Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children

NCT07008092 | Recruiting

• 1 other identifier: 2181-147/01-06/LJ.Z.-25-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosing acute appendicitis in children remains a clinical challenge, with delayed or incorrect diagnosis potentially leading to serious complications or unnecessary surgery. Prostaglandin E urinary metabolites (PGE-M) have been found elevated in various inflammatory conditions, but their diagnostic value in pediatric appendicitis is not well established. This study aims to assess the potential of PGE-M as a biomarker for acute appendicitis in children. The study will be conducted over 12 months and will include 100 children aged 5 to 17 years presenting with acute abdominal pain. In addition to routine laboratory tests, urinary PGE-M levels will be analyzed. The study involves minimal risk to participants

Conditions

Acute Appendicitis; Acute Appendicitis With Rupture; Abdominal Pain (AP)

Keywords

Acute appendicitis; PGE-M; Prostaglandin-E urinary metabolite

Outcome Measures

Primary Outcomes (1)

• PGE-M

  Levels of prostaglandin E urinary metabolite as measured with ELISA test

  72 hours

Study Arms (3)

Acute appendicitis with rupture

Diagnostic Test: Blood specimen collection; Diagnostic Test: Urine collection

Acute appendicitis without rupture

Diagnostic Test: Blood specimen collection; Diagnostic Test: Urine collection

Control group

Patients with abdominal pain in which acute appendicitis has been ruled out as a cause

Diagnostic Test: Blood specimen collection; Diagnostic Test: Urine collection

Interventions

Blood specimen collection DIAGNOSTIC_TEST

Blood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count.

Acute appendicitis with rupture; Acute appendicitis without rupture; Control group

Urine collection DIAGNOSTIC_TEST

Urine sample collection for analysis of creatinine and prostaglandin E urinary metabolites

Acute appendicitis with rupture; Acute appendicitis without rupture; Control group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 Surgical Department at the University Hospital of Split

You may qualify if:

• children of age 5 -17 years with acute abdominal pain
• children with clinical signs of acute appendicitis

You may not qualify if:

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

Sponsors & Collaborators

• KBC Split: lead

Study Sites (1)

University Hospital of Split

Split, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Appendicitis; Abdominal Pain

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Tomislav Žuvela, Doctor of Medicine, MD

CONTACT

+385919008148; tomislav.zuvela29@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine, Plastic surgery resident

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: June 2, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)