View Clinical Trial (Medical Research Study)

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

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Conditions:		Ventral Hernia - Adhesions
Purpose:		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.
Study Summary:
Criteria:		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
NCT ID:		NCT01355939
Primary Contact:		Principal Investigator Brent D Matthews, M.D. Washington University School of Medicine Jaime A Cavallo, M.D. Phone: 314-362-8381 Email: cavalloj@wudosis.wustl.edu
Backup Contact:		Email: baalmans@wudosis.wustl.edu Sara Baalman, M.A. Phone: 314-362-8359
Location Contact:		Columbia, Missouri 65212 United States There is no listed contact information for this specific location. Site Status: Recruiting

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