Acute AppendicitisNCT06051825
Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis
An observational study of Acute Appendicitis, run by University Hospital of Split.
Trial summary
Diagnosing acute appendicitis in children is still a challenge even for experienced clinicians. Failure to recognize this acute condition can result in perforation, with consequent peritonitis, or misdiagnosis can result in negative appendectomies. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levels
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Child
Study population: Patients from 5 to 17 years of age, presenting with acute abdominal pain consistent with diagnosis of acute appendicitis, to Emergency Surgery Department at the University Hospital Split
Who may be able to join
- children with age from 5 to 17 with acute abdominal pain
- children with clinical signs of appendicitis
Who cannot join
- previous diagnosis of chronic and/or malignant disease
- children wich had previous abdominal surgery
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Importance of the Circulating C-reactive Protein in Blood and Saliva in Acute Appendicitis in Pediatric Patients
Diagnosing acute appendicitis in children is still a challenge even for experienced clinicians. Failure to recognize this acute condition can result in perforation, with consequent peritonitis, or misdiagnosis can result in negative appendectomies. C-reactive protein in blood can be elavated in children with acute appendicitis. The aim of this research is to compare the diagnostic value of C-reactive protein from the blood and saliva of children with acute appendicitis and to prove wheter the analysis of biomarker from saliva as a minimally invasive procedure can be sufficient for diagnosis.
- Conditions
- Acute Appendicitis
- Being tested
- Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levels
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levelsDiagnostic test
Blood analysis of CRP and WBC levels Saliva analysis of CRP levels
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute appendicitis | Patients with acute appendicitis, after surgery and with pathohistological confirmation Receives: Diagnostic Test: Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levels | |
| Patients without acute appendicitis | Patients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance Receives: Diagnostic Test: Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of CRP in blood
Levels of CRP in blood as measured by ELISA test
Measured: 72 hours
Secondary outcomes (1)
Level of CRP in saliva
Levels of CRP in saliva as measured by 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 posted25 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Nov 2024 (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
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaudio Pjer Milunovic, University Hospital of Split
- Investigators
- Zenon Pogorelić, PhD.Prof, Principal investigator, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051825
- Sponsor's protocol ID
- CHCSplit
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 25 Sep 2023
- 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Importance of the Circulating C-reactive Protein in Blood and Saliva in Acute Appendicitis in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06051825
- Acronym / sponsor ID
- CHCSplit
- Conditions
- Acute Appendicitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 25 Sep 2023 (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 is still a challenge even for experienced clinicians. Failure to recognize this acute condition can result in perforation, with consequent peritonitis, or misdiagnosis can result in negative appendectomies. C-reactive protein in blood can be elavated in children with acute appendicitis. The aim of this research is to compare the diagnostic value of C-reactive protein from the blood and saliva of children with acute appendicitis and to prove wheter the analysis of biomarker from saliva as a minimally invasive procedure can be sufficient for diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acute appendicitis | – | Diagnostic Test: Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levelsPatients with acute appendicitis, after surgery and with pathohistological confirmation |
| Patients without acute appendicitis | – | Diagnostic Test: Blood specimen collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levelsPatients without acute appendicitis, after laboratory, clinical and/or radiological exclusion of acute admittance |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- 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 Surgery Department at the University Hospital Split
Key inclusion criteria (2 listed)
- children with age from 5 to 17 with acute abdominal pain
- children with clinical signs of appendicitis
Key exclusion criteria (3 listed)
- previous diagnosis of chronic and/or malignant disease
- children wich 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 collection for C-reactive protein (CRP) and WBC (white blood cells). Saliva specimen collection for analysis of CRP levelsBlood analysis of CRP and WBC levels Saliva analysis of CRP levels | Diagnostic test | Patients with acute appendicitis, Patients without acute appendicitis |
Primary outcome
Level of CRP in blood
Time frame: 72 hours
Levels of CRP in blood as measured by ELISA test
1 secondary outcome
Level of CRP in saliva
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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. This study is not recruiting at the moment.
Zenon Pogorelić, PhD.Prof principal investigator
University Hospital of Split
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by University Hospital of Split.
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: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaudio Pjer MD Milunovic (+38521556723, mklaudiopjer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of CRP in blood (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 25 Sep 2023.