Prevention of Parastomal Hernia by Mesh Placement

Not Applicable

Terminated

• Conditions: Parastomal Hernia
• Interventions: Device: Ethicon Physiomesh

• Registration Number: NCT02404545
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Study Start: 2015-08-14
• Primary Completion: 2016-08
• Study Completion: 2017-03
• Results First Submitted: 2017-07-25
• Results First Submitted QC: 2017-07-25
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Results First Posted: 2017-08-25
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Ileal Conduit with Mesh	Ethicon Physiomesh	Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.

Primary Outcome Measures

Name	Time	Method
Rate of Reduction of the Incidence of Parastomal Hernia	18 months	Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Develop Mesh Related Complications	60 months	Assessed by physical examination including: * Mesh erosion and infection; * Stomal stenosis and necrosis; * Frequency of stoma pouch appliance changes.; * Record by physical exam the incidence of parastomal hernia at 5 years.

Trial Locations

Locations (1)

University Of Miami; 🇺🇸 Miami, Florida, United States