- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07643142
Diagnostic Performance of Serum Calprotectin in Acute Appendicitis (SCP-AA)
Diagnostic Performance of Serum Calprotectin in Acute Appendicitis: A Prospective Comparative Analysis Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
ATASEHIR
-
Istanbul, ATASEHIR, Turkey (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Acute Appendicitis
Patients with histopathologically confirmed acute appendicitis who underwent appendectomy.
|
Measurement of serum calprotectin levels using ELISA for diagnostic evaluation of acute appendicitis.
|
|
Non-specific Abdominal Pain
Patients presenting with nonspecific abdominal pain without evidence of appendicitis during follow-up.
|
Measurement of serum calprotectin levels using ELISA for diagnostic evaluation of acute appendicitis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At admission to the emergency department
|
Collaborators and Investigators
Investigators
- Principal Investigator: fatih kilic, MD, Fatih Sultan Mehmet Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSMEAH-KAEK-2015-53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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