Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorKBC Split
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
children of age 5 -17 years with acute abdominal pain
children with clinical signs of acute appendicitis
Disqualifiers
previous diagnosis of chronic and/or malignant disease
children who had previous abdominal surgery
pregnancy
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood specimen collection
Diagnostic testBlood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count.
Urine collection
Diagnostic testUrine sample collection for analysis of creatinine and prostaglandin E urinary metabolites
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Acute appendicitis with rupture2 interventions
Group B: Acute appendicitis without rupture2 interventions
Group C: Control group2 interventions
Trial outcomes
Primary outcomes
1
PGE-M
Levels of prostaglandin E urinary metabolite as measured with ELISA test
Time frame
72 hours Source ClinicalTrials.gov