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Acute AppendicitisAPEXNCT07197489

Prioritisation of Acute Appendicitis Using Appendistat Score

An observational study of Acute Appendicitis and Acute Appendicitis With Rupture, run by University College, London at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction Although non-operative management of acute appendicitis may be appropriate in selected cases, surgery remains the gold standard treatment. Prioritization of patients at risk of developing complicated appendicitis is essential for improving outcomes. Read more about this study

Who is it for?
Ages 16 to 95 years
How many people
592 participants
Where
2 sitesUnited Kingdom
Study dates
6 Jan 2024to 2 Aug 2025
How long will I take part?
5 Months
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 to 95 years
  • All sexes
  • Child, Adult, Older adult

Study population: Patients presenting to the surgical assessment unit with acute right iliac fossa pain

Who may be able to join

  • Patients aged 16-years and above, with a conclusive histological report were included.

Who cannot join

  • hysterectomy, and those without a conclusive pathology report were excluded

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • University College London

    London, OX3 8PF

  • Oxford University Hospitals NHS Trust

    Oxford

Other trials in United Kingdom

About this study

Official title: Prioritization of Patients With Suspected Acute Appendicitis Using the Appendistat Score (APS)

Introduction

Although non-operative management of acute appendicitis may be appropriate in selected cases, surgery remains the gold standard treatment. Prioritization of patients at risk of developing complicated appendicitis is essential for improving outcomes. The aim of this study was to assess the predictive value and clinical utility of the Appendistat (APS) scoring system as a triaging tool to prioritize patients with a high risk of developing complicated appendicitis.

Methods This was a chart review, cross-sectional observational diagnostic study, with a single-gate retrospective design, including 592 patients who underwent appendicectomy. Based on final histological diagnosis, patients were categorized as normal, acute uncomplicated appendicitis (AUA), or acute complicated appendicitis (ACA). The predictive value matrix of the APS score for identifying patients with a histological diagnosis of complicated appendicitis was calculated.

Read the detailed description

Detailed Description

Introduction Although conservative treatment for acute appendicitis may be appropriate in selected patients, appendicectomy remains the gold standard treatment of choice for acute appendicitis, as advocated by clinical guidelines (1,2). The timing of surgery is critical for improving patient outcomes. Guidelines from the National Confidential Inquiry into Patient Outcome and Death (NCEPOD) in the UK recommend prompt surgical intervention within hours of presentation (NCEPOD Category 2) (3). Evidence suggests that delays beyond 24 hours are associated with considerable safety concerns (4,5). Specifically, postponing surgical treatment beyond this timeframe can increase the likelihood of appendiceal perforation, necrosis, gangrene, and postoperative complications (6). Westfall and Charles demonstrated that the relative risk of perforation increases by 9% for each day of delayed treatment (7). However, challenges in emergency theatre capacity across NHS trusts frequently result in delays exceeding 24 hours, placing patients at risk of progression from uncomplicated to complicated appendicitis. A triaging tool capable of predicting patients at high risk of perforation is therefore required to ensure prioritization for timely surgical intervention.

The Appendistat (APS) scoring system was developed to identify patients at risk of complicated appendicitis. The score employs a logistic regression analysis of objective variables, including age, sex, white cell count (WCC), C-reactive protein (CRP), and bilirubin, to identify patients likely to develop complicated appendicitis (8). The APS score can be readily calculated during the initial assessment of patients suspected of acute appendicitis and can be integrated into electronic patient record (EPR) systems without the need to include symptoms, signs, or imaging results.

The purpose of this study was to assess the predictive value and clinical utility of the APS score in identifying patients at risk of complicated appendicitis on admission to a busy surgical emergency unit (SEU) at John Radcliffe Hospital, Oxford.

Methods

Design and Patients This was a retrospective chart review, cross-sectional observational diagnostic study with a single-gate design. A total of 592 patients undergoing appendicectomy at John Radcliffe Hospital, Oxford, between April 2023 and April 2024 were included. Patients were identified retrospectively from the EPR (Cerner Millennium within BT Local Service Provider [LSP]). Approval was obtained from the Trust Clinical Governance Department (reference 9210). Data were anonymized by two clinicians (TPJ and GK) and analysed by the senior investigator (ME), who was blinded to patient identifiers.

Inclusion criteria were: patients aged ≥16 years with a conclusive histological report of the appendix.

Exclusion criteria were: elective appendicectomy, appendicectomy performed as part of another procedure (e.g., hysterectomy), or absence of definitive histopathology.

Data Collection Data extracted included demographics, preoperative WCC, CRP, bilirubin, imaging reports, time from admission to surgery, intraoperative findings, operative duration, postoperative hospital stay, and final histology.

Outcome Groups

Histological diagnosis was used as the reference standard. Three categories were defined by consultant pathologists:

  • Normal appendix: no inflammation.
  • Acute uncomplicated appendicitis (AUA): suppurative/phlegmonous with transmural inflammation, ulceration, thrombosis, or intramural pus.
  • Acute complicated appendicitis (ACA): gangrenous, perforated, or transmural inflammation with intramural/extramural pus.
  1. Primary Outcome
  • Title: Area under the ROC curve (AUC) of the Appendistat Score (APS) for predicting histologically confirmed complicated appendicitis.
  • Description: Diagnostic accuracy of APS calculated using ROC and AUC analyses.
  • Time Frame: At time of hospital admission (within 24 hours of presentation).
  • Safety issue: No
  1. Secondary Outcome 1
  • Title: Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Appendistat Score (APS) for detecting complicated appendicitis.
  • Description: Diagnostic performance of APS compared with histology, expressed as sensitivity, specificity, PPV, and NPV at the defined cut-off point.
  • Time Frame: At the time of hospital admission (within 24 hours of presentation).
  • Safety issue: No
  1. Secondary Outcome 2
  • Title: Mean Appendistat Score (APS) values in patients with acute uncomplicated vs. complicated appendicitis
  • Description: Comparison of mean APS values between patients with histologically confirmed acute uncomplicated appendicitis and those with acute complicated appendicitis.
  • Time Frame: At time of hospital admission (within 24 hours of presentation)
  • Safety Issue: No

Statistical analysis

Data were analysed using the Statistical Package for the Social Sciences (SPSS) version 23 and GraphPad Prism version 10. Continuous variables were analysed with the t-test, and categorical variables with the chi-square test. Receiver operating characteristic (ROC) curve and area under the curve (AUC) analyses were used to establish the diagnostic accuracy and determine the cut-off point of the APS score for ACA. The score was calculated using WCC, CRP, and bilirubin values at first presentation. A p-value of <0.05 was considered statistically significant.

Keywords
Appendicitis, Appendistat score, Triage tool, risk stratification, complicated appendicitis, Emergency surgery
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07197489
Study groupRoleWhat they receive
Right iliac fossa painPost operative classification into: acute uncomplicated appendicitis; acute complicated appendicitis; and normal appendix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the receiver operating characteristic (ROC) curve (AUC) of the Appendistat Score (APS) for predicting histologically confirmed complicated appendicitis

    Diagnostic accuracy of APS assessed by calculating the AUC of the ROC curve for discriminating complicated appendicitis from

    Measured: At time of hospital admission (within 24 hours of presentation)

Secondary outcomes (2)
  1. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Appendistat Score (APS) for detecting complicated appendicitis

    Diagnostic performance of APS compared with histology, reported as sensitivity, specificity, PPV, and NPV at the defined cut-off value.

    Measured: At time of hospital admission (within 24 hours of presentation)

  2. Mean Appendistat Score (APS) values in patients with histologically confirmed uncomplicated vs. complicated appendicitis

    Comparison of mean APS values between patients with acute uncomplicated appendicitis and those with acute complicated appendicitis, based on histological diagnosis

    Measured: At time of hospital admission (within 24 hours of presentation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start6 Jan 2024
  3. Primary completion2 Dec 2024
  4. Study completion2 Aug 2025

Resources

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
Case crossover
Time perspective
Cross-sectional
Enrolment
592 participants (actual)
Target duration
5 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07197489
Sponsor's protocol ID
206417
Acronym
APEX
Status last verified
Sep 2025
First submitted
9 Sep 2025
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eddama M, Fragkos KC, Renshaw S, Aldridge M, Bough G, Bonthala L, Wang A, Cohen R. Logistic regression model to predict acute uncomplicated and complicated appendicitis. Ann R Coll Surg Engl. 2019 Feb;101(2):107-118. doi: 10.1308/rcsann.2018.0152. Epub 2018 Oct 5.

    PubMed 30286649

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Appendicitis and Acute Appendicitis With Rupture, run by University College, London at 2 sites 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 1 inclusion and 1 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Area under the receiver operating characteristic (ROC) curve (AUC) of the Appendistat Score (APS) for predicting histologically confirmed complicated appendicitis (time frame: At time of hospital admission (within 24 hours of presentation)). 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 NCT07197489, which also lists 1 linked publication.

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 29 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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