Hospitalization or Ambulatory Treatment of Acute Diverticulitis
NCT01081054 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2012-06-12
Summary
The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.
Conditions
- Diverticulitis
Interventions
- OTHER
-
Ambulatory versus hospitalisation
Patients are treated with the same antibiotic agent, the difference between the two arms is endovenous treatment for hospitalized patients for the first days till oral feeding. The ambulatory group starts directly with orally administered antibiotic treatment.
Sponsors & Collaborators
-
Hospital Universitari de Bellvitge
lead OTHER
Principal Investigators
-
Sebastiano Biondo, MD, PhD · Hospital Universitari de Bellvitge
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2012-06-30
- Completion
- 2012-06-30
Countries
- Spain
Study Locations
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