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Completed

NCT Number: NCT02439060

PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acellular Cadaveric Dermal Matrix

Other

Undergo intraperitoneal prophylactic mesh placement

Other names: ACDM, AlloDerm, DermaMatrix

Primary outcomes

  1. Rate of development of a clinical or radiologic parastomal hernia

    Time frame: Up to 2 years

    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.

Secondary outcomes

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

    Time frame: Up to 2 years

    All patients randomized, who undergo a radical cystectomy with an ileal conduit, will be classified according to whether or not they received the mesh implant. Observed toxicities and complications during and after surgery will be summarized by treatment received, severity, timing (time from surgery), and frequency.

  2. Rate of development of symptomatic parastomal hernia requiring surgical intervention

    Time frame: Up to 2 years

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Musculoskeletal Transplant Foundation
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
May 8, 2015
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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