Preoperative Oncogeriatric Assessment in Patients Undergoing Hepatectomy

NCT07537569 | Not Yet Recruiting

• 1 other identifier: 8205
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Malignancies; Comprehensive Geriatric Assessment; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Overall Survival

  From enrollment to 12 months after surgery

• Quality of Life Assessed at 3 and 6 Months

  From enrollment to 3 and 6 months after surgery

• Lenght of hospital stay

  From date of surgery to hospital discharge (up to 90 days postoperatively)

• Hospital readmission

  From discharge date to 30 days after surgery

• Functional Status Assessed by Activities of Daily Living (ADL)

  From baseline (preoperative) to 3 and 6 months after surgery

Study Arms (2)

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).

Other: Comprehensive Geriatric Assessment (CGA)

Standard of Care Group

NO INTERVENTION

Subjects receive standard preoperative care including anesthesia, surgical procedures, and postoperative management according to institutional protocols

Interventions

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.

Comprehensive Geriatric Assessment (CGA) Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged ≥ 70 years
• Diagnosed hepatic malignancies requiring hepatectomy
• Eligible for curative surgery as determined by multidisciplinary team
• Ability to provide informed consent.

You may not qualify if:

• Ineligibility for surgery due to advanced disease or severe comorbidities
• Severe cognitive impairment (MMSE score \< 18)
• Refusal to participate

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Related Publications (9)

• 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 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.

  PMID: 36774453 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.

  PMID: 30215973 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.

  PMID: 39197016 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.

  PMID: 25531451 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.

  PMID: 25055155 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.

  PMID: 24867014 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.

  PMID: 22917646 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.

  PMID: 24303856 BACKGROUND

MeSH Terms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Felice Giuliante, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Schipa, MD

CONTACT

+39 0630154386; chiara.schipa@policlinicogemelli.it

Simone Vani, Bsc

CONTACT

simone.vani@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)