Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

Colonic Diverticulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008488
• Other study ID #: AVOD-D33
• Status: Completed
• Phase: N/A
• First received: November 4, 2009
• Last updated: December 22, 2011
• Start date: November 2002
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Diverticulitis
• Diverticulitis
• Diverticulitis, Colonic

Intervention

Drug:
• Antibiotic
Antibiotic according to local treatment routine against bowel pathogenesis

Locations

Country	Name	City	State
Sweden	The Central Hospital	Västerås	Västmanland

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Landstinget i Värmland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	discharge without complications +/- antibiotic therapy		Within 30 days after discharge	Yes
Secondary	to evaluate length of hospital stay, cost and late complications		one year after admission	No