Clinical trial NCT06689176: Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
Official title: Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Urinary Tract Infection
Keywords: Bladder Cancer
Radical Cystectomy
Ileal Conduit
Neobladder
Chlorhexidine Gluconate
Irrisept
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Irrimax Corporation
First posted: 2024-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is single center, open-label study where the participants will be identified from the principal investigator and sub-investigator's clinic. All the participants who meet the study criteria and sign the consent form will be assigned to the study intervention.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants that have negative urine culture
timeFrame: 30 ± 7 days post radical cystectomy with urinary diversion.
measure: Proportion of participants with incident symptomatic UTI
timeFrame: 30 ± 7 days post radical cystectomy with urinary diversion.
Secondary outcomes:
measure: Percentage of urine leak from neobladder/ ileal conduit
timeFrame: 30 ± 7 days post radical cystectomy with urinary diversion
measure: Percentage of patients with sepsis
timeFrame: 30 ± 7 days post radical cystectomy with urinary diversion
measure: Percentage of symptomatic urinary tract infections
timeFrame: 30 ± 7 days post radical cystectomy with urinary diversion
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Associate Professor of Urology
name: John P Sfakianos, MD
role: PRINCIPAL_INVESTIGATOR
References: