Preoperative Oncogeriatric Assessment in Patients Undergoing Hepatectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 70 years
Diagnosed hepatic malignancies requiring hepatectomy
Eligible for curative surgery as determined by multidisciplinary team
Ability to provide informed consent.
Disqualifiers
Ineligibility for surgery due to advanced disease or severe comorbidities
Severe cognitive impairment (MMSE score < 18)
Refusal to participate
Trial design
Design model
Parallel
Treatments tested in this trial
Comprehensive Geriatric Assessment (CGA)
Other interventionThe 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.
Treatment groups
242 Participants
are divided into 2 treatment groupsGroup A: Comprehensive Geriatric Assessment (CGA) GroupExperimental treatment 1 intervention
Group B: Standard of Care GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
From surgery to 30 days after surgerySecondary outcomes
1
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 surgery2
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 surgery3
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)4
Hospital readmission
30-day readmission
Time frame
From discharge date to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov