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NCT02439060Completed

PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
156 (actual)
First submitted
6 May 2015
Start date
25 Nov 2015
Primary completion date
7 Jun 2024
Lead sponsor
University of Southern California
NCT number
NCT02439060

What you commit to

  • Study type: Interventional
  • Participants enrolled: 156
  • From 25 Nov 2015 to the primary completion date, 7 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cadaveric component, i.e. Flex HD

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
USC / Norris Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.