PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)
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ClinicalTrials.gov Identifier: NCT02439060 |
Recruitment Status :
Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : November 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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Bladder Carcinoma Hernia | Other: Acellular Cadaveric Dermal Matrix | Not Applicable |
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 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 : | November 25, 2015 |
Estimated Primary Completion Date : | November 25, 2023 |
Estimated Study Completion Date : | November 25, 2024 |

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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, California | |
USC / Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Hooman Djaladat | University of Southern California |
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: | November 15, 2022 |
Last Verified: | November 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Urinary Bladder Neoplasms Hernia Pathological Conditions, Anatomical Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases |