Hospitalization or Ambulatory Treatment of Acute Diverticulitis

Study Overview
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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.

Official Title
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Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment

Conditions
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Diverticulitis

Intervention / Treatment
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* Other: Ambulatory versus hospitalisation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ambulatory Treatment<br>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. | Other: Ambulatory versus hospitalisation<br>* 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.<br>|
| Active Comparator: Hospital treatment<br>Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally. | Other: Ambulatory versus hospitalisation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | Failure of the conservative treatment within 30 days after randomization which consists in one or more of the mentioned signs: persistent or increasing pain, treatment resistant fever, intestinal oclusion, necesity to drain a new intra-abdominal abscess, indication for surgery, mortality. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence, quality of life, costs | Recurrence of diverticulitis within 30 days; quality of life and patient satisfaction is asessed comparing management with and without admittance to the hospital and costs are calculated for the treatment in both regimens. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diverticulitis, Not complicated diverticulitis