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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy
RECRUITINGIncidence 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.
Time frame: From surgery to 30 days after surgery
Overall Survival
Overall survival (OS), defined as the time from enrollment to death from any cause, assessed at 12 months
Time frame: From enrollment to 12 months after surgery
Quality of Life Assessed at 3 and 6 Months
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
Time frame: 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
Time frame: From date of surgery to hospital discharge (up to 90 days postoperatively)
Hospital readmission
30-day readmission
Time frame: 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
Time frame: 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
Time frame: From baseline (preoperative) to 3 and 6 months after surgery
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