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Infectious Complications After Cystectomy: A Prospective Observational Study

StatusUnknown
PhaseNot specified
Started
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Record status
This record was last updated September 19, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary completion date: Nov 30, 2023 to Dec 31, 2024v2 Show 5 more changesShow less
    • Primary endpoints: 1 to 9
    • Study completion date: Nov 30, 2024 to Dec 31, 2025
    • Secondary endpoints expanded, about 23 words
    • Study description expanded, about 85 words
    • Eligibility criteria expanded, about 5 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05153694
Lead Sponsor Ludwig-Maximilians - University of Munich
Conditions
(from sponsor)		 Bladder Cancer, Infections, Infection, Bacterial, Infection, Hospital, Infection Wound, Urinary Tract Infections, Urinary Bladder Diseases, Urinary Tract Disease
Related terms Bacterial Infections, Cross Infection, Infections, Urinary Bladder Diseases, Urinary Bladder Neoplasms, Urinary Tract Infections, Urologic Diseases, Wound Infection
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov