Hospitalization or Ambulatory Treatment of Acute Diverticulitis (01DIVER)

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.

Study Overview

• Status: Completed
• Conditions: Diverticulitis
• Intervention / Treatment: Other: Ambulatory versus hospitalisation

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari de La Vall D´Hebron
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Doctor Josep Trueta
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari Bellvitge, Colorectal Unit
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Virgen del Camino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Sebastiano Biondo, MD, PhD, Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): June 12, 2012
• Last Update Submitted That Met QC Criteria: June 10, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Diverticulitis; Not complicated diverticulitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: 01DIVER; 2008-008452-17 (EudraCT Number)