Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion

ID#: NCT06689176

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: August 01, 2024

End Date: August 01, 2025

Contact Information:
Monali Fatterpekar, PhD
(212) 241-0751
Sagar Shah, BS
(212) 241-0751
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:

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.
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