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NCT Number: NCT07008092

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

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

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Split

Split, 21000, Croatia

Location status: Recruiting

Location contact

Tomislav Žuvela, MD

CONTACT

[email protected]

0919008148

About this study

The diagnosis of acute appendicitis in children remains a challenge, even for experienced clinicians. Failure to recognize this acute condition may result in perforation and subsequent peritonitis, whereas misdiagnosis can lead to unnecessary (negative) appendectomies. Elevated levels of prostaglandin E urinary metabolites (PGE-M) have been observed in other inflammatory conditions such as inflammatory bowel disease, acute mesenteric ischemia, and necrotizing enterocolitis.

The aim of this study is to determine whether PGE-M levels are elevated in children with acute appendicitis and whether this biomarker could be used in the diagnosis of acute appendicitis.

The planned duration of the study is 12 months, with a projected sample size of 100 participants.

Inclusion criteria

Children aged 5 to 17 years presenting with acute abdominal pain and signs and symptoms suggestive of acute appendicitis, without significant comorbidities.

Exclusion criteria

Children outside the specified age range, those with a previously diagnosed chronic or malignant disease, a history of abdominal surgery, or pregnancy.

For each child included in the study, demographic data, clinical characteristics, laboratory and diagnostic test results, intraoperative findings, and discharge diagnoses will be recorded. Since the child is already indicated for surgery or hospital admission regardless of study participation, there are no significant risks associated with participation in this study-apart from potential, but rare, complications related to peripheral venous blood sampling (e.g., hematoma or discomfort).

For the purposes of the study, a peripheral venous blood sample will be collected (on the day of surgery or hospital admission) to analyze laboratory parameters including leukocyte count, C-reactive protein, and neutrophils. Additionally, a urine sample will be collected to determine the levels of prostaglandin E urinary metabolites (PGE-M) and creatinine

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Blood specimen collection

Diagnostic Test

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

Urine collection

Diagnostic Test

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

Primary outcomes

  1. PGE-M

    Time frame: 72 hours

    Levels of prostaglandin E urinary metabolite as measured with ELISA test

Study contacts

Contact information is provided by the study sponsor or research team.

Tomislav Žuvela, Doctor of Medicine, MD

CONTACT

[email protected]

+385919008148

Sponsors and collaborators

Lead sponsor

KBC Split

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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