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Biologic Mesh for Preventing Hernia in Bladder Cancer

N/A
Waitlist Available
Led By Hooman Djaladat
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bladder cancer, undergoing radical cystectomy and ileal conduit diversion
Must not have
Survival less than 12 months after surgery (either predicted survival before surgery or actual survival after surgery < 12 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how well biologic mesh works in preventing parastomal hernia in patients with bladder cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed, generally, surgical use of biologic mesh could potentially lead to infection, inflammation at the site of implantation, allergic reactions, pain or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having my bladder removed and will have a urinary diversion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My survival after surgery is expected to be less than 12 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of development of a clinical or radiologic parastomal hernia
Secondary study objectives
Incidence of mesh-related complications in Mesh group (Arm I)
Rate of development of symptomatic parastomal hernia requiring surgical intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,535 Total Patients Enrolled
3 Trials studying Hernia
414 Patients Enrolled for Hernia
Musculoskeletal Transplant FoundationOTHER
20 Previous Clinical Trials
1,480 Total Patients Enrolled
3 Trials studying Hernia
512 Patients Enrolled for Hernia
National Cancer Institute (NCI)NIH
13,926 Previous Clinical Trials
41,017,907 Total Patients Enrolled
2 Trials studying Hernia
7,173 Patients Enrolled for Hernia

Media Library

Acellular Cadaveric Dermal Matrix Clinical Trial Eligibility Overview. Trial Name: NCT02439060 — N/A
Hernia Research Study Groups: Arm I (biologic mesh), Arm II (no intervention)
Hernia Clinical Trial 2023: Acellular Cadaveric Dermal Matrix Highlights & Side Effects. Trial Name: NCT02439060 — N/A
Acellular Cadaveric Dermal Matrix 2023 Treatment Timeline for Medical Study. Trial Name: NCT02439060 — N/A
~0 spots leftby Nov 2024
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