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

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).

Emergency surgery in geriatrics: A retrospective evaluation in a single center

“…[17] When a surgical intervention was scheduled for an elderly patient, long-term hospitalization, dependency, home care requirement, institutionalization and even death are the possible outcomes. [18] A previous report indicated that patients with functional dependency have higher 30-day mortality rates than independent patients after major general and vascular surgery. [19] The dependency of the patients was also found to be a significant factor on the ICU admission in our study.…”

The Emergency Surgery Frailty Index (EmSFI): development and internal validation of a novel simple bedside risk score for elderly patients undergoing emergency surgery

“…Clinical decisions, including operative technique, were based on the criteria of individual centers and attending surgeons. The investigators were informed about the objectives of the study and asked for complete details about the surgical management of acute abdomen in elderly patients following standard methods and collection protocols [ 8 ].…”

“…The FRAILESEL study investigates over 130 variables [ 8 ], exploring 5 domains such as patient demographic and clinical data, preoperative risk factors and operative variables, frailty condition, and postoperative outcome and follow-up. Data collected included patient demographic characteristics (age, gender, weight, height, social status), medical and surgical history (comorbidities), common preoperative biochemical blood examination (including PCR, PCT and arterial blood gas analysis), pathological features, and operative details.…”

Emergency Surgery in the Elderly: Could Laparoscopy Be Useful in Frailty? A Single-Center Prospective 2-Year Follow-Up in 120 Consecutive Patients

“…In Italy, according to the Italian National Institute for Statistics (Istituto Nazionale di Statistica, ISTAT), there were approximately 13.5 million people aged 65 and older in 2016, representing 22.3% of inhabitants [3,4], and this value will continue to grow in the following years. Recovery, particularly for surgical emergencies, is considered complicated in the elderly [5][6][7], who tend to have longer hospital stays [7][8][9] (this is related to comorbidities, an elevated number of drugs taken, and reduced physical and mental reserves) [3,5,8,9]. Not all patients of the same age have the same risks or frailty issues (in Surgeries 2021, 2 120 multiple physiological systems, this is defined as age-related cumulative decline, and is considered a better predictor of mortality and morbidity than chronological age in the elderly).…”

“…Despite the urgent need for knowledge in treating elderly and/or frail surgical patients, especially in emergency situations, there are surprisingly few population-based studies [9,[11][12][13][14][15][16] that involve long-term follow-ups. For this reason, our Santa Maria Regina della Misericordia Hospital, General Surgery Department, in Adria (Italy) participated in a study dubbed frailty and emergency surgery in the elderly: protocol of a prospective, multicenter study in Italy for evaluating perioperative outcome (FRAILE-SEL) [3]. Our evaluation started with a standardized evaluation of urgent admissions for surgical interventions in elderly, consequently we considered the Fried frailty score criteria at recovery.…”