Acute AppendicitisDV-AAA ELHTNCT07804238
Comparative Study on the Diagnostic Validity of the Alvarado Score, Appendicitis Inflammatory Response (AIR), and Adult Appendicitis Score (AAS) in Acute Appendicitis at East Lancashire Hospitals NHS Trust (ELHT)
An observational study of Acute Appendicitis, run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This retrospective observational study aims to compare the diagnostic accuracy of Alvarado Score, Appendicitis Inflammatory Response (AIR) Score, and Adult Appendicitis Score (AAS) in predicting histologically confirmed acute appendicitis in adult patients presenting to East Lancashire Hospitals NHS Trust (ELHT). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Appendicitis
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2026to 28 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: All emergency patients of any gender and aged 16 and above who were admitted between June 2023 and June 2024 with a clinical suspicion of acute appendicitis and who subsequently underwent an appendicectomy (via laparoscopy, open surgery, or laparotomy).
Who may be able to join
- Patients of any gender
- Patients aged 16 and above
- Admitted as an emergency with suspected appendicitis
- Must have undergone appendicectomy (laparoscopic, open, or laparotomy) from June 2023 to June 2024 at East Lancashire Hospitals NHS Trust
Who cannot join
- Patients who have undergone elective, interval, or incidental appendicectomies.
- Patients younger than 16
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, BB2 3HH
About this study
This retrospective observational study aims to compare the diagnostic accuracy of Alvarado Score, Appendicitis Inflammatory Response (AIR) Score, and Adult Appendicitis Score (AAS) in predicting histologically confirmed acute appendicitis in adult patients presenting to East Lancashire Hospitals NHS Trust (ELHT). The study will include all emergency patients aged 16 years and above, of any gender, admitted between June 2023 and June 2024 with clinical suspicion of acute appendicitis who subsequently underwent appendicectomy via laparoscopic or open approaches. For each patient, the Alvarado, AIR, and AAS scores will be calculated retrospectively using information from presenting symptoms, physical examination findings, and laboratory investigations recorded at the time of admission. These calculated scores will be compared against the final histopathology results, which serve as the gold standard for diagnosis. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Sensitivity reflects the proportion of patients with appendicitis correctly identified by the score, while specificity measures the ability to correctly exclude those without the condition. PPV indicates the likelihood that a positive score truly represents acute appendicitis, whereas NPV represents the likelihood that a negative score accurately rules it out. Accurate and timely pre-operative diagnosis of acute appendicitis is essential to minimise the incidence of negative appendicectomies while avoiding unnecessary diagnostic investigations. This study also aims to determine the most effective scoring system for risk stratification in the local adult population, considering the demographic diversity, and to provide recommendations for the standardisation of appendicitis risk assessment tools in emergency surgical practice within the trust.
- Conditions
- Acute Appendicitis
- Keywords
- Acute appendicitis, Alvarado score, Appendicitis Inflammatory Response (AIR) score, Adult Appendicitis Score (AAS), Diagnostic accuracy
- 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 |
|---|---|---|
| ELHT Patient Population | All emergency patients of any gender and aged 16 and above who were admitted between June 2023 and June 2024 with a clinical suspicion of acute appendicitis and who subsequently underwent an appendicectomy (via laparoscopy, open surgery, or laparotomy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Which scoring system - Alvarado Score, Appendicitis Inflammatory Response (AIR) Score or Adult Appendicitis Score (AAS) has the highest diagnostic accuracy for predicting histologically confirmed appendicitis among patients undergoing emergency appendicectomy?
[Diagnostic accuracy will be assessed by comparing their sensitivity, specificity, positive predictive value and negative predictive value. Receiver Operating Characteristic (ROC) analysis and Area Under the Curve (AUC) will be presented to assess the overall discriminative performance.]
Measured: From initial clinical assessment at presentation to histological diagnosis following appendicectomy, is up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start13 Apr 2026
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Lancashire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804238
- Sponsor's protocol ID
- DEV123
- Acronym
- DV-AAA ELHT
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to release the anonymised participant-level dataset or statistical code for public access. However, data may be made available upon reasonable request to the Chief Investigator, subject to appropriate ethical and governance approvals and in line with ELHT information governance and data protection standards.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Diagnostic Validity of the Alvarado Score, Appendicitis Inflammatory Response (AIR), and Adult Appendicitis Score (AAS) in Acute Appendicitis at East Lancashire Hospitals NHS Trust (ELHT)
- ClinicalTrials.gov ID
- NCT07804238
- Acronym / sponsor ID
- DV-AAA ELHT / DEV123
- Conditions
- Acute Appendicitis
- Keywords
- Acute appendicitis, Alvarado score, Appendicitis Inflammatory Response (AIR) score, Adult Appendicitis Score (AAS), Diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- East Lancashire Hospitals NHS TrustUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 4 Sep 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.
This retrospective observational study aims to compare the diagnostic accuracy of Alvarado Score, Appendicitis Inflammatory Response (AIR) Score, and Adult Appendicitis Score (AAS) in predicting histologically confirmed acute appendicitis in adult patients presenting to East Lancashire Hospitals NHS Trust (ELHT). The study will include all emergency patients aged 16 years and above, of any gender, admitted between June 2023 and June 2024 with clinical suspicion of acute appendicitis who subsequently underwent appendicectomy via laparoscopic or open approaches. For each patient, the Alvarado, AIR, and AAS scores will be calculated retrospectively using information from presenting symptoms, physical examination findings, and laboratory investigations recorded at the time of admission. These calculated scores will be compared against the final histopathology results, which serve as the gold standard for diagnosis. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Sensitivity reflects the proportion of patients with appendicitis correctly identified by the score, while specificity measures the ability to correctly exclude those without the condition. PPV indicates the likelihood that a positive score truly represents acute appendicitis, whereas NPV represents the likelihood that a negative score accurately rules it out. Accurate and timely pre-operative diagnosis of acute appendicitis is essential to minimise the incidence of negative appendicectomies while avoiding unnecessary diagnostic investigations. This study also aims to determine the most effective scoring system for risk stratification in the local adult population, considering the demographic diversity, and to provide recommendations for the standardisation of appendicitis risk assessment tools in emergency surgical practice within the trust.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELHT Patient Population | – | –All emergency patients of any gender and aged 16 and above who were admitted between June 2023 and June 2024 with a clinical suspicion of acute appendicitis and who subsequently underwent an appendicectomy (via laparoscopy, open surgery, or laparotomy). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All emergency patients of any gender and aged 16 and above who were admitted between June 2023 and June 2024 with a clinical suspicion of acute appendicitis and who subsequently underwent an appendicectomy (via laparoscopy, open surgery, or laparotomy).
Key inclusion criteria (4 listed)
- Patients of any gender
- Patients aged 16 and above
- Admitted as an emergency with suspected appendicitis
- Must have undergone appendicectomy (laparoscopic, open, or laparotomy) from June 2023 to June 2024 at East Lancashire Hospitals NHS Trust
Key exclusion criteria (2 listed)
- Patients who have undergone elective, interval, or incidental appendicectomies.
- Patients younger than 16
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 Accuracy
Time frame: From initial clinical assessment at presentation to histological diagnosis following appendicectomy, is up to 6 months
Which scoring system - Alvarado Score, Appendicitis Inflammatory Response (AIR) Score or Adult Appendicitis Score (AAS) has the highest diagnostic accuracy for predicting histologically confirmed appendicitis among patients undergoing emergency appendicectomy? [Diagnostic accuracy will be assessed by comparing their sensitivity, specificity, positive predictive value and negative predictive value. Receiver Operating Characteristic (ROC) analysis and Area Under the Curve (AUC) will be presented to assess the overall discriminative performance.]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. There are no plans to release the anonymised participant-level dataset or statistical code for public access. However, data may be made available upon reasonable request to the Chief Investigator, subject to appropriate ethical and governance approvals and in line with ELHT information governance and data protection standards.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 4 Sep 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: From initial clinical assessment at presentation to histological diagnosis following appendicectomy, is up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.