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NCT02304653 Clinical Trial

Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making

Acute Appendicitis Clinical Trial

Official title:
Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02304653
Other study ID # 12-132020
Secondary ID
Status Completed
Phase N/A
First received November 24, 2014
Last updated April 30, 2015
Start date February 2013
Est. completion date November 2013

Study information
Verified date April 2015
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 226
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility Acutae abdominal pain Suspect for acute appendicites

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Clinical descision making
Chage in diagnosis before and after the presentation of the reults of CRP and Leucocytes

Locations
Country Name City State
Denmark Odense University Hospital, surgical department A Odense C

Sponsors (2)
Lead Sponsor Collaborator
Odense University Hospital Danish Council for Independent Research

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in diagnosis Two hours No
See also
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Not yet recruiting NCT02789865 - Clinical Trial Comparing ERAT vs Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis Phase 2
Completed NCT02731924 - Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
Completed NCT05104346 - Presentation and Outcomes of Acute Appendicitis During COVID Pandemic N/A
Completed NCT03886896 - Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy Phase 4
Not yet recruiting NCT01720082 - Laparoscopic Appendectomy by Multi-port vs Single Port. Phase 3