A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite Mesh
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/9/2019 |
Start Date: | January 2016 |
End Date: | December 31, 2018 |
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.
option in the repair of grade I and II ventral hernias.
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.
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.
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.
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