Bladder Cancer, Infection, Bacterial, Infection, Hospital, Infections, Infection Wound, Urinary Bladder Diseases, Urinary Tract Disease, Urinary Tract Infections
Conditions
Brief summary
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.
Detailed description
Aims of the study: 1. Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy 2. Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy 3. Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy 4. Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit 5. Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months
Interventions
PROCEDURECystectomy
Removal of the urinary bladder
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Disease which requires removal of the urinary bladder
Exclusion criteria
* Patient does not want to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative interleukin-6 level | 1 day before surgery | IL-6 level before surgery |
| In-hospital complications | Surgery - discharge | Clavien-Dindo Classification and Comprehensive Complication Index |
| Antibiotic therapy within the first year after discharge | 0-12 months after discharge | Proportion of cystectomy patients that needs antibiotic therapy associated with urinary diversion in the first year after discharge |
| Fever within the first year after discharge | 0-12 months after discharge | Proportion of cystectomy patients with urinary tract associated fever in the first year after discharge |
| Emergency consultation | 0-12 months after discharge | Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge |
| Inpatient admission | 0-12 months after discharge | Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge |
| Infectious parameters on the first postoperative day after cystectomy | First postoperative day | IL-6 level, procalcitonin level and wound drainage culture |
| Postoperative fever | Surgery - discharge | Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C) |
| Antibiotic use | Surgery - discharge | Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | Surgery - discharge | Total hospital stay (nights) |
| Subjective grading of in-hospital complications | Assessed time: Surgery - discharge. Assessed 3 months after discharge | Subjective assessment: no complications, minor complications or major complications |
| Rating of the pre-operatively provided medical information | Assessed 3 months after discharge | Subjective assessment: very good, good, satisfactory, sufficient, not sufficient |
| Health related quality of life | Assessed 3 months after discharge | EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months |
| IMCU/ICU nights | Surgery - discharge | Number of nights spent at a IMCU/ICU postoperatively |
Countries
Germany
Contacts
Primary ContactBenedikt Ebner, Dr.
Outcome results
None listed