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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystectomy | Procedure | Removal of the urinary bladder |
| Measure | Description | Time Frame |
|---|---|---|
| Infectious parameters on the first postoperative day after cystectomy | IL-6 level, procalcitonin level and wound drainage culture | First postoperative day |
| Postoperative fever | Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C) | Surgery - discharge |
| Antibiotic use | Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard) | Surgery - discharge |
| In-hospital complications | Clavien-Dindo Classification and Comprehensive Complication Index | 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 | 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 | 0-12 months after discharge |
| Emergency consultation | Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge | 0-12 months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| IMCU/ICU nights | Number of nights spent at a IMCU/ICU postoperatively | Surgery - discharge |
| Duration of hospital stay | Total hospital stay (nights) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who undergo cystectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benedikt Ebner, Dr. | Contact | 004917655197898 | Benedikt.Ebner@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Gerald Schulz, PD Dr. | Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Department - LMU Klinikum | Recruiting | Munich | Outside U.S./Canada | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41334533 | Derived | Ebner B, Hirsch J, Holz A, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Brinkmann I, Aydogdu C, Chaloupka M, Apfelbeck M, Lindner AK, Weinhold P, Stief CG, Volz Y, Schulz GB. Prospective Evaluation of Blood-based and Microbiological Early Indicators of In-hospital Infectious Complications After Open Cystectomy. Eur Urol Open Sci. 2025 Nov 18;83:1-8. doi: 10.1016/j.euros.2025.10.019. eCollection 2026 Jan. | |
| 41006129 |
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| Inpatient admission | Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge | 0-12 months after discharge |
| Preoperative interleukin-6 level | IL-6 level before surgery | 1 day before surgery |
| Surgery - discharge |
| Subjective grading of in-hospital complications | Subjective assessment: no complications, minor complications or major complications | 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 | Assessed 3 months after discharge |
| Health related quality of life | EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months | Assessed 3 months after discharge |
| Derived |
| Ebner B, Hirsch J, Holz A, Volz Y, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Fouladgar ST, Papadopoulos I, Chaloupka M, Apfelbeck M, Marcon J, Weinhold P, Ewert A, Kazmierczak P, Stief CG, Schulz GB. Association of interleukin-6 serum levels with local tumor stage and lymph node metastasis of urothelial carcinoma. Urol Oncol. 2025 Dec;43(12):693.e1-693.e8. doi: 10.1016/j.urolonc.2025.08.026. Epub 2025 Sep 25. |
| 39928165 | Derived | Ebner B, Hirsch J, Holz A, Volz Y, Eismann L, Hermans J, Pyrgidis N, Kidess M, Semmler M, Brinkmann I, Aydogdu C, Chaloupka M, Lindner AK, Weinhold P, Stief CG, Schulz GB. Discrepancies between physician-assessed and patient-reported complications after cystectomy - a prospective analysis. World J Urol. 2025 Feb 10;43(1):115. doi: 10.1007/s00345-025-05487-7. |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D007239 | Infections |
| D001424 | Bacterial Infections |
| D003428 | Cross Infection |
| D014946 | Wound Infection |
| D014552 | Urinary Tract Infections |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015653 | Cystectomy |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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