Elderly frail patients with digestive cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 65 to 90 years; 2. Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract; 3. Clinical Frailty Scale >= 5; 4. Provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 2. Inability to communicate due to coma, profound dementia, or language barrier; 3. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder; 4. Inability to take oral diet due to preoperative gastrointestinal disease or other disease; 5. Severe heart dysfunction (left ventricular ejection fraction <30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher; 6. Other reasons that are considered unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of delirium and non-delirium complications within 7 days after surgery (sub-study);Recurrence-free survival after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intensive care unit admission after surgery (sub-study);Incidence of delirium within 7 days after surgery (sub-study);Time to oral fluid intake after surgery (sub-study);Time to oral food intake after surgery (sub-study);Time to out-of-bed activity after surgery (sub-study);6-minute walk distance at hospital discharge (sub-study);Length of hospital stay after surgery (sub-study);Incidence of non-delirium complication within 30 days after surgery (sub-study);All-cause 30-day mortality after surgery (sub-study);Quality of life at 30 days after surgery (sub-study);Cognitive function at 30 days after surgery (sub-study);Sleep quality at 30 days after surgery (sub-study);Overall survival after surgery;Cancer specific survival after surgery;Event-free survival after surgery; | — |
Countries
China
Contacts
Peking University People's Hospital