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

September 20, 2023 updated by: Klaudio Pjer Milunovic, University Hospital of Split

Diagnostic Importance of the Circulating C-reactive Protein in Blood and Saliva in Acute Appendicitis in Pediatric Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Child

Accepts Healthy Volunteers

N/A

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

Description

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 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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of CRP in blood
Time Frame: 72 hours
Levels of CRP in blood as measured by ELISA test
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of CRP in saliva
Time Frame: 72 hours
Levels of CRP in saliva as measured by ELISA test
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Investigators

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

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 (Estimated)

November 1, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHCSplit

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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