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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of development of a clinical or radiologic parastomal hernia

Secondary outcome measures

Incidence of mesh-related complications in Mesh group (Arm I)

Rate of development of symptomatic parastomal hernia requiring surgical intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,168 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

13,657 Previous Clinical Trials

40,933,557 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental research looking to enroll new participants?

"The clinical trial data hosted on clinicialtrials.gov reveals that this investigation, which was initially posted November 25th 2015, is no longer recruiting patients. However, there are 473 other trials actively taking in participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

2015. "PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02439060.

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