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

Completed

Conditions studied: Ventral Hernia, Adhesions

In brief

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.

Key facts

Study ID

NCT01355939

Run by

Washington University School of Medicine

People needed

173

Starts

2011-05-01

Expected to finish

2015-01-01

Last updated by the study team

2015-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• less than 18 years of age
• inability to verify intraperitoneal mesh type or location
• active abdominal wound infection or open abdominal wound

Where it is running

• Mayo Clinic Scottsdale — Phoenix, Arizona, United States
• University of California-San Diego — San Diego, California, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• Greenville Medical Center — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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