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| ID | Type | Description | Link |
|---|---|---|---|
| 1KM1CA156708-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
| Atrium Medical Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal surgery after prior VHR with barrier-coated mesh |
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| Abdominal surgery after prior VHR with nonbarrier-coated mesh |
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| Lap adhesiolysis during abdominal surgery after prior VHR |
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| Open adhesioloysis during abdominal surgery after prior VHR |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinically-Indicated Abdominal Re-Exploration Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mesh adhesiolysis time:Mesh surface area | Intraoperatively (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Mesh Contracture | Intraoperatively (day 1) | |
| Mesh adhesion tenacity | Intraoperatively (day 1) | |
| Percentage mesh surface area covered with adhesions |
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Inclusion Criteria:
Exclusion Criteria:
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Investigators' patient population
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| Name | Affiliation | Role |
|---|---|---|
| Michael Brunt, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Phoenix | Arizona | 85054 | United States | ||
| University of California-San Diego |
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|
| 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 |
| San Diego |
| California |
| 92103 |
| United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Mount Sinai Medical Center | New York | New York | 10028 | United States |
| Greenville Medical Center | Greenville | South Carolina | 29615 | United States |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000267 | Tissue Adhesions |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009074 | Melanocyte-Stimulating Hormones |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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