C67
Conditions
Interventions
Group 1: Retrospective observational cohort of adult patients aged 18 years or older who underwent radical cystectomy for urinary bladder cancer in Germany or Denmark during the study period. The expo
Sponsors
Universitätsklinikum Schleswig Holstein, Campus Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years or older are included if they underwent radical cystectomy for urinary bladder cancer during an inpatient hospitalisation in Germany or Denmark within the defined study period. Inclusion requires a procedure code for radical cystectomy during the index hospitalisation and a primary or secondary diagnosis of urinary bladder cancer using ICD-10 C67.x. The unit of analysis is the index hospitalisation, defined as the first hospitalisation with radical cystectomy within the study period. Both patients treated with open radical cystectomy and patients treated with robotic-assisted radical cystectomy are included.
Exclusion criteria
Exclusion criteria: Patients younger than 18 years are excluded, as are patients without a diagnosis of urinary bladder cancer using ICD-10 C67.x as a primary or secondary diagnosis. Cases with partial or simple cystectomy only, without radical cystectomy, are excluded. If more than one cystectomy occurs within the study period, only the chronologically first hospitalisation is included as the index event; subsequent cystectomy hospitalisations are excluded. Non-oncological cystectomies, for example for neurogenic bladder or trauma, are excluded through the requirement for a urinary bladder cancer diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is in-hospital mortality during the index hospitalisation after radical cystectomy. The outcome is assessed for all included patients during the index hospitalisation. In Germany, in-hospital mortality is identified from the discharge disposition in the DRG microdata of the Federal Statistical Office. In Denmark, the corresponding discharge status or registry-based mortality information is used. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are severe perioperative events and healthcare utilisation measures during the index hospitalisation. These include a composite MACCE outcome, defined as death, myocardial infarction, stroke, acute kidney injury, sepsis, cardiopulmonary resuscitation, or unplanned reoperation, as well as the individual components of this composite outcome. Further secondary outcomes include length of hospital stay, mechanical ventilation, prolonged mechanical ventilation for more than 24 hours, intensive care unit admission, acute renal replacement therapy, temporal trends in radical cystectomy and robotic-assisted radical cystectomy, and the association between annual hospital cystectomy volume and in-hospital mortality. | — |
Countries
Denmark, Germany
Contacts
Public ContactJakob Kohler
Universitätsklinikum Schleswig Holstein, Campus Kiel
Outcome results
None listed