Prevention of Parastomal Hernia by Mesh Placement

August 24, 2017 updated by: University of Miami

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: Murugesan Manoharan, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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