Biologic Mesh for Preventing Hernia in Bladder Cancer

Overseen By Ileana Aldana

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Previous scar, Survival < 12 months, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery duration

156 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo radical cystectomy and placement of the ileal conduit, with or without biologic mesh

Surgery duration

1 visit (in-person)

Follow-up

Participants are monitored for the development of parastomal hernia and mesh-related complications

Up to 2 years

Every 2-4 months

Treatment Details

Interventions

• Acellular Cadaveric Dermal Matrix

Trial Overview The 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

Group I: Arm I (biologic mesh) Experimental Treatment 1 Intervention

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

Group II: Arm II (no intervention) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Musculoskeletal Transplant Foundation

Collaborator

Trials

22

Recruited

1,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+