Hospitalization or Ambulatory Treatment of Acute Diverticulitis

Phase 4

Completed

• Conditions: Diverticulitis
• Interventions: Other: Ambulatory versus hospitalisation

• Registration Number: NCT01081054
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-10
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambulatory Treatment	Ambulatory versus hospitalisation	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.
Hospital treatment	Ambulatory versus hospitalisation	Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally.

Primary Outcome Measures

Name	Time	Method
Treatment failure	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence, quality of life, costs	30 days	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.

Trial Locations

Locations (5)

Hospital Universitari Bellvitge, Colorectal Unit; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Virgen del Camino; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitari de la Vall d´Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitari de Girona Doctor Josep Trueta; 🇪🇸 Girona, Spain

Hospital Clinico Universitario De Valencia; 🇪🇸 Valencia, Spain