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

NCT07537205 | Enrolling By Invitation

• 1 other identifier: hlb-gzwk-2026-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Can this pre-rehabilitation program improve patients' perioperative motor function?
2. 2.Can this pre-rehabilitation program enhance patients' perioperative nutritional status?
3. 3.Can this pre-rehabilitation program improve patients' psychological state?
4. 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.

Conditions

Liver Cancer

Keywords

Liver Neoplasms; Prehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Complication incidence rate

  30 days after discharge

• 30-day readmission 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

Study Arms (2)

Pre-rehabilitation intervention group

EXPERIMENTAL

This group implemented preoperative pre-rehabilitation based on TGA and perioperative EARS measures.

Other: A nurse-led TGA-based Pre-rehabilitation Planning

Control group

OTHER

This group implemented perioperative EARS measures after patient admission.

Other: ERAS control group

Interventions

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.

Pre-rehabilitation intervention 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.

Control group

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Xuhui, 200032, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced practice nurse

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: October 8, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)