Clinical trial · Interventional
Prophylactic Antibiotics in Cystectomy With Diversion
Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion
NCT06190197CI-TRIAL-00097307recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ileal Conduit | — | UNRESOLVED | — |
| Muscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neobladder Diversion | — | UNRESOLVED | — |
| Radical Cystectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic antibiotics postoperatively. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Prophylactic antibiotics postoperatively.
- interventionNames
- Drug: Prophylactic antibiotics postoperatively.
Primary outcomes (2)
- measure
- test for non-inferiority
- timeFrame
- 90 days
- description
- Test for non-inferiority of no 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.