Better in Better Out Cystectomy. (BIBOCYS-1)

East Limburg Hospital

Status: Not yet enrolling

Conditions: Bladder Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06694649

Z-2024064

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

100 participants in 3 patient groups

Independent aerobic exercise

Primary care physiotherapy in own area

Full internal prehabilitation program