An observational study in Acute Appendicitis, sponsored by Sanliurfa Education and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Sanliurfa Education and Research Hospital · Observational
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.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 151 observational studies indexed under Appendicitis.
Browse Appendicitis studies →Sanliurfa Education and Research Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with suspected acute appendicitis who underwent CT evaluation and subsequent appendectomy after a CT report compatible with acute appendicitis.
Diagnostic agreement between CT report and final histopathology
Concordance between computed tomography findings reported as compatible with acute appendicitis and final histopathologic diagnosis.
Time frame: From CT evaluation to final pathology report, up to 30 days
Negative appendectomy rate
The proportion of patients who undergo appendectomy but whose final histopathologic examination does not confirm acute appendicitis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From admission to final pathology report, up to 30 days
Plan to share: No — 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.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.
Of 54 non-industry observational studies under Appendicitis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's planned 10 months is below that.
Counting every sponsor, half of 56 studies reached it within 23 months; a quarter within 7 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Sanliurfa Education and Research Hospital