Nutrition and EXercise Prehabilitation to Reduce Morbidity (NEXPREM) Following Major Liver Surgery in Sarcopenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of participants experiencing 90 day morbidity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Preoperative Nutrition+Exercise
Preoperative nutrition and exercise pre-habilitation followed by major liver resection.
干预措施: Nutrition (Dietary Supplement)
Preoperative Nutrition+Exercise
Preoperative nutrition and exercise pre-habilitation followed by major liver resection.
干预措施: Exercise (Behavioral)
Upfront Surgery
Upfront major liver resection.
结局指标
主要结局
Number of participants experiencing 90 day morbidity
时间窗: 90 days
Patients experiencing complications within 90 days of surgery
次要结局
- Number of participants being readmitted within 90 days of surgery.(90 days)
- Number of participants being disease free (Disease free survival)(3 years)
- 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)
- Number of participants being Sarcopenic after 6 weeks of prehabilitation.(6 weeks)
- Number of participants Alive ( Overall Survival)(3 years)
研究者
Giammauro Berardi
Principal Investigator
San Camillo Hospital, Rome