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Emergency Surgery in the Elderly: Comparison of Frailty Index and Surgical Risk Score (FRAILESEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02825082
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : August 28, 2018
Information provided by (Responsible Party):
Gianluca Costa, University of Roma La Sapienza

Brief Summary:

Condition or disease Intervention/treatment
Surgery Emergency Procedure: Abdominal emergency surgery

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.

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Study Type : Observational
Actual Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Risk Stratification Tools and Frailty Index for Predicting Perioperative Outcome in Elderly Patients Undergoing Abdominal Emergency Surgery
Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : June 2018

Intervention Details:
  • Procedure: Abdominal emergency surgery
    all abdominal emergency surgery procedures

Primary Outcome Measures :
  1. 30-day mortality rate [ Time Frame: 18 months ]
  2. 30-day morbidity rate [ Time Frame: 18 months ]
    Morbidity defined by mean of the Clavien's Classification scoring system

Secondary Outcome Measures :
  1. Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM) [ Time Frame: 18 months ]
    Observed to expected (O:E) mortality ratio

  2. Calculation of Charlson Age-Comorbidity Index (CACI) [ Time Frame: 18 months ]
    Calculation and evaluation of its predictive value for morbidity and mortality

  3. Simplified Acute Physiology Score-II (SAPS-II) [ Time Frame: 18 months ]
    Calculation and evaluation of its predictive value for mortality

  4. American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator [ Time Frame: 18 months ]
    Calculation and evaluation of its predictive value for post-operative complications

  5. Calculation of post-Operative Risk in Emergency Surgery (CORES) [ Time Frame: 18 months ]
    Calculation and evaluation of its predictive value for mortality

  6. Surgical mortality probability model (S-MPM) [ Time Frame: 18 months ]
    Observed to expected (O:E) mortality ratio

  7. Colorectal-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (CR-POSSUM) [ Time Frame: 18 months ]
    Observed to expected (O:E) mortality ratio

  8. Frailty Fried Index [ Time Frame: 18 months ]
    Frailty stratification in participants

  9. Canadian Study of Health and Ageing (CSHA) frailty score [ Time Frame: 18 months ]
    Frailty stratification in participants

  10. Total number of subjects underwent emergency surgery [ Time Frame: 18 months ]
    Elderly to non elderly patient ratio

  11. Geographical area inhabitants [ Time Frame: 18 months ]
    Emergency surgery in the elderly per 100.000 inhabitants

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multicenter italian national survey cohort study

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

Exclusion Criteria: None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02825082

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Sponsors and Collaborators
University of Roma La Sapienza
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Study Director: Gianluca Costa, MD, PhD University of Roma La Sapienza, Sant' Andrea University Hospital
Principal Investigator: Giuseppe Nigri, MD, FACS University of Roma La Sapienza, Sant' Andrea University Hospital
Publications of Results:

Other Publications:
A, Frezza B, Scandavini CM, Fransvea P, Costa G, Balducci Mortalità e morbilità per chirurgia colica in urgenza nel paziente anziano Lo Conte G Osp. Ital. Chirurgia 2012
Costa G, Nigri G, Tierno SM, Tomassini F, Varano GM, Venturini Emergency abdominal surgery in the elderly: a ten-year experience L BMC Geriatrics 2009, 9(Suppl 1):A53

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gianluca Costa, MD, PhD,, University of Roma La Sapienza Identifier: NCT02825082    
Other Study ID Numbers: 4252_2016 - 12/12/2016
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gianluca Costa, University of Roma La Sapienza:
Emergency general surgery
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes