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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hernia; Bladder Carcinoma
• Intervention / Treatment: Other: Acellular Cadaveric Dermal Matrix

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: DermaMatrix; ACDM; AlloDerm
No Intervention: Arm II (no intervention); Patients undergo standard of care radical cystectomy and placement of the ileal conduit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI); Musculoskeletal Transplant Foundation
• Investigators: Principal Investigator: Hooman Djaladat, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2015
• Primary Completion (Estimated): November 25, 2024
• Study Completion (Estimated): November 25, 2025

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimated): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hernia; Urinary Bladder Neoplasms
• Other Study ID Numbers: 4B-14-2 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2015-00278 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No