CClinicalTrials.gg
Not yet recruitingNCT06694649BIBOCYS-1Updated Nov 19, 2024

Better in Better Out Cystectomy.

An observational study in Bladder Cancer, sponsored by Ziekenhuis Oost-Limburg. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Ziekenhuis Oost-Limburg · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bladder Cancer
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 100 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Ziekenhuis Oost-Limburg is the lead sponsor of 66 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Independent aerobic exercise
  • Primary care physiotherapy in own area
  • Full internal prehabilitation program
06

What researchers measure

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

  5. Type of complications

    Time frame: Until 90 days after RC

  6. Readmission rate

    Time frame: Until 90 days after RC

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06694649
Lead sponsor
Ziekenhuis Oost-Limburg
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Nov 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Nov 19, 2024

Study contacts

Yannic Raskin, MD
Contact
yannic.raskin@zol.be
+32 89 80 83 80

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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