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临床试验/NCT02825082
NCT02825082已完成不适用

Risk Stratification Tools and Frailty Index for Predicting Perioperative Outcome in Elderly Patients Undergoing Abdominal Emergency Surgery

University of Roma La Sapienza43 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,200
试验地点
43
主要终点
30-day mortality rate

研究概览

简要总结

EMERGENCY GENERAL SURGERY IN GERIATRIC PATIENTS: EPIDEMIOLOGY, AND EVALUATION OF FACTORS AFFECTING MORBIDITY AND MORTALITY

详细描述

BACKGROUND: nowadays becoming old is considered a results from the socioeconomic development and improvements in health care systems worldwide. The life expectancy of the average person doubled over the course of the last century and it is currently estimated at 85-90 years in western countries.. The number of elderly people will increase dramatically over the next few decades with population projections towards 2040 indicating a 66% increase in the age-groups 65 to 74 years. More importantly, the age groups 75 years and above are projected to increase with >100%, which clearly will have implications for future health services. Thus, an acute medical insult may thus deprive a healthy 65- or 75-years old person from a considerable numbers of future life-years (20-30 years), either as lived in dependency. Older adults make up a large portion of surgical practice worldwide. In 2010, 37% of all inpatient operations performed in the United States were in patients 65 years and older, and this percentage will rise in the coming decades. Also, with increasing age comes an added risk of additional disease as well as the use of drugs, some of which clearly can interfere with emergency surgical conditions. Elderly patients with life-threatening abdominal disease are undergoing emergency surgery in increasing numbers and despite recent advances in surgical and anaesthetic techniques, elderly patients are at increased risk for major perioperative complications such as delirium, urinary incontinence, pressure ulcers,depression, infection, functional decline and adverse drug affects, longer hospital stays, and postoperative institutionalization. Even after controlling for co-morbid illnesses and functional impairment, age remains an independent risk factor for adverse postoperative events. Elderly who receive acute surgery often survives the initial treatment, but often suffers from severe complications due to comorbidity. If a complication occurs, it can lead to a cascade of events resulting in disability, loss of independence, diminished quality of life, high health care costs, and mortality. It is important with close post-operative follow up to avoid life threatening complicating conditions, and to involve geriatric consultants and other specialties if needed. Additional surgery and aggressive life-prolonging care, can in some cases, do more harm than good. Surgical decision making in this population is challenging because of the heterogeneity of health status in older adults and the paucity of tools for predicting operative risk. Commonly used predictors of postoperative complications have substantial limitations; most are based on a single organ system or are subjective, and none estimate a patient's physiologic reserves. therefore may need to undergo special pretreatment assessments that incorporate frailty assessments. Frailty is commonly associated with older adults and is identified by decreased reserves in multiple organ systems because of disease, lack of activity, inadequate nutrition, stress, and the physiological changes of aging. Given the inevitable rise of the aging population, it is vital that surgeons understand the concept of frailty and how it may affect surgical decisions and outcomes. Improving outcomes in emergency surgery for the geriatric population is a multifaceted task but has great clinical and health care system implications. valuation of current practice is important to improve outcomes for the future. Acting on the identified deficits and finding new areas for research is important to improve outcomes in the elderly.

AIM: to evaluate stratification of the surgical risk in patient > 65yo underwent general emergency surgery. To evaluate specific parameters as variables for new score in the elderly patient. To underline hotspot in the managements of such patients.

STUDY DESIGN: both retrospective and prospective cohort, multicenter, observational, no profit clinical study. All the study participants will collect data on elderly patients underwent general emergency surgery during a 18 month old period, guaranteeing a whole completeness of the picked data > 95%. This study was approved by the Health Sciences Research Ethics Board of the University of Rome La Sapienza.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All elderly patients submitted to emergency surgery considered as not-scheduled procedure within 7 days from admission

排除标准

  • 未提供

结局指标

主要结局

30-day mortality rate

时间窗: 18 months

30-day morbidity rate

时间窗: 18 months

Morbidity defined by mean of the Clavien's Classification scoring system

次要结局

  • Surgical mortality probability model (S-MPM)(18 months)
  • Calculation of Charlson Age-Comorbidity Index (CACI)(18 months)
  • Simplified Acute Physiology Score-II (SAPS-II)(18 months)
  • Total number of subjects underwent emergency surgery(18 months)
  • Colorectal-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (CR-POSSUM)(18 months)
  • Canadian Study of Health and Ageing (CSHA) frailty score(18 months)
  • Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM)(18 months)
  • American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator(18 months)
  • Calculation of post-Operative Risk in Emergency Surgery (CORES)(18 months)
  • Frailty Fried Index(18 months)
  • Geographical area inhabitants(18 months)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Costa

MD, PhD,

University of Roma La Sapienza

研究点 (43)

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