Infectious Complications After Cystectomy: A Prospective Observational Study

NCT05153694 | Recruiting

• 1 other identifier: RCXINFLMU
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (5)

• IMCU/ICU nights

  Surgery - discharge

• Duration of hospital stay

  Surgery - discharge

• Subjective grading of in-hospital complications

  Assessed time: Surgery - discharge. Assessed 3 months after discharge

• Rating of the pre-operatively provided medical information

  Assessed 3 months after discharge

• Health related quality of life

  Assessed 3 months after discharge

Interventions

Cystectomy PROCEDURE

Removal of the urinary bladder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo cystectomy

You may qualify if:

• Disease which requires removal of the urinary bladder

You may not qualify if:

• Patient does not want to participate

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Urology Department - LMU Klinikum

Munich, Outside U.S./Canada, 81377, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 41334533 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.

  PMID: 41006129 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.

  PMID: 39928165 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Infections; Bacterial Infections; Cross Infection; Wound Infection; Urinary Tract Infections; Urinary Bladder Diseases; Urologic Diseases

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections and Mycoses; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Gerald Schulz, PD Dr.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedikt Ebner, Dr.

CONTACT

004917655197898; Benedikt.Ebner@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Urology

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)