Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

NCT ID: NCT01008488

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Diverticulitis

Keywords

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colonic diverticulitis diverticular disease antibiotic therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibiotic

Group Type ACTIVE_COMPARATOR

Antibiotic

Intervention Type DRUG

Antibiotic according to local treatment routine against bowel pathogenesis

No antibiotic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antibiotic

Antibiotic according to local treatment routine against bowel pathogenesis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landstinget i Värmland

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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achabok

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Smedh

Role: PRINCIPAL_INVESTIGATOR

Center of Clinical Research, Västerås

Locations

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The Central Hospital

Västerås, Västmanland County, Sweden

Site Status

Countries

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Sweden

References

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Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.

Reference Type DERIVED
PMID: 22290281 (View on PubMed)

Other Identifiers

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AVOD-D33

Identifier Type: -

Identifier Source: org_study_id