Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04211532
Status:
UNKNOWN
Last Update Posted:
2019-12-26
First Post:
2019-12-17
Brief Title:
Evaluation of the ACS-NSQIP Risk Calculator for Emergent Surgery in a Spanish Population
Sponsor:
Corporacion Parc Tauli
Organization:
Corporacion Parc Tauli
Study Overview
Official Title:
Evaluation of the ACS-NSQIP Risk Calculator for Emergent Surgery in a Spanish Population
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nowadays quality of life and individualised medicine are becoming more important in the everyday medical practice and surgery it is not an exception In recent years the interest in the improvement of the quality of surgical procedures and outcomes has increased This quality can be improved by assessing the surgical or operative risk by evaluating the postoperative mortality and morbidity
Most of the risk stratification tools are used in elective surgery Only few have been specifically validated for immediate or urgent However there are different situations In elective interventions the patient and the surgeon can discuss the advantages and drawbacks and postpone the decision Moreover an improvement in the physical status of the patient can be performed whereas in immediate or urgent surgery there is no time to neither of them
POSSUM is used as the main tool for the prediction of mortality and morbidity and for assessing the quality care of the General Surgery Unit of Corporació Sanitària Parc Taulí Nevertheless this system has its limitations It overestimates mortality in low risk patients and it does not take into account the specific surgical procedure
That is why it is believed that the ACS-NSQIP risk calculator -created in 2013- is a potential good tool to stratify surgical risks In contrast with POSSUM it considers any surgical procedure -according to the Current Procedural Terminology
The calculator has been externally validated in population of North-America which requires emergent surgery with a somewhat underestimation of the risk As populations have different profiles and there are different levels of care it is needed the external validation in other countries
In essence there is a need of validation of risk calculators in different populations and emergency surgery immediate and urgent is distinct from the elective operation therefore they should be considered separately when risk is calculated
Therefore there is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency immediate and urgent surgery On the other hand it is suggested that ACS NSQIP risk calculator performs better than POSSUM Hence its prediction performance is compared with POSSUM
Most of the risk stratification tools are used in elective surgery Only few have been specifically validated for immediate or urgent However there are different situations In elective interventions the patient and the surgeon can discuss the advantages and drawbacks and postpone the decision Moreover an improvement in the physical status of the patient can be performed whereas in immediate or urgent surgery there is no time to neither of them
POSSUM is used as the main tool for the prediction of mortality and morbidity and for assessing the quality care of the General Surgery Unit of Corporació Sanitària Parc Taulí Nevertheless this system has its limitations It overestimates mortality in low risk patients and it does not take into account the specific surgical procedure
That is why it is believed that the ACS-NSQIP risk calculator -created in 2013- is a potential good tool to stratify surgical risks In contrast with POSSUM it considers any surgical procedure -according to the Current Procedural Terminology
The calculator has been externally validated in population of North-America which requires emergent surgery with a somewhat underestimation of the risk As populations have different profiles and there are different levels of care it is needed the external validation in other countries
In essence there is a need of validation of risk calculators in different populations and emergency surgery immediate and urgent is distinct from the elective operation therefore they should be considered separately when risk is calculated
Therefore there is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency immediate and urgent surgery On the other hand it is suggested that ACS NSQIP risk calculator performs better than POSSUM Hence its prediction performance is compared with POSSUM
Detailed Description:
A prospective validation cohort study is proposed The surgical risk of the patients recruited in the study was calculated by the ACS NSQIP risk calculator and by POSSUM
In order to compare the performance of ACS NSQIP risk calculator with POSSUM area under the receiver operating characteristic curve AUC was calculated for each tool The statistical differences between the two AUC curves were compared using P value Calibration of the agreement between observed and predicted outcomes was tested using the Brier score The Brier score ranges from 0 to 1 The closer the score is to 0 the more accurate is the risk prediction model
There is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency immediate and urgent surgery Besides it is suggested that ACS NSQIP risk calculator performs better than POSSUM Hence its prediction performance is compared with POSSUM
In order to compare the performance of ACS NSQIP risk calculator with POSSUM area under the receiver operating characteristic curve AUC was calculated for each tool The statistical differences between the two AUC curves were compared using P value Calibration of the agreement between observed and predicted outcomes was tested using the Brier score The Brier score ranges from 0 to 1 The closer the score is to 0 the more accurate is the risk prediction model
There is a need of validation of the ACS NSQIP risk calculator in Spanish population which requires emergency immediate and urgent surgery Besides it is suggested that ACS NSQIP risk calculator performs better than POSSUM Hence its prediction performance is compared with POSSUM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None