The Effects of a Nurse-led TGA-based Pre-rehabilitation Planning on Perioperative Outcomes in Patients With Liver Cancer: Study and Protocol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- 6-minute walk test distance
研究概览
简要总结
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:
- Can this pre-rehabilitation program improve patients' perioperative motor function?
- Can this pre-rehabilitation program enhance patients' perioperative nutritional status?
- Can this pre-rehabilitation program improve patients' psychological state?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Pre-rehabilitation intervention group
This group implemented preoperative pre-rehabilitation based on TGA and perioperative EARS measures.
干预措施: A nurse-led TGA-based Pre-rehabilitation Planning (Other)
Control group
This group implemented perioperative EARS measures after patient admission.
干预措施: ERAS control group (Other)
结局指标
主要结局
6-minute walk test distance
时间窗: Day of admission, Postoperative day 4
Measurement was performed using a 6-minute walk test
Prognosis nutrition index
时间窗: Day of admission; Postoperative day 4
Prognostic nutritional index = Lymphocyte count × 5 + Serum albumin
Anxiety
时间窗: 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
时间窗: 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
时间窗: 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.)
次要结局
- 30-day readmission rate(30 days after discharge)
- Complication incidence rate(30 days after discharge)
- First anal flatus time(Patient reports at the time of their first flatus after surgery)
- 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)
- Quality of life(Postoperative day 4)
研究者
Jingjing Guo
Advanced practice nurse
Fudan University