NCT03414853

Brief Summary

Computer-aided diagnostic software has been used to assist physicians in various ways. Text-based prediction algorithms have been trained on past medical records through data mining and feature analysis. Currently, all text-based machine learning prediction problem models have been built on extracted data with no research completed on free text based prediction algorithms. This study aims to determine the accuracy of a free text prediction algorithm in predicting the probability of appendicitis in patients presenting to the Emergency Department with abdominal pain and gastrointestinal symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
689

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

January 23, 2018

Last Update Submit

March 2, 2021

Conditions

Keywords

Appendicitis, abdominal pain, free text prediction

Outcome Measures

Primary Outcomes (1)

  • Accuracy of predictive algorithm for acute appendicitis

    Accuracy of predictive algorithm and accuracy of doctors with input from the algorithm in diagnosing acute appendicitis

    30 days

Study Arms (2)

With algorithm use

Diagnostic Test: Free text prediction algorithm for appendicitis

No algorithm use

Interventions

A free-text prediction software that predicts the probability of acute appendicitis

With algorithm use

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Attending physicians will be recruited as study participants and randomised weekly into "algorithm use" versus "no algorithm use". Patients who fulfilled the above eligibility criteria will have their data collected and entered into the predictive algorithm.

You may not qualify if:

  • Eligibility criteria of patients-
  • Presence of abdominal pain, OR
  • Presence of gastrointestinal symptoms such as nausea, vomiting or diarrhea, OR
  • Fever with anorexia
  • Previous history of appendicectomy
  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

AppendicitisAbdominal Pain

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Kee Yuan Ngiam, Dr

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

December 4, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations