- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02304653
Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making
April 30, 2015 updated by: Niels Qvist, Odense University Hospital
Aim: To investigate if the results of CRP and leucocytes had any positive or negative influence on the surgeon's decision-making when handling patients with suspected AA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A prospective observational cohort study including patients (≥15 years of age) admitted on suspicion of AA.
The surgeons were instructed to perform their physical examination and register whether they found the patient more or less than 50% likely to have AA.
Thereafter, the surgeons had to assess the blood results and reevaluate their diagnosis.
The surgeon's diagnosis before and after was compared to the final diagnosis defined by surgical findings or follow up.
Gold standard was any degree of appendicitis on histology.
Study Type
Observational
Enrollment (Actual)
226
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Odense C, Denmark, DK-5000
- Odense University Hospital, surgical department A
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Acute abdominal pain with the suspicion of acute appendicitis
Description
Acutae abdominal pain Suspect for acute appendicites
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in diagnosis
Time Frame: Two hours
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Two hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Niels Qvist, Professor, Head of surgical eserach unit
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tind S, Qvist N. Acute Appendicitis: A Weak Concordance Between Perioperative Diagnosis, Pathology and Peritoneal Fluid Cultivation. World J Surg. 2017 Jan;41(1):70-74. doi: 10.1007/s00268-016-3686-8.
- Tind S, Lassen AT, Zimmerman-Nielsen E, Qvist N. C-reactive protein and white blood cell count do not improve clinical decision-making in acute appendicitis. Dan Med J. 2015 Dec;62(12):A5167.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
November 24, 2014
First Submitted That Met QC Criteria
November 26, 2014
First Posted (Estimate)
December 2, 2014
Study Record Updates
Last Update Posted (Estimate)
May 4, 2015
Last Update Submitted That Met QC Criteria
April 30, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-132020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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