Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

• Sponsor: Uppsala University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01008488
• Collaborator: Landstinget i Värmland (Other)
• Enrollment: 600
• Location: 1
• Arms: 2
• Duration (Months): 97
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2002
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. discharge without complications +/- antibiotic therapy [Within 30 days after discharge]

Secondary Outcome Measures

1. to evaluate length of hospital stay, cost and late complications [one year after admission]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Central Hospital	Västerås	Västmanland	Sweden

Sponsors and Collaborators

• Uppsala University
• Landstinget i Värmland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: achabok, MD, Uppsala University
• ClinicalTrials.gov Identifier: NCT01008488
• Other Study ID Numbers: AVOD-D33
• First Posted: Nov 5, 2009
• Last Update Posted: Dec 23, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by achabok, MD, Uppsala University: colonic diverticulitis; diverticular disease; antibiotic therapy
• Additional relevant MeSH terms: Diverticulitis; Diverticulitis, Colonic; Anti-Bacterial Agents

Study Results

No Results Posted as of Dec 23, 2011