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SurgeryFRAILESELNCT02825082

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

An observational study of Surgery and Emergency, run by University of Roma La Sapienza at 43 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

EMERGENCY GENERAL SURGERY IN GERIATRIC PATIENTS: EPIDEMIOLOGY, AND EVALUATION OF FACTORS AFFECTING MORBIDITY AND MORTALITY Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Surgery, Emergency
What is being tested?
Abdominal emergency surgery
Type of treatment
Surgery or procedure
How many people
2,200 participants
Where
43 sitesItaly
Study dates
Jan 2017to Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Multicenter italian national survey cohort study

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

Exclusion Criteria: None

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Italy43 sites

  • Policlinico Abano Terme

    Abano Terme, Veneto, 35031

  • Ospedale Convenzionato Villa dei Fiori

    Acerra, Campania

  • Ospedale Civile di Adria

    Adria, Rovigo

  • Azienda Ospedaliero Universitaria Ospedale Riuniti Ancona

    Ancona, The Marches, 60121

  • Ospedale San Donato

    Arezzo, Tuscany, 52100

  • Azienda Ospedaliera di Rilievo Nazionale e di alta Specialità

    Avellino, Campania

  • Ospedale Civile Sant'Agostino Estense

    Baggiovara, Modena

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    Bari, Apulia

  • A.O.R.N Gaetano Rummo

    Benevento, Campania

  • Ospedale Papa Giovanni XXIII

    Bergamo, Lombardy

  • Azienda Ospedaliera G. Brotzu

    Cagliari, Sardinia

  • P.O. Santissima Trinità ASL8

    Cagliari, Sardinia

  • Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele

    Catania, Sicily

  • Ospedale M. Bufalini Cesena

    Cesena, Emilia-Romagna, 47521

  • Ospedale di Civita Castellana

    Civita Castellana, Viterbo

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

    Ferrara, Emilia-Romagna

  • Ospedale San Giovanni Battista

    Foligno, Umbria, 06034

  • Ospedale della Misericordia Grosseto

    Grosseto, Tuscany, 58100

  • Ospedale del Delta

    Lagosanto, Ferrara

  • ULSS21 Legnago (Verona_ASL2)

    Legnago, Verona

  • Ospedale di Macerata

    Marche

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • AAS2 Bassa Friulana Isotina - Presidio Ospedaliero di Gorizia

    Monfalcone, Gorizia

  • Presidio Ospedaliero Duilio Casula

    Monserrato, Cagliari, Sardegna

  • Azienda Ospedaliera Cardarelli

    Naples, Campania

  • Ospedale San Francesco

    Nuoro, Sardinia

  • Ospedale Santa Maria della Stella

    Orvieto, Umbria

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo

  • Ospedale Maggiore di Parma

    Parma, Emilia-Romagna

  • Ospedale Civile Spirito Santo

    Pescara, Abruzzo

  • Azienda Ospedaliera Pisana Policlinico Universitario Cisanello

    Pisa, Tuscany, 56121

  • Ospedale San Jacopo di Pistoia

    Pistoia, Tuscany

  • Policlinico San Pietro

    Ponte San Pietro, Bergamo

  • Ospedale Infermi

    Rimini, Emilia-Romagna

  • Presidio Ospedaliero San Filippo Neri

    Rome, Lazio, 00100

  • Azienda Ospedaliera San Camillo Forlanini di Roma

    Rome, Lazio

  • Ospedale Cristo Re

    Rome, Lazio

  • Policlinico Umberto I

    Rome, Lazio

  • Ospedale Santissima Annunziata A.O.U. Sassari

    Sassari, Sardinia

  • Presidio Ospedaliero Centrale SS Annunziata di Taranto

    Taranto, Apulia

  • Azienda Ospedaliera Santa Maria

    Terni, Umbria

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

    Turin, Piedmont

  • Ospedale Civile di Voghera

    Voghera, Pavia

Other trials in Italy

About this study

Official title: 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

Read the 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
Being tested
Abdominal emergency surgery
Keywords
Emergency general surgery, Geriatric, Outcomes, Frailty
Medical subject headings
Emergencies, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal emergency surgeryProcedure or surgery

    all abdominal emergency surgery procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality rate

    Measured: 18 months

  2. 30-day morbidity rate

    Morbidity defined by mean of the Clavien's Classification scoring system

    Measured: 18 months

Secondary outcomes (11)

  1. Portsmouth-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM)

    Observed to expected (O:E) mortality ratio

    Measured: 18 months

  2. Calculation of Charlson Age-Comorbidity Index (CACI)

    Calculation and evaluation of its predictive value for morbidity and mortality

    Measured: 18 months

  3. Simplified Acute Physiology Score-II (SAPS-II)

    Calculation and evaluation of its predictive value for mortality

    Measured: 18 months

  4. 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

    Measured: 18 months

  5. Calculation of post-Operative Risk in Emergency Surgery (CORES)

    Calculation and evaluation of its predictive value for mortality

    Measured: 18 months

  6. Surgical mortality probability model (S-MPM)

    Observed to expected (O:E) mortality ratio

    Measured: 18 months

  7. Colorectal-Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (CR-POSSUM)

    Observed to expected (O:E) mortality ratio

    Measured: 18 months

  8. Frailty Fried Index

    Frailty stratification in participants

    Measured: 18 months

  9. Canadian Study of Health and Ageing (CSHA) frailty score

    Frailty stratification in participants

    Measured: 18 months

  10. Total number of subjects underwent emergency surgery

    Elderly to non elderly patient ratio

    Measured: 18 months

  11. Geographical area inhabitants

    Emergency surgery in the elderly per 100.000 inhabitants

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02825082
Sponsor's protocol ID
4252_2016 - 12/12/2016
Acronym
FRAILESEL
Status last verified
Aug 2018
First submitted
28 Jun 2016
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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, 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

  • 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.

    PubMed 27113515

  • 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.

    PubMed 27086200

  • 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.

    PubMed 27033960

  • 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.

    PubMed 18482658

  • 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.

    PubMed 26922129

  • 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.

    PubMed 26892599

  • 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.

    PubMed 25050133

  • 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.

    PubMed 26620724

  • 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.

    PubMed 26038035

  • 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.

    PubMed 27241560

  • 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.

    PubMed 25170867

  • 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.

    PubMed 20380259

  • 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.

    PubMed 29383680

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Emergency, run by University of Roma La Sapienza at 43 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day mortality rate (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02825082, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

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