Urinary PGE-M to help predict acute appendicitis in children
Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children
KBC Split · NCT07008092
We will test whether a urine marker called PGE-M can help diagnose acute appendicitis in children ages 5 to 17 who come in with sudden belly pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | KBC Split (other) |
| Locations | 1 site (Split) |
| Trial ID | NCT07008092 on ClinicalTrials.gov |
What this trial studies
This is a 12-month observational study enrolling about 100 children aged 5–17 who present with acute abdominal pain and signs suggestive of appendicitis at the University Hospital of Split. Participants will have routine labs and a urine sample collected to measure prostaglandin E urinary metabolite (PGE-M) levels, with clinical course, imaging, surgical findings, and final diagnosis recorded. Investigators will compare PGE-M levels between children with confirmed appendicitis and those with other causes of abdominal pain to see if PGE-M is higher in appendicitis. The study involves minimal additional risk because urine and routine blood samples are collected as part of care.
Who should consider this trial
Good fit: Children aged 5 to 17 who present with acute abdominal pain and clinical signs suggestive of acute appendicitis and who do not have significant comorbidities qualify for this study.
Not a fit: Children outside the 5–17 age range, those with prior abdominal surgery, chronic or malignant disease, pregnancy, or whose pain is clearly due to another diagnosis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, using urinary PGE-M could help doctors diagnose appendicitis faster and more accurately, reducing missed cases and unnecessary surgeries.
How similar studies have performed: PGE-M has been reported elevated in other inflammatory conditions, but using urinary PGE-M to diagnose pediatric appendicitis is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Split
- University Hospital of Split — Split, Croatia (RECRUITING)
Study contacts
- Study coordinator: Tomislav Žuvela, Doctor of Medicine, MD
- Email: tomislav.zuvela29@gmail.com
- Phone: +385919008148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Appendicitis, Acute Appendicitis With Rupture, Abdominal Pain, Acute appendicitis, PGE-M, Prostaglandin-E urinary metabolite