• Laura Mora-López, Neus Ruiz-Edo, Oscar Estrada-Ferrer, Maria Luisa Piñana-Campón, Meritxell Labró-Ciurans, Jordi Escuder-Perez, Ricard Sales-Mallafré, Pere Rebasa-Cladera, Salvador Navarro-Soto, Xavier Serra-Aracil, and DINAMO-study Group.
• Coloproctology Unit. Parc Tauli University Hospital, Sabadell. Institut d'investigació i innovació Parc Tauli I3PT. Despartment of Surgery, Universitat Autonoma de Barcelona, Spain.
• Ann. Surg. 2021 Nov 1; 274 (5): e435-e442.

ObjectiveMild AD can be treated safely and effectively on an outpatient basis without antibiotics.Summary Of Background DataIn recent years, it has shown no benefit of antibiotics in the treatment of uncomplicated AD in hospitalized patients. Also, outpatient treatment of uncomplicated AD has been shown to be safe and effective.MethodsA Prospective, multicentre, open-label, noninferiority, randomized controlled trial, in 15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria were randomly assigned to control arm (ATB-Group): classical treatment (875/125 mg/8 h amoxicillin/clavulanic acid apart from anti-inflammatory and symptomatic treatment) or experimental arm (Non-ATB-Group): experimental treatment (antiinflammatory and symptomatic treatment). Clinical controls were performed at 2, 7, 30, and 90 days.The primary endpoint was hospital admission. Secondary endpoints included number of emergency department revisits, pain control and emergency surgery in the different arms.ResultsFour hundred and eighty patients meeting the inclusion criteria were randomly assigned to Non-ATB-Group (n = 242) or ATB-Group (n = 238). Hospitalization rates were: ATB-Group 14/238 (5.8%) and Non-ATB-Group 8/242 (3.3%) [mean difference 2.58%, 95% confidence interval (CI) 6.32 to -1.17], confirming noninferiority margin. Revisits: ATB-Group 16/238 (6.7%) and Non-ATB-Group 17/242 (7%) (mean difference -0.3, 95% CI 4.22 to -4.83). Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18).ConclusionsNonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment.Trial RegistrationClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

23 keywords...

hide…