NCT05153694

Infectious Complications After Cystectomy: A Prospective Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Cystectomy	Removal of the urinary bladder

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2021-12-10
• Last updated: 2024-09-19

Locations

1 site across 1 country: Germany