Clinical Trials Directory

Trials / Completed

CompletedNCT05281211

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
San Camillo Hospital, Rome · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNutrition6 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
BEHAVIORALExercise6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily

Timeline

Start date
2022-03-15
Primary completion
2025-04-15
Completion
2025-04-15
First posted
2022-03-16
Last updated
2025-04-18

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT05281211. Inclusion in this directory is not an endorsement.