Evaluation of Surgical Risk Prediction Tools.

NCT04615520 | Completed

• 1 other identifier: 1681/26-02-2020
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of deaths within 30 days from emergency laparotomy

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

  30 days after emergency laparotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 ).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Crete: lead
• Nicosia General Hospital: collaborator
• Laikο General Hospital, Athens: collaborator
• Attikon Hospital: collaborator
• Evangelismos Hospital: collaborator
• Trikala General Hospital, Trikala: collaborator
• Ippokrateio General Hospital of Thessaloniki: collaborator
• General Hospital of Volos: collaborator
• General University Hospital of Patras: collaborator
• University Hospital, Ioannina: collaborator

Study Sites (1)

Department of Surgery, University Hospital of Heraklion

Heraklion, 71110, Greece

Location

Related Publications (1)

• 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.

  PMID: 36726191 DERIVED

Study Officials

• Konstantinos Lasithiotakis

  University Hospital of Heraklion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj Professor of Surgery

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: May 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)