Cystectomy Clinical Trials

Clinical trials related to Cystectomy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai Hospital
RECRUITING
New York
Contact Information
Primary
Monali Fatterpekar, PhD
monali.fatterpekar@mountsinai.org
(212) 241-0751
Backup
Sagar Shah, BS
sagar.shah@mountsinai.org
(212) 241-0751
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 23
Treatments
Experimental: Patients undergoing radical cystectomy with urinary diversion
Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention
Sponsors
Collaborators: Irrimax Corporation
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov