NCT00630071

Brief Summary

The values of laboratory examinations which are useful for the diagnoses of acute appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). Another laboratory value which has recently received considerable attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (PCT). In recent studies it has been clearly shown that PCT is one of the most important biochemical indicators which closely correlates with the severity of inflammatory host response to microbial infections. Aim of this open, prospective study is therefore to investigate if PCT has an accurate diagnostic value for the diagnosis of acute appendicitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

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

February 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

First QC Date

February 26, 2008

Last Update Submit

October 15, 2012

Conditions

Appendicitis

Keywords

Diagnostic AppendicitisProcalcitonin

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical Emergency Room

You may qualify if:

  • Clinical diagnosis of appendicitis

You may not qualify if:

  • Antibiotic therapy
  • Infection at other body sites
  • Age \< 14 years
  • Appendectomy in the medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany

Bochum, 44791, Germany

Location

Related Publications (1)

  • Sand M, Trullen XV, Bechara FG, Pala XF, Sand D, Landgrafe G, Mann B. A prospective bicenter study investigating the diagnostic value of procalcitonin in patients with acute appendicitis. Eur Surg Res. 2009;43(3):291-7. doi: 10.1159/000232939. Epub 2009 Aug 7.

    PMID: 19672084RESULT

Biospecimen

Retention: SAMPLES WITH DNA

1.5 ml whole blood

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Benno Mann, PD Dr. med.

    Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum

    STUDY CHAIR

  • Michael Sand, Dr. med.

    Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

February 1, 2008

Study Completion

August 1, 2008

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

DE(1)