EUCTR2016-001596-75-ES
Active, not recruiting
Phase 1
Multicentre controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics
Fundació Parc Taulí0 sitesAugust 5, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Mild acute diverticulitis
- Sponsor
- Fundació Parc Taulí
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 80 years old
- •Patients with acute diverticulitis grade 0 according to the modified Neff classification
- •Absence of acute diverticulitis episode in the previous 3 months
- •No treatment with antibiotics for any reason within the previous 2 weeks
- •Absence of relevant comorbidities
- •Patients giving their informed consent to participate in the study. Adecuate cognitive functions
- •Good family support
- •Good symptom control at emergency room
- •Oral tolerance
- •Immunocompetent patients
Exclusion Criteria
- •Pregnant or breast feeding women
- •Younguer than 18 years or older than 80 years
- •Patients with acute diverticulitis grade I or more according to the Neff classification
- •Acute diverticulitis episode within the last 3 months
- •Imflammatory Bowel Disease
- •Atibiotic intake in the previous 2 weeks
- •Presence of relevant comorbidities
- •Contraindications or alergy to any of the study treatments (amoxicillin\-clavulanic, parecetamol, ibuprofen, omeprazol)
- •Patients unable to give their informed consent freely. Unadequate cognitive function
- •absence of good family support
Outcomes
Primary Outcomes
Not specified
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