A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh

Study Overview
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Brief Summary
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This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.

Detailed Description
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This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.

Official Title
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A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh

Conditions
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Grade I Ventral Hernia, Grade II Ventral Hernia

Intervention / Treatment
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* Device: Symbotex™ Composite Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Grade I or II ventral hernia according to VHWG classification system Pre-operative informed consent is obtainable Exclusion Criteria: Not candidate for laparoscopic approach for repair of their hernia Determination in the operating room that biologic mesh is needed over permanent mesh Fascial defect less than 3 cm in greatest dimension Concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed Grade III or IV ventral hernia according to VHWG system ASA score IV or above Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. These include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation. Pregnancy Use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. In other words, if the hernia defect is larger than the largest Symbotex™ mesh available, two or more Symbotex mesh pieces may be used to appropriately repair the hernia defect.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Symbotex™ Composite Mesh|Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia Recurrence |  | One year | 
| Quality of Life |  | One year | 
| Hernia associated pain and movement limitations pre-surgery compared to post-surgery |  | One year | 
| Reoperation Rate |  | One year | 
| Percutaneous Intervention Rate |  | One year | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia, synthetic mesh