Biologic Mesh in Preventing Hernia in Patients With Bladder Cancer Undergoing Radical Cystectomy With Ileal Conduit Diversion
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/27/2018 |
| Start Date: | August 31, 2015 |
| End Date: | August 31, 2020 |
| Contact: | Ileana Aldana |
| Email: | Ileana.aldana@med.usc.edu |
| Phone: | 323-865-0702 |
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.
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.
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.
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.
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
We found this trial at
1
site
1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Hooman Djaladat
Phone: 323-865-0702
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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