NCT02404545

Prevention of Parastomal Hernia by Mesh Placement

A Randomized Study of the Utility of Composite Mesh Placement to Prevent Parastomal Hernia in Patients Undergoing Urinary Diversion With Ileal Conduit

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
DEVICE	Ethicon Physiomesh	Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit.

Timeline

• Start date: 2015-08-14
• Primary completion: 2016-08-01
• Completion: 2017-03-01
• First posted: 2015-03-31
• Last updated: 2017-09-25
• Results posted: 2017-08-25

Locations

1 site across 1 country: United States