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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help prevent urinary tract infections in patients with bladder cancer who are undergoing surgery to remove their bladder (called radical cystectomy) and create a new way for urine to leave the body (urinary diversion). The study involves using a special antiseptic solution called chlorhexidine to clean the inside of the urinary system both during and after the surgery. Researchers will check if this method helps sterilize the urine and reduces the chances of developing infections in the 30 days following the surgery.

To participate in this trial, individuals must be at least 18 years old, have a confirmed diagnosis of bladder cancer, and be scheduled for the surgery mentioned. They should also be able to follow the study guidelines, which include using the antiseptic solution twice a day after surgery. It's important to note that those who are pregnant, have certain health conditions, or have allergies to the study medication will not be eligible. Participants will receive close monitoring, and their progress will be tracked to see how effective this treatment approach is.

Gender

ALL

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.