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This study aims to bridge the gap between geriatric medicine and surgical oncology. The findings will provide valuable insights into optimizing perioperative care for older adults, enhancing surgical safety, and improving long-term recovery trajectories, thereby supporting a more patient-centered, multidisciplinary approach in the management of elderly patients undergoing hepatectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Geriatric Assessment (CGA) Group | Experimental | Subjects undergo Comprehensive Geriatric Assessment (CGA) assessing frailty, functional status, cognition, comorbidities, nutritional and mental health status using validated tools (Fried Criteria, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Charlson Comorbidity Index, Mini Nutritional Assessment, Geriatric Depression Scale). Subjects receive targeted preoperative interventions (nutritional support, prehabilitation, medical optimization, psychosocial support). |
|
| Standard of Care Group | No Intervention | Subjects receive standard preoperative care including anesthesia, surgical procedures, and postoperative management according to institutional protocols |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Geriatric Assessment (CGA) | Other | The Comprehensive Geriatric Assessment (CGA) is conducted using a structured approach integrating validated tools into routine preoperative evaluation: frailty assessed by Fried Frailty Criteria; functional status by Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL); cognitive function by Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA); comorbidity burden by Charlson Comorbidity Index; nutritional status by Mini Nutritional Assessment (MNA); psychological status by Geriatric Depression Scale (GDS). Based on CGA findings, participants may receive individualized preoperative interventions including nutritional optimization, physical prehabilitation, medical optimization, and psychosocial or educational support. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Postoperative Complications (Clavien-Dindo Grade ≥ III) | Number of participants experiencing major postoperative complications, defined as grade III or higher according to the Clavien-Dindo Classification of Surgical Complications. The Clavien-Dindo classification ranges from grade I (minor complications) to grade V (death), with higher grades indicating more severe complications, assessed within 30 days after surgery. | From surgery to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS), defined as the time from enrollment to death from any cause, assessed at 12 months | From enrollment to 12 months after surgery |
| Quality of Life Assessed at 3 and 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Schipa, MD | Contact | +39 0630154386 | chiara.schipa@policlinicogemelli.it | |
| Simone Vani, Bsc | Contact | simone.vani@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Felice Giuliante, MD | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | RM | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37779566 | Background | Schipa C, Luca E, Ripa M, Sollazzi L, Aceto P. Preoperative evaluation of the elderly patient. Saudi J Anaesth. 2023 Oct-Dec;17(4):482-490. doi: 10.4103/sja.sja_613_23. Epub 2023 Aug 18. | |
| 36774453 | Background | Steenblock J, Braisch U, Brefka S, Thomas C, Eschweiler GW, Rapp M, Metz B, Maurer C, von Arnim CAF, Herrmann ML, Wagner S, Denkinger M, Dallmeier D. Frailty index and its association with the onset of postoperative delirium in older adults undergoing elective surgery. BMC Geriatr. 2023 Feb 11;23(1):90. doi: 10.1186/s12877-022-03663-7. |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
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Change from baseline in quality of life scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The questionnaire includes multiple domains scored from 0 to 100. For functional scales and global health status, higher scores indicate better quality of life; for symptom scales, higher scores indicate worse symptoms
| From enrollment to 3 and 6 months after surgery |
| Lenght of hospital stay | Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge | From date of surgery to hospital discharge (up to 90 days postoperatively) |
| Hospital readmission | 30-day readmission | From discharge date to 30 days after surgery |
| Functional Status Assessed by Activities of Daily Living (ADL) | Functional status measured using the Activities of Daily Living (ADL) scale. ADL scores range from 0 to 6, with higher scores indicating greater independence. Change from baseline will be assessed at 3 and 6 months after surgery | From baseline (preoperative) to 3 and 6 months after surgery |
| Functional Status Assessed by Instrumental Activities of Daily Living (IADL) | Functional status measured using the Instrumental Activities of Daily Living (IADL) scale. IADL scores range from 0 to 8, with higher scores indicating greater independence. Change from baseline will be assessed at 3 and 6 months after surgery | From baseline (preoperative) to 3 and 6 months after surgery |
| 30215973 | Background | Kumar C, Salzman B, Colburn JL. Preoperative Assessment in Older Adults: A Comprehensive Approach. Am Fam Physician. 2018 Aug 15;98(4):214-220. |
| 39197016 | Background | Chen L, Zong W, Luo M, Yu H. The impact of comprehensive geriatric assessment on postoperative outcomes in elderly surgery: A systematic review and meta-analysis. PLoS One. 2024 Aug 28;19(8):e0306308. doi: 10.1371/journal.pone.0306308. eCollection 2024. |
| 25531451 | Background | Hoffmann TC, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015 Feb;175(2):274-86. doi: 10.1001/jamainternmed.2014.6016. |
| 25055155 | Background | Neuman MD, Silber JH, Magaziner JS, Passarella MA, Mehta S, Werner RM. Survival and functional outcomes after hip fracture among nursing home residents. JAMA Intern Med. 2014 Aug;174(8):1273-80. doi: 10.1001/jamainternmed.2014.2362. |
| 24867014 | Background | Oresanya LB, Lyons WL, Finlayson E. Preoperative assessment of the older patient: a narrative review. JAMA. 2014 May;311(20):2110-20. doi: 10.1001/jama.2014.4573. |
| 22917646 | Background | Chow WB, Rosenthal RA, Merkow RP, Ko CY, Esnaola NF; American College of Surgeons National Surgical Quality Improvement Program; American Geriatrics Society. Optimal preoperative assessment of the geriatric surgical patient: a best practices guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society. J Am Coll Surg. 2012 Oct;215(4):453-66. doi: 10.1016/j.jamcollsurg.2012.06.017. Epub 2012 Aug 21. No abstract available. |
| 24303856 | Background | Partridge JS, Harari D, Martin FC, Dhesi JK. The impact of pre-operative comprehensive geriatric assessment on postoperative outcomes in older patients undergoing scheduled surgery: a systematic review. Anaesthesia. 2014 Jan;69 Suppl 1:8-16. doi: 10.1111/anae.12494. |
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |