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

This study is currently recruiting participants.
Verified October 2011 by Washington University School of Medicine
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Atrium Medical Corporation
Information provided by (Responsible Party):
Jaime Cavallo, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01355939
First received: April 26, 2011
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Ventral Hernia
Adhesions
 Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Adhesions Hernia
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Mesh adhesiolysis time:Mesh surface area [ Time Frame: Intraoperatively (day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mesh Contracture [ Time Frame: Intraoperatively (day 1) ] [ Designated as safety issue: No ]
  • Mesh adhesion tenacity [ Time Frame: Intraoperatively (day 1) ] [ Designated as safety issue: No ]
  • Percentage mesh surface area covered with adhesions [ Time Frame: Intraoperatively (day 1) ] [ Designated as safety issue: No ]
  • Adhesiolysis time to abdominal wall [ Time Frame: Intraoperatively (day 1) ] [ Designated as safety issue: No ]
  • Adhesiolysis time to mesh [ Time Frame: Intraoperatively (day 1) ] [ Designated as safety issue: No ]
  • Incidence of adhesiolysis-related intra-operative complications [ Time Frame: Intraoperatively (day 1) ] [ Designated as safety issue: No ]
  • Length of stay of hospital admission [ Time Frame: 30 day postoperative ] [ Designated as safety issue: No ]
  • Length of stay in ICU [ Time Frame: 30 day postoperative ] [ Designated as safety issue: No ]
  • Interval to return to bowel function [ Time Frame: 30 day postoperative ] [ Designated as safety issue: No ]
  • Interval to return to independent ambulation or activities of daily living [ Time Frame: 30 day postoperative ] [ Designated as safety issue: No ]
  • Interval to return to work or routine physical activity [ Time Frame: 30 day postoperative ] [ Designated as safety issue: No ]
  • Incidence of postoperative complications [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]
  • Incidence of surgical site infection [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]
  • Incidence of initiation of antibiotics, blood and TPN [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]
  • Incidence of bedside procedures to address a postoperative surgical complication [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]
  • Incidence of surgery under local anesthesia to address a postoperative complication [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]
  • Incidence of single system organ failure [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]
  • Incidence of multiple-system organ failure [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]
  • Mortality rate [ Time Frame: 30 day, 12 month, and 24 month postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Abdominal surgery after prior VHR with barrier-coated mesh Procedure: 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.
Other Names:
  • 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)
Abdominal surgery after prior VHR with nonbarrier-coated mesh Procedure: 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.
Other Names:
  • 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)
Lap adhesiolysis during abdominal surgery after prior VHR Procedure: 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.
Other Names:
  • 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)
Open adhesioloysis during abdominal surgery after prior VHR Procedure: 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.
Other Names:
  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Investigators' patient population

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355939

Contacts
Contact: Jaime A Cavallo, M.D. 314-362-8381 cavalloj@wudosis.wustl.edu
Contact: Sara Baalman, M.A. 314-362-8359 baalmans@wudosis.wustl.edu

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Phoenix, Arizona, United States, 85054
Principal Investigator: Kristi L Harold, M.D.            
United States, California
University of California-San Diego Recruiting
San Diego, California, United States, 92103
Principal Investigator: Garth Jacobsen, M.D.            
Principal Investigator: Santiago Horgan, M.D.            
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Principal Investigator: David B Earle, M.D.            
United States, Missouri
University of Missouri at Columbia Recruiting
Columbia, Missouri, United States, 65212
Principal Investigator: Arthur J Rawlings, M.D., Mdiv            
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sara Baalman, M.A.     314-362-8539     baalmans@wudosis.wustl.edu    
Principal Investigator: Jaime A Cavallo, M.D.            
Principal Investigator: Brent D Matthews, M.D., F.A.C.S.            
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10028
Principal Investigator: Brian Jacob, M.D.            
Principal Investigator: Mark Reiner, M.D.            
Principal Investigator: Joel Bauer, M.D.            
United States, South Carolina
Greenville Medical Center Recruiting
Greenville, South Carolina, United States, 29615
Principal Investigator: Alfredo M Carbonell, D.O., F.A.C.S., F.A.C.O.S.            
Principal Investigator: William S Cobb, M.D., F.A.C.S.            
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Atrium Medical Corporation
Investigators
Principal Investigator: Brent D Matthews, M.D. Washington University School of Medicine
Principal Investigator: Jaime A Cavallo, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jaime Cavallo, Senior Research Resident, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01355939     History of Changes
Other Study ID Numbers: 2011-02112, 1KM1CA156708-01
Study First Received: April 26, 2011
Last Updated: October 31, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Washington University School of Medicine:
Adhesions
Hernia
Adhesiolysis
Intraperitoneal Mesh
Abdominal Re-exploration
Mesh
 Barrier-Coated Mesh
Non-Barrier-Coated Mesh
Laparoscopic Approach
Open Approach
Abdominal Re-Exploration Surgery

Additional relevant MeSH terms:
Tissue Adhesions
Hernia
Hernia, Ventral
Cicatrix
 Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on June 18, 2013