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Prevention of Parastomal Hernia by Mesh Placement

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ClinicalTrials.gov Identifier: NCT02404545
Recruitment Status : Terminated (Sponsor stopped producing device)
First Posted : March 31, 2015
Results First Posted : August 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
University of Miami

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

Condition or disease Intervention/treatment Phase
Parastomal Hernia Device: Ethicon Physiomesh Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Study of the Utility of Composite Mesh Placement to Prevent Parastomal Hernia in Patients Undergoing Urinary Diversion With Ileal Conduit
Actual Study Start Date : August 14, 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Group 1 - Ideal Conduit No Mesh
No mesh will be placed at the time of radical cystectomy and ileal conduit.
Active Comparator: Group 2 - Ileal Conduit with Mesh
Ethicon Physiomesh will be placed at the time of radical cystectomy and ileal conduit.
 Device: Ethicon Physiomesh
Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Reduction of the Incidence of Parastomal Hernia [ Time Frame: 18 months ]
    Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination


Secondary Outcome Measures :
  1. Number of Participants Who Develop Mesh Related Complications [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404545


Locations
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United States, Florida
University Of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Ethicon, Inc.
Investigators
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Principal Investigator: Murugesan Manoharan, MD University of Miami
More Information
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Publications of Results:

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Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT02404545    
Other Study ID Numbers: 20140277
First Posted: March 31, 2015    Key Record Dates
Results First Posted: August 25, 2017
Last Update Posted: September 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Miami:
Hernia
Mesh
Ileal conduit
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical