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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Ventral Hernia, Adhesions

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Mesh adhesiolysis time:Mesh surface area

Outcome Time Frame:

Intraoperatively (day 1)

Safety Issue:

No

Principal Investigator

Brent D Matthews, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

2011-02112

NCT ID:

NCT01355939

Start Date:

May 2011

Completion Date:

May 2016

Related Keywords:

  • Ventral Hernia
  • Adhesions
  • Hernia
  • Adhesiolysis
  • Adhesions
  • Intraperitoneal Mesh
  • Abdominal Re-exploration
  • Mesh
  • Barrier-Coated Mesh
  • Non-Barrier-Coated Mesh
  • Laparoscopic Approach
  • Open Approach
  • Abdominal Re-Exploration Surgery
  • Tissue Adhesions
  • Hernia
  • Hernia, Ventral

Name

Location
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Baystate Medical Center Springfield, Massachusetts  01199
Mount Sinai Medical Center New York, New York  10029
Washington University St. Louis, Missouri  63110
University of California-San Diego La Jolla, California  92037-0698
University of Missouri at Columbia Columbia, Missouri  65212
Greenville Medical Center Greenville, South Carolina  29615