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Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

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ClinicalTrials.gov Identifier: NCT01008488
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : December 23, 2011
Sponsor:
Collaborator:
Landstinget i Värmland
Information provided by (Responsible Party):
achabok, Uppsala University

Tracking Information
First Submitted Date  ICMJE November 4, 2009
First Posted Date  ICMJE November 5, 2009
Last Update Posted Date December 23, 2011
Study Start Date  ICMJE November 2002
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2009)
discharge without complications +/- antibiotic therapy [ Time Frame: Within 30 days after discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2009)
to evaluate length of hospital stay, cost and late complications [ Time Frame: one year after admission ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
Official Title  ICMJE Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonic Diverticulitis
Intervention  ICMJE Drug: Antibiotic
Antibiotic according to local treatment routine against bowel pathogenesis
Study Arms  ICMJE
  • Active Comparator: Antibiotic
    Intervention: Drug: Antibiotic
  • No Intervention: No antibiotic
Publications * Chabok A, Påhlman 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2009)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008488
Other Study ID Numbers  ICMJE AVOD-D33
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party achabok, Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Landstinget i Värmland
Investigators  ICMJE
Principal Investigator: Kenneth Smedh Center of Clinical Research, Västerås
PRS Account Uppsala University
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP