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 |
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.
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
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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University of California at San Diego UC San Diego is dedicated to the advancement of...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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