Liver Cancer
Conditions
Keywords
Liver Neoplasms, Prehabilitation
Brief summary
The goal of this clinical trial is to to learn if the nurse-led TGA-based Pre-rehabilitation planning can improve compliance, preoperative functional reserve, and reduce the incidence of postoperative complications in patients with hepatocellular carcinoma. The main questions it aims to answer are: 1. Can this pre-rehabilitation program improve patients' perioperative motor function? 2. Can this pre-rehabilitation program enhance patients' perioperative nutritional status? 3. Can this pre-rehabilitation program improve patients' psychological state? 4. Can this pre-rehabilitation program increase patients' overall compliance? Meanwhile, secondary outcome indicators included complication incidence rate, 30-day readmission rate, first anal flatus passage time, hospitalization duration, serum prealbumin, serum albumin, prothrombin time, total bilirubin, satisfaction and quality of Life. Researchers will compare the control group received only ERAS care after the patient's admission to see if the program is effectiveness. Participants who received the intervention group protocol will initiate pre-rehabilitation measures more than 7 days prior to hospital admission, including nutritional support, exercise and respiratory function training, psychological empowerment, pain pre-management, and smoking/alcohol cessation. These interventions will be recorded daily according to the achievement thresholds established by the research team based on outpatient assessment results. After admission, the patients in this group will receive the same EARS care as the control group.
Interventions
OTHERA nurse-led TGA-based Pre-rehabilitation Planning
Participants who received the intervention group protocol will initiate pre-rehabilitation measures more than 7 days prior to hospital admission, including nutritional support, exercise and respiratory function training, psychological empowerment, pain pre-management, and smoking/alcohol cessation. These interventions will be recorded daily according to the achievement thresholds established by the research team based on outpatient assessment results. After admission, the patients in this group will receive the same EARS care as the control group.
OTHERERAS control group
Management follows the standard ERAS nursing pathway for hepatoplastic surgery patients, with specific measures including: 1) Preoperative: ① Admission education and preoperative health education; ② Fasting for 2 hours and water restriction for 6 hours prior to surgery; ③ No intestinal preparation; ④ Preoperative administration of carbohydrate solution; ⑤ Guidance on respiratory function exercises; 2) Intraoperative: ① Selection of appropriate anesthesia method; ② No gastric tube placement; ③ Prevention of intraoperative hypothermia; ④ Control of low central venous pressure; ⑤ Targeted volume management; 3) Postoperative: ① Prophylactic analgesia; ② Prevention of deep vein thrombosis; ③ Early ambulation; ④ Early oral intake; ⑤ Early removal of urinary catheter and drainage tubes; ⑥ Early discharge.
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* (1) Diagnosis of hepatocellular carcinoma based on the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition) or the Diagnosis Guidelines for Hepatic Metastases of Colorectal Cancer (2025 Edition). * (2) Patients undergoing elective liver resection after medical evaluation. * (3) Patients aged from 18-84 years;. * (4) Voluntary participation in this study.
Exclusion criteria
* (1) Patients with severe cognitive impairment or psychiatric disorders. * (2) Patients with severe cardiorenal or cerebral organ failure. * (3) Patients who have participated in other research projects. * (4) Patients requiring reoperation due to severe postoperative complications. * (5) Patients who abandon surgical treatment midway. * (6) Patients who voluntarily discontinue the implementation of prehabilitation programs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test distance | Day of admission, Postoperative day 4 | Measurement was performed using a 6-minute walk test |
| Prognosis nutrition index | Day of admission; Postoperative day 4 | Prognostic nutritional index = Lymphocyte count × 5 + Serum albumin |
| Anxiety | Day of admission, Postoperative day 4 | Anxiety levels of patients were measured using the Generalized Anxiety Disorder 7 (GAD-7).The scale ranges from a minimum score of 0 to a maximum score of 21. 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. |
| Depression | Day of admission, Postoperative day 4 | Depression levels of patients were measured using the Patient Health Questionnaire-9 (PHQ-9). The scale ranges from a minimum score of 0 to a maximum score of 27. Scores of ≤4 indicate no depression, 5-9 indicate mild depression, 10-14 indicate moderate depression, and scores of ≥15 indicate severe depression. |
| Overall adherence | Day of admission | Overall adherence = (Exercise adherence + Nutritional adherence + Psychological adherence) / 3. ①Exercise adherence = Mean value of daily actual exercise time / exercise target. ②Nutritional adherence = Mean value of daily actual protein intake / protein target. ③Psychological adherence = Mean value of daily times of listening to psychological audio / 3. (For patients without anxiety or depression in psychological assessment, psychological adherence is set at 1 by default.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication incidence rate | 30 days after discharge | — |
| 30-day readmission rate | 30 days after discharge | — |
| First anal flatus time | Patient reports at the time of their first flatus after surgery | When the patient reports first flatus after surgery, the nurse records the exact time.Time to first flatus = Time of first flatus - Time of surgery completion (Note: Add days as 24 h × number of days where applicable.) |
| Length of hospital stay | On the day of discharge | — |
| Serum prealbumin | 1 day before surgery and 4 days after surgery | — |
| Seralbumin | 1 day before surgery and 4 days after surgery | — |
| Prothrombin time | 1 day before surgery and 4 days after surgery | — |
| Total bilirubin | 1 day before surgery and 4 days after surgery | — |
| Degree of satisfaction | Postoperative day 4 | Patient satisfaction was assessed using a numerical rating scale, with a minimum score of 0 and a maximum score of 100. Higher scores indicated higher levels of satisfaction. |
| Quality of life | Postoperative day 4 | Quality of life was assessed using the Quality of Life Scale for Liver Cancer Patients. This scale consists of 22 items, each scored from 1 to 10.Items 1, 2, 3, 7, 18 and 22 are reverse-scored.The total score ranges from 22 to 220, with higher scores representing better quality of life. |
Countries
China
Outcome results
None listed