NEXPREM is a single-center non-blinded randomized controlled trial investigating preoperative exercise and nutrition for sarcopenic patients in major hepatic surgery for liver malignancies. Patients with sarcopenia undergoing major hepatectomies have high rates of postoperative complications. Previous studies have demonstrated that preoperative rehabilitation with exercise and nutrition may help reduce the negative impact of sarcopenia. The investigator's hypothesis is that preoperative nutrition and exercise may reduce complications in sarcopenic patients undergoing major hepatectomies. Sarcopenic patients at diagnosis will be randomized in Group A undergoing upfront surgery and Group B undergoing preoperative rehabilitation. Outcome will be overall 90 day morbidity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
70
6 weeks nutrition implementation in the form of branched chain amino acids and immune-system boosters twice daily for 4 weeks and once daily for 2 weeks
6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily
San Camillo Hospital
Rome, Italy, Italy
San Camillo Forlanini
Roma, RM, Italy
Number of participants experiencing 90 day morbidity
Patients experiencing complications within 90 days of surgery
Time frame: 90 days
Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification
Time frame: 90 days
Number of participants experiencing 90 days postoperative mortality.
Time frame: 90 days
Number of participants being readmitted within 90 days of surgery.
Time frame: 90 days
Number of participants being Sarcopenic after 6 weeks of prehabilitation.
Time frame: 6 weeks
Number of participants Alive ( Overall Survival)
Time frame: 3 years
Number of participants being disease free (Disease free survival)
Time frame: 3 years
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