Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative serum prealbumin decline from baseline
研究概览
简要总结
The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.
详细描述
Study subgroups: experimental group (nutritional optimization-led triple prehabilitation), control group (conventional triple prerehabilitation) , with a 1:2 allocation ratio between experimental and control groups.
- Enrollment Criteria ①Patients diagnosed with primary liver cancer.
②Patients between 18 and 80 years old.
③ Patients who are feasible for surgical treatment after clinical evaluation. 2. Exclusion criteria
- Patients with liver metastases or combined with other tumors. ② Patients with allergy to the ingredients of nutritional preparations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with primary liver cancer.
- •Patients between the ages of 18 and
- •Patients who are feasible for surgical treatment after clinical evaluation.
排除标准
- •Patients with liver metastases or combined with other tumors.
- •Patients with allergy to the ingredients of nutritional preparations. ③Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.
研究组 & 干预措施
Conventional triple prehabilitation Intervention
Conventional triple prehabilitation
干预措施: Conventional triple prehabilitation Intervention (Other)
Nutritional optimization-led triple prehabilitation Intervention
Nutritional optimization-led triple prehabilitation
干预措施: Nutritional optimization-led triple prehabilitation Intervention (Other)
结局指标
主要结局
Postoperative serum prealbumin decline from baseline
时间窗: One day after surgery
peripheral blood
次要结局
- Postoperative serum prealbumin(One day after surgery)
- Postoperative albumin(One day after surgery)
- Postoperative retinol-binding protein(One day after surgery)
- Postoperative Six-minute walk test (6MWT)(One week after surgery)