Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

December 22, 2011 updated by: achabok, Uppsala University

Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västmanland
      • Västerås, Västmanland, Sweden
        • The Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antibiotic
Drug: Antibiotic
Antibiotic according to local treatment routine against bowel pathogenesis
No Intervention: No antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
discharge without complications +/- antibiotic therapy
Time Frame: Within 30 days after discharge
Within 30 days after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
to evaluate length of hospital stay, cost and late complications
Time Frame: one year after admission
one year after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Landstinget i Värmland

Investigators

  • Principal Investigator: Kenneth Smedh, Center of Clinical Research, Västerås

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 4, 2009

First Submitted That Met QC Criteria

November 4, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2011

Last Update Submitted That Met QC Criteria

December 22, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVOD-D33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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