Hospitalization or Ambulatory Treatment of Acute Diverticulitis (01DIVER)

Catalan Institute of Health

Status and phase: Completed; Phase 4

Conditions: Diverticulitis

Treatments: Other: Ambulatory versus hospitalisation

Study type: Interventional

Funder types: Other

Identifiers

NCT01081054

2008-008452-17 (EudraCT Number)

01DIVER

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age older than 18 years
• Diagnosis of mild diverticulitis by abdominal computerized tomography
• Signed informed consent

Exclusion criteria

• Severe diverticulitis
• Informed consent not signed
• Suspicion of colon cancer
• Pneumoperitoneum
• Intolerance for oral feeding
• Antibiotics for diverticulitis in the last month
• Immunosuppression
• Pregnancy or lactation
• Severe (decompensated) other illness
• Psychological or social problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Ambulatory Treatment

Other group

Description:

Patients are treated ambulatory with oral antibiotic for 10 days; for the first five days these patients are contacted by telephone daily to progress oral intake.

Treatment:

Other: Ambulatory versus hospitalisation

Hospital treatment

Active Comparator group

Description:

Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally.

Treatment:

Other: Ambulatory versus hospitalisation