Comprehensive Geriatric Assessment, Hepatectomy, Hepatic Malignancies
Conditions
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
Interventions
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Postoperative Complications (Clavien-Dindo Grade ≥ III) | From surgery to 30 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From enrollment to 12 months after surgery | Overall survival (OS), defined as the time from enrollment to death from any cause, assessed at 12 months |
| Quality of Life Assessed at 3 and 6 Months | From enrollment to 3 and 6 months after surgery | 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 |
| Lenght of hospital stay | From date of surgery to hospital discharge (up to 90 days postoperatively) | Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge |
| Hospital readmission | From discharge date to 30 days after surgery | 30-day readmission |
| Functional Status Assessed by Activities of Daily Living (ADL) | From baseline (preoperative) to 3 and 6 months after surgery | 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 |
| Functional Status Assessed by Instrumental Activities of Daily Living (IADL) | From baseline (preoperative) to 3 and 6 months after surgery | 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 |
Countries
Italy
Contacts
CONTACTChiara Schipa, MD
CONTACTSimone Vani, Bsc
PRINCIPAL_INVESTIGATORFelice Giuliante, MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed