PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

University of Southern California

Status: Completed

Conditions: Hernia; Bladder Carcinoma

Treatments: Other: Acellular Cadaveric Dermal Matrix

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02439060

4B-14-2 (Other Identifier)

NCI-2015-00278 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Arm I (biologic mesh)

Experimental group

Description:

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

Treatment:

Other: Acellular Cadaveric Dermal Matrix

Arm II (no intervention)

No Intervention group

Description:

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