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NCT Number: NCT07496723

Comparison of Diagnostic Methods in Patients Operated for Suspected Appendicitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanliurfa Education and Research Hospital

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Location status: Recruiting

Location contact

Vedat Kaplan, MD

CONTACT

[email protected]

+905459045165

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic agreement between CT report and final histopathology

    Time frame: From CT evaluation to final pathology report, up to 30 days

    Concordance between computed tomography findings reported as compatible with acute appendicitis and final histopathologic diagnosis.

Secondary outcomes

  1. Negative appendectomy rate

    Time frame: From appendectomy to final pathology report, up to 30 days

    The proportion of patients who undergo appendectomy but whose final histopathologic examination does not confirm acute appendicitis.

  2. Agreement between AIR score and final histopathology

    Time frame: From admission to final pathology report, up to 30 days

    Association between the Appendicitis Inflammatory Response (AIR) score and histopathologic confirmation of acute appendicitis.

  3. Agreement between intraoperative AAST grading and final histopathology

    Time frame: From surgery to final pathology report, up to 30 days

    Concordance between intraoperative appendicitis severity grading based on the AAST classification and final histopathologic findings.

  4. Comparative diagnostic performance of CT report and AIR score

    Time frame: From admission to final pathology report, up to 30 days

    Comparison of the diagnostic performance of computed tomography reporting and AIR score in predicting histopathologically confirmed acute appendicitis.

  5. Diagnostic performance in patient subgroups

    Time frame: From admission to final pathology report, up to 30 days

    Differences in diagnostic performance according to age, sex, comorbidities, and previous abdominal surgery history.

Study contacts

Contact information is provided by the study sponsor or research team.

Vedat Kaplan, MD

CONTACT

[email protected]

+905459045165

Sponsors and collaborators

Lead sponsor

Sanliurfa Education and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: APP-AIR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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