Clinical trial NCT04615520: Evaluation of Surgical Risk Prediction Tools.
Official title: A Multicenter Comparison of Risk Prediction Tools for Emergency Laparotomy in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Laparotomy
Keywords: emergency laparotomy
risk prediction
postoperative mortality
NELA
ACS-risk calculator
POSSUM
Lead sponsor: University Hospital of Crete
Sponsor class: OTHER
Collaborators: name: Nicosia General Hospital
name: Laikο General Hospital, Athens
name: Attikon Hospital
name: Evangelismos Hospital
name: Trikala General Hospital, Trikala
name: Ippokrateio General Hospital of Thessaloniki
name: General Hospital of Volos
name: General University Hospital of Patras
name: University Hospital, Ioannina
First posted: 2020-11-04
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in a surgical department during a 12-month study period (May 1, 2020 - May 1, 2021 ).

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.


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)
* 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

Primary outcomes:
measure: Number of deaths within 30 days from emergency laparotomy
timeFrame: 30 days after emergency laparotomy
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Department of Surgery, University Hospital of Heraklion
Study officials:
affiliation: University Hospital of Heraklion
name: Konstantinos Lasithiotakis
role: PRINCIPAL_INVESTIGATOR
References: