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Risk Calculators Validation for Elective Major General Surgery

Validation of Postoperative Mortality Prediction for Elective Major Surgical Operation With Existing Risk Calculators Based on Preoperative Parameters

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04041076
Acronym
RCVEMG
Enrollment
5000
Registered
2019-08-01
Start date
2019-11-01
Completion date
2020-12-31
Last updated
2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Surgery

Keywords

preoperative parameters, risk prediction, postoperative mortality, elective major general surgery

Brief summary

Nowadays, over 300 million surgical operations take place every year worldwide, which increase at a rate of 33.6% comparing data from 2005 to 2013. According to Surgical Outcomes Monitoring and Improvement Program (SOMIP) reports, which is an Hospital Authority-wide (HA-wide) audit on postoperative outcomes, a growth in major and ultra-major operations performed in our locality is also observed between 2008 and 2016, which leads to an increasing demand of high dependency and intensive care in the postoperative period. With the advancement in surgical technology, increasing surgical complexity and aging population have raised concerns towards perioperative costs and postoperative complications. Therefore, there is a need of an objective tool for risk stratification, which would be useful to guide clinical decision in terms of the magnitude of operation, level of intraoperative monitoring and postoperative placement plan. Various risk scoring systems have been developed nowadays and each has its own limitations. As nowadays, the calculated risk score is commonly used in shared decision making process with patient and among the perioperative team. Risk calculation solely based on preoperative parameters will be more practical for daily clinical use. Therefore, in this study, the investigators would like to validate the postoperative mortality prediction with the risk calculators that are established merely using preoperative variables. Hopefully this would guide the future risk stratification in patients undergoing elective major surgical operation.

Detailed description

Nowadays, over 300 million surgical operations take place every year worldwide, which increase at a rate of 33.6% comparing data from 2005 to 2013. According to Surgical Outcomes Monitoring and Improvement Program (SOMIP) reports, which is an Hospital Authority-wide (HA-wide) audit on postoperative outcomes, a growth in major and ultra-major operations performed in our locality is also observed between 2008 and 2016, which leads to an increasing demand of high dependency and intensive care in the postoperative period. With the advancement in surgical technology, increasing surgical complexity and aging population have raised concerns towards perioperative costs and postoperative complications. An international prospective cohort study revealed that globally 1 in 6 patients experienced a complication before hospital discharge and 1 in 35 patients who experienced a complication subsequently died without leaving the hospital. Therefore, there is a need of an objective tool for risk stratification, which would be useful to guide clinical decision in terms of the magnitude of operation, level of intraoperative monitoring and postoperative placement plan. There are a variety of risk stratification tools available for use in major non-cardiac surgery. Among all, the American Society of Anaesthesiology Physical Status (ASA-PS) evaluation scale is the most commonly used risk evaluation system in the assessment of patients' physical status in the preoperative period. Although ASA-PS is well-validated in previous studies and simple to use, inter-rater reliability and the lack of consideration in the surgical perspective have raised concerns towards the development of risk prediction models to supplement clinical judgements and strengthen operative mortality estimation. In 2013, a qualitative systematic review found that Portsmouth Variation of the Physiological and Operative Score for the enUmeration of Mortality and Morbidity (P-POSSUM) and Surgical Risk Scale (SRS) to be the most reliable multivariate risk scoring systems,, but both were noted to have limitations. P-POSSUM has overcome the issues of risk overestimation and inadequate generalization across various surgical specialties by POSSUM. But the calculation requires 12 physiological and 6 operative variables, some of which requires subjective interpretation e.g. chest X-ray. These makes P-POSSUM labour-intensive for clinical use. Whereas SRS requires fewer data for risk calculation, it has only been validated in a single centre study. In recent years, newer risk prediction models like the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) model and Preoperative Score to Predict Postoperative Mortality (POSPOM) have been developed to provide a more comprehensive perioperative risk prediction for patients undergoing major operation. ACS-NSQIP model is developed based on high-quality clinical data from ACS-NSQIP and is described as a universal risk calculator, which includes a Surgeon Adjustment Score (SAS) that allows further score modification according to surgical performance. However, owing to the high dependence on preoperative laboratory results, ACS-NSQIP often encounters problems where these parameters are not readily available in emergency situations. POSSOM model involves 17 predictor variables. Together with its excellent discrimination and calibration properties demonstrated in its validation cohort and the easily referable rating system, POSSOM is considered a robust tool for 1-year postoperative mortality prediction. However, further reviews on its external validation are yet available. In 2014, a new risk stratification tool, Surgical Outcome Risk Tool (SORT) was developed in the UK to predict 30-day mortality after non-cardiac surgery in adults, based on post hoc analysis of data in the Knowing the Risk study from the observational National Confidential Enquiry into Patient Outcome and Death (NCEOPD). SORT is a multivariate risk scoring system, which includes 6 variables: 1) American Society of Anesthesiologists Physical Status (ASA-PS) grade, 2) urgency of surgery, 3) surgical specialty, 4) surgical magnitude, 5) cancer or non-cancer surgery and 6) age. In 2018, the Combined Assessment of Risk Encountered in Surgery (CARES) surgical risk calculator has been developed based on Singapore local data, which makes use of 9 preoperative parameters namely: 1) age, 2) gender, 3) ASA classification, 4) surgical risk group, 5) emergency surgery, 6) anaemia status, 7) red cell distribution width (RDW), 8) ischaemic heart disease, , 9) congestive heart failure for prediction of postsurgical mortality and need for intensive care unit admission. When the investigators look into each of these existing risk stratification tools, each of the risk calculators possesses its drawbacks when coming into clinical applications. As nowadays, the calculated risk score is commonly used in shared decision making process with patient and among the perioperative team. Risk calculation solely based on preoperative parameters will be more practical for daily clinical use. Therefore, in this study, the investigators would like to validate the postoperative mortality prediction with the risk calculators that are established merely using preoperative variables. Hopefully this would guide the future risk stratification in patients undergoing elective major surgical operation.

Interventions

PROCEDUREMajor surgical operation

Surgical operation with magnitude defined as major or ultra-major

Sponsors

Tuen Mun Hospital
CollaboratorOTHER_GOV
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. patient aged 18 years or over 2. undergoing elective major surgical operation\* 3. requiring a planned overnight admission

Exclusion criteria

* Patients undergoing day case surgery, obstetric procedures, neurosurgery, cardiac or transplant surgery were excluded. * Patient were also excluded if any of the key variables were missing

Design outcomes

Primary

MeasureTime frameDescription
30-day mortality rate30 days postoperativelyThe Rate of Mortality at or within 30 days after the elective major surgical operation

Secondary

MeasureTime frameDescription
1-year mortality rate1 year postoperativelyThe Rate of Mortality at or within 1 year after the elective major surgical operation

Countries

Hong Kong

Contacts

Primary ContactCarmen KM Lam, MBBS
carmenlam1013@gmail.com+85290804633
Backup ContactMatthew TV Chan, MBBS
mtvchan@cuhk.edu.hk+85291363821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026