Comparison of Diagnostic Methods in Patients Operated for Suspected Appendicitis (APP-AIR)

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

Study Overview

• Status: Recruiting
• Conditions: Acute Appendicitis

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Vedat Kaplan, MD; Phone Number: +905459045165; Email: vedat_kaplan_@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Şanlıurfa
    • Sanliurfa, Şanlıurfa, Turkey (Türkiye)
      • Recruiting
      • Sanliurfa Education and Research Hospital
      • Contact: Vedat Kaplan, MD; Phone Number: +905459045165; Email: vedat_kaplan_@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to the emergency department with suspected acute appendicitis who undergo computed tomography after clinical evaluation, have a CT report compatible with acute appendicitis, and subsequently undergo appendectomy at Sanliurfa Education and Research Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing appendectomy for suspected acute appendicitis; Adult patients with suspected acute appendicitis who underwent CT evaluation and subsequent appendectomy after a CT report compatible with acute appendicitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic agreement between CT report and final histopathology	Concordance between computed tomography findings reported as compatible with acute appendicitis and final histopathologic diagnosis.	From CT evaluation to final pathology report, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative appendectomy rate	The proportion of patients who undergo appendectomy but whose final histopathologic examination does not confirm acute appendicitis.	From appendectomy to final pathology report, up to 30 days
Agreement between AIR score and final histopathology	Association between the Appendicitis Inflammatory Response (AIR) score and histopathologic confirmation of acute appendicitis.	From admission to final pathology report, up to 30 days
Agreement between intraoperative AAST grading and final histopathology	Concordance between intraoperative appendicitis severity grading based on the AAST classification and final histopathologic findings.	From surgery to final pathology report, up to 30 days
Comparative diagnostic performance of CT report and AIR score	Comparison of the diagnostic performance of computed tomography reporting and AIR score in predicting histopathologically confirmed acute appendicitis.	From admission to final pathology report, up to 30 days
Diagnostic performance in patient subgroups	Differences in diagnostic performance according to age, sex, comorbidities, and previous abdominal surgery history.	From admission to final pathology report, up to 30 days

Collaborators and Investigators

• Sponsor: Sanliurfa Education and Research Hospital

Publications and helpful links

General Publications

• Di Saverio S, Podda M, De Simone B, Ceresoli M, Augustin G, Gori A, Boermeester M, Sartelli M, Coccolini F, Tarasconi A, De' Angelis N, Weber DG, Tolonen M, Birindelli A, Biffl W, Moore EE, Kelly M, Soreide K, Kashuk J, Ten Broek R, Gomes CA, Sugrue M, Davies RJ, Damaskos D, Leppaniemi A, Kirkpatrick A, Peitzman AB, Fraga GP, Maier RV, Coimbra R, Chiarugi M, Sganga G, Pisanu A, De' Angelis GL, Tan E, Van Goor H, Pata F, Di Carlo I, Chiara O, Litvin A, Campanile FC, Sakakushev B, Tomadze G, Demetrashvili Z, Latifi R, Abu-Zidan F, Romeo O, Segovia-Lohse H, Baiocchi G, Costa D, Rizoli S, Balogh ZJ, Bendinelli C, Scalea T, Ivatury R, Velmahos G, Andersson R, Kluger Y, Ansaloni L, Catena F. Diagnosis and treatment of acute appendicitis: 2020 update of the WSES Jerusalem guidelines. World J Emerg Surg. 2020 Apr 15;15(1):27. doi: 10.1186/s13017-020-00306-3.
• Mariadason JG, Wang WN, Wallack MK, Belmonte A, Matari H. Negative appendicectomy rate as a quality metric in the management of appendicitis: impact of computed tomography, Alvarado score and the definition of negative appendicectomy. Ann R Coll Surg Engl. 2012 Sep;94(6):395-401. doi: 10.1308/003588412X13171221592131.
• de Castro SM, Unlu C, Steller EP, van Wagensveld BA, Vrouenraets BC. Evaluation of the appendicitis inflammatory response score for patients with acute appendicitis. World J Surg. 2012 Jul;36(7):1540-5. doi: 10.1007/s00268-012-1521-4.
• Andersson M, Andersson RE. The appendicitis inflammatory response score: a tool for the diagnosis of acute appendicitis that outperforms the Alvarado score. World J Surg. 2008 Aug;32(8):1843-9. doi: 10.1007/s00268-008-9649-y.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Computed Tomography; Appendectomy; Appendicitis Inflammatory Response Score
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: SEAH-APP-AIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this is a single-center study involving sensitive patient-level clinical data, and there is no pre-specified plan or institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No