Hospitalization or Ambulatory Treatment of Acute Diverticulitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diverticulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ambulatory Treatment

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.

Group Type OTHER

Ambulatory versus hospitalisation

Intervention Type OTHER

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.

Hospital treatment

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

Group Type ACTIVE_COMPARATOR

Ambulatory versus hospitalisation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No