We have located links that may give you full text access.
EQUIVALENCE TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial.
Annals of Surgery 2021 November 2
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).
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).
Full text links
Related Resources
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices 
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app