DINAMO-study
Trial question
Is nonantibiotic outpatient treatment noninferior to antibiotic treatment in patients with mild acute diverticulitis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 480
480 patients (256 female, 224 male).
Inclusion criteria: adult patients consulting the emergency department with symptoms of acute diverticulitis.
Key exclusion criteria: age < 18 years or > 80 years; allergy to any of the study drugs; modified Neff grade I or upper acute diverticulitis; acute diverticulitis episode in the last 3 months; antibiotic treatment for any reason in the last 2 weeks; presence of significant comorbidities.
Interventions
N=242 non-antibiotic (anti-inflammatory and symptomatic treatment with 600 mg/8 hour ibuprofen alternating with 1 g/8 hour acetaminophen).
N=238 antibiotic (875 mg/125 mg/8 hour amoxicillin/clavulanate apart from anti-inflammatory and symptomatic treatment).
Primary outcome
Hospital admission
3.3%
5.8%
5.8 %
4.3 %
2.9 %
1.4 %
0.0 %
Non-antibiotic
Antibiotic
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in hospital admission (3.3% vs. 5.8%; ARD -2.58, 95% CI -1.17 to 6.32).
Secondary outcomes
No significant difference in emergency department revisits (7% vs. 6.7%; AD 0.3%, 95% CI -4.83 to 4.22).
No significant difference in patients with poor pain control at 2 days (2.3% vs. 5.7%; ARD -3.39, 95% CI -0.18 to 6.96).
Conclusion
In adult patients consulting the emergency department with symptoms of acute diverticulitis, non-antibiotic was noninferior to antibiotic with respect to hospital admission.
Reference
Laura Mora-López, Neus Ruiz-Edo, Oscar Estrada-Ferrer et al. Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial. Ann Surg. 2021 Nov 1;274(5):e435-e442.
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