Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
• 18 years of age or older
Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Maressa Twedt
twedt050@umn.edu
612-626-6661
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-10-15
Participants
Target number of participants: 120
Treatments
No_intervention: Control group
No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection
Experimental: Treatment group
Prophylactic antibiotics postoperatively.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota