Bladder CancerNCT05153694
Infectious Complications After Cystectomy: A Prospective Observational Study
An observational study of Bladder Cancer and Infections, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer, Infections, Infection, Bacterial
- What is being tested?
- Cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who undergo cystectomy
Who may be able to join
- Disease which requires removal of the urinary bladder
Who cannot join
- Patient does not want to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Urology Department - LMU Klinikum
Munich, Outside U.S./Canada, 81377
Benedikt Ebner, 017655197898, Benedikt.Ebner@gmx.at
About this study
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.
Read the detailed description
Aims of the study:
- Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy
- Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy
- Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy
- Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit
- Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months
- Conditions
- Bladder Cancer, Infections, Infection, Bacterial, Infection, Hospital, Infection Wound, Urinary Tract Infections
- Being tested
- Cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms, Infections, Bacterial Infections, Cross Infection, Wound Infection, Urinary Tract Infections, Urinary Bladder Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystectomyProcedure or surgery
Removal of the urinary bladder
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious parameters on the first postoperative day after cystectomy
IL-6 level, procalcitonin level and wound drainage culture
Measured: First postoperative day
Postoperative fever
Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)
Measured: Surgery - discharge
Antibiotic use
Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)
Measured: Surgery - discharge
In-hospital complications
Clavien-Dindo Classification and Comprehensive Complication Index
Measured: 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
Measured: 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
Measured: 0-12 months after discharge
Emergency consultation
Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge
Measured: 0-12 months after discharge
Inpatient admission
Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge
Measured: 0-12 months after discharge
Preoperative interleukin-6 level
IL-6 level before surgery
Measured: 1 day before surgery
Secondary outcomes (5)
IMCU/ICU nights
Number of nights spent at a IMCU/ICU postoperatively
Measured: Surgery - discharge
Duration of hospital stay
Total hospital stay (nights)
Measured: Surgery - discharge
Subjective grading of in-hospital complications
Subjective assessment: no complications, minor complications or major complications
Measured: 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
Measured: Assessed 3 months after discharge
Health related quality of life
EORTC QLQ-C30, FACT-BL- and QLQ-BLM30-questionnaires after 3 months
Measured: Assessed 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedikt Ebner, Ludwig-Maximilians - University of Munich
- Investigators
- Gerald Schulz, PD Dr., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153694
- Sponsor's protocol ID
- RCXINFLMU
- Status last verified
- Sep 2024
- First submitted
- 29 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41334533Ebner 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.
PubMed 41006129Ebner 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.
PubMed 39928165
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious Complications After Cystectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05153694
- Acronym / sponsor ID
- RCXINFLMU
- Conditions
- Bladder Cancer, Infections, Infection, Bacterial, Infection, Hospital, Infection Wound, Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy
- Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy
- Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy
- Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit
- Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergo cystectomy
Key inclusion criteria (1 listed)
- Disease which requires removal of the urinary bladder
Key exclusion criteria (1 listed)
- Patient does not want to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CystectomyRemoval of the urinary bladder | Procedure or surgery | – |
Primary outcome
Infectious parameters on the first postoperative day after cystectomy
Time frame: First postoperative day
IL-6 level, procalcitonin level and wound drainage culture
Postoperative fever
Time frame: Surgery - discharge
Proportion of cystectomy patients that develops fever postoperatively (≥38.0°C)
Antibiotic use
Time frame: Surgery - discharge
Proportion of cystectomy patients that need additional oral or i.v. antibiotic therapy (on top of the hospital standard)
In-hospital complications
Time frame: Surgery - discharge
Clavien-Dindo Classification and Comprehensive Complication Index
Antibiotic therapy within the first year after discharge
Time frame: 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
Time frame: 0-12 months after discharge
Proportion of cystectomy patients with urinary tract associated fever in the first year after discharge
Emergency consultation
Time frame: 0-12 months after discharge
Proportion of cystectomy patients with a cystectomy-associated emergency consultation in the first year after discharge
Inpatient admission
Time frame: 0-12 months after discharge
Proportion of cystectomy patients with a cystectomy-associated inpatient admission in the first year after discharge
Preoperative interleukin-6 level
Time frame: 1 day before surgery
IL-6 level before surgery
5 secondary outcomes
IMCU/ICU nights
Time frame: Surgery - discharge
Duration of hospital stay
Time frame: Surgery - discharge
Subjective grading of in-hospital complications
Time frame: Assessed time: Surgery - discharge. Assessed 3 months after discharge
Rating of the pre-operatively provided medical information
Time frame: Assessed 3 months after discharge
Health related quality of life
Time frame: Assessed 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41334533Ebner 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.
- Derived from this study: PubMed 41006129Ebner 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.
- Derived from this study: PubMed 39928165Ebner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Schulz, PD Dr. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Infections, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedikt Ebner, Dr. (004917655197898, Benedikt.Ebner@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious parameters on the first postoperative day after cystectomy (time frame: First postoperative day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153694, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.