Bladder CarcinomaNCT02439060
PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)
A study testing Acellular Cadaveric Dermal Matrix in people with Bladder Carcinoma and Hernia, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Carcinoma, Hernia
- What is being tested?
- Acellular Cadaveric Dermal Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2015to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Bladder Carcinoma, Hernia
- Being tested
- Acellular Cadaveric Dermal Matrix
- Medical subject headings
- Urinary Bladder Neoplasms, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Cadaveric Dermal MatrixOther
Also called ACDM, AlloDerm, DermaMatrix
Undergo intraperitoneal prophylactic mesh placement
| Study group | Role | What they receive |
|---|---|---|
| Arm I (biologic mesh) | Experimental | Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit. Receives: Other: Acellular Cadaveric Dermal Matrix |
| Arm II (no intervention) | No intervention | Patients undergo standard of care radical cystectomy and placement of the ileal conduit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (2)
Incidence of mesh-related complications in Mesh group (Arm I)
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.
Measured: Up to 2 years
Rate of development of symptomatic parastomal hernia requiring surgical intervention
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start25 Nov 2015
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Musculoskeletal Transplant Foundation
- Responsible party
- Sponsor
- Investigators
- Hooman Djaladat, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439060
- Sponsor's protocol ID
- 4B-14-2
- Other IDs
- NCI-2015-00278, 4B-14-2, P30CA014089
- Status last verified
- Apr 2025
- First submitted
- 6 May 2015
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Djaladat H, Ghoreifi A, Tejura T, Miranda G, Cai J, Sheybaee Moghaddam F, Aldana I, Sotelo R, Gill I, Bhanvadia S, Schuckman A, Desai M, Aron M, Daneshmand S, Duddalwar V. Prophylactic Use of Biologic Mesh in Ileal Conduit (PUBMIC): A Randomized Clinical Trial. J Urol. 2024 Jun;211(6):743-753. doi: 10.1097/JU.0000000000003902. Epub 2024 Apr 15.
PubMed 38620056
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02439060
- Acronym / sponsor ID
- 4B-14-2
- Conditions
- Bladder Carcinoma, Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Musculoskeletal Transplant Foundation
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (biologic mesh) | Experimental | Other: Acellular Cadaveric Dermal MatrixPatients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit. |
| Arm II (no intervention) | No intervention | –Patients undergo standard of care radical cystectomy and placement of the ileal conduit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Cadaveric Dermal MatrixAlso: ACDM, AlloDerm, DermaMatrixUndergo intraperitoneal prophylactic mesh placement | Other | Arm I (biologic mesh) |
Primary outcome
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.
2 secondary outcomes
Incidence of mesh-related complications in Mesh group (Arm I)
Time frame: Up to 2 years
Rate of development of symptomatic parastomal hernia requiring surgical intervention
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 38620056Djaladat H, Ghoreifi A, Tejura T, Miranda G, Cai J, Sheybaee Moghaddam F, Aldana I, Sotelo R, Gill I, Bhanvadia S, Schuckman A, Desai M, Aron M, Daneshmand S, Duddalwar V. Prophylactic Use of Biologic Mesh in Ileal Conduit (PUBMIC): A Randomized Clinical Trial. J Urol. 2024 Jun;211(6):743-753. doi: 10.1097/JU.0000000000003902. Epub 2024 Apr 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hooman Djaladat principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Cadaveric Dermal Matrix in people with Bladder Carcinoma and Hernia, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of development of a clinical or radiologic parastomal hernia (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.