Better in Better Out Cystectomy.
- Conditions
- Bladder Cancer
- Registration Number
- NCT06694649
- Lead Sponsor
- Ziekenhuis Oost-Limburg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Histologically confirmed primary bladder cancer (cTa-4N0-3M0) who underwent RARC.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICU length of stay Until 90 days after RC Mortality Until 3 years after RC Length of hospital stay Until 90 days after RC Complication rate Until 90 days after RC Type of complications Until 90 days after RC Readmission rate Until 90 days after RC
- Secondary Outcome Measures
Name Time Method