Evaluation of Surgical Risk Prediction Tools.

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.

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Key information

Conditions

Emergency Laparotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, University Hospital of Heraklion

Heraklion, 71110, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
Any intra-abdominal procedure not identifiable within exclusion criteria should 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

Treatment and study plan

Primary outcomes

Number of deaths within 30 days from emergency laparotomy

Time frame: 30 days after emergency laparotomy

Patients who died of any cause within 30 days from emergency laparotomy

Sponsors and collaborators

Lead sponsor

University Hospital of Crete

Other

Collaborators

Attikon Hospital
Evangelismos Hospital
General Hospital of Volos
Ippokrateio General Hospital of Thessaloniki
Laikο General Hospital, Athens
Nicosia General Hospital
Trikala General Hospital, Trikala
University General Hospital of Patras
University Hospital, Ioannina

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Nov 4, 2020
Registry last updated: Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed