Acute AppendicitisAPP-AIRNCT07496723
Comparison of Diagnostic Methods in Patients Operated for Suspected Appendicitis
An observational study of Acute Appendicitis, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanliurfa Education and Research Hospital
Sanliurfa, Şanlıurfa
Vedat Kaplan, MD, +905459045165, vedat_kaplan_@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Appendicitis
- Keywords
- Appendicitis Inflammatory Response Score, Appendectomy, Computed Tomography
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic agreement between CT report and final histopathology
Concordance between computed tomography findings reported as compatible with acute appendicitis and final histopathologic diagnosis.
Measured: From CT evaluation to final pathology report, up to 30 days
Secondary outcomes (5)
Negative appendectomy rate
The proportion of patients who undergo appendectomy but whose final histopathologic examination does not confirm acute appendicitis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission to final pathology report, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start18 Mar 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vedat Kaplan, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496723
- Sponsor's protocol ID
- SEAH-APP-AIR
- Acronym
- APP-AIR
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 22943328de 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.
PubMed 22447205Andersson 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.
PubMed 18553045Di 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.
PubMed 32295644
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Impact of Computed Tomography Reporting and AIR Scoring System on Negative Appendectomy Rates in Patients With Acute Appendicitis
- ClinicalTrials.gov ID
- NCT07496723
- Acronym / sponsor ID
- APP-AIR / SEAH-APP-AIR
- Conditions
- Acute Appendicitis
- Keywords
- Appendicitis Inflammatory Response Score, Appendectomy, Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Negative appendectomy rate
Time frame: From appendectomy to final pathology report, up to 30 days
Agreement between AIR score and final histopathology
Time frame: From admission to final pathology report, up to 30 days
Agreement between intraoperative AAST grading and final histopathology
Time frame: From surgery to final pathology report, up to 30 days
Comparative diagnostic performance of CT report and AIR score
Time frame: From admission to final pathology report, up to 30 days
Diagnostic performance in patient subgroups
Time frame: From admission to final pathology report, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 22943328Mariadason 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.
- Background: PubMed 22447205de 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.
- Background: PubMed 18553045Andersson 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.
- Background: PubMed 32295644Di 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vedat Kaplan, MD (+905459045165, vedat_kaplan_@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic agreement between CT report and final histopathology (time frame: From CT evaluation to final pathology report, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07496723, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.