SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 3
- 主要终点
- post-operative morbidity
研究概览
简要总结
Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied in bladder carcinoma requiring cystectomy.
According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed, grip strength and muscle mass. These three elements can easily be measured (specially muscle mass measurement by bioimpedencemetry or tomodensitometry).
This cohort study will collect clinical complementary elements to better understand the associated factors present with sarcopenia, in order to prepare an interventional preoperative physical reconditioning study.
The mobility measurement will be carried out by the QAPPA questionnaire (validated in French in the elderly) and the quantitative measurement of activity and rest hours during a week by a wrist actimeter.
Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool for potentially inappropriate medication.
Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric complications : falls, loss of autonomy and decreased mobility and physical activity, cognitive degradation, undernutrition, institutionalization
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed urothelial bladder carcinoma ( RTUV)
- •indication of radical cystectomy
- •Able, informed and with informed consent for the study
- •affiliated to the social security system
- •talking French
排除标准
- •Life expectancy <6 months
- •other active malignant tumors or other severe concomitant chronic pathologies affecting the general condition of the patient and / or likely to limit compliance with the requirements of the study.
- •treatments incompatible with the study: previous corticosteroid treatment prolonged for more than one month (induces iatrogenic sarcopenia).
结局指标
主要结局
post-operative morbidity
时间窗: at 30 days
evaluated according to Clavien-Dindo classification
post-operative mortality
时间窗: at 30 days
次要结局
- impedancemetric value(2 months)
- sarcopenic status(between baseline; preoperative and at 6 months post-operative)
- quality of life scores(preoperative and 6-month post-operative)
- post-operative complications(8 months)