NCT07197489

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 6, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 9, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

AppendicitisAppendistat scoreTriage toolrisk stratificationcomplicated appendicitisEmergency surgery

Outcome Measures

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

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

Secondary Outcomes (2)

  • Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Appendistat Score (APS) for detecting complicated appendicitis

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

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

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

Study Arms (1)

Right iliac fossa pain

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

Eligibility Criteria

Age16 Years - 95 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University College London

London, OX3 8PF, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

Related Publications (1)

  • Lerea KM, Livingston JN. The different receptor species of liver have similar complex insulin binding properties. Biochem Biophys Res Commun. 1983 Aug 12;114(3):1042-7. doi: 10.1016/0006-291x(83)90667-8.

    PMID: 6351858BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 29, 2025

Study Start

January 6, 2024

Primary Completion

December 2, 2024

Study Completion

August 2, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations