Clinical trial NCT02404545: Prevention of Parastomal Hernia by Mesh Placement
Official title: A Randomized Study of the Utility of Composite Mesh Placement to Prevent Parastomal Hernia in Patients Undergoing Urinary Diversion With Ileal Conduit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parastomal Hernia
Keywords: Hernia
Mesh
Ileal conduit
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2015-03-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.

Detailed description: Subject to inclusion and exclusion criteria, patients will be randomized 1:1 to the control and intervention groups:

Randomization groups:

* Group 1 (control): Ileal Conduit
* Group 2 (intervention): Ileal conduit with concurrent mesh placement.

Ethicon PHYSIOMESH composite mesh will be utilized for this study. This is a composite mesh with a reduced polypropylene content. It is a widely used, commercially available hernia mesh, and its use and placement are simple and well described. The mesh will be placed at the time of radical cystectomy and ileal conduit. A small circle of mesh, the diameter of the ileal conduit, will be excised to allow for fitment around the ileal conduit. The mesh will be placed so that it encompasses the ileal conduit in a non-constricting manner, and will be sutured to the anterior abdominal wall. Product will be stored in a secure, sterile manner at the UMH operating room sterile supply room, and in accordance with institutional policies.

Patients from both groups will be followed up in a standard fashion. Follow up visits and clinical assessment will be at 6 weeks after surgery, 3 monthly during the first year, then every 6 months for at least 5 years. During each visit, patients will be clinically evaluated for the presence or absence of parastomal hernia, and any routine surveillance radiology imaging will be reviewed.

Parastomal hernia is clinically defined as an incisional hernia at the site of the ileal conduit stoma. This may be clinically apparent by examining the patient during performance of abdominal straining or Valsalva maneuver, or may be evident on radiology imaging.

Eligibility criteria: Inclusion Criteria:

1. Patients eligible to undergo urinary diversion with ileal conduit.
2. Patients with the ability to understand and willingness to sign a written informed consent document.
3. Men and Women aged 18 to 80 years.

Exclusion Criteria:

1. Patients unable or unwilling to consent to the proposed surgery
2. Pregnant women
3. Patients with prior ileal conduit surgery undergoing revision.

Primary outcomes:
measure: Rate of Reduction of the Incidence of Parastomal Hernia
timeFrame: 18 months
Secondary outcomes:
measure: Number of Participants Who Develop Mesh Related Complications
timeFrame: 60 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University Of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Murugesan Manoharan, MD
role: PRINCIPAL_INVESTIGATOR
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