SUPPORT HOTLINE (888) 901-2226
Donate Now

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

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


  • Org Study ID: 4B-14-2
  • Secondary ID: NCI-2015-00278,4B-14-2,P30CA014089
  • NCT ID: NCT02439060
  • NCT Alias:
  • Sponsor: University of Southern California - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting August 31, 2015 N/A Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Up to 2 years

Condition:

  • Bladder Carcinoma
  • Hernia

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
Show More

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: Ileana Aldana

Phone: 323-865-0702

Email: Ileana.aldana@med.usc.edu

Location

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