PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. To estimate the rate of developing parastomal hernia detected either clinically or radiologically in patients with radical cystectomy and ileal conduit, with or without mesh. SECONDARY OBJECTIVES: I. To estimate the rate of developing symptomatic parastomal hernia requiring surgical intervention in patients with radical cystectomy and ileal conduit with or without mesh. II. To estimate the time from cystectomy with an ileal conduit to diagnosis of clinical parastomal hernia development in patients with radical cystectomy and ileal conduit with or without mesh. III. To estimate the time from cystectomy with an ileal conduit to diagnosis of radiological parastomal hernia development in patients with radical cystectomy and ileal conduit with or without mesh. IV. To estimate the rate of stomal prolapse and time to its development in patients with radical cystectomy and ileal conduit with or without mesh. V. To evaluate mesh-related complications in mesh group. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit. ARM II: Patients undergo standard of care radical cystectomy and placement of the ileal conduit. After completion of study, patients are followed up every 2-4 months for 2 years.

Official Title
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Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial

Conditions
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Bladder Carcinoma, Hernia

Intervention / Treatment
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* Other: Acellular Cadaveric Dermal Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bladder cancer, undergoing radical cystectomy and ileal conduit diversion Ability to understand and the willingness to sign a written informed consent Follow-up either here at University of Southern California (USC) or centers that are available to transfer the requested clinical and radiological data Exclusion Criteria: Previous scar or mesh at the level of ileal conduit Survival less than 12 months after surgery (either predicted survival before surgery or actual survival after surgery < 12 months) History of allergic reactions attributed to compounds of similar chemical or biologic composition to cadaveric component, i.e. Flex HD
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (biologic mesh)<br>Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit. | Other: Acellular Cadaveric Dermal Matrix<br>* Undergo intraperitoneal prophylactic mesh placement<br>* Other names: DermaMatrix;|
| No Intervention: Arm II (no intervention)<br>Patients undergo standard of care radical cystectomy and placement of the ileal conduit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of development of a clinical or radiologic parastomal hernia | Cumulative incidence curves (using death, local recurrence, other surgical procedures unrelated to the development of parastomal hernias as competing risks) and their associated estimates (at 2 years) and standard errors will be used. To compare the two arms, the Wald test for the estimate at two years will be used, and the log-rank test for the timing of the events will be used. All tests will be one-sided at the 0.05 level. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of mesh-related complications in Mesh group (Arm I) | All patients randomized, who undergo a radical cystectomy with an ileal conduit, will be classified according to whether or not they received the mesh implant. Observed toxicities and complications during and after surgery will be summarized by treatment received, severity, timing (time from surgery), and frequency. | Up to 2 years | 
| Rate of development of symptomatic parastomal hernia requiring surgical intervention | Cumulative incidence curves (using death, local recurrence, other surgical procedures unrelated to the development of parastomal hernias as competing risks) and their associated estimates (at 2 years) and standard errors will be used. To compare the two arms, the Wald test for the estimate at two years will be used, and the log-rank test for the timing of the events will be used. All tests will be one-sided at the 0.05 level. | Up to 2 years |