CClinicalTrials.gg
CompletedNCT07197489APEXUpdated Sep 29, 2025

Prioritisation of Acute Appendicitis Using Appendistat Score

An observational study in Acute Appendicitis and Acute Appendicitis With Rupture, sponsored by University College, London. Completed at 2 sites in United Kingdom. Open to participants aged 16 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by University College, London · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
592
Ages
16 Years to 95 Years
Sex
All
01

Study 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. 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

    2. 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

    3. 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.

02

Conditions studied

  • Acute Appendicitis
  • Acute Appendicitis With Rupture

Browse trials for

Keywords

  • Appendicitis
  • Appendistat score
  • Triage tool
  • risk stratification
  • complicated appendicitis
  • Emergency surgery
03

In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 592 is above the median of 200 across 150 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 95 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

hysterectomy, and those without a conclusive pathology report were excluded

05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
592 participants (actual)
Target follow-up
5 Months
Patient registry
Yes

Groups and cohorts

  • Right iliac fossa pain

    Post operative classification into: acute uncomplicated appendicitis; acute complicated appendicitis; and normal appendix

06

What researchers measure

Primary outcomes

  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

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

Secondary outcomes

  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.

    Time frame: 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

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

07

Study locations

2 sites
  • University College London
    London, OX3 8PF, United Kingdom
  • Oxford University Hospitals NHS Trust
    Oxford, United Kingdom
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07197489
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Jan 6, 2024
Primary completion
Dec 2, 2024
Completion
Aug 2, 2025
Last update
Sep 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion