AppendicitisNCT00630071
Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis
An observational study of Appendicitis, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Appendicitis
- How many people
- 103 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical Emergency Room
Who may be able to join
- Clinical diagnosis of appendicitis
Who cannot join
- Antibiotic therapy
- Infection at other body sites
- Age < 14 years
- Appendectomy in the medical history
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
Bochum, 44791
About this study
Official title: A Prospective Study Investigating the Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis
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.
- Conditions
- Appendicitis
- Keywords
- Diagnostic Appendicitis, Procalcitonin
- Medical subject headings
- Appendicitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sand, Ruhr University of Bochum
- Investigators
- Benno Mann, PD Dr. med., Study chair, Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University BochumMichael Sand, Dr. med., Principal investigator, Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630071
- Sponsor's protocol ID
- PCT 01
- Status last verified
- Oct 2012
- First submitted
- 26 Feb 2008
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19672084
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Investigating the Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis
- ClinicalTrials.gov ID
- NCT00630071
- Acronym / sponsor ID
- PCT 01
- Conditions
- Appendicitis
- Keywords
- Diagnostic Appendicitis, Procalcitonin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Feb 2008
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical Emergency Room
Key inclusion criteria (1 listed)
- Clinical diagnosis of appendicitis
Key exclusion criteria (4 listed)
- Antibiotic therapy
- Infection at other body sites
- Age < 14 years
- Appendectomy in the medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
- Results publication: PubMed 19672084Sand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benno Mann, PD Dr. med. study chair
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
Michael Sand, Dr. med. principal investigator
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.