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 Type
OBSERVATIONAL
Enrollment
173
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.
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, United States
Mount Sinai Medical Center
New York, New York, United States
Greenville Medical Center
Greenville, South Carolina, United States
Mesh adhesiolysis time:Mesh surface area
Time frame: Intraoperatively (day 1)
Mesh Contracture
Time frame: Intraoperatively (day 1)
Mesh adhesion tenacity
Time frame: Intraoperatively (day 1)
Percentage mesh surface area covered with adhesions
Time frame: Intraoperatively (day 1)
Adhesiolysis time to abdominal wall
Time frame: Intraoperatively (day 1)
Adhesiolysis time to mesh
Time frame: Intraoperatively (day 1)
Incidence of adhesiolysis-related intra-operative complications
Time frame: Intraoperatively (day 1)
Length of stay of hospital admission
Time frame: 30 day postoperative
Length of stay in ICU
Time frame: 30 day postoperative
Interval to return to bowel function
Time frame: 30 day postoperative
Interval to return to independent ambulation or activities of daily living
Time frame: 30 day postoperative
Interval to return to work or routine physical activity
Time frame: 30 day postoperative
Incidence of postoperative complications
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of surgical site infection
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of initiation of antibiotics, blood and total parenteral nutrition
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of bedside procedures to address a postoperative surgical complication
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of surgery under local anesthesia to address a postoperative complication
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of single system organ failure
Time frame: 30 day, 12 month, and 24 month postoperative
Incidence of multiple-system organ failure
Time frame: 30 day, 12 month, and 24 month postoperative
Mortality rate
Time frame: 30 day, 12 month, and 24 month postoperative
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