TY - JOUR
T1 - Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study)
T2 - A Multicentre, Randomised, Open-label, Noninferiority Trial
AU - Mora-López, Laura
AU - Ruiz-Edo, Neus
AU - Estrada-Ferrer, Oscar
AU - Piñana-Campón, Maria Luisa
AU - Labró-Ciurans, Meritxell
AU - Escuder-Perez, Jordi
AU - Sales-Mallafré, Ricard
AU - Rebasa-Cladera, Pere
AU - Navarro-Soto, Salvador
AU - Serra-Aracil, Xavier
N1 - Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2021/11/1
Y1 - 2021/11/1
N2 - OBJECTIVE: Mild AD can be treated safely and effectively on an outpatient basis without antibiotics. SUMMARY OF BACKGROUND DATA: In 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. METHODS: A 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. RESULTS: Four 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). CONCLUSIONS: Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).
AB - OBJECTIVE: Mild AD can be treated safely and effectively on an outpatient basis without antibiotics. SUMMARY OF BACKGROUND DATA: In 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. METHODS: A 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. RESULTS: Four 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). CONCLUSIONS: Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).
KW - Acute Disease
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Ambulatory Care/methods
KW - Anti-Bacterial Agents
KW - Disease Management
KW - Diverticulitis, Colonic/diagnosis
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Outpatients
KW - Prospective Studies
KW - Tomography, X-Ray Computed
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=85117582692&partnerID=8YFLogxK
U2 - 10.1097/SLA.0000000000005031
DO - 10.1097/SLA.0000000000005031
M3 - Article
C2 - 34183510
AN - SCOPUS:85117582692
SN - 0003-4932
VL - 274
SP - e435-e442
JO - Annals of Surgery
JF - Annals of Surgery
IS - 5
ER -