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Brief Title: Biologic Mesh in Preventing Hernia in Patients With Bladder Cancer Undergoing Radical Cystectomy With Ileal Conduit Diversion

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

INTRODUCTION

  • Org Study ID: 4B-14-2
  • Secondary ID: NCI-2015-00278, 4B-14-2, P30CA014089
  • NTC ID: NCT02439060
  • Sponsor: University of Southern California

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.

  • Overall Status
    Unknown status
  • Start Date
    August 31, 2015
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Rate of development of a clinical or radiologic parastomal hernia

Primary Outcome 1 - Timeframe: Up to 2 years

CONDITION

  • Bladder Carcinoma
  • Hernia

ELIGIBILITY

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Hooman Djaladat

Role: Principal Investigator

Affiliation: University of Southern California

Overall Contact

Name: Hooman Djaladat

Phone: 323-865-0702

Email: Ileana.aldana@med.usc.edu

LOCATION

Facility Status Contact
Facility: USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Ileana Aldana
323-865-0702
Ileana.aldana@med.usc.edu