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

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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia; Adhesions
• Intervention / Treatment: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Scottsdale
  • California
    • San Diego, California, United States, 92103
      • University of California-San Diego
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10028
      • Mount Sinai Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Investigators' patient population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mesh adhesiolysis time:Mesh surface area	Intraoperatively (day 1)

Secondary Outcome Measures

Outcome Measure	Time Frame
Mesh Contracture	Intraoperatively (day 1)
Mesh adhesion tenacity	Intraoperatively (day 1)
Percentage mesh surface area covered with adhesions	Intraoperatively (day 1)
Adhesiolysis time to abdominal wall	Intraoperatively (day 1)
Adhesiolysis time to mesh	Intraoperatively (day 1)
Incidence of adhesiolysis-related intra-operative complications	Intraoperatively (day 1)
Length of stay of hospital admission	30 day postoperative
Length of stay in ICU	30 day postoperative
Interval to return to bowel function	30 day postoperative
Interval to return to independent ambulation or activities of daily living	30 day postoperative
Interval to return to work or routine physical activity	30 day postoperative
Incidence of postoperative complications	30 day, 12 month, and 24 month postoperative
Incidence of surgical site infection	30 day, 12 month, and 24 month postoperative
Incidence of initiation of antibiotics, blood and total parenteral nutrition	30 day, 12 month, and 24 month postoperative
Incidence of bedside procedures to address a postoperative surgical complication	30 day, 12 month, and 24 month postoperative
Incidence of surgery under local anesthesia to address a postoperative complication	30 day, 12 month, and 24 month postoperative
Incidence of single system organ failure	30 day, 12 month, and 24 month postoperative
Incidence of multiple-system organ failure	30 day, 12 month, and 24 month postoperative
Mortality rate	30 day, 12 month, and 24 month postoperative

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); Atrium Medical Corporation
• Investigators: Principal Investigator: Michael Brunt, M.D., Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 26, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: 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: Pathologic Processes; Pathological Conditions, Anatomical; Hernia, Abdominal; Fibrosis; Cicatrix; Hernia; Hernia, Ventral; Tissue Adhesions; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents; Zinc Oxide
• Other Study ID Numbers: 2011-02112; 1KM1CA156708-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No