Hospitalization or Ambulatory Treatment of Acute Diverticulitis

Diverticulitis Clinical Trial

— 01DIVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081054
• Other study ID #: 01DIVER
• Secondary ID: 2008-008452-17
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2010
• Last updated: June 10, 2012
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari de la Vall d´Hebron	Barcelona
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona
Spain	Hospital Universitari Bellvitge, Colorectal Unit	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Virgen del Camino	Pamplona	Navarra
Spain	Hospital Clinico Universitario De Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No