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Brief Title: 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

INTRODUCTION

  • Org Study ID: STUDY-23-00340
  • Secondary ID: N/A
  • NCT ID: NCT06689176
  • Sponsor: Icahn School of Medicine at Mount Sinai

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.

DETAILED DESCRIPTION

Th research team proposes to increase the rate of sterilization of urine from patients with urinary diversion and reduce the incidence of UTI up to 30 ± 7 days post radical cystectomy and urinary diversion using 50 ± 25ml of Irrisept ® irrigation solution lavage of the bowel segment during surgery for a contact time of 2 minutes. For patients who obtain an ileal conduits irrigation using 50 ± 25ml of Irrisept ® will be performed daily for 10 days +/- 3 days and for those patients obtaining ileal neobladders irrigation using 50 ± 25ml of Irrisept ® will continue for 21 days +/- 7 days. The irrigation will continue for the given time described above as this is usually when stents and catheters are removed.

  • Overall Status
    Recruiting
  • Start Date
    August 1, 2024
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants that have negative urine culture

Primary Outcome 1 - Timeframe: 30 ± 7 days post radical cystectomy with urinary diversion.

Primary Outcome 2 - Measure: Proportion of participants with incident symptomatic UTI

Primary Outcome 2 - Timeframe: 30 ± 7 days post radical cystectomy with urinary diversion.

CONDITION

  • Bladder Cancer
  • Urinary Tract Infection

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: John P Sfakianos, MD

Role: Principal Investigator

Affiliation: Associate Professor of Urology

Overall Contact

Name: Monali Fatterpekar, PhD, Sagar Shah, BS

Phone: (212) 241-0751, (212) 241-0751

Email: [email protected], [email protected]

LOCATION

Facility Status Contact
Facility: Mount Sinai Hospital
New York, New York 10029
United States 		Status: Recruiting Contact: Contact
John Sfakianos, MD
[email protected]

Principal Investigator
John Sfakianos, MD

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