An observational study in Bladder Cancer, Infections and Infection, Bacterial, sponsored by Ludwig-Maximilians - University of Munich. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Ludwig-Maximilians - University of Munich · Observational
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.
Aims of the study:
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 410 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who undergo cystectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Removal of the urinary bladder
Infectious parameters on the first postoperative day after cystectomy
IL-6 level, procalcitonin level and wound drainage culture
Time frame: First postoperative day
Postoperative fever
Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)
Time frame: Surgery - discharge
Antibiotic use
Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)
Time frame: Surgery - discharge
In-hospital complications
Clavien-Dindo Classification and Comprehensive Complication Index
Time frame: Surgery - discharge
Antibiotic therapy within the first year after discharge
Proportion of cystectomy patients that needs antibiotic therapy associated with urinary diversion in the first year after discharge
Time frame: 0-12 months after discharge
Fever within the first year after discharge
Proportion of cystectomy patients with urinary tract associated fever in the first year after discharge
Time frame: 0-12 months after discharge
Emergency consultation
Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge
Time frame: 0-12 months after discharge
Inpatient admission
Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge
Time frame: 0-12 months after discharge
Preoperative interleukin-6 level
IL-6 level before surgery
Time frame: 1 day before surgery
IMCU/ICU nights
Number of nights spent at a IMCU/ICU postoperatively
Time frame: Surgery - discharge
Duration of hospital stay
Total hospital stay (nights)
Time frame: Surgery - discharge
Subjective grading of in-hospital complications
Subjective assessment: no complications, minor complications or major complications
Time frame: Assessed time: Surgery - discharge. Assessed 3 months after discharge
Rating of the pre-operatively provided medical information
Subjective assessment: very good, good, satisfactory, sufficient, not sufficient
Time frame: Assessed 3 months after discharge
Health related quality of life
EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months
Time frame: Assessed 3 months after discharge
Plan to share: No
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