Better in Better Out Cystectomy.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZiekenhuis Oost-Limburg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 3 trial groups
Group A: Independent aerobic exercise
Group B: Primary care physiotherapy in own area
Group C: Full internal prehabilitation program

Trial outcomes

Primary outcomes

1

ICU length of stay

Time frame
Until 90 days after RC
2

Mortality

Time frame
Until 3 years after RC
3

Length of hospital stay

Time frame
Until 90 days after RC
4

Complication rate

Time frame
Until 90 days after RC

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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