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

Completed

• Conditions: Adhesions; Ventral Hernia
• Interventions: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery

• Registration Number: NCT01355939
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-04-26
• Study Start: 2011-05
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

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Exclusion Criteria

• less than 18 years of age
• inability to verify intraperitoneal mesh type or location
• active abdominal wound infection or open abdominal wound

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal surgery after prior VHR with barrier-coated mesh	Clinically-Indicated Abdominal Re-Exploration Surgery	-
Abdominal surgery after prior VHR with nonbarrier-coated mesh	Clinically-Indicated Abdominal Re-Exploration Surgery	-
Lap adhesiolysis during abdominal surgery after prior VHR	Clinically-Indicated Abdominal Re-Exploration Surgery	-
Open adhesioloysis during abdominal surgery after prior VHR	Clinically-Indicated Abdominal Re-Exploration Surgery	-

Primary Outcome Measures

Name	Time	Method
Mesh adhesiolysis time:Mesh surface area	Intraoperatively (day 1)

Secondary Outcome Measures

Name	Time	Method
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
Mesh Contracture	Intraoperatively (day 1)
Mesh adhesion tenacity	Intraoperatively (day 1)
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

Trial Locations

Locations (6)

Washington University; 🇺🇸 St. Louis, Missouri, United States

Mayo Clinic Scottsdale; 🇺🇸 Phoenix, Arizona, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

University of California-San Diego; 🇺🇸 San Diego, California, United States

Greenville Medical Center; 🇺🇸 Greenville, South Carolina, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States