Infectious Complications After Cystectomy: A Prospective Observational Study

Ludwig Maximilian University of Munich

Status: Enrolling

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

Treatments: Procedure: Cystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05153694

RCXINFLMU

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Disease which requires removal of the urinary bladder

Exclusion criteria

• Patient does not want to participate