Nutrition and Exercise Prehabilitation to Reduce Morbidity Following Major Liver Surgery in Sarcopenic Patients (NEXPREM)

  • STATUS
    Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    70
  • sponsor
    San Camillo Hospital, Rome
Updated on 23 May 2022
postoperative complications
amino acids

Summary

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.

Details
Condition Liver Cancer, Surgery, Sarcopenia
Treatment Exercise, nutrition
Clinical Study IdentifierNCT05281211
SponsorSan Camillo Hospital, Rome
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >18\
Sarcopenic patients diagnosed by both qualitative and quantitative analysis
Patients with primary or secondary liver malignancies
Patients undergoing major liver resections intended as 3 or more contiguous segments
Patients undergoing open, laparoscopic, or robotic resections

Exclusion Criteria

Minor liver resections intended as less than 3 contiguous segments
Patients with intrahepatic, hilar, or extrahepatic cholangiocarcinomas
Patients with liver tumors for whom 6 weeks interval from diagnosis to surgery could not be waited (i.e., large HCCs on healthy livers not requiring preoperative portal vein occlusion, CRLM without preoperative administration of anti-VEGF drug who therefore do not require 6 weeks of chemotherapy washout)
Patients with benign liver lesions
Patients undergoing extrahepatic liver resections
Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) procedure
Patients with physical disabilities, unable to exercise
Patients with inadequate kidney function
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