Back to resultsAntibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
Primary Purpose
Colonic Diverticulitis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Antibiotic
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Diverticulitis focused on measuring colonic diverticulitis, diverticular disease, antibiotic therapy
Eligibility Criteria
Inclusion Criteria:
- adults with CT sign of acute colonic uncomplicated diverticulitis
- elevated CRP and LPK
- Temp.38c or more
Exclusion Criteria:
- patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
- pregnancy
- immunological incompetence and immunosuppressive therapy
Sites / Locations
- The Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Antibiotic
No antibiotic
Arm Description
Outcomes
Primary Outcome Measures
discharge without complications +/- antibiotic therapy
Secondary Outcome Measures
to evaluate length of hospital stay, cost and late complications
Full Information
NCT ID
NCT01008488
First Posted
November 4, 2009
Last Updated
December 22, 2011
Sponsor
Uppsala University
Collaborators
Landstinget i Värmland
1. Study Identification
Unique Protocol Identification Number
NCT01008488
Brief Title
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
Official Title
Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Landstinget i Värmland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis.
The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications.
The patients will be randomized to conservative treatment with and without antibiotic therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diverticulitis
Keywords
colonic diverticulitis, diverticular disease, antibiotic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic
Arm Type
Active Comparator
Arm Title
No antibiotic
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
Antibiotic according to local treatment routine against bowel pathogenesis
Primary Outcome Measure Information:
Title
discharge without complications +/- antibiotic therapy
Time Frame
Within 30 days after discharge
Secondary Outcome Measure Information:
Title
to evaluate length of hospital stay, cost and late complications
Time Frame
one year after admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with CT sign of acute colonic uncomplicated diverticulitis
elevated CRP and LPK
Temp.38c or more
Exclusion Criteria:
patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
pregnancy
immunological incompetence and immunosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Smedh
Organizational Affiliation
Center of Clinical Research, Västerås
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Central Hospital
City
Västerås
State/Province
Västmanland
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22290281
Citation
Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.
Results Reference
derived
Learn more about this trial
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
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