PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

NCT02439060 | Completed DMC

• 3 other identifiers: 4B-14-2NCI-2015-00278P30CA014089
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Carcinoma; Hernia

Outcome Measures

Primary Outcomes (1)

• Rate of development of a clinical or radiologic parastomal hernia

  Cumulative incidence curves (using death, local recurrence, other surgical procedures unrelated to the development of parastomal hernias as competing risks) and their associated estimates (at 2 years) and standard errors will be used. To compare the two arms, the Wald test for the estimate at two years will be used, and the log-rank test for the timing of the events will be used. All tests will be one-sided at the 0.05 level.

  Up to 2 years

Secondary Outcomes (2)

• Incidence of mesh-related complications in Mesh group (Arm I)

  Up to 2 years

• Rate of development of symptomatic parastomal hernia requiring surgical intervention

  Up to 2 years

Study Arms (2)

Arm I (biologic mesh)

EXPERIMENTAL

Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit.

Other: Acellular Cadaveric Dermal Matrix

Arm II (no intervention)

NO INTERVENTION

Patients undergo standard of care radical cystectomy and placement of the ileal conduit.

Interventions

Acellular Cadaveric Dermal Matrix OTHER

Undergo intraperitoneal prophylactic mesh placement

Also known as: ACDM, AlloDerm, DermaMatrix

Arm I (biologic mesh)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• Musculoskeletal Transplant Foundation: collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Hernia

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hooman Djaladat

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: November 25, 2015
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

US (1)