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

Ventral Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355939
• Other study ID #: 2011-02112
• Secondary ID: 1KM1CA156708-01
• Status: Completed
• Phase: N/A
• First received: April 26, 2011
• Last updated: February 19, 2015
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adhesions
• Hernia
• Hernia, Ventral
• Tissue Adhesions
• Ventral Hernia

Intervention

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.

Locations

Country	Name	City	State
United States	Greenville Medical Center	Greenville	South Carolina
United States	Mount Sinai Medical Center	New York	New York
United States	Mayo Clinic Scottsdale	Phoenix	Arizona
United States	University of California-San Diego	San Diego	California
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Washington University	St. Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Atrium Medical Corporation, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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