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

Surgery Clinical Trial

— FRAILESEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825082
• Other study ID #: 4252_2016 - 12/12/2016
• Status: Completed
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Exclusion Criteria: None

Related Conditions & MeSH terms

• Emergencies
• Emergency
• Surgery

Intervention

Procedure:
• Abdominal emergency surgery
all abdominal emergency surgery procedures

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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, 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. — View 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

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. — View Citation

Desserud KF, Veen T, Søreide 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. Review. — View 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 s — View 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 — View 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. Epub 2016 May 30. — View 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 — View 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 — View 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. Review. — View 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 nonagenari — View 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 20 — View 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. Ep — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality rate		18 months
Primary	30-day morbidity rate	Morbidity defined by mean of the Clavien's Classification scoring system	18 months
Secondary	Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM)	Observed to expected (O:E) mortality ratio	18 months
Secondary	Calculation of Charlson Age-Comorbidity Index (CACI)	Calculation and evaluation of its predictive value for morbidity and mortality	18 months
Secondary	Simplified Acute Physiology Score-II (SAPS-II)	Calculation and evaluation of its predictive value for mortality	18 months
Secondary	American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator	Calculation and evaluation of its predictive value for post-operative complications	18 months
Secondary	Calculation of post-Operative Risk in Emergency Surgery (CORES)	Calculation and evaluation of its predictive value for mortality	18 months
Secondary	Surgical mortality probability model (S-MPM)	Observed to expected (O:E) mortality ratio	18 months
Secondary	Colorectal-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (CR-POSSUM)	Observed to expected (O:E) mortality ratio	18 months
Secondary	Frailty Fried Index	Frailty stratification in participants	18 months
Secondary	Canadian Study of Health and Ageing (CSHA) frailty score	Frailty stratification in participants	18 months
Secondary	Total number of subjects underwent emergency surgery	Elderly to non elderly patient ratio	18 months
Secondary	Geographical area inhabitants	Emergency surgery in the elderly per 100.000 inhabitants	18 months