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

August 27, 2018 updated by: Gianluca Costa, University of Roma La Sapienza

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Marche, Italy
        • Ospedale di Macerata
      • Palermo, Italy
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
    • Abruzzo
      • Pescara, Abruzzo, Italy
        • Ospedale Civile Spirito Santo
    • Bergamo
      • Ponte San Pietro, Bergamo, Italy
        • Policlinico San Pietro
    • Cagliari, Sardegna
      • Monserrato, Cagliari, Sardegna, Italy
        • Presidio Ospedaliero Duilio Casula
    • Campania
      • Acerra, Campania, Italy
        • Ospedale Convenzionato Villa dei Fiori
      • Avellino, Campania, Italy
        • Azienda Ospedaliera di Rilievo Nazionale e di alta Specialità
      • Benevento, Campania, Italy
        • A.O.R.N Gaetano Rummo
      • Napoli, Campania, Italy
        • Azienda Ospedaliera Cardarelli
    • Emilia-Romagna
      • Cesena, Emilia-Romagna, Italy, 47521
        • Ospedale M. Bufalini Cesena
      • Ferrara, Emilia-Romagna, Italy
        • Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara
      • Parma, Emilia-Romagna, Italy
        • Ospedale Maggiore di Parma
      • Rimini, Emilia-Romagna, Italy
        • Ospedale Infermi
    • Ferrara
      • Lagosanto, Ferrara, Italy
        • Ospedale del Delta
    • Gorizia
      • Monfalcone, Gorizia, Italy
        • AAS2 Bassa Friulana Isotina - Presidio Ospedaliero di Gorizia
    • Lazio
      • Roma, Lazio, Italy
        • Azienda Ospedaliera San Camillo Forlanini di Roma
      • Roma, Lazio, Italy
        • Ospedale Cristo Re
      • Roma, Lazio, Italy
        • Policlinico Umberto I
      • Rome, Lazio, Italy, 00100
        • Presidio Ospedaliero San Filippo Neri
    • Lombardia
      • Bergamo, Lombardia, Italy
        • Ospedale Papa Giovanni XXIII
      • Milano, Lombardia, Italy, 20122
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
    • Marche
      • Ancona, Marche, Italy, 60121
        • Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
    • Modena
      • Baggiovara, Modena, Italy
        • Ospedale Civile Sant'Agostino Estense
    • Pavia
      • Voghera, Pavia, Italy
        • Ospedale Civile di Voghera
    • Piemonte
      • Torino, Piemonte, Italy
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Presidio Molinette
    • Puglia
      • Bari, Puglia, Italy
        • Azienda ospedaliero-universitaria consorziale policlinico di Bari
      • Taranto, Puglia, Italy
        • Presidio Ospedaliero Centrale SS Annunziata di Taranto
    • Rovigo
      • Adria, Rovigo, Italy
        • Ospedale Civile di Adria
    • Sardegna
      • Cagliari, Sardegna, Italy
        • Azienda Ospedaliera G. Brotzu
      • Cagliari, Sardegna, Italy
        • P.O. Santissima Trinità ASL8
      • Nuoro, Sardegna, Italy
        • Ospedale San Francesco
      • Sassari, Sardegna, Italy
        • Ospedale Santissima Annunziata A.O.U. Sassari
    • Sicilia
      • Catania, Sicilia, Italy
        • Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele
    • Toscana
      • Arezzo, Toscana, Italy, 52100
        • Ospedale San Donato
      • Grosseto, Toscana, Italy, 58100
        • Ospedale della Misericordia Grosseto
      • Pisa, Toscana, Italy, 56121
        • Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
      • Pistoia, Toscana, Italy
        • Ospedale San Jacopo di Pistoia
    • Umbria
      • Foligno, Umbria, Italy, 06034
        • Ospedale San Giovanni Battista
      • Orvieto, Umbria, Italy
        • Ospedale Santa Maria della Stella
      • Terni, Umbria, Italy
        • Azienda Ospedaliera Santa Maria
    • Veneto
      • Abano Terme, Veneto, Italy, 35031
        • Policlinico Abano Terme
    • Verona
      • Legnago, Verona, Italy
        • ULSS21 Legnago (Verona_ASL2)
    • Viterbo
      • Civita Castellana, Viterbo, Italy
        • Ospedale di Civita Castellana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multicenter italian national survey cohort study

Description

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

Exclusion Criteria: None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality rate
Time Frame: 18 months
18 months
30-day morbidity rate
Time Frame: 18 months
Morbidity defined by mean of the Clavien's Classification scoring system
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months
Calculation of Charlson Age-Comorbidity Index (CACI)
Time Frame: 18 months
Calculation and evaluation of its predictive value for morbidity and mortality
18 months
Simplified Acute Physiology Score-II (SAPS-II)
Time Frame: 18 months
Calculation and evaluation of its predictive value for mortality
18 months
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
18 months
Calculation of post-Operative Risk in Emergency Surgery (CORES)
Time Frame: 18 months
Calculation and evaluation of its predictive value for mortality
18 months
Surgical mortality probability model (S-MPM)
Time Frame: 18 months
Observed to expected (O:E) mortality ratio
18 months
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
18 months
Frailty Fried Index
Time Frame: 18 months
Frailty stratification in participants
18 months
Canadian Study of Health and Ageing (CSHA) frailty score
Time Frame: 18 months
Frailty stratification in participants
18 months
Total number of subjects underwent emergency surgery
Time Frame: 18 months
Elderly to non elderly patient ratio
18 months
Geographical area inhabitants
Time Frame: 18 months
Emergency surgery in the elderly per 100.000 inhabitants
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4252_2016 - 12/12/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on Abdominal emergency surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe