Acute AppendicitisNCT07008092
Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children
An observational study of Acute Appendicitis and Acute Appendicitis With Rupture, run by KBC Split at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis, Acute Appendicitis With Rupture, Abdominal Pain (AP)
- What is being tested?
- Blood specimen collection and Urine collection
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 2 Jun 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- children of age 5 -17 years with acute abdominal pain
- children with clinical signs of acute appendicitis
Who cannot join
- previous diagnosis of chronic and/or malignant disease
- children who had previous abdominal surgery
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital of Split
Split, 21000
Tomislav Žuvela, MD, 0919008148, tomislav.zuvela29@gmail.com
About this study
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
Read the detailed description
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
- Being tested
- Blood specimen collection, Urine collection
- Keywords
- Acute appendicitis, PGE-M, Prostaglandin-E urinary metabolite
- Medical subject headings
- Appendicitis, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood specimen collectionDiagnostic test
Blood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count.
Urine collectionDiagnostic test
Urine sample collection for analysis of creatinine and prostaglandin E urinary metabolites
| Study group | Role | What they receive |
|---|---|---|
| Acute appendicitis with rupture | Not described Receives: Diagnostic Test: Blood specimen collection; Diagnostic Test: Urine collection | |
| Acute appendicitis without rupture | Not described Receives: 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 Receives: Diagnostic Test: Blood specimen collection; Diagnostic Test: Urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGE-M
Levels of prostaglandin E urinary metabolite as measured with ELISA test
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start2 Jun 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KBC Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomislav Žuvela, KBC Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008092
- Sponsor's protocol ID
- 2181-147/01-06/LJ.Z.-25-02
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children
- ClinicalTrials.gov ID
- NCT07008092
- Acronym / sponsor ID
- 2181-147/01-06/LJ.Z.-25-02
- Keywords
- Acute appendicitis, PGE-M, Prostaglandin-E urinary metabolite
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KBC SplitUniversity, hospital or other
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Blood specimen collection, Diagnostic Test: Urine collectionPatients with abdominal pain in which acute appendicitis has been ruled out as a cause |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- children of age 5 -17 years with acute abdominal pain
- children with clinical signs of acute appendicitis
Key exclusion criteria (3 listed)
- previous diagnosis of chronic and/or malignant disease
- children who had previous abdominal surgery
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood specimen collectionBlood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count. | Diagnostic test | Acute appendicitis with rupture, Acute appendicitis without rupture, Control group |
| Urine collectionUrine sample collection for analysis of creatinine and prostaglandin E urinary metabolites | Diagnostic test | Acute appendicitis with rupture, Acute appendicitis without rupture, Control group |
Primary outcome
PGE-M
Time frame: 72 hours
Levels of prostaglandin E urinary metabolite as measured with ELISA test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis and Acute Appendicitis With Rupture, run by KBC Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomislav Žuvela, Doctor of Medicine, MD (+385919008148, tomislav.zuvela29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGE-M (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.