NCT06689176 Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
| NCT ID | NCT06689176 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 23 participants in total. It began in 2024-08-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single arm, interventional pilot study of using chlorhexidine irrigation intra-operatively and post-operatively among patients undergoing radical cystectomy with urinary diversion. The intervention comprises of using irrigation of ileal conduit or ileal neobladder intra-operatively and then for irrigation of either post-surgery with Irrisept ®. The sterilization of urine will be assessed at 10 days after cystectomy. Incidence of symptomatic urinary tract infections within the 30-day post-operative period will be estimated.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form. * Stated availability for the duration of the study, and willingness to comply with all study procedures, including willingness to adhere to twice daily irrigation of neobladder or ileal conduit. * Male or female, ≥ 18 years of age * Confirmed diagnosis of bladder cancer * Candidate for radical cystectomy with urinary diversion * ECOG performance status of 0-2 * Serum creatinine ≤ 1.5 mg/dL Exclusion Criteria: * Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder. * Pregnancy or lactation. * Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine. * Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Contact & Investigator
John P Sfakianos, MD
PRINCIPAL INVESTIGATOR
Associate Professor of Urology
Frequently Asked Questions
Who can join the NCT06689176 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06689176 currently recruiting?
Yes, NCT06689176 is actively recruiting participants. Contact the research team at monali.fatterpekar@mountsinai.org for enrollment information.
Where is the NCT06689176 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06689176 clinical trial?
NCT06689176 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is John P Sfakianos, MD at Associate Professor of Urology. The trial plans to enroll 23 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.