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Biologic Mesh in Preventing Hernia in Patients With Bladder Cancer Undergoing Radical Cystectomy With Ileal Conduit Diversion

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ClinicalTrials.gov Identifier: NCT02439060
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Musculoskeletal Transplant Foundation
Information provided by (Responsible Party):
University of Southern California

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Carcinoma Hernia Other: Acellular Cadaveric Dermal Matrix Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial
Actual Study Start Date : August 31, 2015
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (biologic mesh)
Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit.
 Other: Acellular Cadaveric Dermal Matrix
Undergo intraperitoneal prophylactic mesh placement
Other Names:
  • ACDM
  • AlloDerm
  • DermaMatrix
No Intervention: Arm II (no intervention)
Patients undergo standard of care radical cystectomy and placement of the ileal conduit.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439060


Contacts
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Contact: Ileana Aldana 323-865-0702 Ileana.aldana@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Ileana Aldana    323-865-0702    Ileana.aldana@med.usc.edu   
Principal Investigator: Hooman Djaladat         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Musculoskeletal Transplant Foundation
Investigators
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Principal Investigator: Hooman Djaladat University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02439060    
Other Study ID Numbers: 4B-14-2
NCI-2015-00278 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4B-14-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Hernia
Pathological Conditions, Anatomical
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases