The Effects of a Nurse-led TGA-based Pre-rehabilitation Planning on Perioperative Outcomes in Patients With Liver Cancer: Study and Protocol

Обзор

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.

Вмешательства

• Другое A 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
• Другое ERAS 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 Pr

Первичные конечные точки

• 6-minute walk test distance [Срок оценки: Day of admission, Postoperative day 4]
• Prognosis nutrition index [Срок оценки: Day of admission; Postoperative day 4]
• Anxiety [Срок оценки: Day of admission, Postoperative day 4]
• Depression [Срок оценки: Day of admission, Postoperative day 4]
• Overall adherence [Срок оценки: Day of admission]

Вторичные конечные точки (10)

• Complication incidence rate [Срок оценки: 30 days after discharge]
• 30-day readmission rate [Срок оценки: 30 days after discharge]
• First anal flatus time [Срок оценки: Patient reports at the time of their first flatus after surgery]
• Length of hospital stay [Срок оценки: On the day of discharge]
• Serum prealbumin [Срок оценки: 1 day before surgery and 4 days after surgery]
• Seralbumin [Срок оценки: 1 day before surgery and 4 days after surgery]
• Prothrombin time [Срок оценки: 1 day before surgery and 4 days after surgery]
• Total bilirubin [Срок оценки: 1 day before surgery and 4 days after surgery]
• Degree of satisfaction [Срок оценки: Postoperative day 4]
• Quality of life [Срок оценки: Postoperative day 4]

Критерии участия

Критерии включения

• (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.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07537205 · hlb-gzwk-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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