Clinical trial NCT02439060: PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)
Official title: Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Carcinoma
Hernia
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Musculoskeletal Transplant Foundation
First posted: 2015-05-08
Enrollment: 156
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of development of a clinical or radiologic parastomal hernia
timeFrame: Up to 2 years
Secondary outcomes:
measure: Incidence of mesh-related complications in Mesh group (Arm I)
timeFrame: Up to 2 years
measure: Rate of development of symptomatic parastomal hernia requiring surgical intervention
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Hooman Djaladat
role: PRINCIPAL_INVESTIGATOR
References: