NCT07804238

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

March 10, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

Acute appendicitisAlvarado scoreAppendicitis Inflammatory Response (AIR) scoreAdult Appendicitis Score (AAS)Diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

  • 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? \[Diagnostic accuracy will be assessed by comparing their sensitivity, specificity, positive predictive value and negative predictive value. Receiver Operating Characteristic (ROC) analysis and Area Under the Curve (AUC) will be presented to assess the overall discriminative performance.\]

    From initial clinical assessment at presentation to histological diagnosis following appendicectomy, is up to 6 months

Study Arms (1)

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).

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have undergone elective, interval, or incidental appendicectomies.
  • Patients younger than 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

September 4, 2026

Study Start

April 13, 2026

Primary Completion

July 28, 2026

Study Completion

July 28, 2026

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations