Infectious Complications After Cystectomy: A Prospective Observational Study

NCT ID: NCT05153694

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-12-31

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

Conditions

Bladder Cancer; Infections; Infection, Bacterial; Infection, Hospital; Infection Wound; Urinary Tract Infections; Urinary Bladder Diseases; Urinary Tract Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cystectomy

Removal of the urinary bladder

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Disease which requires removal of the urinary bladder

Exclusion Criteria

• Patient does not want to participate

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Benedikt Ebner

Resident in Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Schulz, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Urology Department - LMU Klinikum

Munich, Outside U.S./Canada, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Benedikt Ebner, Dr.

Role: CONTACT

Benedikt.Ebner@med.uni-muenchen.de

004917655197898

Facility Contacts

Benedikt Ebner

Role: primary

Benedikt.Ebner@gmx.at

017655197898

References

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 Sep 25:S1078-1439(25)00339-4. doi: 10.1016/j.urolonc.2025.08.026. Online ahead of print.

Reference Type: DERIVED

PMID: 41006129 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39928165 (View on PubMed)

Other Identifiers

RCXINFLMU

Identifier Type: -

Identifier Source: org_study_id