RecruitingEarly Phase 1NCT06190197

Prophylactic Antibiotics in Cystectomy With Diversion

Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion

Sponsor

University of Minnesota

Enrollment

120 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Muscle-Invasive Bladder Carcinoma Radical Cystectomy Ileal Conduit Neobladder Diversion

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether giving preventive antibiotics before bladder removal surgery (cystectomy) helps reduce the risk of infection afterward. **You may be eligible if...** - You have muscle-invasive bladder cancer - You are planning to have your bladder surgically removed (radical cystectomy) with creation of a urinary diversion (ileal conduit or neobladder) - You are 18 or older **You may NOT be eligible if...** - You are currently taking antibiotics for an active infection - Your kidneys are functioning very poorly (GFR under 30) - You are allergic to the study antibiotics and cannot take alternatives - You are pregnant - You have had prior pelvic radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProphylactic 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 they do not remember until the next dose, do not take extra capsules to make up the missed dose.

Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT06190197

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