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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Cancer
• Intervention / Treatment: Other: A nurse-led TGA-based Pre-rehabilitation Planning; Other: ERAS control group

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xuhui
    • Shanghai, Xuhui, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-rehabilitation intervention group; This group implemented preoperative pre-rehabilitation based on TGA and perioperative EARS measures.	Other: 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 will receive the same EARS care as the control group.
Other: Control group; This group implemented perioperative EARS measures after patient admission.	Other: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test distance	Measurement was performed using a 6-minute walk test	Day of admission, Postoperative day 4
Prognosis nutrition index	Prognostic nutritional index = Lymphocyte count × 5 + Serum albumin	Day of admission; Postoperative day 4
Anxiety	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.	Day of admission, Postoperative day 4
Depression	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.	Day of admission, Postoperative day 4
Overall adherence	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.)	Day of admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication incidence rate		30 days after discharge
30-day readmission rate		30 days after discharge
First anal flatus time	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.)	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	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.	Postoperative day 4
Quality of life	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.	Postoperative day 4

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prehabilitation; Liver Neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: hlb-gzwk-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No