Ventral Hernia Clinical Trial
Official title:
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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