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

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.

Conditions3

Locations1 site

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