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Phoenix/Scottsdale, Ariz.
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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
Location:
Phoenix/Scottsdale, Ariz.
Trial status:
Open for Enrollment
Why is this study being done?
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.
NCT ID:
NCT01355939
Who can I contact for additional information about this study?