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临床试验/NCT06694649
NCT06694649尚未招募不适用

Effectiveness of Prehabilitation in Patients Undergoing Radical Cystectomy: a Retrospective Analysis

Ziekenhuis Oost-Limburg0 个研究点目标入组 100 人开始时间: 2024年11月最近更新:
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
100
主要终点
ICU length of stay

研究概览

简要总结

The current gold standard for non-metastatic muscle-invasive bladder cancer or treatment-refractory high-risk non-muscle-invasive bladder cancer is radical cystectomy (RC). This procedure is associated with high rates of perioperative complications (30-65%) and mortality (1.5-10%). Patients who require radical cystectomy often present with multiple co-morbidities, a certain degree of frailty, functional deficits, and a high level of past or current tobacco use. According to the "better in, better out" principle, it is likely that by improving the physical, nutritional and psychological status, a reduction in morbidity and mortality will be observed.

The literature suggests that multimodal prehabilitation may reduce complications and improve functional recovery after major cancer surgery. Therefore, the prehabilitation programme used in this study includes exercise training, dietary advice, psychological support and smoking cessation advice. Prehabilitation has been offered to a selection of patients with increased risk for postoperative complications since 01/05/2023.

At ZOL Genk, patients receive preparation for RC in one of three ways, depending on a balancing exercise that considers the patient's complexity and frailty, functionality, mobility and other factors. Patient preference and place of residence are also taken into account in determining the most appropriate preparation pathway. 1. The patient is solely encouraged to increase his fitness level by means of independent aerobic exercise. 2. The patient receives a prescription for primary care physiotherapy in his own area. 3. The patient undergoes our full internal prehabilitation program. The primary objective of this study is to compare these three different groups in terms of mortality, ICU length of stay, length of hospital stay, complication rate, type of complications and readmission rate. Finally, patient adherence will be examined.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Histologically confirmed primary bladder cancer (cTa-4N0-3M0) who underwent RARC.

排除标准

  • Patients who needed a semi-urgent cystectomy.
  • Patients with severe cognitive or psychiatric impairment.
  • Patients with a contraindication to perform physical exercise training or a cardiopulmonary exercise test (CPET).
  • Metastatic or non-primary disease.

结局指标

主要结局

ICU length of stay

时间窗: Until 90 days after RC

Mortality

时间窗: Until 3 years after RC

Length of hospital stay

时间窗: Until 90 days after RC

Complication rate

时间窗: Until 90 days after RC

Type of complications

时间窗: Until 90 days after RC

Readmission rate

时间窗: Until 90 days after RC

次要结局

未报告次要终点

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Sponsor

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