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Clinical Trials/EUCTR2016-001596-75-ES
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.

Registry
who.int
Start Date
August 5, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundació Parc Taulí

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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