NCT05828914

Brief Summary

This study seeks to utilise retrospective patient data to train machine learning algorithms to predict the short term mortality and morbidity after an emergency laparotomy. Data will be collected via the Electronic Health records system at the Queen Mary Hospital Hong Kong. Machine learning models will be compared and the best-performing one will be explored for further optimization and deployment. Upon completion, we hope that this platform will aid clinicians to identify high risk patients and aid clinical decisions and peri-operative planning, with the aim to reduce mortality and morbidity in this high risk procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

April 12, 2023

Last Update Submit

April 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short term (30-day) mortality rate in emergency laparotomies and accuracy of NELA risk calculator in the Hong Kong population.

    We hypothesize that the machine learning algorithm with incorporation of the frailty will perform better than the existing NELA risk calculator

    January 2017 and April 2021

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that meet the eligibility criteria within the timeframe of observation will be included in this study for machine learning modeling. Hence, no sample size calculation is required for this study.

You may qualify if:

  • Adult patients (\> 18 years old) undergoing EL in Queen Mary Hospital between January 2017 and April 2021 will be included in this study

You may not qualify if:

  • Patients undergoing other emergency general surgical procedures (eg. laparoscopies, cholecystectomy, appendicectomy) will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKU Li Ka Shing Faculty of Medicine

Hong Kong, Guangdong, 999077, China

Location

Study Officials

  • Michael Garnet Irwin, M.B. Ch.B

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Garnet Irwin, M.B. Ch.B

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

April 28, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2025

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations