Acute AppendicitisSCP-AANCT07643142
Diagnostic Performance of Serum Calprotectin in Acute Appendicitis
An observational study of Acute Appendicitis and Abdominal Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated the diagnostic performance of serum calprotectin in patients presenting with acute abdominal pain and suspected acute appendicitis. Patients with histopathologically confirmed acute appendicitis were compared with patients diagnosed with nonspecific abdominal pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Appendicitis, Abdominal Pain
- What is being tested?
- Serum Calprotectin Measurement
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2015to 21 Apr 2016
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting to the emergency department with acute abdominal pain and suspected acute appendicitis. Participants were divided into two groups: patients diagnosed with acute appendicitis and patients with non-specific abdominal pain.
Who may be able to join
- Age between 18 and 75 years
- Presentation to the emergency department with acute abdominal pain and suspected acute appendicitis
- Willingness to participate and provide informed consent
Who cannot join
- Previous abdominal surgery
- Chronic inflammatory or autoimmune disease
- Active infection other than suspected appendicitis
- Use of systemic anti-inflammatory or immunosuppressive therapy
- Pregnancy
- Incomplete clinical or laboratory data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, ATASEHIR, 34752
About this study
Official title: Diagnostic Performance of Serum Calprotectin in Acute Appendicitis: A Prospective Comparative Analysis Study
This prospective observational study evaluated the diagnostic performance of serum calprotectin in patients presenting with acute abdominal pain and suspected acute appendicitis. Patients with histopathologically confirmed acute appendicitis were compared with patients diagnosed with nonspecific abdominal pain. Serum calprotectin levels were analyzed and compared with conventional inflammatory markers and the Alvarado score to assess their diagnostic value in acute appendicitis.
Read the detailed description
Acute appendicitis is one of the most common causes of acute abdominal pain requiring emergency surgical intervention. However, establishing an accurate diagnosis may be difficult, particularly in patients presenting with nonspecific abdominal pain or atypical clinical findings. Conventional inflammatory markers and clinical scoring systems are useful adjuncts, but their diagnostic accuracy remains limited.
This prospective single-center observational study evaluated the diagnostic performance of serum calprotectin in adult patients presenting with acute abdominal pain and suspected acute appendicitis. Patients with histopathologically confirmed acute appendicitis were compared with a control group consisting of patients diagnosed with nonspecific abdominal pain after clinical, laboratory, radiological evaluation, and follow-up.
Serum calprotectin concentrations were measured and compared with white blood cell count, C-reactive protein, ferritin, and the Alvarado score. The relationship between serum calprotectin levels and histopathological severity of appendicitis was also assessed.
The primary objective of the study was to determine the diagnostic accuracy of serum calprotectin in distinguishing acute appendicitis from nonspecific abdominal pain.
- Conditions
- Acute Appendicitis, Abdominal Pain
- Being tested
- Serum Calprotectin Measurement
- Keywords
- serum calprotectin, acute appendicitis, diagnostic biomarker, inflammatory marker
- 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.
Serum Calprotectin MeasurementDiagnostic test
Measurement of serum calprotectin levels using ELISA for diagnostic evaluation of acute appendicitis.
| Study group | Role | What they receive |
|---|---|---|
| Acute Appendicitis | Patients with histopathologically confirmed acute appendicitis who underwent appendectomy. Receives: Diagnostic Test: Serum Calprotectin Measurement | |
| Non-specific Abdominal Pain | Patients presenting with nonspecific abdominal pain without evidence of appendicitis during follow-up. Receives: Diagnostic Test: Serum Calprotectin Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of serum calprotectin for acute appendicitis
Comparison of serum calprotectin levels between patients with acute appendicitis and nonspecific abdominal pain.
Measured: At admission to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start13 Dec 2015
- Primary completion19 Apr 2016
- Study completion21 Apr 2016
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fatih kilic, MD, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643142
- Sponsor's protocol ID
- FSMEAH-KAEK-2015-53
- Acronym
- SCP-AA
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data sharing plans are currently undecided.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Serum Calprotectin in Acute Appendicitis: A Prospective Comparative Analysis Study
- ClinicalTrials.gov ID
- NCT07643142
- Acronym / sponsor ID
- SCP-AA / FSMEAH-KAEK-2015-53
- Conditions
- Acute Appendicitis, Abdominal Pain
- Keywords
- serum calprotectin, acute appendicitis, diagnostic biomarker, inflammatory marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Dec 2015 (actual)
- Primary completion
- 19 Apr 2016 (actual)
- Study completion
- 21 Apr 2016 (actual)
- First posted
- 11 Jun 2026 (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.
This prospective observational study evaluated the diagnostic performance of serum calprotectin in patients presenting with acute abdominal pain and suspected acute appendicitis. Patients with histopathologically confirmed acute appendicitis were compared with patients diagnosed with nonspecific abdominal pain. Serum calprotectin levels were analyzed and compared with conventional inflammatory markers and the Alvarado score to assess their diagnostic value in acute appendicitis.
Detailed description
Acute appendicitis is one of the most common causes of acute abdominal pain requiring emergency surgical intervention. However, establishing an accurate diagnosis may be difficult, particularly in patients presenting with nonspecific abdominal pain or atypical clinical findings. Conventional inflammatory markers and clinical scoring systems are useful adjuncts, but their diagnostic accuracy remains limited.
This prospective single-center observational study evaluated the diagnostic performance of serum calprotectin in adult patients presenting with acute abdominal pain and suspected acute appendicitis. Patients with histopathologically confirmed acute appendicitis were compared with a control group consisting of patients diagnosed with nonspecific abdominal pain after clinical, laboratory, radiological evaluation, and follow-up.
Serum calprotectin concentrations were measured and compared with white blood cell count, C-reactive protein, ferritin, and the Alvarado score. The relationship between serum calprotectin levels and histopathological severity of appendicitis was also assessed.
The primary objective of the study was to determine the diagnostic accuracy of serum calprotectin in distinguishing acute appendicitis from nonspecific abdominal pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Appendicitis | – | Diagnostic Test: Serum Calprotectin MeasurementPatients with histopathologically confirmed acute appendicitis who underwent appendectomy. |
| Non-specific Abdominal Pain | – | Diagnostic Test: Serum Calprotectin MeasurementPatients presenting with nonspecific abdominal pain without evidence of appendicitis during follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the emergency department with acute abdominal pain and suspected acute appendicitis. Participants were divided into two groups: patients diagnosed with acute appendicitis and patients with non-specific abdominal pain.
Key inclusion criteria (3 listed)
- Age between 18 and 75 years
- Presentation to the emergency department with acute abdominal pain and suspected acute appendicitis
- Willingness to participate and provide informed consent
Key exclusion criteria (6 listed)
- Previous abdominal surgery
- Chronic inflammatory or autoimmune disease
- Active infection other than suspected appendicitis
- Use of systemic anti-inflammatory or immunosuppressive therapy
- 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 |
|---|---|---|
| Serum Calprotectin MeasurementMeasurement of serum calprotectin levels using ELISA for diagnostic evaluation of acute appendicitis. | Diagnostic test | Acute Appendicitis, Non-specific Abdominal Pain |
Primary outcome
Diagnostic accuracy of serum calprotectin for acute appendicitis
Time frame: At admission to the emergency department
Comparison of serum calprotectin levels between patients with acute appendicitis and nonspecific abdominal pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided. individual participant data sharing plans are currently undecided.
Related trials for Acute Appendicitis
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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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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.
fatih kilic, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
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 Abdominal Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jun 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of serum calprotectin for acute appendicitis (time frame: At admission to the emergency department). 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 11 Jun 2026.