跳至主要内容
临床试验/NCT03582631
NCT03582631已完成不适用

Biomarkers in Acute High-risk AbdoMinAl Surgery

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
No of patients died within 30 days postoperatively

研究概览

简要总结

Acute high-risk abdominal surgery (AHA) is performed in hospitals worldwide. Ethiologies are heterogeneous, but it carries a high mortality rate (1)(2). In particular, emergency laparotomies performed on elderly people has a high mortality rate(3)(4). Different quality improvement programs have been suggested, but the quality of care and mortality varies between hospitals (5)(6). The use of postoperative intensive care seem to be inadequate for this high risk population (1)(7)(8). It is of paramount importance to identify the frailest and acutely deranged patients, who are in risk of poor outcome, to allocate resources for optimization postoperatively. Failure to escalate care intensity after having developed postoperative complications affect outcome. Organization, teamwork and culture is important postoperatively to be able to escalate care especially in standard care wards (9)(10). However, it is difficult to predict which patients will develop complications.

Different risk assessment tools have been proposed for patients undergoing AHA (11)(12). The APACHE-II score, even though developed for critical care, seems to give the best prediction of outcome. Objective risk assessment tools support clinical decision making as subjective clinical assessment often underestimates the risk for the patients in highest risk of complications and death (13). Good clinical decision-making is likely to improve the clinical outcome by allocating appropriate resources. Prognostic tools are also useful to inform patients about what to expect in the postoperative phase and of long-term outcome. Especially in the elder population with increased risk of loss of function or independency, this can be useful to give informed consent to treatment. Furthermore, good risk assessment is important to optimize palliative care after end-of-life decisions, which is often ignored in research, but highly relevant in clinical work.

Prognostic biomarkers in other high mortality populations have received much attention for risk stratification (14). An ideal biomarker should be readily available upon decision-making, easy to measure, and reliable. Furthermore, it should accurately differentiate prognosis for patients to have value in the clinical decision-making and guide the treatment. It should also be linked to the clinical outcomes.

The investigators aim to identify AHA biomarkers that are prognostic or predictive for postoperative morbidity, mortality and length of hospitalization.

详细描述

Acute high-risk abdominal surgery (AHA) is performed in hospitals worldwide. Ethiologies are heterogeneous, but overall emergency surgery carries a very high mortality rate (1)(2). In particular, emergency laparotomies performed on elderly people has a high mortality rate(3)(4). Different quality improvement programmes for that particular patient group have been suggested, but the quality of care and thereby mortality varies considerably between hospitals(5)(6). The use of postoperative intensive care and monitoring seem to be inadequate for this high risk population in a variety of hospitals(1)(7)(8). It is of paramount importance to identify the frailest and most acutely deranged patients, who are in risk of poor outcome, in order to allocate resources for improved monitoring and optimisation postoperatively. It has been shown that failure to rescue patients after having developed postoperative complications and inability to escalate care intensity affects the outcome. Organisation, teamwork and culture is important in the postoperative phase to be able to escalate care especially in standard care wards(9)(10). However, it is found difficult to predict which patients will experience complications in a standard care ward.

Different risk assessment tools have been proposed for patients undergoing AHA(11)(12). The APACHE-II score, even though developed for critical care, seems to be the one with best prediction of outcome. Risk assessment tools are important to support clinical decision making by the perioperative team as subjective clinical assessment often underestimates the risk for the patients in highest risk of complications and death(13). Good clinical decision-making is likely to improve the clinical outcome by allocating appropriate resources. Prognostic tools are also useful to inform patients about what to expect in the immediate postoperative phase and of long-term outcome. Especially in the elder population with increased risk of long hospitalisation and loss of function or independency this can be useful to give informed consent to treatment strategy. Furthermore, good risk assessment is important to optimize palliative care after end-of-life decisions, which is often ignored in research, but highly relevant in clinical work.

During recent years use of prognostic biomarkers in other high mortality populations have received much attention for risk stratification(14). An ideal biomarker should be readily available upon decision-making, easy to measure, reliable and biologically stable. Furthermore it has to be able to accurately differentiate prognosis for patients to have value in the clinical decision-making and guide the treatment of the patient. It should be linked to the clinical outcomes.

The investigators aim to identify serological AHA biomarkers that are prognostic or predictive for postoperative morbidity, mortality and length of hospitalisation.

Data collection Data on mortality was obtained using the Danish Civil Registration System(30). This register is maintained by the Danish government and assigns a unique personal identification number to all Danish citizens. It contains data on address, immigration emigration, gender, date of birth and exact day of death. It is updated within days of any change in information.

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

入选标准

  • Patients aged 18 or older with the suspicion for abdominal pathology requiring immediate emergency laparotomy or laparoscopy including reoperations after elective surgery and reoperations after previous AHA surgery.

排除标准

  • We excluded the following procedures: appendectomies; negative laparoscopies and laparotomies; cholecystectomies; simple herniotomies following incarceration (without intestinal resection); reoperation due to fascial separation with no other abdominal pathology; internal herniation after roux-en-y gastric bypass surgery; sub-acute surgery (planned within 48 hours) for inflammatory bowel disease; and sub-acute colorectal cancer surgery.
  • We excluded, traumas, pregnant woman, uro-genital, gynaecological and vascular pathology except for mesenteric ischemia.

结局指标

主要结局

No of patients died within 30 days postoperatively

时间窗: 30 days

30 day mortality after surgery

No of patients with major postoperative complications within 30 days afer surgery

时间窗: 30 days

Clavien Dindo grade more than 3a

No of patients died within 180 days postoperatively

时间窗: 180 days

180-day mortality after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rune Børch Hasselager

Principal Investigator, Medical Doctor

University of Copenhagen

研究点 (1)

Loading locations...

相似试验