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.
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.
China1 site
HKU Li Ka Shing Faculty of Medicine
Hong Kong, Guangdong, 999077
Chong, (852)22553749
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:
- (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/)
- (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/)
- (Ref 3: NELA Project Team. Seventh Patient Report of the National Emergency Laparotomy Audit RCoA London 2021)
- (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/)
- (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/)
- (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 )
- (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 )
- (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)
- (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)
- (Ref 10: Lee et.al, 2020, https://doi.org/10.1111/jgs.16334 (https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16334))
- (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.
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.
- First posted25 Apr 2023
- Study start28 Apr 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mortality RateStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael G. Irwin, The University of Hong Kong
- Investigators
- Michael Garnet Irwin, M.B. Ch.B, Principal investigator, The University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05828914
- Acronym / sponsor ID
- UW 22-334
- Conditions
- Mortality Rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 28 Apr 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- (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/)
- (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/)
- (Ref 3: NELA Project Team. Seventh Patient Report of the National Emergency Laparotomy Audit RCoA London 2021)
- (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/)
- (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/)
- (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 )
- (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 )
- (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)
- (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)
- (Ref 10: Lee et.al, 2020, https://doi.org/10.1111/jgs.16334 (https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16334))
- (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 )
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Adult patients (> 18 years old) undergoing EL in Queen Mary Hospital between January 2017 and April 2021 will be included in this study
Key exclusion criteria (1 listed)
- Patients undergoing other emergency general surgical procedures (eg. laparoscopies, cholecystectomy, appendicectomy) will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
We hypothesize that the machine learning algorithm with incorporation of the frailty will perform better than the existing NELA risk calculator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Garnet Irwin, M.B. Ch.B principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
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.