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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008452-17 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory Treatment | Other | 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. |
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| Hospital treatment | Active Comparator | Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory versus hospitalisation | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastiano Biondo, MD, PhD | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de la Vall d“Hebron | Barcelona | Barcelona | 08035 | Spain | ||
| Hospital Universitari Bellvitge, Colorectal Unit |
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| ID | Term |
|---|---|
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| Hospital Universitari de Girona Doctor Josep Trueta | Girona | Girona | 17007 | Spain |
| Hospital Virgen del Camino | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinico Universitario De Valencia | Valencia | Valencia | 46010 | Spain |