Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion
- Conditions
- Bladder CancerUrinary Tract Infection
- Registration Number
- NCT06689176
- Lead 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of participants that have negative urine culture 30 ± 7 days post radical cystectomy with urinary diversion. Negative urine culture will be defined as a colony count of less than or equal to 100000 CFU/ml. The urine sample will be collected by catheterization of the conduit with a 16F Foley catheter, which provides the least number of CFU of bacteria compared to collection from the ostomy bag. Patients with ileal neobladder will give a spontaneously voided urine sample when able or will be obtained from catheterized urine for those who cannot void.
Proportion of participants with incident symptomatic UTI 30 ± 7 days post radical cystectomy with urinary diversion. Proportion of participants with incident symptomatic UTI by 30 ± 7 days post radical cystectomy with urinary diversion. Symptomatic UTI will be defined as a positive urine culture in the presence of fever (≥38°C) with or without associated flank/abdominal pain.
- Secondary Outcome Measures
Name Time Method Percentage of urine leak from neobladder/ ileal conduit 30 ± 7 days post radical cystectomy with urinary diversion Percentage of patients with sepsis 30 ± 7 days post radical cystectomy with urinary diversion Percentage of patients with sepsis (when the body reacts to an infection) will be assessed. In case \>/= 10% of participants experience sepsis, the intervention will be considered unacceptable.
Percentage of symptomatic urinary tract infections 30 ± 7 days post radical cystectomy with urinary diversion Symptomatic urinary tract infection is when a person has positive UTI and has fever and other symptoms including pain when passing urine and pain in the lower belly.
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸New York, New York, United States