Hospitalization or Ambulatory Treatment of Acute Diverticulitis (01DIVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01081054
First received: March 4, 2010
Last updated: June 10, 2012
Last verified: June 2012

March 4, 2010
June 10, 2012
September 2009
June 2012   (final data collection date for primary outcome measure)
Treatment failure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01081054 on ClinicalTrials.gov Archive Site
Recurrence, quality of life, costs [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Hospitalization or Ambulatory Treatment of Acute Diverticulitis
Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diverticulitis
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.
  • 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.
    Intervention: Other: Ambulatory versus hospitalisation
  • Active Comparator: Hospital treatment
    Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally.
    Intervention: Other: Ambulatory versus hospitalisation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01081054
01DIVER, 2008-008452-17
No
Sebastiano Biondo, Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
Not Provided
Principal Investigator: Sebastiano Biondo, MD, PhD Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP