Adhesions, Ventral Hernia
Conditions
Keywords
Hernia, Adhesiolysis, Adhesions, Intraperitoneal Mesh, Abdominal Re-exploration, Mesh, Barrier-Coated Mesh, Non-Barrier-Coated Mesh, Laparoscopic Approach, Open Approach, Abdominal Re-Exploration Surgery
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.
Interventions
PROCEDUREClinically-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.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Atrium Medical Corporation
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mesh adhesiolysis time:Mesh surface area | Intraoperatively (day 1) |
Secondary
| 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 |
| Incidence of single system organ failure | 30 day, 12 month, and 24 month 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 multiple-system organ failure | 30 day, 12 month, and 24 month postoperative |
| Mortality rate | 30 day, 12 month, and 24 month postoperative |
| Interval to return to independent ambulation or activities of daily living | 30 day postoperative |
Countries
United States
Outcome results
None listed