Evaluation of Surgical Risk Prediction Tools.

NCT ID: NCT04615520

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-08-01

Brief 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

Keywords

emergency laparotomy; risk prediction; postoperative mortality; NELA; ACS-risk calculator; POSSUM

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age >18yrs
• Emergency laparotomy (operation simultaneously with resuscitation usually within one hour) or urgent (operation as soon as possible after resuscitation, within 24hrs)
• Operation in the gastrointestinal tract:
• Open or laparoscopic, or laparoscopically assisted procedures.
• Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
• Wash out/evacuation of intraperitoneal abscess or haematoma
• Bowel resection/repair due to incarcerated/incisional hernias
• Bowel resection or repair due to incarcerated umbilical, inguinal or femoral hernias
• Open or laparoscopic adhesiolysis
• Laparotomy/laparoscopy with inoperable pathology
• Return to theatre for repair of a substantial dehiscence of major abdominal wound (i.e. "burst abdomen")
• Return to theatre after any operation (including vascular, gynecology, urology, cardiac) meeting the criteria above
• In the case of multiple procedures in the abdominopelvic cavity the patient is included if the main procedure is a general surgical one (i.e. if bowel resection happens during an open aneurysm repair it should not be included)

Exclusion Criteria

• Patients under 18
• Elective operation
• Diagnostic laparoscopy or laparotomy where no other procedure is performed (NB, if no procedure is performed due to inoperable pathology, then include)
• Appendicectomy with or without drainage of localized abscess
• Cholecystectomy with or without drainage of localized abscess
• Hernia repair without bowel resection
• Minor abdominal wound revision
• Vascular surgery
• Gynecological surgery - c-section - ruptured ectopic pregnancy
• Surgery relating to organ transplantation
• Removal of dialysis catheters

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicosia General Hospital

OTHER

Sponsor Role: collaborator

Laikο General Hospital, Athens

OTHER

Sponsor Role: collaborator

Attikon Hospital

OTHER

Sponsor Role: collaborator

Evangelismos Hospital

OTHER

Sponsor Role: collaborator

Trikala General Hospital, Trikala

UNKNOWN

Sponsor Role: collaborator

Ippokrateio General Hospital of Thessaloniki

OTHER

Sponsor Role: collaborator

General Hospital of Volos

OTHER

Sponsor Role: collaborator

General University Hospital of Patras

OTHER

Sponsor Role: collaborator

University Hospital, Ioannina

OTHER

Sponsor Role: collaborator

University Hospital of Crete

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Lasithiotakis

Adj Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantinos Lasithiotakis

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Heraklion

Locations

Department of Surgery, University Hospital of Heraklion

Heraklion, , Greece

Countries

Greece

References

Kokkinakis S, Kritsotakis EI, Paterakis K, Karali GA, Malikides V, Kyprianou A, Papalexandraki M, Anastasiadis CS, Zoras O, Drakos N, Kehagias I, Kehagias D, Gouvas N, Kokkinos G, Pozotou I, Papatheodorou P, Frantzeskou K, Schizas D, Syllaios A, Palios IM, Nastos K, Perdikaris M, Michalopoulos NV, Margaris I, Lolis E, Dimopoulou G, Panagiotou D, Nikolaou V, Glantzounis GK, Pappas-Gogos G, Tepelenis K, Zacharioudakis G, Tsaramanidis S, Patsarikas I, Stylianidis G, Giannos G, Karanikas M, Kofina K, Markou M, Chrysos E, Lasithiotakis K. Prospective multicenter external validation of postoperative mortality prediction tools in patients undergoing emergency laparotomy. J Trauma Acute Care Surg. 2023 Jun 1;94(6):847-856. doi: 10.1097/TA.0000000000003904. Epub 2023 Feb 2.

Reference Type: DERIVED

PMID: 36726191 (View on PubMed)

Other Identifiers

1681/26-02-2020

Identifier Type: -

Identifier Source: org_study_id