Not yet recruiting NCT07537569
Preoperative Oncogeriatric Assessment in Patients Undergoing Hepatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive Geriatric Assessment (CGA).
- Who it may be relevant to
- Registry conditions: Hepatic Malignancies, Comprehensive Geriatric Assessment, Hepatectomy. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Preoperative Oncogeriatric Assessment in Elderly Patients Undergoing Surgery for Hepatectomy
Overview
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
Interventions
- Other Comprehensive Geriatric Assessment (CGA)
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 Assessmen
Primary outcome measures
- Incidence of Major Postoperative Complications (Clavien-Dindo Grade ≥ III) [Time frame: From surgery to 30 days after surgery]
Secondary outcome measures (6)
- Overall Survival [Time frame: From enrollment to 12 months after surgery]
- Quality of Life Assessed at 3 and 6 Months [Time frame: From enrollment to 3 and 6 months after surgery]
- Lenght of hospital stay [Time frame: From date of surgery to hospital discharge (up to 90 days postoperatively)]
- Hospital readmission [Time frame: From discharge date to 30 days after surgery]
- Functional Status Assessed by Activities of Daily Living (ADL) [Time frame: From baseline (preoperative) to 3 and 6 months after surgery]
- Functional Status Assessed by Instrumental Activities of Daily Living (IADL) [Time frame: From baseline (preoperative) to 3 and 6 months after surgery]
Eligibility criteria
Inclusion criteria
- Patients aged ≥ 70 years
- Diagnosed hepatic malignancies requiring hepatectomy
- Eligible for curative surgery as determined by multidisciplinary team
- Ability to provide informed consent.
Exclusion criteria
- Ineligibility for surgery due to advanced disease or severe comorbidities
- Severe cognitive impairment (MMSE score < 18)
- Refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Publications
- 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. PMID 37779566
- 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. PMID 36774453
- Kumar C, Salzman B, Colburn JL. Preoperative Assessment in Older Adults: A Comprehensive Approach. Am Fam Physician. 2018 Aug 15;98(4):214-220. PMID 30215973
- 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. PMID 39197016
- 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. PMID 25531451
- 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. PMID 25055155
- 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. PMID 24867014
- 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;21 PMID 22917646
Identifiers
NCT: NCT07537569 · 8205