Biologic Mesh for Preventing Hernia in Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byHooman Djaladat

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies how well biologic mesh works in preventing parastomal hernia in patients with bladder cancer who are undergoing radical cystectomy, or removal of the bladder, and ileal conduit diversion. An ileal conduit is a tube created from your small intestine that will be used as a tube for urine to flow out of your body. Parastomal hernia is a type of hernia that can occur in the stomach area where the ileal conduit is placed. Biologic mesh may help prevent parastomal hernia following surgery and ileal conduit diversion.

Research Team

Hooman Djaladat

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for bladder cancer patients who are having their bladders removed and an ileal conduit created. Participants must understand the study and agree to sign a consent form. They should be able to follow up at USC or centers that can share clinical data. Those with previous scars, short life expectancy, or allergies to similar biologic materials cannot join.

Inclusion Criteria

I am having my bladder removed and will have a urinary diversion.

Follow-up either here at University of Southern California (USC) or centers that are available to transfer the requested clinical and radiological data

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

My survival after surgery is expected to be less than 12 months.

You have had allergic reactions to substances similar to the cadaveric component in Flex HD.

You have had a previous surgery in the area where the ileal conduit is located.

Treatment Details

Interventions

Acellular Cadaveric Dermal Matrix (Biologic Mesh)

Trial OverviewThe PUBMIC trial is testing if using a biologic mesh can prevent parastomal hernias in patients undergoing bladder removal and ileal conduit diversion. It's a phase III study where participants are randomly chosen to receive either the biologic mesh or not during surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (biologic mesh)Experimental Treatment1 Intervention

Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit.

Group II: Arm II (no intervention)Active Control1 Intervention

Patients undergo standard of care radical cystectomy and placement of the ileal conduit.