RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy

Quick Facts

Study Start:2024-08-01
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06689176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form.
  2. * 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.
  3. * Male or female, ≥ 18 years of age
  4. * Confirmed diagnosis of bladder cancer
  5. * Candidate for radical cystectomy with urinary diversion
  6. * ECOG performance status of 0-2
  7. * Serum creatinine ≤ 1.5 mg/dL
  1. * Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder.
  2. * Pregnancy or lactation.
  3. * Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine.
  4. * 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.

Contacts and Locations

Study Contact

Monali Fatterpekar, PhD
CONTACT
(212) 241-0751
monali.fatterpekar@mountsinai.org
Sagar Shah, BS
CONTACT
(212) 241-0751
sagar.shah@mountsinai.org

Principal Investigator

John P Sfakianos, MD
PRINCIPAL_INVESTIGATOR
Associate Professor of Urology

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • John P Sfakianos, MD, PRINCIPAL_INVESTIGATOR, Associate Professor of Urology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • Bladder Cancer
  • Radical Cystectomy
  • Ileal Conduit
  • Neobladder
  • Chlorhexidine Gluconate
  • Irrisept

Additional Relevant MeSH Terms

  • Bladder Cancer
  • Urinary Tract Infection