Clinical trial · Interventional
PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)
Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hernia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acellular Cadaveric Dermal Matrix | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (biologic mesh)
- description
- Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit.
- interventionNames
- Other: Acellular Cadaveric Dermal Matrix
- type
- NO_INTERVENTION
- label
- Arm II (no intervention)
- description
- Patients undergo standard of care radical cystectomy and placement of the ileal conduit.
Primary outcomes (1)
- measure
- Rate of development of a clinical or radiologic parastomal hernia
- timeFrame
- Up to 2 years
- description
- 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
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDjaladat 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. PMID 38620056