the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Liver Carcinoma
Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial
Study Overview
Status
Detailed Description
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.
Exclusion criteria
Patients with liver metastases or combined with other tumors. ② Patients with allergy to the ingredients of nutritional preparations.
- Patients who cannot eat by mouth. ④ Patients with severe malnutrition that cannot be corrected by oral nutrition. ⑤ Patients with hyperthyroidism, fistula, and combined digestive system diseases.
Intervention measures The nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan. The experimental group used normal dietary supplementation + oral nutritional supplementation, and the control group used normal dietary supplementation. Target energy was defined as basal energy metabolism level*physical activity level, which was 1.55 for men and 1.56 for women; basal energy level was defined as basal metabolism standard value*body weight. Depending on the patient, a 20% increase in energy intake is calculated on top of the target energy. One scoop of oral nutritional powder has an energy of 27.5kcal, and the dose of nutritional powder needed is calculated from the increased energy intake value. The required amount of powder should be taken orally in 200ml of warm water three times a day, and the exact time of taking the powder should be customized according to the patient's condition.
Other interventions:
A personalized exercise program was developed with the rehabilitation physician, and the experimental and control groups underwent exercise to increase lung capacity and cardiorespiratory tolerance: respiratory exercise was included: the patients were guided to learn to cough and cough up sputum with deep breaths before the operation, and the respiratory trainer was used to carry out bedside training. The patients were instructed to learn to cough and cough up sputum with deep breaths before surgery. Exercise planning: aerobic exercise (jogging or walking) three times a day for 15 minutes.
The experimental group and the control group underwent psychiatric intervention: patients were psychologically evaluated according to the Hospital Anxiety and Depression Scale (HADS), and the scores of the anxiety and depression subscales were as follows: 0-7 was negative; 8-10 was mild; 11-14 was moderate; and 15-21 was severe. Patients with anxiety tendencies were counseled at least three times during the preoperative week and given medication if necessary. At the same time, the patients were guided to self-psychological counseling: no less than 15 minutes before bedtime every day.At the same time, patients were guided to self-help psychological guidance: every day before bedtime, they should listen to soothing music for at least 15 minutes, which was provided by the project team.
The patients will undergo routine clinical blood tests at the time of enrollment, 1 day before the operation and the 1st, 3rd and 5th days after the operation.
- Follow-up The patients will be followed up by telephone or outpatient clinic at 1 month after the operation; the patients' clinical data will be recorded.
The relevant clinical data during the process will be recorded.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuan Ding
- Phone Number: +86 18858101960
- Email: dingyuan@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recruiting
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Contact:
- Human Subject Research Ethics Committee
- Phone Number: +86 0571 87783759
- Email: keyanlunli_zheer@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients diagnosed with primary liver cancer.
Patients between the ages of 18 and 80.
- Patients who are feasible for surgical treatment after clinical evaluation.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutritional optimization-led triple prehabilitation Intervention
Nutritional optimization-led triple prehabilitation
|
The nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan.
The experimental group used ordinary dietary supplementation + transoral nutritional supplementation, and the control group used ordinary dietary supplementation.
The target energy was basal energy metabolism level * physical activity level, physical activity level was male: 1.55 female: 1.56; basal energy level was basal metabolism standardized value * body weight (basal metabolism standardized value for obese patients was 25; basal metabolism standardized value for normal or emaciated patients was 30).
Add 600kcal capacity supplement to this.
Exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance.
Specialized psychological interventions.
|
|
Other: Conventional triple prehabilitation Intervention
Conventional triple prehabilitation
|
Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative serum prealbumin decline from baseline
Time Frame: One day after surgery
|
peripheral blood
|
One day after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Six-minute walk test (6MWT)
Time Frame: One week after surgery
|
walk test for six minutes
|
One week after surgery
|
|
Postoperative serum prealbumin
Time Frame: One day after surgery
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peripheral blood
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One day after surgery
|
|
Postoperative albumin
Time Frame: One day after surgery
|
peripheral blood
|
One day after surgery
|
|
Postoperative retinol-binding protein
Time Frame: One day after surgery
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peripheral blood
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One day after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drainage tube removal time
Time Frame: Postoperative, an average of 3 days
|
remove abdominal drainage
|
Postoperative, an average of 3 days
|
Collaborators and Investigators
Investigators
- Study Chair: Yuan Ding, Second Affiliated Hospital, Zhejiang University, School of Medicine
Publications and helpful links
General Publications
- Noba L, Rodgers S, Chandler C, Balfour A, Hariharan D, Yip VS. Enhanced Recovery After Surgery (ERAS) Reduces Hospital Costs and Improve Clinical Outcomes in Liver Surgery: a Systematic Review and Meta-Analysis. J Gastrointest Surg. 2020 Apr;24(4):918-932. doi: 10.1007/s11605-019-04499-0. Epub 2020 Jan 3.
- Lin Y, Zheng L, Fang K, Zheng Y, Wu J, Zheng M. Proportion of liver cancer cases and deaths attributable to potentially modifiable risk factors in China. Int J Epidemiol. 2023 Dec 25;52(6):1805-1814. doi: 10.1093/ije/dyad100.
- Zhou YM, Zhang XF, Li B, Sui CJ, Yang JM. Postoperative complications affect early recurrence of hepatocellular carcinoma after curative resection. BMC Cancer. 2015 Oct 14;15:689. doi: 10.1186/s12885-015-1720-0.
- Forsmo HM, Pfeffer F, Rasdal A, Sintonen H, Korner H, Erichsen C. Pre- and postoperative stoma education and guidance within an enhanced recovery after surgery (ERAS) programme reduces length of hospital stay in colorectal surgery. Int J Surg. 2016 Dec;36(Pt A):121-126. doi: 10.1016/j.ijsu.2016.10.031. Epub 2016 Oct 22.
- Davis JF, van Rooijen SJ, Grimmett C, West MA, Campbell AM, Awasthi R, Slooter GD, Grocott MP, Carli F, Jack S. From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. Curr Anesthesiol Rep. 2022;12(1):129-137. doi: 10.1007/s40140-022-00516-2. Epub 2022 Feb 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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