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OpenTrials
Completed

NCT Number: NCT01008488

Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

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.

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Key information

Conditions

Colonic Diverticulitis Colonic Diseases Digestive System Diseases Diverticular Diseases Diverticulitis Diverticulitis, Colonic Diverticulosis, Colonic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Central Hospital

Västerås, Västmanland County, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic

Drug

Antibiotic according to local treatment routine against bowel pathogenesis

Primary outcomes

  1. discharge without complications +/- antibiotic therapy

    Time frame: Within 30 days after discharge

Secondary outcomes

  1. to evaluate length of hospital stay, cost and late complications

    Time frame: one year after admission

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Landstinget i Värmland

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Nov 5, 2009
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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