A Multicenter Comparison of Risk Prediction Tools for Emergency Laparotomy in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Number of deaths within 30 days from emergency laparotomy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of deaths within 30 days from emergency laparotomy
时间窗: 30 days after emergency laparotomy
Patients who died of any cause within 30 days from emergency laparotomy
次要结局
未报告次要终点
研究者
Konstantinos Lasithiotakis
Adj Professor of Surgery
University Hospital of Crete