NCT04615520

Evaluation of Surgical Risk Prediction Tools.

A Multicenter Comparison of Risk Prediction Tools for Emergency Laparotomy in Greece

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 660 (actual)
• Sponsor: University Hospital of Crete · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction: In modern surgery, the prediction of perioperative death gains significant importance due to the availability of treatment options, means of improving the surgical outcome and for proper patient information. However, patient heterogeneity and the existence of multiple risk prediction tools complicate the prediction of perioperative mortality. Thus, prognostic tools are developed based on the analysis of preoperative variables. Most commonly used models are POSSUM, ACS-NSQIP, NELA and POTTER. The models have been assessed in West-European and North-American populations, each with different prognostic value. Aim: Comparative analysis of predictive accuracy of the aforementioned risk prediction tools in Greek population. Materials and Methods: The study is multicenter, non-interventional, prospective and observational and includes patients undergoing emergency laparotomies of general surgery. In cases of multiple operations in one hospitalization, the first operation is included. The clinical-laboratory variables, derived from POSSUM, NELA, ACS-NSQIP and POTTER models are recorded anonymously in a secure online database, REDCap (Research Electronic Data Capture).The minimum estimated number of included patients in order to accomplish statistically significant results is 600. Each of the centers submitted in the study, is expected to include approximately 60 patients in a period of 6-12 months. For the statistical analysis of data, Brier Score will be used and ROC with statistical significance lower than 0.05. Conclusions: Upon completion of this study, the most accurate perioperative risk prediction tool in the Greek population is expected to be proposed.

Conditions

• Emergency Laparotomy

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2020-11-04
• Last updated: 2021-12-28

Locations

1 site across 1 country: Greece