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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
Atrium Medical Corporation
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01355939
First received: April 26, 2011
Last updated: August 4, 2014
Last verified: August 2014
  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:


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 total parenteral nutrition [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Sara Baalman, MA 314-362-8539 baalmans@wudosis.wustl.edu

Locations
United States, Arizona
Mayo Clinic Scottsdale Terminated
Phoenix, Arizona, United States, 85054
United States, California
University of California-San Diego Terminated
San Diego, California, United States, 92103
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Principal Investigator: David B Earle, M.D.         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sara Baalman, M.A.    314-362-8539    baalmans@wudosis.wustl.edu   
Principal Investigator: Michael Brunt, M.D.         
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
Atrium Medical Corporation
Investigators
Principal Investigator: Michael Brunt, M.D. Washington University School of Medicine
  More Information

No publications provided

Responsible Party: 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: August 4, 2014
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:
Hernia
Tissue Adhesions
Hernia, Ventral
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes
Hernia, Abdominal

ClinicalTrials.gov processed this record on October 19, 2014