2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009, China
Location status: Recruiting
NCT Number: NCT06549829
The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310009, China
Location status: Recruiting
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.
②Patients between 18 and 80 years old.
③ Patients who are feasible for surgical treatment after clinical evaluation.
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.
The relevant clinical data during the process will be recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions.
Time frame: One day after surgery
peripheral blood
Time frame: One week after surgery
walk test for six minutes
Time frame: One day after surgery
peripheral blood
Time frame: One day after surgery
peripheral blood
Time frame: One day after surgery
peripheral blood
Time frame: Postoperative, an average of 3 days
remove abdominal drainage
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, Zhejiang University, School of Medicine
Other
Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT02424955
Adenocarcinoma, Carcinoma
Stanford, California, United States
View Trial DetailsNCT03178409
Adenocarcinoma, Carcinoma
View Trial DetailsNCT07760012
Adenocarcinoma, Adnexal Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT06880523
Adenocarcinoma, Carcinoma
Calgary, Alberta, Canada
View Trial Details