NCT07643142

Brief 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. Serum calprotectin levels were analyzed and compared with conventional inflammatory markers and the Alvarado score to assess their diagnostic value in acute appendicitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2016

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 2, 2026

Last Update Submit

June 7, 2026

Conditions

Keywords

serum calprotectinacute appendicitisdiagnostic biomarkerinflammatory marker

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of serum calprotectin for acute appendicitis

    Comparison of serum calprotectin levels between patients with acute appendicitis and nonspecific abdominal pain.

    At admission to the emergency department

Study Arms (2)

Acute Appendicitis

Patients with histopathologically confirmed acute appendicitis who underwent appendectomy.

Diagnostic Test: Serum Calprotectin Measurement

Non-specific Abdominal Pain

Patients presenting with nonspecific abdominal pain without evidence of appendicitis during follow-up.

Diagnostic Test: Serum Calprotectin Measurement

Interventions

Measurement of serum calprotectin levels using ELISA for diagnostic evaluation of acute appendicitis.

Acute AppendicitisNon-specific Abdominal Pain

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, ATASEHIR, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AppendicitisAbdominal Pain

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • fatih kilic, MD

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 11, 2026

Study Start

December 13, 2015

Primary Completion

April 19, 2016

Study Completion

April 21, 2016

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations