Better in Better Out Cystectomy.

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

ICU length of stay

Time frame: Until 90 days after RC
Mortality

Time frame: Until 3 years after RC
Length of hospital stay

Time frame: Until 90 days after RC
Complication rate

Time frame: Until 90 days after RC
Type of complications

Time frame: Until 90 days after RC
Readmission rate

Time frame: Until 90 days after RC

Study contacts

Contact information is provided by the study sponsor or research team.

Yannic Raskin, MD

CONTACT

[email protected]

+32 89 80 83 80

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

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

Acronym: BIBOCYS-1

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Nov 19, 2024
Registry last updated: Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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