Frailty and emergency surgery in the elderly: protocol of a prospective, multicenter study in Italy for evaluating perioperative outcome (The FRAILESEL Study)
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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).
KeywordsEmergency surgery Frailty Elderly patient Geriatric Scores Risk assessment
Frailty and Emergency Surgery in the Elderly
Elderly Risk Assessment and Surgical Outcome
Società Italiana di Chirurgia d’Urgenza e del Trauma
Associazione dei Chirurghi Ospedalieri Italiani
Società Italiana di Chirurgia Geriatrica SICE Società Italiana Chirurgia Endoscopica
World Society of Emergency Surgery
Data Coordination Center
Ninth revision of international classification of disease clinical modification
Portsmouth-Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity
ColoRectal Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity
- SAPS II
Simplified Acute Physiology Score II
Modified Frailty Index
Charlson Age-Comorbidity Index
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 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.
The author(s) declared that no Grants were involved in supporting this work.
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