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Enrolling by Invitation

NCT Number: NCT07537205

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Xuhui, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A nurse-led TGA-based Pre-rehabilitation Planning

Other

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.

ERAS control group

Other

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.

Primary outcomes

  1. 6-minute walk test distance

    Time frame: Day of admission, Postoperative day 4

    Measurement was performed using a 6-minute walk test

  2. Prognosis nutrition index

    Time frame: Day of admission; Postoperative day 4

    Prognostic nutritional index = Lymphocyte count × 5 + Serum albumin

  3. Anxiety

    Time frame: 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.

  4. Depression

    Time frame: 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.

  5. Overall adherence

    Time frame: 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 outcomes

  1. Complication incidence rate

    Time frame: 30 days after discharge

  2. 30-day readmission rate

    Time frame: 30 days after discharge

  3. First anal flatus time

    Time frame: 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.)

  4. Length of hospital stay

    Time frame: On the day of discharge

  5. Serum prealbumin

    Time frame: 1 day before surgery and 4 days after surgery

  6. Seralbumin

    Time frame: 1 day before surgery and 4 days after surgery

  7. Prothrombin time

    Time frame: 1 day before surgery and 4 days after surgery

  8. Total bilirubin

    Time frame: 1 day before surgery and 4 days after surgery

  9. Degree of satisfaction

    Time frame: 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.

  10. Quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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