Updates in Surgery

, Volume 70, Issue 1, pp 97–104 | Cite as

Frailty and emergency surgery in the elderly: protocol of a prospective, multicenter study in Italy for evaluating perioperative outcome (The FRAILESEL Study)

  • Gianluca Costa
  • Giulia Massa
  • ERASO (Elderly Risk Assessment for Surgical Outcome) Collaborative Study Group
Original Article
  • 122 Downloads

Abstract

Improvements in living conditions and progress in medical management have resulted in better quality of life and longer life expectancy. Therefore, the number of older people undergoing surgery is increasing. Frailty is often described as a syndrome in aged patients where there is augmented vulnerability due to progressive loss of functional reserves. Studies suggest that frailty predisposes elderly to worsening outcome after surgery. Since emergency surgery is associated with higher mortality rates, it is paramount to have an accurate stratification of surgical risk in such patients. The aim of our study is to characterize the clinicopathological findings, management, and short-term outcome of elderly patients undergoing emergency surgery. The secondary objectives are to evaluate the presence and influence of frailty and analyze the prognostic role of existing risk-scores. The final FRAILESEL protocol was approved by the Ethical Committee of “Sapienza” University of Rome, Italy. The FRAILESEL study is a nationwide, Italian, multicenter, observational study conducted through a resident-led model. Patients over 65 years of age who require emergency surgical procedures will be included in this study. The primary outcome measures are 30-day postoperative mortality and morbidity rates. The Clavien-Dindo classification system is used to categorize complications. The secondary outcome measures include length of hospital stay, length of stay in intensive care unit, and predictive value for morbidity and mortality of several frailty and surgical risk-scores. The results of the FRAILESEL study will be disseminated through national and international conference presentations and peer-reviewed journals. The study is also registered at ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT02825082).

Keywords

Emergency surgery Frailty Elderly patient Geriatric Scores Risk assessment 

Abbreviations

FRAILESEL

Frailty and Emergency Surgery in the Elderly

ERASO

Elderly Risk Assessment and Surgical Outcome

SICUT

Società Italiana di Chirurgia d’Urgenza e del Trauma

ACOI

Associazione dei Chirurghi Ospedalieri Italiani

SICG

Società Italiana di Chirurgia Geriatrica SICE Società Italiana Chirurgia Endoscopica

WSES

World Society of Emergency Surgery

DCC

Data Coordination Center

PI

Principal Investigator

ICD-9-CM

Ninth revision of international classification of disease clinical modification

P-POSSUM

Portsmouth-Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity

CR-POSSUM

ColoRectal Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity

SAPS II

Simplified Acute Physiology Score II

mFI

Modified Frailty Index

CACI

Charlson Age-Comorbidity Index

Notes

 Appendix list

List of ERASO Collaborative Study Group members on behalf of SICUT, ACOI, SICG, SICE, and the WSES Italian Chapter: Agresta F, Anania G, Ansaloni L, Antropoli M, Argenio G, Atzeni J, Avenia N, Azzinnaro A, Balani A, Baldazzi G, Balducci G, Barbera G, Bellanova G, Bergamini C, Bersigotti L, Bianchi PP, Bombardini C, Borzellino G, Bozzo S, Brachini G, Buccoliero F, Buonanno GM, Buononato M, Campanile FC, Canini T, Cardella S, Carrara G, Cascini F, Cassini D, Castriconi M, Catalini G, Catena F, Ceccarelli G, Celi D, Ceresoli M, Chiarugi M, Cillara N, Cimino F, Cobuccio L, Coccolini F, Cocorullo G, Colangelo E, Costa G, Crafa F, Crucitti A, Dalla Caneva P, De Luca M, de Manzoni Garberini A, De Nisco C, De Sol A, Falcioni T, Falco N, Farina C, Filippone G, Finotti E, Fiume S, Fontana T, Francioni G, Fransvea P, Frezza B, Gemini S, Genna M, Giannessi S, Gioffrè A, Giordano A, Gozzo D, Grimaldi S, Gulotta G, Iarussi T, Laterza E, Lepre L, Lorenzon L, Lotti R, Luridiana G, Marini P, Marzaioli R, Massa G, Mingoli A, Mulas S, Nagliati C, Nigri G, Niolu P, Noviello A, Occhionorelli S, Paderno N, Palini GM, Paradies D, Paroli M, Perrone F, Petruzzelli L, Pezzolla A, Piazza D, Piazza V, Piccoli M, Pisanu A, Podda M, Poillucci G, Porfidia R, Rossi G, Ruscelli P, Santella S, Sartelli M, Spagnoli A, Sulis R, Tarasconi A, Tranà C, Travaglino A, Valeri A, Vasquez G, Zago M, Zanoni E.

Compliance with ethical standards

Conflict of interest

No competing interests were disclosed.

Research involving Human Participants and/or Animals

The final FRAILESEL protocol was approved by the Ethics Committee of the “Sapienza” University of Rome, Italy on 12/12/2016 (allocated under approval number 4252_2016). Secondary approval has been obtained from all Ethics Committees of the other participating centers. The DCC provided assistance to each participating center during their local IRB application.

Informed consent

Informed consent was obtained from all individual participants included in the study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Grant information

The author(s) declared that no Grants were involved in supporting this work.

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Copyright information

© Italian Society of Surgery (SIC) 2018

Authors and Affiliations

  • Gianluca Costa
    • 1
  • Giulia Massa
    • 1
  • ERASO (Elderly Risk Assessment for Surgical Outcome) Collaborative Study Group
  1. 1.Surgical and Medical Department of Translational Medicine, Sant’Andrea Teaching Hospital“Sapienza” UniversityRomeItaly

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