Infectious Complications After Cystectomy: A Prospective Observational Study

Last updated: September 13, 2024
Sponsor: Ludwig-Maximilians - University of Munich
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Tract Infections

Bacterial Infections

Urothelial Carcinoma

Treatment

Cystectomy

Clinical Study ID

NCT05153694
RCXINFLMU
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Disease which requires removal of the urinary bladder

Exclusion

Exclusion Criteria:

  • Patient does not want to participate

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Cystectomy
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
December 31, 2025

Study 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

Connect with a study center

  • Urology Department - LMU Klinikum

    Munich, Outside U.S./Canada 81377
    Germany

    Active - Recruiting

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