Prospective Evaluation of Blood-based and Microbiological Early Indicators of In-hospital Infectious Complications After Open Cystectomy.
Benedikt Ebner, Judith Hirsch, Annkathrin Holz...
https://pubmed.ncbi.nlm.nih.gov/41334533Actively Recruiting
All Genders
ID05153694
Infectious Complications After Cystectomy: A Prospective Observational Study
Led by Ludwig-Maximilians - University of Munich · Updated on 2024-09-19
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand infectious complications in patients undergoing cystectomy, which is the surgical removal of the urinary bladder, performed for both cancerous and non-cancerous reasons. The study prospectively collects detailed medical history and clinicopathological data, focusing on markers of infection before and after surgery. It also compares patient-reported and physician-assessed complications, and explores how in-hospital complications relate to quality of life after surgery. Participants undergo cystectomy, and the study monitors inflammatory markers like interleukin-6 and procalcitonin, as well as wound drainage cultures, to evaluate early signs of infection. Researchers also compare infection rates between different types of urinary diversion surgeries, such as ileal neobladder versus ileal conduit. Follow-up periods extend up to 12 months after surgery to assess infectious complications and their impact. Participants are involved through structured follow-up interviews at 3, 6, and 12 months post-surgery, which use standardized questionnaires to record post-discharge infections and patient experiences in the hospital. The study carefully tracks in-hospital complications, antibiotic use, fever episodes, emergency visits, and hospital readmissions. Outcomes also include quality of life assessments and subjective ratings of preoperative information and complications, providing a comprehensive view of patient health and recovery over time.
CONDITIONS
Brief Title
Infectious Complications After Cystectomy: A Prospective Observational Study
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Disease which requires removal of the urinary bladder
You will not qualify if you...
- Patient does not want to participate
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day through hospital discharge
Participants undergo cystectomy surgery followed by hospital stay for monitoring of infectious complications and in-hospital outcomes.
1 surgical procedure and daily hospital visits until discharge
Post-operative Follow-up
Duration - Up to 12 months after discharge
Participants are monitored for infectious complications, antibiotic use, and quality of life up to 12 months after discharge.
Periodic follow-up visits during the first year after discharge
Trial Site Locations
Total: 1 location
1
Urology Department - LMU Klinikum
Munich, Outside U.S./Canada, Germany, 81377
Actively Recruiting
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Research Team
B
Benedikt Ebner, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Association of interleukin-6 serum levels with local tumor stage and lymph node metastasis of urothelial carcinoma.
Benedikt Ebner, Judith Hirsch, Annkathrin Holz...
https://pubmed.ncbi.nlm.nih.gov/41006129Discrepancies between physician-assessed and patient-reported complications after cystectomy - a prospective analysis.
Benedikt Ebner, Judith Hirsch, Annkathrin Holz...
https://pubmed.ncbi.nlm.nih.gov/39928165