NCT06689176Recruiting
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 12 Nov 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Bladder cancer
- NCT number
- NCT06689176
What you commit to
- Study type: Interventional
- Planned participants: 23
- From 1 Aug 2024 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder.
- Pregnancy or lactation.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.