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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Nutrition+Exercise | Experimental | Preoperative nutrition and exercise pre-habilitation followed by major liver resection. |
|
| Upfront Surgery | No Intervention | Upfront major liver resection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing 90 day morbidity | Patients experiencing complications within 90 days of surgery | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing 90 days postoperative major complications according to Clavien-Dindo classification | 90 days | |
| Number of participants experiencing 90 days postoperative mortality. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Camillo Hospital | Rome | Italy | 00100 | Italy | ||
| San Camillo Forlanini |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40864449 | Derived | Berardi G, Cucchetti A, Colasanti M, Angrisani M, Moschetta G, Chiappori D, Marini A, Antonelli G, Ferretti S, Meniconi RL, Guglielmo N, Mariano G, Usai S, Ettorre GM. Prehabilitation With Exercise and Nutrition to Reduce Morbidity of Major Hepatectomy in Patients With Sarcopenia: The PREHEP Randomized Clinical Trial. JAMA Surg. 2025 Oct 1;160(10):1068-1075. doi: 10.1001/jamasurg.2025.3102. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| Exercise | Behavioral | 6 weeks exercise 30 minutes' walk/day or 2000 extra steps daily |
|
| Number of participants being readmitted within 90 days of surgery. | 90 days |
| Number of participants being Sarcopenic after 6 weeks of prehabilitation. | 6 weeks |
| Number of participants Alive ( Overall Survival) | 3 years |
| Number of participants being disease free (Disease free survival) | 3 years |
| Roma |
| RM |
| 00135 |
| Italy |
| D008107 |
| Liver Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |