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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

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.


Condition or disease Intervention/treatment Phase
Colonic Diverticulitis Drug: Antibiotic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
Study Start Date : November 2002
Actual Primary Completion Date : May 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Antibiotic Drug: Antibiotic
Antibiotic according to local treatment routine against bowel pathogenesis

No Intervention: No antibiotic



Primary Outcome Measures :
  1. discharge without complications +/- antibiotic therapy [ Time Frame: Within 30 days after discharge ]

Secondary Outcome Measures :
  1. to evaluate length of hospital stay, cost and late complications [ Time Frame: one year after admission ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008488


Locations
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Sweden
The Central Hospital
Västerås, Västmanland, Sweden
Sponsors and Collaborators
Uppsala University
Landstinget i Värmland
Investigators
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Principal Investigator: Kenneth Smedh Center of Clinical Research, Västerås

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: achabok, MD, Uppsala University
ClinicalTrials.gov Identifier: NCT01008488     History of Changes
Other Study ID Numbers: AVOD-D33
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Keywords provided by achabok, Uppsala University:
colonic diverticulitis
diverticular disease
antibiotic therapy

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Diverticulitis
Diverticulitis, Colonic
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases