About this trial
Patients undergoing cystectomy for either oncological or non-oncological indications are prospectively enrolled following informed consent. This study design incorporates a comprehensive medical history, detailed prospective documentation of clinicopathological parameters, and serial measurements of infectious markers pre- and post-operatively. In-hospital complications are meticulously recorded, and long-term outcomes assessed through structured follow-up interviews at 3, 6, and 12 months. These follow-ups utilize standardized questionnaires to evaluate post-discharge infectious complications and gather patients' perspectives on their in-hospital experiences, providing a robust understanding of both clinical outcomes and patient-reported experiences.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Disease which requires removal of the urinary bladder
Disqualifiers
Patient does not want to participate
Trial population
Patients who undergo cystectomy
Trial design
Cohort
Prospective
Treatments tested in this trial
Cystectomy
Procedure/SurgeryRemoval of the urinary bladder
Treatment groups
Trial outcomes
Primary outcomes
Infectious parameters on the first postoperative day after cystectomy
IL-6 level, procalcitonin level and wound drainage culture
Postoperative fever
Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)
Antibiotic use
Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)
In-hospital complications
Clavien-Dindo Classification and Comprehensive Complication Index
Secondary outcomes
IMCU/ICU nights
Number of nights spent at a IMCU/ICU postoperatively
Duration of hospital stay
Total hospital stay (nights)
Subjective grading of in-hospital complications
Subjective assessment: no complications, minor complications or major complications
Rating of the pre-operatively provided medical information
Subjective assessment: very good, good, satisfactory, sufficient, not sufficient
Sponsors and contacts
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