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Comparison of Diagnostic Methods in Patients Operated for Suspected Appendicitis

Prospective Evaluation of the Impact of Computed Tomography Reporting and AIR Scoring System on Negative Appendectomy Rates in Patients With Acute Appendicitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07496723
Acronym
APP-AIR
Enrollment
200
Registered
2026-03-27
Start date
2026-03-18
Completion date
2027-01-31
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis

Keywords

Appendicitis Inflammatory Response Score, Appendectomy, Computed Tomography

Brief summary

Acute appendicitis is one of the most common surgical emergencies, but diagnostic uncertainty may still lead to unnecessary appendectomy in some patients. This prospective observational study aims to evaluate the diagnostic performance of computed tomography (CT) reporting and the Appendicitis Inflammatory Response (AIR) score in adult patients undergoing appendectomy for suspected acute appendicitis. The primary objective is to determine the negative appendectomy rate based on final histopathology. Secondary objectives are to assess the agreement between AIR score, CT findings, intraoperative severity grading, and pathology results, and to explore diagnostic performance across patient subgroups. No study-specific intervention beyond routine clinical care will be performed.

Detailed description

This is a single-center, prospective observational study conducted in adult patients presenting to the emergency department with suspected acute appendicitis. Patients aged 18 years or older who undergo computed tomography (CT) after clinical evaluation, have a CT report compatible with acute appendicitis, and subsequently undergo appendectomy will be eligible for inclusion. Patients younger than 18 years, pregnant patients or those with suspected pregnancy, patients taken directly to surgery without CT evaluation, patients whose CT report suggests a diagnosis other than acute appendicitis, patients requiring an additional non-appendectomy surgical procedure because of another intraoperative pathology, and patients who decline participation will be excluded. Clinical and demographic data will be collected prospectively using a standardized study form. Recorded variables will include age, sex, comorbidities, previous abdominal surgery history, symptom duration, physical examination findings, and laboratory parameters relevant to appendicitis assessment. The Appendicitis Inflammatory Response (AIR) score will be calculated using routine clinical and laboratory data. CT examinations obtained as part of routine emergency care will be reviewed according to the official radiology reports. Intraoperative findings will be graded using the American Association for the Surgery of Trauma (AAST) appendicitis severity grading system. Final histopathologic examination of the resected appendix specimen will be used as the reference standard. The primary outcome measure is the negative appendectomy rate, defined as appendectomy with final pathology not confirming acute appendicitis. Secondary outcome measures include agreement between AIR score and final pathology, agreement between CT report and final pathology, agreement between intraoperative AAST grading and final pathology, and differences in diagnostic performance across patient subgroups such as age, sex, and previous abdominal surgery history. No study-specific intervention will be applied beyond routine diagnostic and therapeutic management. Treatment decisions will be made according to standard clinical practice. All data will be coded and recorded without directly identifiable patient information.

Interventions

None listed

Sponsors

Sanliurfa Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Presentation to the emergency department with suspected acute appendicitis * Underwent computed tomography after clinical evaluation * Computed tomography report compatible with acute appendicitis * Underwent appendectomy for presumed acute appendicitis * Provided informed consent

Exclusion criteria

* Age younger than 18 years * Pregnancy * Planned additional surgical intervention in the same session for a reason other than appendicitis * Intraoperative finding of a non-appendiceal pathology requiring a different surgical procedure * Refusal to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic agreement between CT report and final histopathologyFrom CT evaluation to final pathology report, up to 30 daysConcordance between computed tomography findings reported as compatible with acute appendicitis and final histopathologic diagnosis.

Secondary

MeasureTime frameDescription
Negative appendectomy rateFrom appendectomy to final pathology report, up to 30 daysThe proportion of patients who undergo appendectomy but whose final histopathologic examination does not confirm acute appendicitis.
Agreement between AIR score and final histopathologyFrom admission to final pathology report, up to 30 daysAssociation between the Appendicitis Inflammatory Response (AIR) score and histopathologic confirmation of acute appendicitis.
Agreement between intraoperative AAST grading and final histopathologyFrom surgery to final pathology report, up to 30 daysConcordance between intraoperative appendicitis severity grading based on the AAST classification and final histopathologic findings.
Comparative diagnostic performance of CT report and AIR scoreFrom admission to final pathology report, up to 30 daysComparison of the diagnostic performance of computed tomography reporting and AIR score in predicting histopathologically confirmed acute appendicitis.
Diagnostic performance in patient subgroupsFrom admission to final pathology report, up to 30 daysDifferences in diagnostic performance according to age, sex, comorbidities, and previous abdominal surgery history.

Countries

Turkey (Türkiye)

Contacts

CONTACTVedat Kaplan, MD
vedat_kaplan_@hotmail.com+905459045165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026