Prophylactic Antibiotics in Cystectomy With Diversion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prophylactic antibiotics postoperatively..
- Who it may be relevant to
- Registry conditions: Muscle-Invasive Bladder Carcinoma, Radical Cystectomy, Ileal Conduit, Neobladder Diversion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion
Overview
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.
Interventions
- Drug Prophylactic antibiotics postoperatively.
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
Primary outcome measures
- test for non-inferiority [Time frame: 90 days]
- Difference in risk [Time frame: 30 and 90 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06190197 · URO-2023-32133