About this trial
The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥65 years but <90 years;
Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract;
Clinical Frailty Scale ≥5;
Provide written informed consent.
Disqualifiers
Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
Inability to communicate due to coma, profound dementia, or language barrier;
Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
Trial design
Parallel
Treatments tested in this trial
Preoperative nutritional optimization
Dietary supplement1. Indication for oral nutritional supplementation: Patients at risk of malnutrition (MNA-SF 8-11) or with malnutrition (MNA-SF 0-7). 2. Protocol of nutritional optimization: Enteral nutritional powder (Ensure for patients without diabetes and Glucerna for patients with diabetes) twice a day. The target protein intake is 1.5-1.8 g/kg/d. Patients with iron deficient anemia (hemoglobin \<130 g/L for men and \<120 g/L for women) will be given oral iron therapy. 3. The duration of nutritional optimization: The day admitted to the hospital to the surgery to one day prior to the surgery.
Preoperative exercise training
Behavioral1. The respiratory training will be performed for at least 2-3 times per day. Respiratory training include thoracic breathing exercise and cough training. 2. Aerobic exercise will be performed for at least 1-2 times per day. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible. 3. Every training should be last for 45 minutes to 1 hour. If the patient can not tolerate, the training time should be reduce to 30 minutes. 4. The duration of exercise training: The day admitted to the hospital to the surgery to one day prior to the surgery.
Postoperative exercise training
Behavioral1. Muscle strength training in the bedside and walking in the ward. 2. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible. 3. Exercise training is performed under the supervision of physiotherpists durign hospital stay, and is reminded by regular telephone calls and phone messages after hospital discharge.
Treatment groups
Trial outcomes
Primary outcomes
A composite of delirium and non-delirium complications within 7 days after surgery (sub-study).
Delirium will be assessed with the 3-Dimensional Confusion Assessment Method. Non-delirium complications are defined as new onset medical events other than delirium that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or higher on Clavien-Dindo classification.
Recurrence-free survival after surgery.
Events include recurrence, metastasis, or all-cause death, whichever come first.
Secondary outcomes
Intensive care unit admission after surgery (sub-study).
Intensive care unit admission after surgery.
Incidence of delirium within 7 days after surgery (sub-study).
Delirium will be assessed with the 3-Dimensional Confusion Assessment Method.
Time to oral fluid intake after surgery (sub-study).
Time to oral fluid intake after surgery.
Time to oral food intake after surgery (sub-study).
Time to oral food intake after surgery.
Other outcomes
Intensity of pain after surgery (sub-study).
Intensity of pain will be assessed twice daily with the numeric rating scale which is a 11-point scale where 0=no pain and 10=the worst pain.
Subjective sleep quality after surgery (sub-study).
Subjective sleep quality will be assessed daily with the numeric rating scale which is a 11-point scale where 0=the best sleep and 10=the worst sleep.
Sleep architecture during the night of surgery (sub-study, part of enrolled patients).
Sleep will be evaluated with the polysomnographic monitoring during the night of surgery.
Quality of life at 1 year after surgery.
Quality of life will be assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
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