Prophylactic Antibiotics in Cystectomy With Diversion

University of Minnesota (UMN)

Status and phase: Enrolling; Early Phase 1

Conditions: Muscle-Invasive Bladder Carcinoma; Neobladder Diversion; Ileal Conduit; Radical Cystectomy

Treatments: Drug: Prophylactic antibiotics postoperatively.

Study type: Interventional

Funder types: Other

Identifiers

NCT06190197

URO-2023-32133

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Control group

No Intervention group

Description:

No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection

Treatment group

Experimental group

Description:

Prophylactic antibiotics postoperatively.

Treatment:

Drug: Prophylactic antibiotics postoperatively.