NCT05281211Completed
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
Source: ClinicalTrials.gov · Last updated 18 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 12 Feb 2022
- Start date
- 15 Mar 2022
- Primary completion date
- 15 Apr 2025
- Lead sponsor
- San Camillo Hospital, Rome
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05281211
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 15 Mar 2022 to the primary completion date, 15 Apr 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- Minor liver resections intended as less than 3 contiguous segments.
- Patients with intrahepatic, hilar, or extrahepatic cholangiocarcinomas.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Camillo Forlanini Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| San Camillo Hospital Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.