Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/8/2015
Start Date:May 2011
End Date:May 2016
Contact:Sara Baalman, MA
Email:baalmans@wudosis.wustl.edu
Phone:314-362-8539

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A Prospective Multicenter Trial to Evaluate Adhesion Characteristics and Adhesiolysis-related Complications of Barrier-coated and Non-barrier-coated Intraperitoneal Mesh During Abdominal Re-exploration After Prior Ventral Hernia Repair

The proposed study will compare the benefits, harms, and comparative effectiveness of
intraperitoneal barrier-coated and non-barrier coated ventral hernia repair (VHR) mesh in
reducing adhesions, adhesion-related complications, and adhesiolysis sequelae in actual
patient subpopulations and clinical circumstances. A subset of the data will be analyzed to
compare the benefits, harms, and comparative effectiveness of the laparoscopic and open
approaches to adhesiolysis. A comprehensive array of health-related risk factors and
patient-centered outcomes will be assessed in the investigators diverse patient population
for proper multivariate data analysis.

Specific Aim I: To evaluate and compare the adhesion characteristics of intraperitoneal
barrier-coated versus non-barrier-coated mesh during abdominal re-exploration after prior
ventral hernia repair.

Specific Aim II: To evaluate and compare the adhesion-related complications and
adhesiolysis-related complications of intraperitoneal barrier-coated versus
non-barrier-coated mesh during abdominal re-exploration after prior ventral hernia repair.

Specific Aim III: To determine the comparative effectiveness of intraperitoneal
barrier-coated versus non-barrier-coated ventral hernia repair mesh in reducing adhesions,
adhesion-related complications, and adhesiolysis sequelae in actual patient subpopulations
and clinical circumstances.

Specific Aim IV: To evaluate and compare the adhesiolysis-related complications of the
laparoscopic and open approaches to adhesiolysis during abdominal re-exploration after prior
ventral hernia repair.

Specific Aim V: To determine the comparative effectiveness of the laparoscopic and open
approaches to adhesiolysis during abdominal re-exploration after prior ventral hernia
repair.


Inclusion Criteria:

- greater than or equal to 18 years of age

- prior ventral hernia repair with intraperitoneal placement of mesh (open or
laparoscopic approach; absorbable barrier-coated mesh, permanent barrier-coated
composite mesh, permanent barrier-coated noncomposite mesh, non-barrier-coated
polypropylene mesh, or biologic mesh)

- subsequent abdominal procedure requiring exposure of entire surface area of
intraperitoneal mesh

Exclusion Criteria:

- less than 18 years of age

- inability to verify intraperitoneal mesh type or location

- active abdominal wound infection or open abdominal wound
We found this trial at
6
sites
759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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9500 Gilman Dr
San Diego, California 92093
(858) 534-2230
University of California at San Diego UC San Diego is dedicated to the advancement of...
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San Diego, CA
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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St. Louis, MO
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Greenville, South Carolina 29615
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Greenville, SC
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Phoenix, Arizona 85054
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