Emergency Laparotomy
Conditions
Keywords
emergency laparotomy, risk prediction, postoperative mortality, NELA, ACS-risk calculator, POSSUM
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.
Interventions
None listed
Sponsors
Nicosia General Hospital
Laikο General Hospital, Athens
Attikon Hospital
Evangelismos Hospital
Trikala General Hospital, Trikala
Ippokrateio General Hospital of Thessaloniki
General Hospital of Volos
General University Hospital of Patras
University Hospital, Ioannina
University Hospital of Crete
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of deaths within 30 days from emergency laparotomy | 30 days after emergency laparotomy | Patients who died of any cause within 30 days from emergency laparotomy |
Countries
Greece
Outcome results
None listed