Prophylactic Antibiotics in Cystectomy With Diversion
Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion
University of Minnesota
120 participants
May 13, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
- years of age or older
Exclusion Criteria6
- Currently receiving antimicrobials for active infection
- Poor renal function with GFR \< 30 ml/min
- Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
- Pregnancy
- Unable to provide Informed consent
- Prior pelvic radiation
Interventions
Prophylactic antibiotics postoperatively. All participants in this arm will receive nitrofurantoin 100 milligrams by mouth daily for either 10 or 21 days based on whether they had an ileal conduit or orthotopic neobladder, respectively, for the diversion. Participants will be instructed to swallow the capsule whole, preferably with food and at the same time each day. If a dose is forgotten, participants will be asked to take it when they remember and then take the next dose as usual. However, if they do not remember until the next dose, do not take extra capsules to make up the missed dose.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06190197