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

NCT ID: NCT01355939

Last Updated: 2015-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventral Hernia Adhesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominal surgery after prior VHR with barrier-coated mesh

Clinically-Indicated Abdominal Re-Exploration Surgery

Intervention Type PROCEDURE

This is a prospective observational study. Abdominal re-exploration surgery is clinically-indicated and planned as the standard of care for the patients regardless of their decision to participate in the study.

Abdominal surgery after prior VHR with nonbarrier-coated mesh

Clinically-Indicated Abdominal Re-Exploration Surgery

Intervention Type PROCEDURE

This is a prospective observational study. Abdominal re-exploration surgery is clinically-indicated and planned as the standard of care for the patients regardless of their decision to participate in the study.

Lap adhesiolysis during abdominal surgery after prior VHR

Clinically-Indicated Abdominal Re-Exploration Surgery

Intervention Type PROCEDURE

This is a prospective observational study. Abdominal re-exploration surgery is clinically-indicated and planned as the standard of care for the patients regardless of their decision to participate in the study.

Open adhesioloysis during abdominal surgery after prior VHR

Clinically-Indicated Abdominal Re-Exploration Surgery

Intervention Type PROCEDURE

This is a prospective observational study. Abdominal re-exploration surgery is clinically-indicated and planned as the standard of care for the patients regardless of their decision to participate in the study.

Interventions

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Clinically-Indicated Abdominal Re-Exploration Surgery

This is a prospective observational study. Abdominal re-exploration surgery is clinically-indicated and planned as the standard of care for the patients regardless of their decision to participate in the study.

Intervention Type PROCEDURE

Other Intervention Names

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Bard(TM) Mesh PROLENE(TM) ProLite(TM) ProLite(TM) Ultra(TM) Bard(TM) Soft Mesh PROLENE(TM) Soft Parietex(TM) Flat Sheet TEC INFINIT(TM) Mesh C-QUR Lite(TM) ULTRAPRO(TM) PROLENE(TM) Hernia System Bard(TM) Mesh PerFix Plug Bard(TM) Ventralex C-QUR(TM) Mesh PROCEED(TM) Bard(TM) Sepramesh(TM) IP Composite Parietex(TM) Composite PHYSIOMESH(TM) Bard(TM) Composix(TM) E/X Bard(TM) Composix(TM) L/P DUALMESH(R) DUALMESH(R) Plus VICRYL(TM) TIGR(R) Matrix Gore (R) Bio-A(R) AlloDerm(R) AlloMax(TM) FlexHD(R) Biodesign(TM) Surgisis(R) Strattice(TM) XenMatrix(TM) Veritas(R) SurgiMend(R) Peri-Guard(R) Permacol(TM) CollaMend(TM) FM CollaMend(TM)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Atrium Medical Corporation

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Brunt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Mayo Clinic Scottsdale

Phoenix, Arizona, United States

Site Status

University of California-San Diego

San Diego, California, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Greenville Medical Center

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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1KM1CA156708-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-02112

Identifier Type: -

Identifier Source: org_study_id

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