-volume regimens in clinical practice. Because of the higher tolerability and acceptability profile, NaPico+MgCit would appear as the most suitable regimen for bowel preparation in children.
Authors: Thomas Berger; Martin Classen; Harald Engelhardt; Klaus-Michael Keller; Martin W Laass; Ralph Melchior; Carsten Posovszky; Burkhard Rodeck; Katharina Schaper; Rolf Behrens Journal: Endosc Int Open Date: 2016-06-02
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