Clinical trial NCT02825082: Emergency Surgery in the Elderly: Comparison of Frailty Index and Surgical Risk Score
Official title: Risk Stratification Tools and Frailty Index for Predicting Perioperative Outcome in Elderly Patients Undergoing Abdominal Emergency Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Emergency
Keywords: Emergency general surgery
Geriatric
Outcomes
Frailty
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 2200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multicenter italian national survey cohort study

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.

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

Exclusion Criteria: None

Primary outcomes:
measure: 30-day mortality rate
timeFrame: 18 months
measure: 30-day morbidity rate
timeFrame: 18 months
Secondary outcomes:
measure: Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM)
timeFrame: 18 months
measure: Calculation of Charlson Age-Comorbidity Index (CACI)
timeFrame: 18 months
measure: Simplified Acute Physiology Score-II (SAPS-II)
timeFrame: 18 months
measure: American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator
timeFrame: 18 months
measure: Calculation of post-Operative Risk in Emergency Surgery (CORES)
timeFrame: 18 months
measure: Surgical mortality probability model (S-MPM)
timeFrame: 18 months
measure: Colorectal-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (CR-POSSUM)
timeFrame: 18 months
measure: Frailty Fried Index
timeFrame: 18 months
measure: Canadian Study of Health and Ageing (CSHA) frailty score
timeFrame: 18 months
measure: Total number of subjects underwent emergency surgery
timeFrame: 18 months
measure: Geographical area inhabitants
timeFrame: 18 months
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Ospedale Civile Spirito Santo
state: Abruzzo
city: Ponte San Pietro
country: Italy
facility: Policlinico San Pietro
state: Bergamo
city: Monserrato
country: Italy
facility: Presidio Ospedaliero Duilio Casula
state: Cagliari, Sardegna
city: Acerra
country: Italy
facility: Ospedale Convenzionato Villa dei Fiori
state: Campania
city: Avellino
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e di alta Specialità
state: Campania
city: Benevento
country: Italy
facility: A.O.R.N Gaetano Rummo
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Cardarelli
state: Campania
city: Cesena
country: Italy
facility: Ospedale M. Bufalini Cesena
state: Emilia-Romagna
city: Ferrara
country: Italy
facility: Arcispedale S. Anna di Cona - Azienda Ospedaliero-Universitaria di Ferrara
state: Emilia-Romagna
city: Parma
country: Italy
facility: Ospedale Maggiore di Parma
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi
state: Emilia-Romagna
city: Lagosanto
country: Italy
facility: Ospedale del Delta
state: Ferrara
city: Monfalcone
country: Italy
facility: AAS2 Bassa Friulana Isotina - Presidio Ospedaliero di Gorizia
state: Gorizia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini di Roma
state: Lazio
city: Roma
country: Italy
facility: Ospedale Cristo Re
state: Lazio
city: Roma
country: Italy
facility: Policlinico Umberto I
state: Lazio
city: Rome
country: Italy
facility: Presidio Ospedaliero San Filippo Neri
state: Lazio
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
state: Lombardia
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona
state: Marche
city: Baggiovara
country: Italy
facility: Ospedale Civile Sant'Agostino Estense
state: Modena
city: Voghera
country: Italy
facility: Ospedale Civile di Voghera
state: Pavia
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria città della salute e della scienza di Torino, presidio Molinette
state: Piemonte
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
state: Puglia
city: Taranto
country: Italy
facility: Presidio Ospedaliero Centrale SS Annunziata di Taranto
state: Puglia
city: Adria
country: Italy
facility: Ospedale Civile di Adria
state: Rovigo
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu
state: Sardegna
city: Cagliari
country: Italy
facility: P.O. Santissima Trinità ASL8
state: Sardegna
city: Nuoro
country: Italy
facility: Ospedale San Francesco
state: Sardegna
city: Sassari
country: Italy
facility: Ospedale Santissima Annunziata A.O.U. Sassari
state: Sardegna
city: Catania
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele
state: Sicilia
city: Arezzo
country: Italy
facility: Ospedale San Donato
state: Toscana
city: Grosseto
country: Italy
facility: Ospedale della Misericordia Grosseto
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana Policlinico Universitario Cisanello
state: Toscana
city: Pistoia
country: Italy
facility: Ospedale San Jacopo di Pistoia
state: Toscana
city: Foligno
country: Italy
facility: Ospedale San Giovanni Battista
state: Umbria
city: Orvieto
country: Italy
facility: Ospedale Santa Maria della Stella
state: Umbria
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
state: Umbria
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
state: Veneto
city: Legnago
country: Italy
facility: ULSS21 Legnago (Verona_ASL2)
state: Verona
city: Civita Castellana
country: Italy
facility: Ospedale di Civita Castellana
state: Viterbo
city: Marche
country: Italy
facility: Ospedale di Macerata
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Study officials:
affiliation: University of Roma La Sapienza, Sant' Andrea University Hospital
name: Gianluca Costa, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Roma La Sapienza, Sant' Andrea University Hospital
name: Giuseppe Nigri, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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
citation: Joseph B, Zangbar B, Pandit V, Fain M, Mohler MJ, Kulvatunyou N, Jokar TO, O'Keeffe T, Friese RS, Rhee P. Emergency General Surgery in the Elderly: Too Old or Too Frail? J Am Coll Surg. 2016 May;222(5):805-13. doi: 10.1016/j.jamcollsurg.2016.01.063. Epub 2016 Feb 26.
citation: Shah AA, Zafar SN, Kodadek LM, Zogg CK, Chapital AB, Iqbal A, Greene WR, Cornwell EE 3rd, Havens J, Nitzschke S, Cooper Z, Salim A, Haider AH. Never giving up: outcomes and presentation of emergency general surgery in geriatric octogenarian and nonagenarian patients. Am J Surg. 2016 Aug;212(2):211-220.e3. doi: 10.1016/j.amjsurg.2016.01.021. Epub 2016 Mar 19.
citation: Hewitt J, McCormack C, Tay HS, Greig M, Law J, Tay A, Asnan NH, Carter B, Myint PK, Pearce L, Moug SJ, McCarthy K, Stechman MJ. Prevalence of multimorbidity and its association with outcomes in older emergency general surgical patients: an observational study. BMJ Open. 2016 Mar 31;6(3):e010126. doi: 10.1136/bmjopen-2015-010126.
citation: Poldermans D, Hoeks SE, Feringa HH. Pre-operative risk assessment and risk reduction before surgery. J Am Coll Cardiol. 2008 May 20;51(20):1913-24. doi: 10.1016/j.jacc.2008.03.005.
citation: Vasivej T, Sathirapanya P, Kongkamol C. Incidence and Risk Factors of Perioperative Stroke in Noncardiac, and Nonaortic and Its Major Branches Surgery. J Stroke Cerebrovasc Dis. 2016 May;25(5):1172-1176. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.051. Epub 2016 Feb 24.
citation: McLean RC, McCallum IJ, Dixon S, O'Loughlin P. A 15-year retrospective analysis of the epidemiology and outcomes for elderly emergency general surgical admissions in the North East of England: A case for multidisciplinary geriatric input. Int J Surg. 2016 Apr;28:13-21. doi: 10.1016/j.ijsu.2016.02.044. Epub 2016 Feb 23.
citation: Merani S, Payne J, Padwal RS, Hudson D, Widder SL, Khadaroo RG. Predictors of in-hospital mortality and complications in very elderly patients undergoing emergency surgery. World J Emerg Surg. 2014 Jul 7;9:43. doi: 10.1186/1749-7922-9-43. eCollection 2014.
citation: Desserud KF, Veen T, Soreide K. Emergency general surgery in the geriatric patient. Br J Surg. 2016 Jan;103(2):e52-61. doi: 10.1002/bjs.10044. Epub 2015 Dec 1.
citation: St-Louis E, Sudarshan M, Al-Habboubi M, El-Husseini Hassan M, Deckelbaum DL, Razek TS, Feldman LS, Khwaja K. The outcomes of the elderly in acute care general surgery. Eur J Trauma Emerg Surg. 2016 Feb;42(1):107-13. doi: 10.1007/s00068-015-0517-9. Epub 2015 Apr 8.
citation: Lorenzon L, Costa G, Massa G, Frezza B, Stella F, Balducci G. The impact of frailty syndrome and risk scores on emergency cholecystectomy patients. Surg Today. 2017 Jan;47(1):74-83. doi: 10.1007/s00595-016-1361-1. Epub 2016 May 30.
citation: Costa G, La Torre M, Frezza B, Fransvea P, Tomassini F, Ziparo V, Balducci G. Changes in the surgical approach to colonic emergencies during a 15-year period. Dig Surg. 2014;31(3):197-203. doi: 10.1159/000365254. Epub 2014 Aug 28.
citation: Costa G, Tomassini F, Tierno SM, Venturini L, Frezza B, Cancrini G, Mero A, Lepre L. [Emergency colonic surgery: analysis of risk factors predicting morbidity and mortality]. Chir Ital. 2009 Sep-Dec;61(5-6):565-71. Italian.
citation: Costa G, Massa G; ERASO (Elderly Risk Assessment for Surgical Outcome) Collaborative Study Group. Frailty and emergency surgery in the elderly: protocol of a prospective, multicenter study in Italy for evaluating perioperative outcome (The FRAILESEL Study). Updates Surg. 2018 Mar;70(1):97-104. doi: 10.1007/s13304-018-0511-y. Epub 2018 Jan 30.