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

• Sponsor: University Hospital of Split (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06051825
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 13

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Appendicitis	Diagnostic Test: Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levels

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diagnostic Importance of the Circulating C-reactive Protein in Blood and Saliva in Acute Appendicitis in Pediatric Patients
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Oct 30, 2024
• Anticipated Study Completion Date: Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; Blood analysis of CRP and WBC levels Saliva 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; Blood analysis of CRP and WBC levels Saliva analysis of CRP levels

Outcome Measures

Primary Outcome Measures

1. Level of CRP in blood [72 hours]

   Levels of CRP in blood as measured by ELISA test

Secondary Outcome Measures

1. Level of CRP in saliva [72 hours]

   Levels of CRP in saliva as measured by ELISA test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital of Split

Investigators

• Principal Investigator: Zenon Pogorelić, PhD.Prof, University Hospital of Split

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Klaudio Pjer Milunovic, principal investigator, University Hospital of Split
• ClinicalTrials.gov Identifier: NCT06051825
• Other Study ID Numbers: CHCSplit
• First Posted: Sep 25, 2023
• Last Update Posted: Sep 25, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Appendicitis; Acute Disease

Study Results

No Results Posted as of Sep 25, 2023