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

The Washington University

Status: Completed

Conditions: Adhesions; Ventral Hernia

Treatments: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01355939

2011-02112

1KM1CA156708-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

173 participants in 4 patient groups

Abdominal surgery after prior VHR with barrier-coated mesh

Treatment:

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Abdominal surgery after prior VHR with nonbarrier-coated mesh

Treatment:

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Lap adhesiolysis during abdominal surgery after prior VHR

Treatment:

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Open adhesioloysis during abdominal surgery after prior VHR

Treatment:

Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery