NCT04615520

Evaluation of Surgical Risk Prediction Tools.

Completed Last updated 28 December 2021

What this trial tests

trial in Emergency Laparotomy in 660 participants. Completed in 1 August 2021.

Timeline

1 May 2020

Primary endpoint
1 August 2021

1 August 2021

Quick facts

Lead sponsor	University Hospital of Crete
Status	Completed
Study type	OBSERVATIONAL
Enrollment	660
Start date	1 May 2020
Primary completion	1 August 2021
Estimated completion	1 August 2021
Sites	1 location across Greece

Conditions studied

• Emergency Laparotomy — all drugs for Emergency Laparotomy →

Sponsor

University Hospital of Crete

Who can join

18 and older, any sex, with Emergency Laparotomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Hellenic Emergency Laparotomy Study (HELAS): A Prospective Multicentre Study on the Outcomes of Emergency Laparotomy in Greece.
   Lasithiotakis K, Kritsotakis EI, Kokkinakis S, Petra G, et al · · 2023 · cited 18× · PMID 36109368 · DOI 10.1007/s00268-022-06723-6