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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.
This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Fixating Hernia Mesh | Active Comparator | Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair. |
|
| Non-Fixating Hernia Mesh | Placebo Comparator | Non-fixating polyester mesh will be used for laparoscopic hernia repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of self-fixating mesh for inguinal hernia repair | Procedure | Parietex ProGrip will be used to repair inguinal hernia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic postoperative pain | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hernia recurrence | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Op adverse events related to mesh | 1 year | |
| Post-Op quality of life and pain scores | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Linn, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Use of non-fixating mesh for inguinal hernia repair | Procedure | Parietex Anatomic mesh will be used to repair inguinal hernias. |
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| Absorbable tacks may be used in hernias >2cm | Procedure | Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures >2cm |
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