Comparison of Diagnostic Methods in Patients Operated for Suspected Appendicitis

NCT07496723 | Recruiting

• 1 other identifier: SEAH-APP-AIR
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Appendicitis

Keywords

Appendicitis Inflammatory Response Score; Appendectomy; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Negative appendectomy rate

  From appendectomy to final pathology report, up to 30 days

• Agreement between AIR score and final histopathology

  From admission to final pathology report, up to 30 days

• Agreement between intraoperative AAST grading and final histopathology

  From surgery to final pathology report, up to 30 days

• Comparative diagnostic performance of CT report and AIR score

  From admission to final pathology report, up to 30 days

• Diagnostic performance in patient subgroups

  From admission to final pathology report, up to 30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 22943328 BACKGROUND

• 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.

  PMID: 22447205 BACKGROUND

• 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.

  PMID: 18553045 BACKGROUND

• 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.

  PMID: 32295644 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Central Study Contacts

Vedat Kaplan, MD

CONTACT

+905459045165; vedat_kaplan_@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)