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Mortality RateNCT05828914

Machine Learning Platforms to Predict 30-day Mortality After Emergency Laparotomy

An observational study of Mortality Rate, run by The University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mortality Rate
How many people
5,000 participants
Where
1 siteChina
Study dates
28 Apr 2023to 31 Jul 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Michael Garnet Irwin, M.B. Ch.B contact

97018342

mgirwin@hku.hk

China1 site
  • HKU Li Ka Shing Faculty of Medicine

    Hong Kong, Guangdong, 999077

    Chong, (852)22553749

Other trials in China

About this study

Official title: Development and Validation of a Novel Machine Learning Model to Predict the 30-day Mortality of Emergency Laparotomy in the Hong Kong Population

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.

Read the detailed description

Emergency laparotomy (EL) is a commonly performed procedure and high risk surgery that is known to have a high mortality and morbidity rate. Despite various audits and studies to identify the risk factors and introduce protocols aimed at improving surgical outcomes, the short term mortality after EL remains high. Worldwide data demonstrates that short term (30-day) mortality ranges between 5.3-21.8%, and long term (1-year) mortality rates ranges between 15-47% (Ref 1). Older patients have been identified as the subgroup suffering from highest mortality rates, and efforts implemented in older patients undergoing EL including: the use of risk calculators for mortality prediction, increased peri-operative input from geriatrician and critical care, higher consultant surgeon and anesthetist presence in the operating theatre, and introduction of enhanced care pathways. Apart from age and specialist input, other risk factors for mortality after EL include: frailty, surgical duration, cancer-related surgery, stoma care, patient selection, pre-operative sepsis and physiological parameters, pre-existing comorbidities, ASA status (Ref 2).

Mortality prediction models currently in clinical use for EL include the Portsmouth-Physiologic and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), Acute Physiology and Chronic Health Evaluation II (APACHE-II), American College of Surgeons National Surgical Quality Improvement (ACS-NSQIP), and the most recent addition of the (NELA) risk calculator. The National Emergency Laparotomy Audit (NELA) performed in the UK since 2012 has been a paradigm shift in evidence-based improvement for patients undergoing EL, demonstrating a reduction in national 30-day mortality rate (11.8% vs.8.7% in 2012 vs. 2012) after identification and implementation of specific recommendations (Ref 3).

Using the data from the large NELA UK cohort between 2014-2016, the NELA risk calculation tool was developed to estimate 30-day mortality, and takes into account patient demographics, ASA status, physiological parameters, vital signs, and details regarding severity and nature of surgical intervention. Multiple studies in the UK, Australia, Singapore have shown the NELA risk calculator is comparable, if not superior, to P-POSSUM for mortality prediction and risk stratification to differentiate between lowand high-risk patients undergoing EL (Ref 5, 6, 7). However, no risk scoring is perfect. The NELA risk model was shown to underpredict, and P-POSSUM to over-predict observed mortality (Ref 8). Since its introduction, NELA has been a pioneer in developing evidence-based interventions and guiding directions for future research in patients undergoing EL, but its implementation in Hong Kong has been limited by lack of validation of accuracy in our patient population.

Frailty is defined as: an objective measure of increased vulnerability and decreased physiological reserve, resulting in accumulation of physiological deficits in multiple systems, and can occur in patients of all ages, but occurs most commonly in older patients. Frailty is a well known risk factor for poor surgical outcomes in EL (Ref 9, 10), but has yet to be incorporated into commonly used risk calculators. There are many risk scoring and surrogate indices for frailty, sarcopenia and osteopenia. Clinical frailty score (CFS) is the most commonly used index for frailty, and CFS alone has been shown to provide prognostic information for patients undergoing EL, but still underperforming compared to NELA. Interestingly, addition of CFS to NELA did not increase the accuracy of the risk model prediction (Ref 11).

The application of deep learning and machine learning is gaining traction, and has been used to develop various risk prediction models and future event prediction (Ref 4). Accumulation of vast datasets from anesthetic records can prove to be a treasure trove for data scientists to uncover new trends and predictions which would previously be overlooked. Risk calculators are helpful tools for clinicians to aid in clinical decision making, but the accuracy and validation of these risk calculators have not been done in this vicinity. Using machine learning algorithms and incorporation of frailty into risk calculators, we hope to develop a novel algorithm with high accuracy and generalizability, to be introduced into clinical use.

References:

  1. (Ref 1: Ng et. al, One year outcomes following emergency laparotomy: A systematic review, World J surg, 2022, https://pubmed.ncbi.nlm.nih.gov/34837122/)
  2. (Ref 2: (Ref: Boyd-Carson et al, A review of surgical and perii-operative factors to consider in emergency laparotomy care, 2020, Anesthesia, https://pubmed.ncbi.nlm.nih.gov/31903572/)
  3. (Ref 3: NELA Project Team. Seventh Patient Report of the National Emergency Laparotomy Audit RCoA London 2021)
  4. (Ref 4: Kwon et al, Machine learning: a new opportunity for risk prediction, Korean Circ J. 2020, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6923232/)
  5. (Ref 5: Lai et al, A comparison of the P-POSUSM and NELA risk score for patients undergoing emergency laparotomy in Singapore, World J Surg, 2021, https://pubmed.ncbi.nlm.nih.gov/33903953/)
  6. (Ref 6: Eliezer et al, High risk emergency laparotomy in Australia: comparing NELA, P-POSSUM and ACS-NSQIP calculators, J of surg research, 2020, https://www.sciencedirect.com/science/article/abs/pii/S0022480419306584 )
  7. (Ref 7: Eugene et al, Development and internal validation of a novel risk adjustment model for adult patients undergoing emergency laparotomy surgery: the national emergency laparotomy audit risk model, BJA, 2018, https://www.sciencedirect.com/science/article/pii/S0007091218305786 )
  8. (Ref 8: Thahir A, Pinto-Lopes R, Madenlidou S, Daby L, Halahakoon C. Mortality risk scoring in emergency general surgery: Are we using the best tool? Journal of Perioperative Practice. 2021;31(4):153-158. doi:10.1177/1750458920920133, https://journals.sagepub.com/doi/abs/10.1177/1750458920920133)
  9. (Ref 9: Fehlmann et al, Association between mortality and frailty in emergency general surgery: a systematic review and meta-analysis, Euro J Trauma Emerg Surg, 2022, https://link.springer.com/article/10.1007/s00068-020-01578-9)
  10. (Ref 10: Lee et.al, 2020, https://doi.org/10.1111/jgs.16334 (https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16334))
  11. (Ref 11: Palaniappan - Comparison of the clinical frailty score CFS to the National Emergency.Palaniappan et al, Comparison of CFS to the NELA risk calculator in all patients undergoing emergency laparotomy, Colorectal disease, 2022, https://onlinelibrary.wiley.com/doi/full/10.1111/codi.16089 )
Conditions
Mortality Rate

What is being measured

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

  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

    Measured: January 2017 and April 2021

Timeline

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

  1. First posted25 Apr 2023
  2. Study start28 Apr 2023 (estimated)
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2025 (estimated)

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
Cohort
Time perspective
Retrospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828914
Sponsor's protocol ID
UW 22-334
Status last verified
Apr 2023
First submitted
12 Apr 2023
Last updated
25 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Mortality Rate, run by The University of Hong Kong at 1 site in China.

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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Garnet Irwin, M.B. Ch.B (97018342, mgirwin@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short term (30-day) mortality rate in emergency laparotomies and accuracy of NELA risk calculator in the Hong Kong population. (time frame: January 2017 and April 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Apr 2023.

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