Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis

NCT06051825 | Unknown

• 1 other identifier: CHCSplit
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

• Level of CRP in blood

  Levels of CRP in blood as measured by ELISA test

  72 hours

Secondary Outcomes (1)

• Level of CRP in saliva

  72 hours

Study Arms (2)

Patients with acute appendicitis

Patients with acute appendicitis, after surgery and with pathohistological confirmation

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

Patients without acute appendicitis

Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance

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

Interventions

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

Blood analysis of CRP and WBC levels Saliva analysis of CRP levels

Patients with acute appendicitis; Patients without acute appendicitis

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 5 to 17 years of age, presenting with acute abdominal pain consistent with diagnosis of acute appendicitis, to Emergency Surgery Department at the University Hospital Split

You may qualify if:

• children with age from 5 to 17 with acute abdominal pain
• children with clinical signs of appendicitis

You may not qualify if:

• previous diagnosis of chronic and/or malignant disease
• children wich had previous abdominal surgery
• pregnancy

Sponsors & Collaborators

• University Hospital of Split: lead

MeSH Terms

Conditions

Appendicitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Zenon Pogorelić, PhD.Prof

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaudio Pjer MD Milunovic

CONTACT

+38521556723; mklaudiopjer@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 25, 2023
• Study Start: November 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share