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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06051825
Other study ID # CHCSplit
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date November 30, 2024

Study information

Verified date September 2023
Source University Hospital of Split
Contact Klaudio Pjer MD Milunovic
Phone +38521556723
Email mklaudiopjer@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diagnosing acute appendicitis in children is still a challenge even for experienced clinicians. Failure to recognize this acute condition can result in perforation, with consequent peritonitis, or misdiagnosis can result in negative appendectomies. C-reactive protein in blood can be elavated in children with acute appendicitis. The aim of this research is to compare the diagnostic value of C-reactive protein from the blood and saliva of children with acute appendicitis and to prove wheter the analysis of biomarker from saliva as a minimally invasive procedure can be sufficient for diagnosis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers
Gender All
Age group 5 Years to 17 Years
Eligibility Inclusion Criteria: - children with age from 5 to 17 with acute abdominal pain - children with clinical signs of appendicitis Exclusion Criteria: - previous diagnosis of chronic and/or malignant disease - children wich had previous abdominal surgery - pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levels
Blood analysis of CRP and WBC levels Saliva analysis of CRP levels

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Split

Outcome

Type Measure Description Time frame Safety issue
Primary Level of CRP in blood Levels of CRP in blood as measured by ELISA test 72 hours
Secondary Level of CRP in saliva Levels of CRP in saliva as measured by ELISA test 72 hours
See also
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Active, not recruiting NCT03324165 - Comparing Proposed Algorithm and Current Practice in the Evaluation of Suspected Appendicitis N/A
Active, not recruiting NCT01022567 - Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis N/A
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Recruiting NCT04947748 - Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous N/A
Terminated NCT04207645 - Modification and Validation of the RIPASA Score for Diagnosis of Acute Appendicitis
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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
Completed NCT01348464 - A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy N/A