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

NCT ID: NCT02825082

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Surgery; Emergency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Abdominal emergency surgery

all abdominal emergency surgery procedures

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria: None

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Costa

MD, PhD,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianluca Costa, MD, PhD

Role: STUDY_DIRECTOR

University of Roma La Sapienza, Sant' Andrea University Hospital

Giuseppe Nigri, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza, Sant' Andrea University Hospital

Locations

Ospedale Civile Spirito Santo

Pescara, Abruzzo, Italy

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, Apulia, Italy

Presidio Ospedaliero Centrale SS Annunziata di Taranto

Taranto, Apulia, Italy

Policlinico San Pietro

Ponte San Pietro, Bergamo, Italy

Presidio Ospedaliero Duilio Casula

Monserrato, Cagliari, Sardegna, Italy

Ospedale Convenzionato Villa dei Fiori

Acerra, Campania, Italy

Azienda Ospedaliera di Rilievo Nazionale e di alta Specialità

Avellino, Campania, Italy

A.O.R.N Gaetano Rummo

Benevento, Campania, Italy

Azienda Ospedaliera Cardarelli

Napoli, Campania, Italy

Ospedale M. Bufalini Cesena

Cesena, Emilia-Romagna, Italy

Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Emilia-Romagna, Italy

Ospedale Maggiore di Parma

Parma, Emilia-Romagna, Italy

Ospedale Infermi

Rimini, Emilia-Romagna, Italy

Ospedale del Delta

Lagosanto, Ferrara, Italy

AAS2 Bassa Friulana Isotina - Presidio Ospedaliero di Gorizia

Monfalcone, Gorizia, Italy

Presidio Ospedaliero San Filippo Neri

Rome, Lazio, Italy

Azienda Ospedaliera San Camillo Forlanini di Roma

Rome, Lazio, Italy

Ospedale Cristo Re

Rome, Lazio, Italy

Policlinico Umberto I

Rome, Lazio, Italy

Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Ospedale Civile Sant'Agostino Estense

Baggiovara, Modena, Italy

Ospedale Civile di Voghera

Voghera, Pavia, Italy

Azienda Ospedaliero-Universitaria città della salute e della scienza di Torino, presidio Molinette

Turin, Piedmont, Italy

Ospedale Civile di Adria

Adria, Rovigo, Italy

Azienda Ospedaliera G. Brotzu

Cagliari, Sardinia, Italy

P.O. Santissima Trinità ASL8

Cagliari, Sardinia, Italy

Ospedale San Francesco

Nuoro, Sardinia, Italy

Ospedale Santissima Annunziata A.O.U. Sassari

Sassari, Sardinia, Italy

Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele

Catania, Sicily, Italy

Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona

Ancona, The Marches, Italy

Ospedale San Donato

Arezzo, Tuscany, Italy

Ospedale della Misericordia Grosseto

Grosseto, Tuscany, Italy

Azienda Ospedaliera Pisana Policlinico Universitario Cisanello

Pisa, Tuscany, Italy

Ospedale San Jacopo di Pistoia

Pistoia, Tuscany, Italy

Ospedale San Giovanni Battista

Foligno, Umbria, Italy

Ospedale Santa Maria della Stella

Orvieto, Umbria, Italy

Azienda Ospedaliera Santa Maria

Terni, Umbria, Italy

Policlinico Abano Terme

Abano Terme, Veneto, Italy

ULSS21 Legnago (Verona_ASL2)

Legnago, Verona, Italy

Ospedale di Civita Castellana

Civita Castellana, Viterbo, Italy

Ospedale di Macerata

Marche, , Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Countries

Italy

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Reference Type: DERIVED

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Other Identifiers

4252_2016 - 12/12/2016

Identifier Type: -

Identifier Source: org_study_id