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Clinical Trials/NCT02825082
NCT02825082
Completed
Not Applicable

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

University of Roma La Sapienza43 sites in 1 country2,200 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
University of Roma La Sapienza
Enrollment
2200
Locations
43
Primary Endpoint
30-day mortality rate
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
June 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Gianluca Costa

MD, PhD,

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

30-day mortality rate

Time Frame: 18 months

30-day morbidity rate

Time Frame: 18 months

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

Secondary Outcomes

  • 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)

Study Sites (43)

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