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临床试验/NCT06591507
NCT06591507尚未招募不适用

Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation: a Clinical Multicenter Study

Zhejiang University0 个研究点目标入组 750 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
750
主要终点
2-year overall survival

研究概览

简要总结

Patients undergoing liver transplantation frequently experience a reduction in skeletal muscle mass, malnutrition, and decreased levels of physical activity. These complications can adversely affect early postoperative recovery and the therapeutic effect of the transplant. This clinical study aims to investigate the effects of nutritional supplementation and rehabilitation therapy on sarcopenia associated with liver transplantation in adults. The goal is to establish a comprehensive perioperative intervention strategy to reduce the incidence of postoperative sarcopenia and improve transplantation outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 70 years.
  • Patients with end-stage liver disease who meet the criteria for liver transplantation (for liver cancer cases, only recipients meeting specific standards are included).
  • Complete clinical information, including documented pre-transplant muscle status (e.g., preoperative CT scans and handgrip strength tests).
  • High compliance with treatment, fully capable of independent action or having at least one assistant.
  • No contraindications to the planned interventions.

排除标准

  • Presence of musculoskeletal disorders before transplantation, such as myositis, idiopathic muscle atrophy, or history of hip surgery within the past three months.
  • Coexisting severe cardiovascular or cerebrovascular diseases, infectious diseases, or epilepsy.
  • Liver transplantation due to autoimmune liver disease or drug-induced liver failure.
  • Re-transplantation, multi-organ transplantation, living donor liver transplantation, split liver transplantation, or pediatric liver transplantation.
  • ABO-incompatible liver transplantation.
  • Incomplete clinical information.
  • Difficulty in follow-up.

结局指标

主要结局

2-year overall survival

时间窗: From enrollment to the end of follow-up at 2 years

At the 2-year mark, record the survival status of each patient (alive or deceased).

次要结局

  • Muscle mass(From enrollment to the end of treatment at 6 months)

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiao Xu

Professor

Zhejiang University

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