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Better in Better Out Cystectomy.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06694649
Acronym
BIBOCYS-1
Enrollment
100
Registered
2024-11-19
Start date
2024-11-30
Completion date
2024-12-31
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

None listed

Sponsors

Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
ICU length of stayUntil 90 days after RC
MortalityUntil 3 years after RC
Length of hospital stayUntil 90 days after RC
Complication rateUntil 90 days after RC
Type of complicationsUntil 90 days after RC
Readmission rateUntil 90 days after RC

Contacts

Primary ContactYannic Raskin, MD
yannic.raskin@zol.be+32 89 80 83 80

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026