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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Diverticulitis
 Other: Ambulatory versus hospitalisation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 132
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
Active Comparator: Hospital treatment
Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081054

Locations
Spain
Hospital Universitari Bellvitge, Colorectal Unit
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Virgen del Camino
Pamplona, Navarra, Spain, 31008
Hospital Universitari de la Vall d´Hebron
Barcelona, Spain, 08035
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain, 17007
Hospital Clinico Universitario De Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Sebastiano Biondo, MD, PhD Hospital Universitari de Bellvitge
  More Information

No publications provided

Responsible Party: Sebastiano Biondo, S. Biondo, MD, PhD, Colorectal Unit, Department of Surgery, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01081054     History of Changes
Other Study ID Numbers: 01DIVER, 2008-008452-17
Study First Received: March 4, 2010
Last Updated: June 10, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Diverticulitis
Not complicated diverticulitis

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013