PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

NCT02439060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

  • Bladder Carcinoma
  • Hernia

Interventions

OTHER

Acellular Cadaveric Dermal Matrix

Undergo intraperitoneal prophylactic mesh placement

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Musculoskeletal Transplant Foundation

    collaborator OTHER
  • University of Southern California

    lead OTHER

Principal Investigators

  • Hooman Djaladat · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-25
Primary Completion
2024-06-07
Completion
2024-06-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439060 on ClinicalTrials.gov