Emergency Surgery in the Elderly: Comparison of Frailty Index and Surgical Risk Score
- Conditions
- EmergencySurgery
- Registration Number
- NCT02825082
- Lead Sponsor
- University of Roma La Sapienza
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2200
All elderly patients submitted to emergency surgery considered as not-scheduled procedure within 7 days from admission
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 30-day mortality rate 18 months 30-day morbidity rate 18 months Morbidity defined by mean of the Clavien's Classification scoring system
- Secondary Outcome Measures
Name Time Method Surgical mortality probability model (S-MPM) 18 months Observed to expected (O:E) mortality ratio
Calculation of Charlson Age-Comorbidity Index (CACI) 18 months Calculation and evaluation of its predictive value for morbidity and mortality
Simplified Acute Physiology Score-II (SAPS-II) 18 months Calculation and evaluation of its predictive value for mortality
Total number of subjects underwent emergency surgery 18 months Elderly to non elderly patient ratio
Colorectal-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (CR-POSSUM) 18 months Observed to expected (O:E) mortality ratio
Canadian Study of Health and Ageing (CSHA) frailty score 18 months Frailty stratification in participants
Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM) 18 months Observed to expected (O:E) mortality ratio
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator 18 months Calculation and evaluation of its predictive value for post-operative complications
Calculation of post-Operative Risk in Emergency Surgery (CORES) 18 months Calculation and evaluation of its predictive value for mortality
Frailty Fried Index 18 months Frailty stratification in participants
Geographical area inhabitants 18 months Emergency surgery in the elderly per 100.000 inhabitants
Trial Locations
- Locations (43)
A.O.R.N Gaetano Rummo
🇮🇹Benevento, Campania, Italy
Ospedale Infermi
🇮🇹Rimini, Emilia-Romagna, Italy
Ospedale San Francesco
🇮🇹Nuoro, Sardegna, Italy
Azienda Ospedaliera Santa Maria
🇮🇹Terni, Umbria, Italy
Policlinico Abano Terme
🇮🇹Abano Terme, Veneto, Italy
ULSS21 Legnago (Verona_ASL2)
🇮🇹Legnago, Verona, Italy
Ospedale di Macerata
🇮🇹Marche, Italy
Ospedale Civile Spirito Santo
🇮🇹Pescara, Abruzzo, Italy
Presidio Ospedaliero Duilio Casula
🇮🇹Monserrato, Cagliari, Sardegna, Italy
Ospedale Convenzionato Villa dei Fiori
🇮🇹Acerra, 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
Azienda Ospedaliera San Camillo Forlanini di Roma
🇮🇹Roma, Lazio, Italy
Ospedale Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
Ospedale del Delta
🇮🇹Lagosanto, Ferrara, Italy
AAS2 Bassa Friulana Isotina - Presidio Ospedaliero di Gorizia
🇮🇹Monfalcone, Gorizia, Italy
Ospedale Cristo Re
🇮🇹Roma, Lazio, Italy
Policlinico Umberto I
🇮🇹Roma, Lazio, Italy
Ospedale Civile di Voghera
🇮🇹Voghera, Pavia, Italy
Ospedale San Jacopo di Pistoia
🇮🇹Pistoia, Toscana, Italy
Ospedale di Civita Castellana
🇮🇹Civita Castellana, Viterbo, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Presidio Ospedaliero San Filippo Neri
🇮🇹Rome, Lazio, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
🇮🇹Bari, Puglia, Italy
Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
🇮🇹Ancona, Marche, Italy
Ospedale Civile Sant'Agostino Estense
🇮🇹Baggiovara, Modena, Italy
Azienda Ospedaliero-Universitaria città della salute e della scienza di Torino, presidio Molinette
🇮🇹Torino, Piemonte, Italy
Ospedale Civile di Adria
🇮🇹Adria, Rovigo, Italy
Azienda Ospedaliera G. Brotzu
🇮🇹Cagliari, Sardegna, Italy
P.O. Santissima Trinità ASL8
🇮🇹Cagliari, Sardegna, Italy
Ospedale Santissima Annunziata A.O.U. Sassari
🇮🇹Sassari, Sardegna, Italy
Presidio Ospedaliero Centrale SS Annunziata di Taranto
🇮🇹Taranto, Puglia, Italy
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele
🇮🇹Catania, Sicilia, Italy
Ospedale San Donato
🇮🇹Arezzo, Toscana, Italy
Ospedale della Misericordia Grosseto
🇮🇹Grosseto, Toscana, Italy
Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
🇮🇹Pisa, Toscana, Italy
Ospedale Santa Maria della Stella
🇮🇹Orvieto, Umbria, Italy
Policlinico San Pietro
🇮🇹Ponte San Pietro, Bergamo, Italy
Ospedale San Giovanni Battista
🇮🇹Foligno, Umbria, Italy
Azienda Ospedaliera di Rilievo Nazionale e di alta SpecialitÃ
🇮🇹Avellino, Campania, Italy