Hospitalization or Ambulatory Treatment of Acute Diverticulitis (01DIVER)
Primary Purpose
Diverticulitis
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ambulatory versus hospitalisation
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulitis focused on measuring Diverticulitis, Not complicated diverticulitis
Eligibility 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
Sites / Locations
- Hospital Universitari Bellvitge, Colorectal Unit
- Hospital Virgen del Camino
- Hospital Universitari de la Vall d´Hebron
- Hospital Universitari de Girona Doctor Josep Trueta
- Hospital Clinico Universitario De Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Ambulatory Treatment
Hospital treatment
Arm Description
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.
Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01081054
First Posted
March 4, 2010
Last Updated
June 10, 2012
Sponsor
Hospital Universitari de Bellvitge
1. Study Identification
Unique Protocol Identification Number
NCT01081054
Brief Title
Hospitalization or Ambulatory Treatment of Acute Diverticulitis
Acronym
01DIVER
Official Title
Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
Keywords
Diverticulitis, Not complicated diverticulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ambulatory Treatment
Arm Type
Other
Arm Description
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.
Arm Title
Hospital treatment
Arm Type
Active Comparator
Arm Description
Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally.
Intervention Type
Other
Intervention Name(s)
Ambulatory versus hospitalisation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment failure
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Recurrence, quality of life, costs
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastiano Biondo, MD, PhD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Bellvitge, Colorectal Unit
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Virgen del Camino
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari de la Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari de Girona Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Clinico Universitario De Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
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Hospitalization or Ambulatory Treatment of Acute Diverticulitis
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