Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 4, 2009
CompletedFirst Posted
Study publicly available on registry
November 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 23, 2011
December 1, 2011
7.5 years
November 4, 2009
December 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
discharge without complications +/- antibiotic therapy
Within 30 days after discharge
Secondary Outcomes (1)
to evaluate length of hospital stay, cost and late complications
one year after admission
Study Arms (2)
Antibiotic
ACTIVE COMPARATORNo antibiotic
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- adults with CT sign of acute colonic uncomplicated diverticulitis
- elevated CRP and LPK
- Temp.38c or more
You may not qualify if:
- patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
- pregnancy
- immunological incompetence and immunosuppressive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Landstinget i Värmlandcollaborator
Study Sites (1)
The Central Hospital
Västerås, Västmanland County, Sweden
Related Publications (1)
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.
PMID: 22290281DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Smedh
Center of Clinical Research, Västerås
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 4, 2009
First Posted
November 5, 2009
Study Start
November 1, 2002
Primary Completion
May 1, 2010
Study Completion
December 1, 2010
Last Updated
December 23, 2011
Record last verified: 2011-12