Better in Better Out Cystectomy.

NCT06694649 | Not Yet Recruiting

• 1 other identifier: Z-2024064
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

Independent aerobic exercise

Primary care physiotherapy in own area

Full internal prehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target group of this study are patients who have undergone robot-assisted radical cystectomy (RARC) for primary bladder cancer since 01/01/2021 and who have participated in one of the three preoperative prehabilitation programmes: 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yannic Raskin, MD

CONTACT

+32 89 80 83 80; yannic.raskin@zol.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share