PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-25

Study Completion Date

2024-06-07

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.

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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.

Conditions

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Bladder Carcinoma Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (biologic mesh)

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

Group Type EXPERIMENTAL

Acellular Cadaveric Dermal Matrix

Intervention Type OTHER

Undergo intraperitoneal prophylactic mesh placement

Arm II (no intervention)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acellular Cadaveric Dermal Matrix

Undergo intraperitoneal prophylactic mesh placement

Intervention Type OTHER

Other Intervention Names

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ACDM AlloDerm DermaMatrix

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No