NCT00469430

Brief Summary

The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 21, 2009

Status Verified

April 1, 2009

Enrollment Period

1.3 years

First QC Date

May 3, 2007

Last Update Submit

April 20, 2009

Conditions

Appendicitis

Keywords

appendicitistreatmentantibiotics

Outcome Measures

Primary Outcomes (1)

  • treatment efficacy

    one year

Secondary Outcomes (1)

  • complications

    one year

Study Arms (2)

Op

NO INTERVENTION

traditional surgery

Ab

EXPERIMENTAL

antibiotic treatment

Drug: cefotaxim and metronidazol

Interventions

cefotaxim and metronidazolDRUG

iv administration for at least 24 h

Ab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected appendicitis in patients over 18 years

You may not qualify if:

  • Under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göteborg University, Sahlgrenska Universitetssjukhuset

Gothenburg, Göteborg, Sweden

Location

Related Publications (3)

  • Eriksson S, Granstrom L. Randomized controlled trial of appendicectomy versus antibiotic therapy for acute appendicitis. Br J Surg. 1995 Feb;82(2):166-9. doi: 10.1002/bjs.1800820207.

    PMID: 7749676BACKGROUND

  • Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, Rex L, Badume I, Granstrom L. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006 Jun;30(6):1033-7. doi: 10.1007/s00268-005-0304-6.

    PMID: 16736333BACKGROUND

  • Hansson J, Korner U, Khorram-Manesh A, Solberg A, Lundholm K. Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients. Br J Surg. 2009 May;96(5):473-81. doi: 10.1002/bjs.6482.

    PMID: 19358184DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

CefotaximeBenchmarking

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

CephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsManagement AuditOrganization and AdministrationHealth Services AdministrationProgram EvaluationQuality of Health CareQuality Assurance, Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation Mechanisms

Study Officials

  • Kent Lundholm

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

May 1, 2006

Primary Completion

September 1, 2007

Study Completion

October 1, 2008

Last Updated

April 21, 2009

Record last verified: 2009-04

Locations

SE(1)