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临床试验/NCT06763068
NCT06763068已完成不适用

BIA-measured Skeletal Muscle Mass Used to Assess Frailty in Older Gastric Cancer Patients

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 575 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
575
试验地点
1
主要终点
Skeletal muscle mass

研究概览

简要总结

The primary aim of this study was to quantify the diagnosis of pre-surgical skeletal muscle mass in elderly gastric cancer patients and to analyse its correlation with frailty. The second aim was to investigate whether skeletal muscle mass, or sarcopenia, is associated with mobility and nutritional status, and anxiety and depression. The main questions it aims to answer are whether skeletal muscle mass is significantly associated with frailty and whether it can be used as a brief screening tool for preoperative frailty.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • diagnosed with gastric cancer by endoscopy or pathology; age >60 years old; radical gastrectomy was proposed; be able to communicate simply in writing and verbal.

排除标准

  • received preoperative radiotherapy or chemotherapy; combined with other sites of malignant tumors; combined with severe heart, liver, lung and renal insufficiency; recent using hormones, immunosuppressants; with physical disabilities.

结局指标

主要结局

Skeletal muscle mass

时间窗: Within 24 hours of admission

Skeletal muscle mass was measured by bioelectrical impedance analysis(BIA) and was classified as sarcopenia if it was less than 7.0 kg/m2 in men and 5.7 kg/m2 in women.

frailty

时间窗: Within 24 hours of admission and discharge

The Tilburg frailty scale was used to assess the frailty of older people with gastric cancer. The Tilburg frailty scale was compiled by Gobbens et al. The scale contains 15 items in three dimensions of physical, psychological and social frailty. The total score of the scale is 0-15 points and the cut-off value of the total scale was 5, with higher score indicating more severe frailty.

次要结局

  • Nutritional Status(Within 24 hours of admission and discharge)
  • anxiety and depression(Within 24 hours of admission and discharge)

研究者

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

Yinning Guo

PhD student

Nanjing Medical University

研究点 (1)

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